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Aseptic technique: a single technique, or any technique fulfilling criteria, or collection of said techniques?

Aseptic technique: a single technique, or any technique fulfilling criteria, or collection of said techniques?



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My friend just used the following sentence in her lab report:

Aseptic technique is used in this step:

I immediately felt something was wrong. She used the term as if it were a specific technique. Is her usage correct, and if so is "aseptic technique" indeed a specific technique with a specific procedure?

Rather, I thought "aseptic technique" referred to any technique that involves complete sterilization of a certain environment or apparatus/instrument. If this were right, then perhaps "an aseptic technique" should be used instead?

Further still, if "aseptic technique" refers to the collection of all techniques that involve sterilization as described above, the perhaps it should have been "the aseptic technique" instead?

Which one(s) is/are correct, grammatically and semantically (hence conveying the concept accurately)?


This is primarily a linguistic question and I am answering it on the basis that it will be migrated to This Site, English Language and Usage.

The question is whether, in the context of a report describing (otherwise unspecified) student work, the phrase “aseptic technique” can be used without an article, or whether it requires the definite or indefinite article. This is a question of meaning and usage, and, without using any technical grammatical terms, can be answered by anlysis of scientific publications and by analogy.

“The aseptic technique” (definite article)?

The definite article would normally be used in this type of situation if reference was to one specific clearly defined technique. As an anlogy I would take 'The Heimlich manoeuvre' (where 'manoeuvre' occupies an analagous position to 'technique'. Clearly the phrase does not refer to a standard defined procedure like the Heimlich manoeuvre, but merely that the work was performed asceptically (i.e. under sterile conditions). So in this context the definite article is certainly not necesary. In some circumstances employing sterile conditions requires satisfying certain enumerated criteria (example below), in which case the definite article may be used.

“An aseptic technique” (indefinite article)?

I think that this is possible but not obligatory. The use of the indefinite article indicates that the asceptic technique used was one of several possible. Although sometimes this would be used in the context of a limited number of items, this is not a necessary requirement. Analogies with a different adjective would be “she executed the dive with a graceful technique”. Here, the article is (almost) obligatory, but less so in the case of “she showed superb technique in executing the dive”.

“Aseptic technique” (no article)?

As the last example shows (“she showed superb technique in executing the dive”), omitting the article is perfectly acceptable in analagous phrases. I would say it is perfectly acceptable in this case.

The arguments above are only useful to the extent that they reflect actual practice. A quick internet search brought up an interesting example in which both no article and the indefinite article were used in the same text. This is the entry for Asceptic Technique on a website called Healthline.

The second paragraph omits the article:

Aseptic technique is a method designed to prevent contamination from microorganisms.

But when it gets down to specifics:

According to The Joint Commission, there are four chief aspects of the aseptic technique

So unless your friend was referring to 'The Joint Commission' (which I doubt) there is nothing wrong with that sentence of her lab report.

Other Professional Examples

ThermoFisher Scientific - no article

Aseptic technique, designed to provide a barrier between the microrganisms in the environment and the sterile cell culture, depends upon a set of procedures to reduce the probability of contamination from these sources

Nuffield Foundation - indefinite article (implied by use of 'any')

There are some general rules to follow for any aseptic technique.

ANTT - definite article used in reference to a specific named technique

Aseptic technique is the most commonly performed infection prevention procedure in healthcare; it is also probably the most critical. This article looks at the Aseptic Non Touch Technique (ANTT) model for reducing healthcare-associated infections

(You could argue that the definite article refers to the model, rather than the technique, although I think if you omitted 'model' you would be left with an example like the Haemlich manoeuvre. In any case the English in this article is appalling - “infection prevention procedure” gives a foretaste of the stylistic horrors that follow.)


High Purity Water System (7/93)

Note: This document is reference material for investigators and other FDA personnel. The document does not bind FDA, and does no confer any rights, privileges, benefits, or immunities for or on any person(s).

This guide discusses, primarily from a microbiological aspect, the review and evaluation of high purity water systems that are used for the manufacture of drug products and drug substances. It also includes a review of the design of the various types of systems and some of the problems that have been associated with these systems. As with other guides, it is not all-inclusive, but provides background and guidance for the review and evaluation of high purity water systems. The Guide To Inspections of Microbiological Pharmaceutical Quality Control Laboratories (May, 1993) provides additional guidance.

I. SYSTEM DESIGN

One of the basic considerations in the design of a system is the type of product that is to be manufactured. For parenteral products where there is a concern for pyrogens, it is expected that Water for Injection will be used. This applies to the formulation of products, as well as to the final washing of components and equipment used in their manufacture. Distillation and Reverse Osmosis (RO) filtration are the only acceptable methods listed in the USP for producing Water for Injection. However, in the bulk Pharmaceutical and Biotechnology industries and some foreign companies, Ultra Filtration (UF) is employed to minimize endotoxins in those drug substances that are administered parenterally.

For some ophthalmic products, such as the ophthalmic irrigating solution, and some inhalation products, such as Sterile Water for Inhalation, where there are pyrogen specifications, it is expected that Water for Injection be used in their formulation. However, for most inhalation and ophthalmic products, purified water is used in their formulation. This also applies to topicals, cosmetics and oral products.

Another design consideration is the temperature of the system. It is recognized that hot (65 - 80oC) systems are self sanitizing. While the cost of other systems may be less expensive for a company, the cost of maintenance, testing and potential problems may be greater than the cost of energy saved. Whether a system is circulating or one-way is also an important design consideration. Obviously, water in constant motion is less liable to have high levels of contaminant. A one-way water system is basically a "dead-leg".

Finally, and possibly the most important consideration, is the risk assessment or level of quality that is desired. It should be recognized that different products require different quality waters. Parenterals require very pure water with no endotoxins. Topical and oral products require less pure water and do not have a requirement for endotoxins. Even with topical and oral products there are factors that dictate different qualities for water. For example, preservatives in antacids are marginally effective, so more stringent microbial limits have to be set. The quality control department should assess each product manufactured with the water from their system and determine the microbial action limits based on the most microbial sensitive product. In lieu of stringent water action limits in the system the manufacturer can add a microbial reduction step in the manufacturing process for the sensitive drug product(s).

II. SYSTEM VALIDATION

A basic reference used for the validation of high purity water systems is the Parenteral Drug Association Technical Report No. 4 titled, "Design Concepts for the Validation of a Water for Injection System."

The introduction provides guidance and states that, "Validation often involves the use of an appropriate challenge. In this situation, it would be undesirable to introduce microorganisms into an on-line system therefore, reliance is placed on periodic testing for microbiological quality and on the installation of monitoring equipment at specific checkpoints to ensure that the total system is operating properly and continuously fulfilling its intended function."

In the review of a validation report, or in the validation of a high purity water system, there are several aspects that should be considered. Documentation should include a description of the system along with a print. The drawing needs to show all equipment in the system from the water feed to points of use. It should also show all sampling points and their designations. If a system has no print, it is usually considered an objectionable condition. The thinking is if there is no print, then how can the system be validated? How can a quality control manager or microbiologist know where to sample? In those facilities observed without updated prints, serious problems were identified in these systems. The print should be compared to the actual system annually to insure its accuracy, to detect unreported changes and confirm reported changes to the system.

After all the equipment and piping has been verified as installed correctly and working as specified, the initial phase of the water system validation can begin. During this phase the operational parameters and the cleaning/ sanitization procedures and frequencies will be developed. Sampling should be daily after each step in the purification process and at each point of use for two to four weeks. The sampling procedure for point of use sampling should reflect how the water is to be drawn e.g. if a hose is usually attached the sample should be taken at the end of the hose. If the SOP calls for the line to be flushed before use of the water from that point, then the sample is taken after the flush. At the end of the two to four week time period the firm should have developed its SOPs for operation of the water system.

The second phase of the system validation is to demonstrate that the system will consistently produce the desired water quality when operated in conformance with the SOPs. The sampling is performed as in the initial phase and for the same time period. At the end of this phase the data should demonstrate that the system will consistently produce the desired quality of water.

The third phase of validation is designed to demonstrate that when the water system is operated in accordance with the SOPs over a long period of time it will consistently produce water of the desired quality. Any variations in the quality of the feedwater that could affect the operation and ultimately the water quality will be picked up during this phase of the validation. Sampling is performed according to routine procedures and frequencies. For Water for Injection systems the samples should be taken daily from a minimum of one point of use, with all points of use tested weekly. The validation of the water system is completed when the firm has a full years worth of data.

While the above validation scheme is not the only way a system can be validated, it contains the necessary elements for validation of a water system. First, there must be data to support the SOPs. Second, there must be data demonstrating that the SOPs are valid and that the system is capable of consistently producing water that meets the desired specifications. Finally, there must be data to demonstrate that seasonal variations in the feedwater do not adversely affect the operation of the system or the water quality.

The last part of the validation is the compilation of the data, with any conclusions into the final report. The final validation report must be signed by the appropriate people responsible for operation and quality assurance of the water system.

A typical problem that occurs is the failure of operating procedures to preclude contamination of the system with non-sterile air remaining in a pipe after drainage. In a system illustrated as in Figure 1, (below) a typical problem occurs when a washer or hose connection is flushed and then drained at the end of the operation. After draining, this valve (the second off of the system) is closed. If on the next day or start-up of the operation the primary valve off of the circulating system is opened, then the non-sterile air remaining in the pipe after drainage would contaminate the system. The solution is to pro-vide for operational procedures that provide for opening the secondary valve before the primary valve to flush the pipe prior to use.

Another major consideration in the validation of high purity water systems is the acceptance criteria. Consistent results throughout the system over a period of time constitute the primary element.

III. MICROBIAL LIMITS

Water For Injection Systems

Regarding microbiological results, for Water For Injection, it is expected that they be essentially sterile. Since sampling frequently is performed in non-sterile areas and is not truly aseptic, occasional low level counts due to sampling errors may occur. Agency policy, is that less than 10 CFU/100ml is an acceptable action limit. None of the limits for water are pass/fail limits. All limits are action limits. When action limits are exceeded the firm must investigate the cause of the problem, take action to correct the problem and assess the impact of the microbial contamination on products manufactured with the water and document the results of their investigation.

With regard to sample size, 100 - 300 mL is preferred when sampling Water for Injection systems. Sample volumes less than 100 mL are unacceptable.

The real concern in WFI is endotoxins. Because WFI can pass the LAL endotoxin test and still fail the above microbial action limit, it is important to monitor WFI systems for both endotoxins and microorganisms.

For purified water systems, microbiological specifications are not as clear. USP XXII specifications, that it complies with federal Environmental Protection Agency regulations for drinking water, are recognized as being minimal specifications. There have been attempts by some to establish meaningful microbiological specifications for purified water. The CFTA proposed a specification of not more than 500 organisms per ml. The USP XXII has an action guideline of not greater than 100 organisms per ml. Although microbiological specifications have been discussed, none (other than EPA standards) have been established. Agency policy is that any action limit over 100 CFU/mL for a purified water system is unacceptable.

The purpose of establishing any action limit or level is to assure that the water system is under control. Any action limit established will depend upon the overall purified water system and further processing of the finished product and its use. For example, purified water used to manufacture drug products by cold processing should be free of objectionable organisms. We have defined "objectionable organisms" as any organisms that can cause infections when the drug product is used as directed or any organism capable of growth in the drug product. As pointed out in the Guide to Inspections of Microbiological Pharmaceutical Quality Control Laboratories, the specific contaminant, rather than the number is generally more significant.

Organisms exist in a water system either as free floating in the water or attached to the walls of the pipes and tanks. When they are attached to the walls they are known as biofilm, which continuously slough off organisms. Thus, contamination is not uniformly distributed in a system and the sample may not be representative of the type and level of contamination. A count of 10 CFU/mL in one sample and 100 or even 1000 CFU/mL in a subsequent sample would not be unrealistic.

Thus, in establishing the level of contamination allowed in a high purity water system used in the manufacture of a non-sterile product requires an understanding of the use of the product, the formulation (preservative system) and manufacturing process. For example, antacids, which do not have an effective preservative system, require an action limit below the 100 CFU/mL maximum.

The USP gives some guidance in their monograph on Microbiological Attributes of Non-Sterile Products. It points out that, "The significance of microorganisms in non-sterile pharmaceutical products should be evaluated in terms of the use of the product, the nature of the product, and the potential harm to the user." Thus, not just the indicator organisms listed in some of the specific monographs present problems. It is up to each manufacturer to evaluate their product, the way it is manufactured, and establish am acceptable action level of contamination, not to exceed the maximum, for the water system, based on the highest risk product manufactured with the water.

IV. WATER FOR INJECTION SYSTEMS

In the review and evaluation of Water For Injection systems, there are several concerns.

Pretreatment of feedwater is recommended by most manufacturers of distillation equipment and is definitely required for RO units. The incoming feedwater quality may fluctuate during the life of the system depending upon seasonal variations and other external factors beyond the control of the pharmaceutical facility. For example, in the spring (at least in the N.E.), increases in gram negative organisms have been known. Also, new construction or fires can cause a depletion of water stores in old mains which can cause an influx of heavily contaminated water of a different flora.

A water system should be designed to operate within these anticipated extremes. Obviously, the only way to know the extremes is to periodically monitor feedwater. If the feedwater is from a municipal water system, reports from the municipality testing can be used in lieu of in-house testing.

Figures 3-5 represent a typical basic diagram of a WFI system. Most of the new systems now use multi-effect stills. In some of the facilities, there has been evidence of endotoxin contamination. In one system this occurred, due to malfunction of the feedwater valve and level control in the still which resulted in droplets of feedwater being carried over in the distillate.

In another system with endotoxin problems, it was noted that there was approximately 50 liters of WFI in the condenser at the start-up. Since this water could lie in the condenser for up to several days (i.e., over the weekend), it was believed that this was the reason for unacceptable levels of endotoxins.

More common, however, is the failure to adequately treat feedwater to reduce levels of endotoxins. Many of the still fabricators will only guarantee a 2.5 log to 3 log reduction in the endotoxin content. Therefore, it is not surprising that in systems where the feedwater occasionally spikes to 250 EU/ml, unacceptable levels of endotoxins may occasionally appear in the distillate (WFI). For example, recently three new stills, including two multi-effect, were found to be periodically yielding WFI with levels greater than .25 EU/ml. Pretreatment systems for the stills included only deionization systems with no UF, RO or distillation. Unless a firm has a satisfactory pretreatment system, it would be extremely difficult for them to demonstrate that the system is validated.

The above examples of problems with distillation units used to produce WFI, point to problems with maintenance of the equipment or improper operation of the system indicating that the system has not been properly validated or that the initial validation is no longer valid. If you see these types of problems you should look very closely at the system design, any changes that have been made to the system, the validation report and the routine test data to determine if the system is operating in a state of control.

Typically, conductivity meters are used on water systems to monitor chemical quality and have no meaning regarding microbiological quality.

Figures 3-5 also show petcocks or small sampling ports between each piece of equipment, such as after the still and before the holding tank. These are in the system to isolate major pieces of equipment. This is necessary for the qualification of the equipment and for the investigation of any problems which might occur.

VI. HEAT EXCHANGERS

One principal component of the still is the heat exchanger. Because of the similar ionic quality of distilled and deionized water, conductivity meters cannot be used to monitor microbiological quality. Positive pressure such as in vapor compression or double tubesheet design should be employed to prevent possible feedwater to distillate contamination in a leaky heat exchanger.

An FDA Inspectors Technical Guide with the subject of "Heat Exchangers to Avoid Contamination" discusses the design and potential problems associated with heat exchangers. The guide points out that there are two methods for preventing contamination by leakage. One is to provide gauges to constantly monitor pressure differentials to ensure that the higher pressure is always on the clean fluid side. The other is to utilize the double-tubesheet type of heat exchanger.

In some systems, heat exchangers are utilized to cool water at use points. For the most part, cooling water is not circulated through them when not in use. In a few situations, pinholes formed in the tubing after they were drained (on the cooling water side) and not in use. It was determined that a small amount of moisture remaining in the tubes when combined with air caused a corrosion of the stainless steel tubes on the cooling water side. Thus, it is recommended that when not in use, heat exchangers not be drained of the cooling water.

VII. HOLDING TANK

In hot systems, temperature is usually maintained by applying heat to a jacketed holding tank or by placing a heat exchanger in the line prior to an insulated holding tank.

The one component of the holding tank that generates the most discussion is the vent filter. It is expected that there be some program for integrity testing this filter to assure that it is intact. Typically, filters are now jacketed to prevent condensate or water from blocking the hydrophobic vent filter. If this occurs (the vent filter becomes blocked), possibly either the filter will rupture or the tank will collapse. There are methods for integrity testing of vent filters in place.

It is expected, therefore, that the vent filter be located in a position on the holding tank where it is readily accessible.

Just because a WFI system is relatively new and distillation is employed, it is not problem-free. In an inspection of a manufacturer of parenterals, a system fabricated in 1984 was observed. Refer to Figure 6. While the system may appear somewhat complex on the initial review, it was found to be relatively simple. Figure 7 is a schematic of the system. The observations at the conclusion of the inspection of this manufacturer included, "Operational procedures for the Water For Injection system failed to provide for periodic complete flushing or draining. The system was also open to the atmosphere and room environment. Compounding equipment consisted of non-sealed, open tanks with lids. The Water for Injection holding tank was also not sealed and was never sampled for endotoxins." Because of these and other comments, the firm recalled several products and discontinued operations.

Pumps burn out and parts wear. Also, if pumps are static and not continuously in operation, their reservoir can be a static area where water will lie. For example, in an inspection, it was noted that a firm had to install a drain from the low point in a pump housing. Pseudomonas sp. contamination was periodically found in their water system which was attributed in part to a pump which only periodically is operational.

Piping in WFI systems usually consist of a high polished stainless steel. In a few cases, manufacturers have begun to utilize PVDF (polyvinylidene fluoride) piping. It is purported that this piping can tolerate heat with no extractables being leached. A major problem with PVDF tubing is that it requires considerable support. When this tubing is heated, it tends to sag and may stress the weld (fusion) connection and result in leakage. Additionally, initially at least, fluoride levels are high. This piping is of benefit in product delivery systems where low level metal contamination may accelerate the degradation of drug product, such as in the Biotech industry.

One common problem with piping is that of "dead-legs". The proposed LVP Regulations defined dead-legs as not having an unused portion greater in length than six diameters of the unused pipe measured from the axis of the pipe in use. It should be pointed out that this was developed for hot 75 - 80o circulating systems. With colder systems (65 - 75oC), any drops or unused portion of any length of piping has the potential for the formation of a biofilm and should be eliminated if possible or have special sanitizing procedures. There should be n o threaded fittings in a pharmaceutical water system. All pipe joints must utilize sanitary fittings or be butt welded. Sanitary fittings will usually be used where the piping meets valves, tanks and other equipment that must be removed for maintenance or replacement. Therefore, the firm's procedures for sanitization, as well as the actual piping, should be reviewed and evaluated during the inspection.

X. REVERSE OSMOSIS

Another acceptable method for manufacturing Water for Injection is Reverse Osmosis (RO). However, because these systems are cold, and because RO filters are not absolute, microbiological contamination is not unusual. Figure 8 shows a system that was in use several years ago. There are five RO units in this system which are in parallel. Since RO filters are not absolute, the filter manufacturers recommend that at least two be in series. The drawing also illustrates an Ultraviolet (UV) light in the system downstream from the RO units. The light was needed to control microbiological contamination.

Also in this system were ball valves. These valves are not considered sanitary valves since the center of the valve can have water in it when the valve is closed. This is a stagnant pool of water that can harbor microorganisms and provide a starting point for a biofilm.

As an additional comment on RO systems, with the recognition of microbiological problems, some manufacturers have installed heat exchangers immediately after the RO filters to heat the water to 75 - 80oC to minimize microbiological contamination.

With the development of biotechnology products, many small companies are utilizing RO and UF systems to produce high purity water. For example, Figure 9 illustrates a wall mounted system that is fed by a single pass RO unit.

As illustrated, most of these systems employ PVC or some type of plastic tubing. Because the systems are typically cold, the many joints in the system are subject to contamination. Another potential problem with PVC tubing is extractables. Looking at the WFI from a system to assure that it meets USP requirements without some assurance that there are no extractables would not be acceptable.

The systems also contain 0.2 micron point of use filters which can mask the level of microbiological contamination in the system. While it is recognized that endotoxins are the primary concern in such a system, a filter will reduce microbiological contamination, but not necessarily endotoxin contamination. If filters are used in a water system there should be a stated purpose for the filter, i.e., particulate removal or microbial reduction, and an SOP stating the frequency with which the filter is to be changed which is based on data generated during the validation of the system.

As previously discussed, because of the volume of water actually tested (.1ml for endotoxins vs. 100ml for WFI), the microbiological test offers a good index of the level of contamination in a system. Therefore, unless the water is sampled prior to the final 0.2 micron filter, microbiological testing will have little meaning.

At a reinspection of this facility, it was noted that they corrected the deficient water system with a circulating stainless steel piping system that was fed by four RO units in series. Because this manufacturer did not have a need for a large amount of water (the total system capacity was about 30 gallons), they attempted to let the system sit for approximately one day. Figure 9 shows that at zero time (at 9 AM on 3/10), there were no detectable levels of microorganisms and of endotoxins. After one day, this static non-circulating system was found to be contaminated. The four consecutive one hour samples also illustrate the variability among samples taken from a system. After the last sample at 12 PM was collected, the system was resanitized with 0.5% peroxide solution, flushed, recirculated and resampled. No levels of microbiological contamination were found on daily samples after the system was put back in operation. This is the reason the agency has recommended that non-recirculating water systems be drained daily and water not be allowed to sit in the system.

XI. PURIFIED WATER SYSTEMS

Many of the comments regarding equipment for WFI systems are applicable to Purified Water Systems. One type system that has been used to control microbiological contamination utilizes ozone. Figure 10 illustrates a typical system. Although the system has purported to be relatively inexpensive, there are some problems associated with it. For optimum effectiveness, it is required that dissolved ozone residual remain in the system. This presents both employee safety problems and use problems when drugs are formulated.

Published data for Vicks Greensboro, NC facility showed that their system was recontaminated in two to three days after the ozone generator was turned off. In an inspection of another manufacturer, it was noted that a firm was experiencing a contamination problem with Pseudomonas sp. Because of potential problems with employee safety, ozone was removed from the water prior to placing it in their recirculating system. It has been reported that dissolved ozone at a level of 0.45 mg/liter will remain in a system for a maximum of five to six hours.

Another manufacturer, as part of their daily sanitization, removes all drops off of their ozonated water system and disinfects them in filter sterilized 70% isopropyl alcohol. This manufacturer has reported excellent microbiological results. However, sampling is only performed immediately after sanitization and not at the end of operations. Thus, the results are not that meaningful.

Figure 11 and Figure12 illustrate another purified water system which had some problems. Unlike most of the other systems discussed, this is a one-way and not recirculating system. A heat exchanger is used to heat the water on a weekly basis and sanitize the system. Actually, the entire system is a "dead-leg."

Figure 11 also shows a 0.2 micron in line filter used to sanitize the purified water on a daily basis. In addition to the filter housing providing a good environment for microbiological contamination, a typical problem is water hammer that can cause "ballooning" of the filter. If a valve downstream from the filter is shut too fast, the water pressure will reverse and can cause "ballooning". Pipe vibration is a typical visible sign of high back pressure while passage of upstream contaminants on the filter face is a real problem. This system also contains several vertical drops at use points. During sanitization, it is important to "crack" the terminal valves so that all of the elbows and bends in the piping are full of water and thus, get complete exposure to the sanitizing agent.

It should be pointed out that simply because this is a one-way system, it is not inadequate. With good Standard Operational Procedures, based on validation data, and routine hot flushings of this system, it could be acceptable. A very long system (over 200 yards) with over 50 outlets was found acceptable. This system employed a daily flushing of all outlets with 80oC water.

The last system to be discussed is a system that was found to be objectionable. Pseudomonas sp. found as a contaminant in the system (after FDA testing) was also found in a topical steroid product (after FDA testing). Product recall and issuance of a Warning Letter resulted. This system (Figure 13) is also one-way that employs a UV light to control microbiological contamination. The light is turned on only when water is needed. Thus, there are times when water is allowed to remain in the system. This system also contains a flexible hose which is very difficult to sanitize. UV lights must be properly maintained to work. The glass sleeves around the bulb(s) must be kept clean or their effectiveness will decrease. In multibulb units there must be a system to determine that each bulb is functioning. It must be remembered that at best UV light will only kill 90% of the organisms entering the unit.

XIII. PROCESS WATER

Currently, the USP, pg. 4, in the General Notices Section, allows drug substances to be manufactured from Potable Water. It comments that any dosage form must be manufactured from Purified Water, Water For Injection, or one of the forms of Sterile Water. There is some inconsistency in these two statements, since Purified Water has to be used for the granulation of tablets, yet Potable Water can be used for the final purification of the drug substance.

The FDA Guide to Inspection of Bulk Pharmaceutical Chemicals comments on the concern for the quality of the water used for the manufacture of drug substances, particularly those drug substances used in parenteral manufacture. Excessive levels of microbiological and/or endotoxin contamination have been found in drug substances, with the source of contamination being the water used in purification. At this time, Water For Injection does not have to be used in the finishing steps of synthesis/purification of drug substances for parenteral use. However, such water systems used in the final stages of processing of drug substances for parenteral use should be validated to assure minimal endotoxin/ microbiological contamination.

In the bulk drug substance industry, particularly for parenteral grade substances, it is common to see Ultrafiltration (UF) and Reverse Osmosis (RO) systems in use in water systems. While ultrafiltration may not be as efficient at reducing pyrogens, they will reduce the high molecular weight endotoxins that are a contaminant in water systems. As with RO, UF is not absolute, but it will reduce numbers. Additionally, as previously discussed with other cold systems, there is considerable maintenance required to maintain the system.

For the manufacture of drug substances that are not for parenteral use, there is still a microbiological concern, although not to the degree as for parenteral grade drug substances. In some areas of the world, Potable (chlorinated) water may not present a microbiological problem. However, there may be other issues. For example, chlorinated water will generally increase chloride levels. In some areas, process water may be obtained directly from neutral sources.

In one inspection, a manufacturer was obtaining process water from a river located in a farming region. At one point, they had a problem with high levels of pesticides which was a run-off from farms in the areas. The manufacturing process and analytical methodology was not designed to remove and identify trace pesticide contaminants. Therefore, it would seem that this process water when used in the purification of drug substances would be unacceptable.

XIV. INSPECTION STRATEGY

Manufacturers typically will have periodic printouts or tabulations of results for their purified water systems. These printouts or data summaries should be reviewed. Additionally, investigation reports, when values exceed limits, should be reviewed.

Since microbiological test results from a water system are not usually obtained until after the drug product is manufactured, results exceeding limits should be reviewed with regard to the drug product formulated from such water. Consideration with regard to the further processing or release of such a product will be dependent upon the specific contaminant, the process and the end use of the product. Such situations are usually evaluated on a case-by-case basis. It is a good practice for such situations to include an investigation report with the logic for release/rejection discussed in the firm's report. End product microbiological testing, while providing some information should not be relied upon as the sole justification for the release of the drug product. The limitations of microbiological sampling and testing should be recognized.

Manufacturers should also have maintenance records or logs for equipment, such as the still. These logs should also be reviewed so that problems with the system and equipment can be evaluated.

In addition to reviewing test results, summary data, investigation reports and other data, the print of the system should be reviewed when conducting the actual physical inspection. As pointed out, an accurate description and print of the system is needed in order to demonstrate that the system is validated.


Advantages of Case-Control Studies

Case-control studies have specific advantages compared to other study designs. They are comparatively quick, inexpensive, and easy. They are particularly appropriate for (1) investigating outbreaks, and (2) studying rare diseases or outcomes. An example of (1) would be a study of endophthalmitis following ocular surgery. When an outbreak is in progress, answers must be obtained quickly. An example of (2) would be a study of risk factors for uveal melanoma, or corneal ulcers. Since case-control studies start with people known to have the outcome (rather than starting with a population free of disease and waiting to see who develops it) it is possible to enroll a sufficient number of patients with a rare disease. The practical value of producing rapid results or investigating rare outcomes may outweigh the limitations of case-control studies. Because of their efficiency, they may also be ideal for preliminary investigation of a suspected risk factor for a common condition conclusions may be used to justify a more costly and time-consuming longitudinal study later.


Koch’s postulates in the 21st century

For thousands of years, epidemics of contagious diseases were believed to be caused by the wrath of the gods, configuration of stars, or miasma. The association of specific microorganisms with disease came about as a consequence of the work of the German physician Robert Koch. He formulated a set of criteria that could be used to identify the pathogen responsible for a specific disease. These criteria came to be known as Koch’s postulates:

  1. The organism must be regularly associated with the disease and its characteristic lesions.
  2. The organism must be isolated from the diseased host and grown in culture.
  3. The disease must be reproduced when a pure culture of the organism is introduced into a healthy, susceptible host.
  4. The same organism must be reisolated from the experimentally infected host.

Koch applied these criteria to show that anthrax, a common disease of cattle, was caused by the bacterium Bacillus anthracis, and that tuberculosis in humans was caused by a different bacterial species. His postulates provided a framework for proving the role of microbes in disease. As a consequence of his work, the study of infectious disease was placed on a secure scientific foundation, which ultimately made possible rational treatment and control.

Despite the importance of Koch’s postulates in the development of microbiology, they have severe limitations, which even Koch realized. For example, he believed that cholera and leprosy were caused by microbes, but could not fulfill all four postulates. Furthermore, Koch knew that the putative agent of cholera, Vibrio cholerae, could be isolated from both sick and healthy people, invalidating postulate #2.

The limitations of Koch’s criteria are even more obvious when we consider viral diseases, which were not yet discovered when the postulates were formulated. Thomas Rivers, who has been called the ‘father of modern virology’, wrote:

‘‘It is unfortunate that so many workers blindly followed the rules, because Koch himself quickly realized that in certain instances all the conditions could not be met. . . . Thus, in regard to certain diseases, particularly those caused by viruses, the blind adherence to Koch’s postulates may act as a hindrance instead of an aid.’’

Many viruses do not cause illness in all infected individuals, a requirement of postulate #1. An example is poliovirus, which causes paralytic disease in about 1% of those infected. Further compromising postulate #1 is the fact that infection with the same virus may lead to markedly different diseases, while different viruses may cause the same disease. Postulates #2 and #3 cannot be fulfilled for viruses that do not replicate in cell culture, or for which a suitable animal model has not been identified.

The application of nucleic acid-based methods of microbial identification has made Koch’s postulates even less applicable. Polymerase chain reaction and high-throughput sequence analysis have revealed a great deal about microbes that are associated with pathology or disease, but proving causation has become even more difficult as the number of uncultivable viruses rapidly multiplies. Nucleic acid based detection methods are so sensitive that they detect small numbers of viruses that may occur in the absence of disease. The use of these new methods have lead to revised versions of Koch’s postulates that are fundamentally sound: both hepatitis C virus and human papillomaviruses were convincingly shown to be causative agents of hepatitis and cervical cancer, respectively, long before methods were developed for propagation of the viruses in cell culture.

Here are Koch’s postulates for the 21st century as suggested by Fredricks and Relman:

  1. A nucleic acid sequence belonging to a putative pathogen should be present in most cases of an infectious disease. Microbial nucleic acids should be found preferentially in those organs or gross anatomic sites known to be diseased, and not in those organs that lack pathology.
  2. Fewer, or no, copy numbers of pathogen-associated nucleic acid sequences should occur in hosts or tissues without disease.
  3. With resolution of disease, the copy number of pathogen-associated nucleic acid sequences should decrease or become undetectable. With clinical relapse, the opposite should occur.
  4. When sequence detection predates disease, or sequence copy number correlates with severity of disease or pathology, the sequence-disease association is more likely to be a causal relationship.
  5. The nature of the microorganism inferred from the available sequence should be consistent with the known biological characteristics of that group of organisms.
  6. Tissue-sequence correlates should be sought at the cellular level: efforts should be made to demonstrate specific in situ hybridization of microbial sequence to areas of tissue pathology and to visible microorganisms or to areas where microorganisms are presumed to be located.
  7. These sequence-based forms of evidence for microbial causation should be reproducible.

Fredericks DN, & Relman DA (1996). Sequence-based identification of microbial pathogens: a reconsideration of Koch’s postulates. Clinical microbiology reviews, 9 (1), 18-33 PMID: 8665474

Lipkin, W. (2008). Microbe hunting in the 21st century Proceedings of the National Academy of Sciences, 106 (1), 6-7 DOI: 10.1073/pnas.0811420106


Frequently Asked Questions

OLAW welcomes comments on any of its policy guidance, click here for more information.

OLAW develops and monitors, as well as exercises compliance oversight relative to the Public Health Service Policy on Humane Care and Use of Laboratory Animals (the "PHS Policy"). One of OLAW's primary functions is to advise awarding units and awardee institutions concerning the implementation of the PHS Policy. OLAW often provides this advice by responding to policy-related questions submitted by such units and institutions. The following FAQs provide guidance that represents OLAW's current thinking on these topics. This guidance is based on OLAW's experience with the subject matter and draws on best practices followed by the biomedical community regarding the use of research animals. Unless specific statutory or regulatory requirements are cited, the FAQs should be viewed as recommendations in that an institution may use an alternative approach if the approach satisfies the requirements of the PHS Policy.

The USDA Animal and Plant Health Inspection Service (APHIS), Animal Care has reviewed and concurs with the guidance provided in these FAQs where applicable.

A. Applicability of the PHS Policy

Should institutions apply the PHS Policy to all animal activities regardless of the source of funding? Updated

There are many valid reasons for institutions to perform program oversight institution-wide using uniform and consistent standards for animal care and use. Likewise, it is generally impractical to separate activities based on the source of funding. Institutions must implement the PHS Policy for all PHS supported activities involving animals, and must ensure that any standards that might not be consistent with PHS Policy do not affect or pose risks to PHS supported activities.

It is permissible for institutions to delineate animal areas that are programmatically and functionally separate and that do not support PHS animal activities such as a herd of beef cattle used for food production or a stable of riding horses. The Assurance should explicitly reflect the exclusion of any specific area or activity. [A1, A4]

Does the PHS Policy apply to the production of custom antibodies or to the purchase of surgically modified animals?

The generation of custom antibodies is an activity involving vertebrate animals and covered by PHS Policy. Antibodies are considered customized if produced using antigen(s) provided by or at the request of the investigator (i.e., not purchased off-the-shelf). An organization producing custom antibodies for an awardee must have or obtain an Assurance, or be included as a component of the awardee&rsquos Assurance. In addition, the awardee must provide verification of project-specific IACUC approval for the production of the antibodies.

Similar guidance applies to surgical procedures. Surgery conducted in response to a specific, custom request is covered by the PHS Policy. An organization conducting custom surgery for an awardee must have or obtain an Assurance, or be included as a component of the awardee&rsquos Assurance. In addition, the awardee must provide verification of project-specific IACUC approval for conducting the surgery. When both organizations hold Assurances, some latitude is allowed in determining which IACUC will review the proposal. However, the awardee always retains primary responsibility for ensuring compliance with PHS Policy. [D6, A11]

See also FAQ F8: Is the mouse ascites method an acceptable method of monoclonal antibody production?

Does the PHS Policy apply to use of animal tissue or materials obtained from dead animals?

Does the PHS Policy apply to live embryonated eggs?

Does the PHS Policy apply to larval forms of amphibians and fish?

Does the PHS Policy apply to animal research that is conducted in the field?

The IACUC is responsible for oversight of vertebrate animal activities supported by the PHS and those supported by NSF and VA in accord with PHS Policy. To conduct such activities in the field, the investigator must provide the IACUC with the following information:

  • where the activity will be conducted
  • what procedures will be involved
  • a brief description of how those procedures are likely to affect the biology and ecology of the study animals by describing the relationship of that species to the habitat and to other species found in the study area (including the nature and duration of potential effects) and
  • assurance that permit requirements of pertinent local, state, national, and international wildlife regulations will be obtained before work begins.

If the IACUC determines that the proposed activity is likely to alter or influence the activity of the study animals or other species found in the study area, then protocol review and approval is required. However, if the IACUC determines that the proposed activity will not alter or influence the activity of the study animals, IACUC review and approval is not needed.

Investigators are encouraged to consult relevant professional societies, available guidelines, wildlife biologists, and veterinarians, as applicable, in the design of the field studies (Guide page 32, Appendix A). Studies with the potential to impact the health or safety of personnel (Guide page 18) or the animal&rsquos environment may need IACUC oversight, even if described as purely observational or behavioral. When capture, handling, confinement, transportation, anesthesia, euthanasia, or invasive procedures are involved, the IACUC must ensure that proposed studies are in accord with the Guide (page 32). A study on free-living wild USDA-covered species that involves invasive procedures, harms or materially alters the behavior of an animal under study is covered by USDA animal welfare regulations and requires IACUC review and approval.

See also FAQ E4: Is the IACUC required to inspect field study sites?

Does the IACUC need to approve research studies that use privately owned animals, such as pets?

How can the IACUC determine if activities involving privately owned animals constitute veterinary clinical care or research activities?

When a privately owned animal is recruited, with the owner&rsquos consent, for participation in a research study or veterinary clinical trial and the activity includes collection or generation of data for research purposes, such activities are considered research and are subject to IACUC oversight.

Veterinary research activities are typically supported by a grant or contract. The data are collected for the advancement of animal and/or human health. If the study is PHS funded, the institution must have an OLAW-approved Animal Welfare Assurance covering all performance sites and IACUC approval for the research activity. If the study is being conducted in collaboration with a private clinical veterinary practice, the operational components of the practice associated with the research activity should be a covered component of an Assured institution.

When doing research on a pet, the institution is responsible for obtaining informed consent for the research activity. If the research activity is being conducted in collaboration with a private veterinary practice, the institution should consider the use of a memorandum of understanding agreement. The institutional legal counsel may be involved in the development of the document.

The veterinary clinical care of a privately owned animal is not a research activity and does not require IACUC approval. Veterinary clinical care is typically offered as a fee-for-service activity and is regulated by state veterinary licensing boards.

B. IACUC Composition, Functions and Authority

What are the IACUC membership criteria?

The IACUC must consist of at least 5 members who are appointed by the institution's chief executive officer (CEO). If the CEO delegates appointment authority, the delegation must be specific and in writing.

The appointed members must be qualified through experience and expertise to provide oversight for the institution's animal programs, facilities, and procedures. At a minimum the IACUC must include a veterinarian, a practicing scientist experienced in animal research, a person whose primary concerns are in a nonscientific area, and a person who is unaffiliated with the institution except as a member of the IACUC (sometimes referred to as a public member). An individual who qualifies to fill more than one of the specified categories may be appointed to do so, but the committee must still consist of at least 5 members. The unaffiliated member should have no discernible ties or ongoing affiliation with the institution, and may not be a member of the immediate family of a person who is affiliated with the institution. Immediate family includes parent, spouse, child and sibling. Appointment of an individual who is unambiguously unaffiliated is the best way to fulfill the letter and spirit of this provision. PHS Policy incorporates the Guide which specifies that public members should not be laboratory animal users (Guide page 24). The veterinarian on the IACUC must have direct or delegated program authority and responsibility for animal-related activities and therefore is always considered to be affiliated with the institution.

May the IACUC have alternate members?

Provisions for appointing alternate members are addressed in the NIH Guide for Grants and Contracts NOT-OD-11-053.

NOT-OD-11-053 does not preclude designation of one alternate for multiple regular members, provided the alternate for a member fulfilling a specific membership requirement (e.g., nonscientist) also fulfills that requirement. An alternate may not represent more than one member at any one time. Conversely, it is permissible to appoint more than one alternate to represent a particular member, but again, if the member fulfills a specific membership requirement then the alternate must also fulfill that requirement.

Must certain members be present in order to conduct official business?

Is a certain level of meeting attendance required of IACUC members?

What is a quorum and when is a quorum required?

A quorum is a majority of the total number of voting members of the IACUC. For example, to achieve a quorum in an IACUC with 20 committee members, at least 11 members must participate. A majority vote of the quorum present at a convened meeting is required for the IACUC to:

  1. conduct full committee review and approval of a proposed project or of a significant change to a project, and
  2. suspend an activity.

Members may not participate in the review or approval of a project(s) in which they have a conflict of interest, except to provide information. Recused members also may not contribute to the quorum for the vote on that specific project. Abstentions from voting due to a conflict of interest:

  • do notalter the total quorum requirements, and
  • do notchange the number of votes required to conduct business at a meeting of the convened quorum as described in 1 and 2 above.

For a vote to be valid, a quorum (>50% of the total IACUC voting members) must be maintained. If a member recusal reduces the number of IACUC members qualified to vote, for example, if the minimum number of eligible voting members present changes from 11 to 10, then the IACUC may not vote on that specific project. IACUCs must ensure that the required number of voting members present are able to meet the minimum quorum requirements by considering alternate member(s) (see NOT-OD-11-053 and FAQ B.2.) and/or telecommunications (see NOT-OD-06-052). If a recusal results in the loss of a quorum, the business associated with the conflict of interest must be tabled until a quorum is present.

Does the IACUC have authority over activities not supported by PHS?

Institutions have discretion to subject animal activities to IACUC oversight regardless of the source of funding. This practice ensures uniform standards, appropriate oversight and accountability, and therefore is often in the best interest of the institution. (See also FAQ A1).

USDA requires IACUC oversight of any covered animal activity where (1) the animal has been acquired or transported by the facility, or (2) the research is being supported by any Federal funding source.

What information should be in IACUC minutes?

May an IACUC conduct business on a teleconference call?

May an IACUC suspend (stop) animal activities that it did not initially approve?

Yes. The PHS Policy, Guide,and the USDA Animal Welfare Regulations presume that all ongoing animal activities have received the required prospective review and approval. An activity that has been undertaken without prior approval should be halted and subsequently reported to OLAW because it constitutes serious noncompliance.

Does the Institutional Official have authority to halt an activity that was previously approved by the IACUC, or to approve one that was not initially approved by the IACUC?

May the institution pay or reimburse expenses incurred by nonaffiliated members?

How does OLAW define nonscientific IACUC member?

The PHS Policy IV.A.3.b.(3) describes the nonscientific member as one member whose primary concerns are in a nonscientific area (for example, ethicist, lawyer, member of the clergy). The intent of the Policy is to have a diversity of perspectives in the membership of the committee and have an individual with a naïve attitude with regard to science and scientific activities. A person without scientific training meets the intent of the Policy, such as an ethicist, lawyer, or member of the clergy, as the Policy gives as examples. Some other examples include librarians, those working in business or finance, or instructors in English, history, or other liberal arts disciplines. When the rationale for categorizing an individual as a nonscientist is not apparent based on their occupation or training, the institution should maintain written documentation of the reason for the categorization. (See NOT-OD-15-109)

For guidance on nonaffiliated members, see FAQ B14.

Does OLAW expect the IACUC to notify NIH when there is a change in an animal activity supported by PHS funds?

The terms &ldquosignificant change&rdquo and &ldquochange in scope&rdquo have different meanings. According to NIH Grants Policy Statement (NIH GPS, chapter 8.1.2.5), change in scope refers to a change in the direction, type of research or training from the aims, objectives, or purposes of the approved project. A change in an animal activity can be both a significant change requiring IACUC review and a change in scope requiring notification to the NIH funding component. However, a significant change is not necessarily a change in scope.

For guidance regarding significant changes that require IACUC approval see NOT-OD-14-126. As described in the PHS Policy IV.B.7, the IACUC is responsible for reviewing significant changes and approving, requiring modifications (to secure approval), or disapproving the proposed change. The IACUC is not required to notify OLAW or the NIH funding component of this type of change. However, conducting procedures that constitute a significant change in approved animal activities without prior IACUC approval is serious noncompliance that must be reported to OLAW. Additional information may be found at FAQ B9 of IACUC Composition, Functions and Authority and Notice NOT-OD-05-034.

Prior approval of a change in the scope of the research is required by GPS, which provides examples of potential indicators of changes in scope. These examples are not intended to imply that any change in animal model or in approved use of animals always represents a change in scope.

The IACUC is not responsible for notifying the NIH of changes in scope rather the Principal Investigator (PI) and the Authorized Organization Representative (AOR) are responsible for requesting approval of a change in scope. The request for a change in scope must be made in writing to the Grants Management Officer (GMO) of the NIH Institute or Center (IC) that funds the grant (the funding component). The request must be made no less than 30 days before the proposed change and must be signed by both the PI and the AOR.

How does OLAW define nonaffiliated IACUC member?

The PHS Policy IV.A.3.b.(4) describes the nonaffiliated member as &ldquoone individual who is not affiliated with the institution in any way other than as a member of the IACUC, and is not a member of the immediate family of a person who is affiliated with the institution.&rdquo The nonaffiliated member represents the general community interests in the proper care and use of animals. The nonaffiliated member is (1) not a laboratory animal user or former user, (2) not affiliated with the institution, or (3) not an immediate family member of an individual affiliated with the institution. Immediate family includes parent, spouse, child, and sibling.

In evaluating the qualifications of an individual to serve as a nonaffiliated member, the Chief Executive Officer should confirm the appointee has no discernible ties or ongoing affiliation with the institution. Regarding service of former employees or students as nonaffiliated members, the appointing official must be assured that the person is not in any way obligated to the institution. Real or perceived conflicts of interest must be avoided to ensure the IACUC&rsquos and the institution&rsquos integrity. Appointment of an individual who is unambiguously unaffiliated is the most effective way to fulfill the intent of the Policy. Public member is another term for nonaffiliated member. (See NOT-OD-15-109)

For guidance on nonscientific members, see FAQ B12.

May one individual fulfill the requirement for both a nonaffiliated and a nonscientific member?

Yes, as long as that individual meets the requirements for each position. The PHS Policy states, &ldquoAn individual who meets the requirements of more than one of the categories detailed in IV.A.3.b.(1)-(4) of this Policy may fulfill more than one requirement. However, no committee may consist of fewer than five members.&rdquo (See NOT-OD-15-109)

See also FAQ B12: How does OLAW define nonscientific IACUC member?

C. Institutional Reporting to OLAW

What is the Annual Report to OLAW and when is it due?

The Annual Report is a document prepared by the IACUC and submitted to OLAW through the Institutional Official. It describes any changes in the institution&rsquos program of animal care and use, AAALAC accreditation status, changes of Institutional Official and in IACUC membership, the dates that the IACUC conducted its semiannual evaluations of the program and facilities, and any minority views.

Descriptions of program changes should be comprehensive and in sufficient detail to replace information in the currently approved Assurance. If there are no changes, then a statement to that effect must be provided. Annual Reports must represent the consensus of the Committee and include any minority views filed by members of the IACUC.

In the year 2020, the report will cover a partial year (January 1 &ndash September 30, 2020), with the report due to OLAW by December 1, 2020 (but no earlier than September 30, 2020).

Beginning in 2021, the reporting period for the Annual Report to OLAW will be harmonized with the reporting period for the Annual Report to USDA to occur over the fiscal year (October 1 &ndash September 30). Therefore, in 2021 and beyond, the Annual Report to OLAW will be due by December 1 st (but no earlier than September 30) for the previous fiscal year.

To learn more and for a sample Annual Report, see the Annual Report to OLAW.

What kinds of situations should be reported to OLAW under IV.F.3. of the PHS Policy, and when, where, and how should they be reported?

Should the IACUC report sanctions other than suspensions that are imposed by the Committee or by other institutional officials?

Sanctions imposed by the IACUC or by an institutional official due to serious or continuing noncompliance or serious deviations from the Guide must be reported to OLAW. Guidance on reporting noncompliance is in the NIH Guide for Grants and Contracts NOT-OD-05-034.

Are all documents submitted to OLAW subject to the Freedom of Information Act?

The Freedom of Information Act (FOIA), 5 U.S.C.522, provides individuals with a right of access to records in the possession of the federal government. All documents submitted to OLAW are subject to the FOIA. However, the government may withhold information pursuant to the exemptions and exclusions contained in FOIA. To learn more about the NIH FOIA process, see the OLAW Online Seminar: Openness and Transparency and Biomedical Research Oversight.

In a ruling by the US District Court for the District of Columbia Div. No 99-3024, In Defense of Animals v. Department of Health and Human Services (HHS), 9/28/2001, the Court ruled that HHS (NIH&rsquos parent organization) may withhold IACUC members&rsquo names. NIH does release the names of the IACUC Chairperson, veterinarian, and Institutional Official as reported in Assurances.

Note also that footnote 6 in the PHS Policy allows institutions to represent the name of IACUC members other than the chair and veterinarian by using numbers or other symbols, provided there is sufficient information to allow OLAW to determine that appointees are appropriately qualified. Identities of members must be readily ascertainable by the institution and available to OLAW upon request.

In providing the facility and species inventory as part of the Assurance submitted to OLAW, institutions may identify animal areas in any manner, e.g., initials, ID number. It is not necessary to provide OLAW with detailed diagrams of facilities or room numbers, unless specifically requested by OLAW.

Institutions are also advised to consult the Guidance on Prompt Reporting to OLAW under the PHS Policy (NIH Guide for Grants and Contracts NOT-OD-05-034) with respect to what information is expected to be reported when reporting noncompliance. Disciplinary documents (e.g., letters of reprimand) and correspondence between the IACUC and investigators are generally not required by OLAW, although they may be requested.

Additional information about the FOIA, including guidelines for submitting FOIA requests, is available at: http://www.nih.gov/icd/od/foia/index.htm

Are institutions required by FOIA to release information about their research, animal care programs, and IACUCs?

What are PHS requirements for recording and reporting minority views?

Institutions must maintain records of minority views expressed (1) as recommendations to the Institutional Official and/or (2) during semiannual inspections. These minority views must be included in the Annual Report to OLAW. PHS requirements for recording and reporting minority views are described in the PHS Policy at IV.E.1.d. OLAW provides a sample annual report document that institutions may find useful.

Some IACUCs have expressed confusion about the difference between a minority view and a dissenting vote.

  • Both protocol approval and suspension of animal study protocols by the IACUC require a majority vote of a quorum of the IACUC. Although an IACUC member&rsquos dissenting vote on these issues must be recorded in the minutes, this does not constitute a minority view for reporting purposes.
  • Any IACUC member may submit a minority view to OLAW addressing any aspect of the institution&rsquos animal program, facilities, or personnel training. Whether OLAW receives a minority view as part of an annual report, renewal Assurance document materials, or directly from the dissenting IACUC member, it carefully reviews the information provided in accordance with requirements of the PHS Policy and provisions of the Guide.

What are PHS Policy reporting requirements for departures from the Guide?

The IACUC must review and approve departures from the Guide. IACUC approval of departures from the Guide must be based on scientific, veterinary medical, or animal welfare issues. Semiannual reports from the IACUC to the Institutional Official (IO) must identify specifically any departures from the Guide (PHS Policy IV.B.3.). Read the Guide carefully it establishes exceptions in specific situations these are not departures from the Guide and are not required to be reported to the IO.

Guidance in the Eighth Edition of the Guide is stated in terms of standards that must be met, standards that should be met, and standards that may be met.

OLAW defines must as a minimum standard required of all Assured institutions. Deviation from these standards with IACUC approval is a departure from the Guide and must be reported in the semiannual report. Deviation from a must statement without IACUC approval is a noncompliance that must be reported to OLAW through the IO.

Reporting requirements for should statements in the Guide vary. Should statements often involve performance standards. Well-established performance standards are not departures from the Guide and need not be reported in the semiannual report to the IO. Deviation from a should statement with IACUC approval is a departure from the Guide and must be reported in the semiannual report to the IO. Deviation from a should statement without IACUC approval is a noncompliance that must be reported to OLAW through the IO.

May statements in the Guide are suggestions that institutions can choose to implement if suitable for their program and deviations are not included in the semiannual report to the IO.

How frequently should the IACUC review research protocols?

May the IACUC administratively extend approval of a project that has expired?

What are the possible methods of IACUC approval?

There are only two valid methods of IACUC review allowed by the PHS Policy: (1) full-committee review by a convened quorum of the members of the IACUC, or (2) designated member review by one or more members, employed only after all voting members have been provided an opportunity to call for full-committee review.

Full IACUC review may result in approval, a requirement for modifications (to secure approval), or withholding of approval. Full committee review must occur during a convened meeting of a quorum of the IACUC members, and with a formal vote. It is insufficient to poll each member individually in lieu of a convened quorum when using the full committee method of review. See NIH Guide for Grants and Contracts NOT-OD-06-052 regarding use of tele- or videoconferencing when a convened meeting is required.

Designated member review may be utilized only after all members have been provided the opportunity to call for full-committee review. If any member requests full committee review then that method must be used. If not, the IACUC Chairperson may appoint one or more appropriately qualified IACUC members to serve as the designated reviewer(s). Designated review may result in approval, a requirement for modifications (to secure approval), or referral to the full committee for review. Designated review may not result in withholding of approval.

If a protocol is assigned more than one designated reviewer, the reviewers must be unanimous in any decision. They must all review identical versions of the protocol and if modifications are requested by any one of the reviewers then the other reviewers must be aware of and agree to the modifications.

May the IACUC grant conditional or provisional approval?

May the investigator begin animal work before receiving IACUC approval?

What criteria should the IACUC consider when reviewing protocols?

  • the protocol is consistent with the Guide unless a scientific justification for a departure is presented and is acceptable to the IACUC
  • the protocol conforms with the institution's Assurance
  • the protocol will be conducted in accordance with the USDA Animal Welfare Regulations if applicable and
  • the protocol meets the requirements of the PHS Policy at IV.C.1.a.-g.

For further guidance, the IACUC should refer to the U.S. Government Principles.

Should the IACUC consider the three Rs of alternatives when reviewing protocols? (Refinements to research, Reduction of animal numbers, and Replacement with non-animal models)

When institutions collaborate, or when the performance site is not the awardee institution, which IACUC is responsible for review of the research activity?

There are many circumstances that involve partnerships between collaborating institutions or relationships between institutional animal care programs. Interinstitutional collaborations have the potential to create ambiguities. Therefore it is imperative that institutions define their respective responsibilities. OLAW and APHIS agree that review of a research project or evaluation of a program or facility by more than one recognized IACUC is not a federal requirement. Institutions should have a formal written understanding (e.g., memorandum of understanding) that addresses responsibilities for animal care and use, ownership, and IACUC review and oversight (Guide page 15).

PHS Policy requires that all awardees and performance sites hold an approved Animal Welfare Assurance. If an institution does not have an animal care and use program, facilities to house animals, and an IACUC, the awardee institution will conduct the animal activity at an Assured institution (performance site). Assured institutions also have the option to amend their Assurance to cover performance sites that do not have an approved Assurance with OLAW, which effectively subjugates the performance site to the Assured institution and makes the Assured institution responsible for the performance site.

If both the awardee institution and the performance site institution have Domestic Assurances, they may exercise discretion in determining which IACUC reviews animal activities and under which institutional program the research will be performed. There is no requirement for dual review IACUCs may choose which IACUC will review protocols for the animal activities being conducted. It is recommended that if an IACUC defers protocol review to another IACUC, documentation of the review should be maintained by both committees. Additionally, the IACUC conducting the review should notify the other IACUC of significant questions or issues raised during a semiannual program inspection of a facility housing a research activity for which that IACUC bears some oversight responsibility.

What is considered a significant change to a project that would require IACUC review?

Guidance on what is considered a significant change to an ongoing animal activity that requires IACUC review can be found in NIH Guide Notice NOT-OD-14-126 or Significant Changes webpage.

Is the IACUC required to review the grant application?

May the IACUC approve pilot studies?

Yes. Pilot studies may be appropriate to determine the technical feasibility of larger studies or to make initial assessments of the effect of procedures on animals (Guide pages 26, 28). Whether proposed by investigators or required by the IACUC, pilot studies require review and approval by the IACUC in accordance with the PHS Policy.

Is the IACUC responsible for judging the scientific merit of proposals?

Peer review of the scientific and technical merit of an application is considered the purview of the NIH Scientific Review Groups (SRG), which are composed of scientific experts from the extramural research community in a particular area of expertise. However, SRGs also have authority to raise specific animal welfare concerns that can require resolution prior to a grant award.

Although not intended to conduct peer review of research proposals, the IACUC is expected to include consideration of the U.S. Government Principles in its review of protocols. Principle II calls for an evaluation of the relevance of a procedure to human or animal health, the advancement of knowledge, or the good of society. Other PHS Policy review criteria refer to sound research design, rationale for involving animals, and scientifically valuable research. Presumably a study that could not meet these basic criteria is inherently unnecessary and wasteful and, therefore, not justifiable.

The primary focus of the SRG is scientific merit and the primary focus of the IACUC is animal welfare. The two bodies have differing constitutions, mandates and functions. However, since it is not entirely possibly to separate scientific value from animal welfare some overlap is inevitable. SRGs may raise concerns about animal welfare and IACUCs may question the scientific rationale or necessity for a procedure. [A1]

If an animal activity will be performed outside of the US (either by a foreign awardee or by a foreign institution as a subproject for a domestic awardee), is the awardees IACUC required to review and approve that activity?

When the awardee is a domestic institution (i.e., domestic award with a foreign component), PHS animal welfare requirements are applicable. Accordingly, the awardee remains responsible for animal activity conducted at a foreign site and must provide verification of IACUC approval. That approval certifies that the activity, as conducted at the foreign performance site, is acceptable to the awardee. The awardee IACUC may accept, as its own, the approval of a foreign entity's IACUC however, the awardee IACUC remains responsible for the review. Additionally, the foreign institution must complete the Animal Welfare Assurance for Foreign Institutions (Foreign Assurance) available from OLAW. This document certifies that the institution will comply with the applicable laws, regulations, and policies of the jurisdiction in which the research will be conducted, and that the institution will be guided by the International Guiding Principles for Biomedical Research Involving Animals (PDF). OLAW encourages, but does not require, foreign institutions to use the standards in the Guide. If the prime awardee is a foreign institution, IACUC approval is not required.

May standard operating procedures (SOPs) or blanket protocols that cover a number of procedures be utilized in lieu of repeating descriptions of identical procedures in multiple protocols?

Is IACUC approval required for the collection of samples in foreign countries from captive wild animals or research colonies?

Collection of biological samples from any live vertebrate animal for the purpose of a PHS-supported activity is covered by the PHS Policy. If the awardee is a domestic institution, the IACUC should consider the species involved, nature of the specimens, invasiveness of the procedure, risks to personnel, and qualifications of the individual(s) taking the sample(s). (For further information concerning foreign performance sites see FAQ D13.)

Awardee institutions should also consult with other agencies of the federal government as appropriate, e.g., US Fish and Wildlife Service, USDA-APHIS-Veterinary Services, and the CDC for specimen importation requirements . [A7]

Is IACUC approval required for the use of animals in breeding programs, as blood donors, as sentinels in disease surveillance programs, or for other non-research purposes?

What guidelines should IACUCs follow for fishes, amphibians, reptiles, birds, and other nontraditional species used in research?

PHS Policy is intentionally broad in scope and does not prescribe specifics about the care and use of any species, assigning that task to the IACUC and allowing for professional judgment. Many of the principles embodied in the Guide can generally be adapted to the care and use of various kinds of nontraditional research animals. IACUCs may seek the advice of experts when necessary, and refer to scientific-based publications prepared by professional organizations with interest in various species. Appendix A of the Guide references many such publications. [A7]

Is it acceptable to have different individuals named as PI on the grant application and the IACUC protocol?

May an IACUC use designated member review (DMR) to review an animal study protocol subsequent to full committee review (FCR) when modifications are needed to secure approval?

When substantive information is lacking from a protocol, the committee may have questions requiring a response from the PI. In such situations, the IACUC may take the following actions:

    If all members of the IACUC are present at a meeting, the committee may vote to require modifications to secure approval and have the revised research protocol reviewed and approved by designated member review, or returned for FCR at a convened meeting.

  • All IACUC members agree in advance in writing that the quorum of members present at a convened meeting may decide by unanimous vote to use DMR subsequent to FCR when modification is needed to secure approval. However, any member of the IACUC may, at any time, request to see the revised protocol and/or request FCR of the protocol.
  • In order to conduct reviews by DMR subsequent to FCR, the institution should specify its intention to conduct reviews in this manner in its Assurance with OLAW. (IACUCs that newly elect to utilize a standard operating procedure for DMR subsequent to FCR should provide information about this program change to OLAW in the next Annual Report.)

If a protocol is reviewed and approved by DMR, the IACUC may use the date that the designated reviewer(s) approved the protocol as the date of approval. To facilitate efficient business practice, the IACUC also has the option of selecting a reasonable later approval date as described in NOT-OD-11-053. The approval date will appear in the written notification of approval to the principal investigator. If animal work is conducted before the approval date, as stated in the written notification of approval, this is to be reported to OLAW as a serious noncompliance with the PHS Policy. (PHS Policy IV.F.3)

In response to questions from the community regarding this guidance, OLAW offers the following clarifications:

To avoid temporal delays associated with the PHS Policy requirement that all members of the IACUC must be provided the opportunity to call for FCR for a proposal requiring modifications to proceed to DMR (PHS Policy IV.C.2.), OLAW formally recognized an alternative practice in NOT-OD-09-035 (Guidance to IACUCs Regarding the Use of DMR for Animal Study Proposal Review Subsequent to FCR) issued on January 8, 2009. USDA concurred with this practice.

What is &ldquosubstantive information&rdquo?
&ldquoSubstantive information&rdquo is the information the IACUC needs to evaluate the proposal in accordance with the requirements of the PHS Policy. IACUCs are required to evaluate proposals to ensure that they conform with the institution&rsquos Animal Welfare Assurance and meet the requirements specified in the PHS Policy at IV.C.1., provide the information described in the PHS Policy at IV.D.1., and adhere to provisions of the Guide for the Care and Use of Laboratory Animals. Should a proposal fail to address any of these items to the IACUC&rsquos satisfaction, the Committee may determine that the proposal lacks substantive information and require modifications to secure its approval. Typographical or arithmetic errors, misspellings, incorrect room or telephone numbers, etc., are not considered substantive. While these corrections must be made, additional IACUC review is not required.

Can a quorum of the IACUC decide to establish the DMR subsequent to FCR policy?
No. A DMR subsequent to FCR policy, along with appropriate implementing procedures, may be established only by unanimous consent of all members of the IACUC. While all members need not be physically present at the meeting where the policy is proposed, each individual must be given the opportunity to provide their input in person or via facsimile, email, or memorandum prior to its approval.

What does &ldquoin advance, in writing&rdquo mean?
&ldquoIn advance&rdquo means that the IACUC-approved policy must be in place prior to the first meeting at which it is used. &ldquoIn writing&rdquo means that the policy and procedures must be written down and documented in the IACUC&rsquos permanent records as having been established by unanimous agreement of all Committee members. Members are not required to physically sign the DMR subsequent to FCR policy.

Does there have to be a written statement for every meeting?
No. The IACUC-approved DMR subsequent to FCR policy allows an appropriately constituted Committee, by unanimous consent, to implement the policy, whenever appropriate, to evaluate revised proposals using DMR. The outcomes of DMRs must then be appropriately documented in the IACUC minutes or elsewhere.

When can the IACUC start using DMR subsequent to FCR?
As soon as all members agree to the process and the IACUC-approved, written DMR subsequent to FCR policy and procedures are in place. In addition, when an IACUC establishes the new policy and procedures, OLAW must be notified in the next institutional Annual Report, and the policy must be documented in the institution&rsquos Assurance renewal.

Does the IACUC have to review proposed animal research activities at the time of grant award if the animal research activities will not be conducted until year 4 or 5 of a grant?

The IACUC must review and approve the proposed use of animals described in the application or proposal prior to the conduct of any PHS-supported animal activity (PHS Policy V.B.). Approval is valid for a maximum of 3 years. A brief description of the animal activities planned for the 4 th and 5 th year of the award period should be provided in the animal protocol recognizing that the experimental details and procedures will be refined or amended at a later time or at the time of the 3-year renewal.

Because the scientific enterprise is not static, the need for changes to animal protocols is anticipated and can occur at any time during the life of the protocol. Significant changes to previously approved animal activities require prior IACUC approval. For guidance on what is considered a significant change, see FAQ D9.

In rare cases, IACUC review of animal activities is conducted later in the life cycle of a grant or contract. IACUC review may be delayed if the animal activities will not occur until a year or later in the award period as part of the research design described in the grant application or contract proposal (e.g., the initial development of a drug or device with subsequent animal testing projected into the future). In these circumstances, the funding component will issue a Notice of Award with a special term and condition indicating that no funds may be drawn from the grant or contract for animal activities until a valid IACUC approval date has been provided to the funding component.

Additional OLAW Guidance regarding IACUC review of grant applications can be found at FAQ D10, previous OLAW Commentary, and OLAW Online Seminar The 2016 Vertebrate Animals Section, Grants Policy, and Congruence.

E. Program Review and Inspection of Facilities

Should the IACUC inspect laboratories or other sites where investigators use animals?

How does the IACUC distinguish between significant and minor deficiencies?

May the IACUC use an AAALAC International site visit as its semiannual evaluation?

Is the IACUC required to inspect field study sites?

While semiannual IACUC inspections of field study sites are not required and in many circumstances are impractical, IACUCs should be apprised of the circumstances under which studies are conducted so that they can consider risks to personnel and impact on study subjects. This may be partially accomplished by written descriptions, photographs, or videos that document specified aspects of the study site. The IACUC should also ensure that appropriate permits are in place. USDA animal welfare regulations exempt areas containing free-living wild animals in their natural habitat from inspection [See Quick Reference Guide: 9 CFR, Part 2, Section 2.31(c)(2)].

See also FAQ A6: Does the PHS Policy apply to research that is conducted in the field?

F. Animal Use and Management

Is the use of carbon dioxide an acceptable euthanasia agent?

Although carbon dioxide (CO2) is generally considered an acceptable euthanasia agent for small animals when properly administered, its acceptability is predicated on a number of critical factors as described in the AVMA Guidelines for the Euthanasia of Animals (page 31). The Guidelines recommend that euthanasia chambers be filled at a gradual displacement rate of 30% to 70% to minimize aversion and distress while maintaining CO2 flow for at least one minute after respiratory arrest. It is important to verify death after CO2 exposure, and CO2 narcosis must be followed by a secondary method of euthanasia where necessary. Because immature animals are resistant to the hypoxia-inducing effects of CO2 and require longer exposure times to the agent, alternative methods should be considered, such as injection with chemical agents, cervical dislocation, or decapitation (Guide page 124).

Is the IACUC responsible for tracking animal usage?

May an investigator transfer animals and research to an institution different than the grantee institution?

May investigators use non-pharmaceutical-grade substances in animals?

OLAW and USDA agree that pharmaceutical-grade 1 substances, when available, must be used to avoid toxicity or side effects that may threaten the health and welfare of vertebrate animals and / or interfere with the interpretation of research results 2 . However, it is frequently necessary to use non-pharmaceutical-grade substances such as investigational substances, veterinarian- or pharmacy-compounded 3 substances, and / or Schedule I 4 controlled substances to meet scientific and research goals.

The IACUC is responsible for evaluating the potential adverse consequences of non-pharmaceutical-grade substances when used for research. In making its evaluation, the IACUC may consider factors including, for example:

  • grade,
  • purity,
  • sterility,
  • acid-base balance,
  • pyrogenicity,
  • osmolality,
  • stability,
  • site and route of administration,
  • compatibility of components,
  • side effects and adverse reactions,
  • storage, and
  • pharmacokinetics.

The IACUC may use a variety of administrative methods to review and approve the use of non-pharmaceutical-grade substances. For example, the IACUC may establish acceptable scientific criteria for use of these substances within the institution, rather than on a case-by-case basis. Investigators and IACUCs should consider relevant animal welfare and scientific issues including safety, efficacy, availability of pharmaceutical-grade substances, and the inadvertent introduction of new variables. Cost savings alone are not an adequate justification for the use of non-pharmaceutical-grade substances in animals. However, unavailability or shortages of pharmaceutical-grade substances may lead to cost increases and the IACUC may determine that this justifies the use of the non-pharmaceutical-grade substitution.

Although the potential animal welfare consequences of complications are less evident in non-survival studies, the scientific issues remain the same. The principles and need for professional judgment outlined above apply to non-survival studies.

Procedures that may cause more than momentary or slight pain or distress to animals must be relieved by sedation, analgesia, or anesthesia using veterinary or human pharmaceutical-grade substances, unless the use of a non-pharmaceutical-grade substance is scientifically necessary, appropriately justified, and approved by the IACUC. The use of a non-pharmaceutical-grade euthanasia agent must meet the same criteria.

1 A pharmaceutical-grade substance is any active or inactive drug, biologic, reagent, etc., manufactured under Good Manufacturing Practices (GMP) which is approved, conditionally approved, or indexed by the Food and Drug Administration (FDA) or for which a chemical purity standard has been written or established by a recognized compendia (e.g., United States Pharmacopeia-National Formulary (USP-NF), British Pharmacopeia (BP) ).

2 A listing of pharmaceutical-grade drugs and biologics is available through the FDA database. The Orange Book is the reference for FDA-approved human drugs. The Green Book is the reference for FDA-approved veterinary drugs.

3 Veterinary compounding is the customized manipulation of an approved drug by a veterinarian, or by a pharmacist upon the prescription of a veterinarian, to meet the needs of a research study. IACUCs considering the use of veterinary compounding for research purposes are advised to consult: https://www.avma.org/KB/Resources/Reference/Pages/Compounding.aspx for more information about federal regulations.

4 United States Department of Justice Drug Enforcement Agency controlled substances Schedule I and II-IV drugs may be used in biomedical research according to the standards of the Code of Federal Regulations 1301.13.

May investigators use expired pharmaceuticals, biologics, and supplies in animals?

The use of expired pharmaceuticals, biologics, and supplies is not consistent with acceptable veterinary practice or adequate veterinary care. Euthanasia, anesthesia and analgesia agents should not be used beyond their expiration date, even if a procedure is terminal. Other expired materials should not be used unless the manufacturer verifies efficacy beyond the expiration date, or the investigator is able to document to the satisfaction of the IACUC that such use would not negatively impact animal welfare or compromise the validity of the study. The veterinarian and IACUC must maintain control over the use of expired medical materials in order to meet their responsibilities to avoid or minimize discomfort, pain or distress to animals.

How can institutions assure animal welfare when HVAC systems malfunction or fail?

Institutions that conduct PHS-supported research, testing, or training have a responsibility to ensure animal welfare and an obligation to protect the federal investments in these activities. The Guide provides recommendations regarding temperature, humidity, and ventilation for common laboratory animals and discusses parameters regarding heating, ventilating, and air conditioning (HVAC) that must be considered. It also states, &ldquoIn the event of an HVAC system or component failure, systems should, at a minimum, supply facility needs at a reduced level, address the adverse effects of loss of temperature control, and, where necessary, maintain critical pressurization gradients. It is essential that life-threatening heat accumulation or loss be prevented during mechanical failure.&rdquo (Guide page 140) Monitoring HVAC equipment performance is important to ensure timely identification of local or regional power disruptions or system malfunctions. Institutions are strongly encouraged to consider using available electronic technology to measure temperature in each animal room on a continuous basis. Appropriately installed and powered sensors and electronic alarm systems can rapidly notify maintenance and animal care staff of the need to take immediate action to prevent harm to animals (Guide page 143). Sole reliance on employees to identify changes in animal room conditions or the use of high-low thermometers to track changes in temperature may not be sufficient to allow timely intervention and prevent catastrophic loss.

Institutions are also responsible to ensure the welfare of fishes, amphibians, and other vertebrates whose environment is aquatic, with the emphasis on water temperature and quality, including oxygenation, circulation and filtration. (Guide pages 77-88)

The Guide requires that institutions develop a plan that can be instituted if a disaster occurs. (Guide pages 35, 74-75) The disaster plan must include a scheme for relocating or euthanizing animals when power cannot be restored or repairs effected promptly. HVAC, alarm malfunctions, failures in primary and emergency power sources, mechanisms for maintaining appropriate temperatures and ventilation are important issues that must be considered and included in the disaster plan. OLAW provides a Disaster Planning and Response Resources web page to assist institutions in planning and responding to natural and other disasters affecting animal facilities.

See also FAQ G3: Do awardee institutions need animal facility disaster plans?

What are the requirements for conducting rodent survival surgery?

The Guide requires that aseptic technique be followed for all survival surgical procedures. The manner in which asepsis is achieved varies by species. Modification of standard techniques may be desirable or even required, but should not compromise the well-being of the animals. &ldquoThe design of a surgical facility should accommodate the species to be operated on and the complexity of the procedure to be performed.&rdquo (Guide page 144) For most rodent survival surgery, &ldquoan animal procedure laboratory is recommended the space should be dedicated to surgery&hellipand appropriately managed to minimize contamination from other activities conducted in the room at other times.&rdquo (Guide page 144)

Is the mouse ascites method an acceptable method of monoclonal antibody production?

The NIH concurs with the findings and recommendations in the 1999 report of the National Research Council Monoclonal Antibody Production (PDF) which indicates that during the accumulation of ascites there is likely to be pain and distress, particularly when some cell lines that are tissue-invasive are used and in situations of significant ascites development. The Report concluded that there is and will continue to be scientific necessity for this method, but that as tissue-culture systems are further developed, tissue-culture methods for the production of monoclonal antibodies should be adopted as the routine method unless there is a clear reason why they cannot be used.

Accordingly, IACUCs are expected to critically evaluate the proposed uses of the mouse ascites method. Prior to approval of such protocols, IACUCs must determine that (i) the proposed use is scientifically justified, (ii) methods that avoid or minimize discomfort, distress, and pain (including in vitro methods) have been considered, and (iii) the latter have been found unsuitable. [D6]

Are multiple major survival surgical procedures permitted on a single animal?

Surgical procedures should be defined as major or minor on a case-by-case basis and evaluated by the veterinarian and IACUC to determine their impact on the animal&rsquos well-being. (Guide pages 30, 117) Multiple procedures that may induce substantial post-procedural pain or impairment may be conducted on a single animal only if justified by the PI, and reviewed and approved by the IACUC. Multiple major surgical procedures on a single animal are acceptable only if they are:

  • included in and essential components of a single research project or proposal
  • scientifically justified by investigator
  • or necessary for clinical reasons. (Note, clinically necessary procedures do not necessarily require review and approval by the IACUC in advance of the procedure.)

Cost savings alone are not an adequate justification for performing multiple major survival surgical procedures. (Guide page 30)

Note that under USDA regulations (AWR 2.31 (x) A-C), &ldquoNo animal will be used in more than one major operative procedure from which it is allowed to recover, unless: (A) Justified for scientific reasons by the principal investigator, in writing (B) Required as routine veterinary procedure or to protect the health or well-being of the animal as determined by the attending veterinarian or (C) In other special circumstances as determined by the [Animal Care] Administrator on an individual basis. Written requests and supporting data should be sent to the Animal and Plant Health Inspection Service, Animal Care, 4700 River Road, Unit 84, Riverdale MD 20737-1234&rdquo.

See also FAQ F13: Are laparoscopic procedures considered major surgery?

Can performance standards be used in determining rodent housing practices including management of rodent breeding colonies?

Performance standards are to be applied to rodent housing issues. (See Guide pages 56-58.) While the Guide's space recommendations are accepted reference points for addressing space needs, performance standards allow flexibility to improve animal welfare and scientific research. Adjustments to recommendations for primary enclosures may be made at the institutional level by the IACUC. The IACUC should critically evaluate objective measures of outcome-based performance. The Guide identifies examples of performance indices to assess adequacy of housing including:

  • health,
  • reproduction,
  • growth,
  • behavior,
  • activity, and
  • use of space.

Rodent cages of the size commonly used in the United States may be appropriate for pair or trio breeding. The Guide does not add specific, additional engineering standards for breeding configurations. This empowers institutions to determine appropriate housing. The IACUC must consider relevant factors when assessing the adequacy of cage space according to performance standards. Examples of these factors may include:

  • average litter size of the strain(s) of rodents
  • whether multiple litters are present in the cage
  • difference in the age of the pups of different litters
  • growth rate
  • need for cross-fostering
  • cage dimensions and
  • overall management and husbandry practices such as cage sanitation or bedding change.

Blanket, program-wide departures from the Guide for reasons of convenience, cost, or other non-animal welfare considerations are not acceptable. Cages that might be acceptable when litters are born may have insufficient space as pups grow. Whatever parameters are used to establish breeding configurations and weaning procedures, the IACUC must ensure that cage population does not negatively impact animal well-being and overcrowding does not occur.

Can IACUCs authorize the adoption of research animals as pets after the animals are no longer needed for study?

The PHS Policy and the Guide are silent on the issue of private adoption of research animals for pets after a study has been completed and the animals are no longer required. For purposes of property standards under the uniform administrative requirements for HHS grant awards, animals purchased for research purposes are considered to be supplies. Generally, the title to supplies vests with the grant recipient upon acquisition (2 CFR § 200.314). OLAW supports the safety and protection of animals and reminds institutions that their policies must clarify the disposition of animals acquired for research once the research has ended, which may include adoption. The PHS will not assume legal or financial responsibility for any adoption program or any matters arising from or related to the adoption of research animals. The institution should ensure that its policy meets pertinent state and local laws and regulations for the transfer of animal ownership and is encouraged to coordinate with local animal shelters.

What are the institutions responsibilities in ensuring that animals are shipped safely and in reporting adverse events that occur in shipment of animals to or from the institution?

Animals should be transported according to international, federal, state and local regulations summarized in the Guide (page 107). Needs of the animals and protection of personnel should be considered in advance of transportation and met during loading, transportation and unloading, as described in the Guide (pages 107-109).OLAW expects all parties involved in the transportation of animals to apply due diligence in assuring that animals are shipped under appropriate conditions to prevent morbidity or mortality due to temperature extremes or other adverse events. When animals are shipped from an institution, that institution should consider and address all relevant factors to ensure safe transport of the animals. OLAW expects shipping institutions to report adverse events that occur to animals in transit. Receiving institutions should notify the shipping institution when animals are received in extremis or dead.

Are laparoscopic procedures considered major surgery?

Surgical procedures can be categorized as major or minor. (See Guide page 117.) Major survival surgery penetrates and exposes a body cavity, produces substantial impairment of physical or physiologic functions, or involves extensive tissue dissection or transection (e.g., laparotomy, thoracotomy, joint replacement, and limb amputation). Minor survival surgery does not expose a body cavity and causes little or no physical impairment (e.g., wound suturing, peripheral vessel cannulation, percutaneous biopsy, and most procedures routinely done on an outpatient basis in veterinary clinical practice). Animals undergoing a minor survival surgical procedure typically do not show significant signs of postoperative pain, have minimal complications, and quickly return to normal function.

OLAW recognizes the authority of the IACUC to determine whether specific manipulations used in research are major operative procedures. The IACUC&rsquos determination must be based on a detailed description of the procedure and the anticipated or actual consequences, as characterized by the investigator. In some cases, the classification by the IACUC of a procedure as major or minor may be readjusted post-procedurally depending on clinical outcome. If the IACUC, after thorough review, determines that the surgical procedure only penetrates but does not expose a body cavity and that the procedure does not produce substantial impairment, the IACUC may conclude that it is not a major operative procedure. Any laparoscopic surgery that produces substantial impairment of physical or physiological function must be considered a major operative procedure. Whether the laparoscopic procedure is classified as major or minor, the IACUC must ensure that the appropriate analgesia, sterile technique, and perioperative monitoring is employed.

Multiple major survival surgical procedures on a single animal are discouraged but may be permitted if they are related components of a research project, are scientifically justified by the investigator, or if they are needed for clinical reasons. Cost savings alone is not an adequate reason for performing multiple major survival surgical procedures.

See also FAQ F9: Are multiple major surgical procedures permitted on a single animal?

Is social housing required for nonhuman primates when housed in a research setting?

There is universal agreement among oversight agencies that nonhuman primates should be socially housed. (See U.S. Government Principles for the Utilization and Care of Vertebrate Animals Used in Testing, Research, and Training Principle VII.) The Guide endorses social housing as the default for nonhuman primates. (Guide page xviii) The USDA requires regulated facilities to address the social needs of nonhuman primates known to exist in social groups in nature [See 9 CFR 3.81(a)], with certain specified exceptions [See 9 CFR 3.81(a)(1),(2), and (3) and 3.81(e)(1) and (2)]. Single housing of social primates is considered an exception to the standards under 9 CFR and must be reported as such in a research facility&rsquos annual report [See 9 CFR 2.36(b)(3)].

Staff performing nonhuman primate socialization should be trained and competent in the procedure and knowledgeable about the animals. Behaviorally compatible animals should be used whenever possible in socialization attempts. Group composition is critical and numerous species-specific factors should be taken into consideration when forming a group. Due to conformational differences of animals within groups, more space or height may be required to meet the animals&rsquo physical and behavioral needs. Determination of the appropriate cage size is not based on body weight alone. Professional judgment is paramount in making such determinations. (See Guide pages 58-61.)

Exemptions to the social housing requirement must be based on strong scientific justification approved by the IACUC or for a specific veterinary or behavioral reason. Lack of appropriate caging does not constitute an acceptable justification for exemption. When necessary, single housing of social animals should be limited to the minimum period necessary. When single housing is necessary, visual, auditory, olfactory, and (depending on the species) protected tactile contact with compatible conspecifics should be provided, if possible. (Protected tactile contact is considered single housing by USDA, with rare exceptions.) In the absence of other animals, additional enrichment should be offered (as appropriate to the species or individual animal), such as safe and positive interaction with the animal care staff, periodic release into larger enclosures, supplemental enrichment items, and/or the addition of a companion animal in the room or housing area.

Institutions are encouraged to consult the Animal Welfare Act and Regulations on primate housing requirements. Compliance with the USDA regulations is an absolute requirement of this [PHS] Policy. (Footnote 2, page 9) OLAW and USDA positions are further defined at the Nonhuman Primate Enrichment and Social Housing resource on the OLAW website.

Should positive reinforcement training be used for nonhuman primates?

In situations where it is safe and feasible, nonhuman primates should be given positive reinforcement training to perform desired cooperative activities involved with research and husbandry. This type of training may also aid in reducing stress from capture and restraint and the need for chemical darts. The Guide comments on procedural habitation and training on pages 64-65.

May performance standards determine housing issues?

Performance standards are to be applied to housing issues. Outcome-based performance standards are paramount when evaluating cage or pen space for housing animals used for research, research training, and biological testing. While the Guide's space recommendations are accepted reference points for addressing space needs (Guide pages 50-63), performance standards allow flexibility to improve animal welfare and scientific research. (Guide pages 6-7) An institution&rsquos animal housing practices must be species-specific, appropriate for the animals, and in compliance with all applicable federal and local regulatory requirements. Compliance with the applicable regulations (9 CFR Subchapter A) issued by the U.S. Department of Agriculture under the Animal Welfare Act are an absolute requirement of the PHS Policy (Footnote 2, page 9).

May performance standards determine environmental enrichment issues?

An institution&rsquos environmental enrichment practices must be species-specific and appropriate for the animals. Devices that animals climb on or through, perch on, or nest in contribute to, rather than detract from, the animal&rsquos living space and need not be subtracted from the floor dimensions. Some species are upset by the introduction of novel items. Animals should not be subjected to the presence of items that they find distressing. (See Guide pages 52-54.) Compliance with the applicable regulations (9 CFR Subchapter A) issued by the U.S. Department of Agriculture under the Animal Welfare Act are an absolute requirement of the PHS Policy (Footnote 2, page 9).

Can performance standards be used in determining rabbit housing practices?

OLAW concurs with the Guide that animals &ldquoshould be housed under conditions that provide sufficient space&hellipto meet physical, physiologic, and behavioral needs.&rdquo (Guide pages 50-51) &ldquoThe height of an enclosure can be important to allow for expression of species-specific behaviors and postural adjustments. Cage height should take into account the animals&rsquo typical posture and provide adequate clearance for the animal from cage structures, such as feeders and water devices.&rdquo (Guide page 56) Space allocations should be assessed, reviewed, and modified as necessary by the IACUC considering the performance indices and special needs determined by the characteristics of the animal (Guide page 56). IACUCs may consider the use of a rabbit cage that is 14 inches in height, if appropriate for specific animals. The IACUC should establish, through performance indices related to animal well-being, that the cage provides sufficient space to meet the physical, physiologic and behavioral needs of the animal. For example, the rabbit must be able to hold its ears in an upright position (if this is natural for the breed) and ears must not be forced to fold over by contact with the cage ceiling.

May investigators restrict animals food and fluid?

Ingestion of food and fluid are requirements for proper nutrition. When food or fluid is restricted, the amount of the regulated item earned during testing and the amount of the regulated item freely given should be recorded to ensure each animal receives its minimum daily requirements. (NRC 2003, Guidelines for the Care and Use of Mammals in Neuroscience and Behavioral Research, Washington: National Academies Press) The IACUC must evaluate the level of restriction and potential adverse consequences in regulating food or fluid. The IACUC must also evaluate the methods for assessing the health and well-being of animals involved in activities that regulate food or fluid consumption. The IACUC has the authority to approve scientific justifications for departures from the recommendations in the Guide. For instance, using scheduled access to food or fluid sources may be justified by describing procedures based on performance standards that assure adequate maintenance of hydration, body weight, and behavioral and clinical health. It may be necessary to monitor both food and fluid intake if regulation of one influences consumption of the other. The Guide discusses food and fluid restriction on pages 30-31.

G. Institutional Responsibilities

What kind of training is necessary to comply with PHS Policy, and how frequently should it be provided?

The U.S. Government Principles 1 , Health Research Extension Act of 1985 2 and the PHS Policy 3 repeatedly refer to appropriately trained, qualified, and experienced personnel, and availability of instruction and training. The institution is responsible for the training of its staff. The size and nature of institutional research programs varies significantly and accounts for the corresponding variation in the scope and depth of instructional programs and the frequency at which they are offered.

  • ensure that individuals who use or provide care for animals are trained and qualified in the appropriate species-specific housing methods, husbandry procedures, and handling techniques
  • ensure that research staff members performing experimental manipulation, including anesthesia and surgery, are qualified through training or experience to accomplish such procedures humanely and in a scientifically acceptable fashion
  • provide training or instruction in research and testing methods that minimize the number of animals required to obtain valid results and minimize animal distress
  • ensure that professional staff whose work involves hazardous biological, chemical, or physical agents have training or experience to assess potential dangers and select and oversee the implementation of appropriate safeguards and
  • ensure compliance with any initial and continuing education regarding State requirements for the licensing of veterinary or animal health technicians.

1 The U.S. Government Principles direct that, &ldquo&helliphousing, care, and feeding&hellipmust be directed by a veterinarian or other scientist trained and experienced in the proper care, handling, and use of the species being maintained or studied&rdquo (VII) and that, &ldquoInvestigators and other personnel shall be appropriately qualified and experienced for conducting procedures on living animals. Adequate arrangements shall be made for their in-service training, including the proper and humane care and use of laboratory animals&rdquo (VIII).

2 The Health Research Extension Act of 1985 requires that, &ldquoscientists, animal technicians, and other personnel involved with animal care, treatment, and use&helliphave available to them instruction or training in the humane practice of animal maintenance and experimentation&hellip&rdquo (Sec. 495.(c) (1) (B)).

3 The PHS Policy requires that institutions seeking an Assurance provide &ldquoa synopsis of training or instruction in the humane practice of animal care and use, as well as training or instruction in research or testing methods that minimize the number or animals required to obtain valid results and minimize animal distress, offered to scientists, animal technicians, and other personnel involved in animal care, treatment or use&rdquo (IV.A.1.g.) that medical care for animals will be provided by &ldquoqualified&rdquo veterinarians (IV.C.1.e.) and that, &ldquoPersonnel conducting procedures on the species being maintained or studied will be appropriately qualified and trained in those procedures&rdquo (IV.C.1.f.).

What is required for an occupational health and safety program?

The PHS Policy requires a &ldquohealth program for personnel who work in laboratory animal facilities or have frequent contact with animals&rdquo (IV.A.1.f.). The Guide states that, &ldquoEach institution must establish and maintain an occupational health and safety program as an essential part of the overall Program of animal care and use&hellipThe nature of the OHSP will depend on the facility, research activities, hazards, and animal species involved.&rdquo (Guide pages 17-23)

&ldquoA comprehensive OHSP should include a hierarchy of control and prevention strategies that begins with the identification of hazards and the assessment of risk associated with those hazards.&rdquo (Guide page 18) An effective occupational health and safety program must encompass all personnel that have contact with animals. Depending on the species of animal or the amount of animal exposure, the program may not affect all personnel equally. Minimally, the program must include:

  • pre-placement medical evaluation
  • identification of hazards to personnel and safeguards appropriate to the risks associated with the hazards
  • appropriate testing and vaccinations
  • training of personnel regarding their duties, any hazards, and necessary safeguards
  • policies and facilities that promote cleanliness
  • provisions for treating and documenting job-related injuries and illnesses
  • facilities, equipment, and procedures should be designed, selected, and developed to reduce the possibility of physical injury or health risk to personnel
  • good personal hygiene practices, prohibiting eating and drinking, use of tobacco products, and application of cosmetics and/or contact lenses in animal rooms and laboratories and
  • personal protective equipment (PPE).

Occupational Health and Safety in the Care and Use of Research Animals, published in 1997 by the National Research Council, includes helpful guidelines and references for establishing and maintaining an effective and comprehensive program.

Do awardee institutions need animal facility disaster plans?

The Guide (pages 35, 74-75) requires that institutions develop disaster plans that take into account the well-being of animals and personnel during unexpected events. Conducting a risk assessment will help to identify potential major hazards and threats, such as power outages, HVAC malfunctions, and natural disasters. Considering the geographic location of a facility &ldquomay provide guidance as to the probability of a particular type of disaster&rdquo (Guide page 35). Location-based risk should be accounted for in the disaster plan with mitigation strategies to address all known vulnerabilities.

The disaster plan &ldquoshould define the actions necessary to prevent animal pain, distress, and deaths&rdquo (Guide page 35). Institutions may find consideration of the following components useful in the development of a comprehensive, effective plan:

  • Backup systems for maintaining appropriate temperatures and ventilation if critical systems fail, including HVAC and alarms
  • Schemes for transportation and relocation, or euthanasia of animals
  • Provision of food, water, sanitation, and bedding during the disaster period
  • Provision of services during significant personnel absences
  • Establishment of institutional policies and procedures
  • Approval of the plan as a part of the overall institutional and/or local disaster plan
  • Identification of emergency responders and designation of responsibilities
  • Personnel training and practice in the disaster response
  • Utility needs in the event that primary and emergency power sources fail.

Institutions should periodically review and update the plan to adapt to program changes, evolving risk, and lessons learned from drills and actual disasters. Recent hurricanes and tropical storms provide lessons on the unpredictable nature and devastating effects of extreme weather events. Examples of the impact of these events include loss of animals located in basement facilities due to flooding, failure of back-up generators and loss of fuel supplies located in low-lying areas due to flooding, and loss of frozen reagents/specimens due to sustained power outages. Institutions are encouraged to continually re-assess their vulnerabilities as future climate changes are expected to cause higher sea levels and effect precipitation patterns and the severity of storms.

Disasters can happen at any time. With advance preparation, institutions may be able to lessen or eliminate the impact before a disaster occurs. Actions to consider are relocating animals from facilities located in storm surge areas or locations prone to flooding, cryopreserving valuable strains of animals, repositioning emergency power supplies, and backing up vital records in an off-site location.

OLAW provides a Disaster Planning and Response Resources webpage to assist institutions in planning and responding to natural and other disasters affecting animal facilities.

What kind of administrative organization works best for ensuring compliance?

Direct, clear and straight forward lines of responsibility and corresponding authority function well and allow organizations to respond quickly and effectively when necessary. Key components in such organizations are the Institutional Official (IO), the IACUC, and the attending veterinarian. The IO should have the authority to allocate organizational resources needed to maintain a smoothly functioning animal care and use program based on recommendations and advice received from the IACUC and the veterinarian. The IO should also clearly define and assign responsibilities and reporting channels for other essential program elements such as training and occupational health. The IACUC, appointed by the organization's chief executive officer, reports directly to the IO and is empowered to perform its duties without undue interference. It is recommended that the veterinarian report directly to the IO in connection with his or her responsibilities for implementing those parts of the animal care and use program that are set forth in the PHS Policy, the Animal Welfare Act, and the Guide. [A2]

What is the difference between the Institutional Official and the Chief Executive Officer?

Is post approval monitoring required?

Continuing IACUC oversight of animal activities is required and can be accomplished through a variety of mechanisms. (Guide pages 33-34) Monitoring animal care and use is required by the PHS Policy, but the Policy does not explicitly require specific post approval monitoring (PAM) procedures to compare the practices described in approved protocols and SOPs against the manner in which they are actually conducted. IACUCs are charged, however, with program oversight and as such are responsible for program evaluations, reviews of protocols, reporting noncompliance, ensuring that individuals who work with animals are appropriately trained and qualified, and addressing concerns involving the care and use of animals at the institution. The veterinarian with program authority and responsibility for animal activities along with the animal care and technical staff, add another important level of program supervision.

Related components of institutional programs provide monitoring by a multi-disciplinary team of individuals. Examples of such components include daily observation of animals by trained animal care personnel and communication to the veterinary staff for follow-up, facility monitoring by facility maintenance personnel, post operative care by trained personnel, evaluation of outcomes of animal procedures by investigators and staff, hands-on training in animal procedures, and appropriate reporting of incidents involving occupational health and safety. All of these functions and responsibilities imply a level of monitoring. Ultimately the institution has flexibility in how it achieves compliance.

Some institutions have developed PAM programs with dedicated staff that physically monitor procedures and practices associated with animal use protocols. This is one acceptable method that institutions may elect to adopt, but it is not a federally mandated requirement. Whatever methods an institution incorporates, it is important that the authority and responsibility of the IACUC not be contravened by a PAM program, institutional compliance officials, or other mechanism established to monitor animal care and use.

May institutions utilize the Guide for the Care and Use of Agricultural Animals in Research and Teaching (Ag Guide) if their programs include traditional farm animals?

PHS Policy mandates that institutions use the Guide for the Care and Use of Laboratory Animals (Guide) as a basis for developing and implementing a program for activities involving animals. The Guide states that it &ldquo&hellipapplies to agricultural animals used in biomedical research, including those maintained in typical farm settings.&rdquo It further emphasizes that the use of farm animals in research should be subject to the same ethical considerations as the use of other animals in research. (Guide, page 32)

The Guide for the Care and Use of Agricultural Animals in Research and Teaching (Ag Guide) primarily refers to agricultural animals used in agricultural research for which the scientific objectives are to improve understanding of the animals&rsquo use in production agriculture. It is therefore inappropriate to substitute the Ag Guide for the Guide based on the species of animal. However, there may be circumstances where it is appropriate to follow the standards of the Ag Guide in biomedical research (e.g., transmission studies of avian influenza under poultry production conditions). Information about environmental enrichment, transport, and handling in the Ag Guide may be helpful in both agricultural and biomedical research settings. Proposals to conduct such activities should be reviewed on a case-by-case basis and any approval to depart from provisions of the Guide must be based on scientific justifications acceptable to the IACUC.

What are the institutions responsibilities in preparing for targeting by animal rights activists?

Acts of vandalism and the threat or use of violence are tactics used by some animal rights extremist groups. Such actions endanger lives, cause millions of dollars in damage and destruction, and jeopardize biomedical research, training and biological testing. These actions are considered domestic terrorism by the FBI and are a source of serious concern for NIH and the awardee community. The Guide requires that institutions develop a plan that can be instituted if a disaster occurs. (Guide pages 35, 74-75). Additional detailed guidance on how IACUCs and Institutional Officials can prepare and protect their institution can be found in the ARENA OLAW Institutional Animal Care and Use Committee Guidebook (page 71):

&ldquoSince the IACUC has responsibility for the welfare of animals at its facility, it shares responsibility for the security of the animals and associated personnel with other groups within the institution, including the units responsible for security, public information, and governmental relations. Institutions receiving federal funds have an obligation to protect the federal investment in research by exercising due diligence in this area. The IACUC can serve a key role in advising the IO and the institution of potential risks and vulnerabilities, and in developing a plan for responding to potential or real threats. In all cases the IACUC must consider allegations of noncompliance or animal welfare issues as concerns that must be addressed in accordance with relevant PHS Policy provisions and Animal Welfare Regulations (AWRs). There are four key elements to an institution's preparedness:

  • An animal care and use program of impeccable integrity
  • A security program based on risk assessment
  • An integrated communication plan with descriptions of research projects in lay terminology, spokespersons, and a telephone tree and
  • An internal and external community outreach program that includes legislators and funding agencies.&rdquo

The ARENA OLAW Institutional Animal Care and Use Committee Guidebook goes on to describe in more detail the elements of a crisis management plan and how the institution should best prepare to respond to allegations in an honest and forthcoming fashion. OLAW encourages IOs and IACUCs to evaluate their institution's readiness to deal with potential threats in accordance with the Guidebook's recommendations. OLAW shares the concerns of Institutional Officials and IACUC members about the threats and intimidation their institutions may face and strongly encourages each institution, if it has not already done so, to:

  • Operate its program of animal care and use and its animal research facilities in accordance with its approved Animal Welfare Assurance, provisions of the PHS Policy and recommendations of the Guide.
  • Examine its portfolio of research and determine those activities that may be potentially targeted.
  • Ensure that the institutional security group works closely with local and state law enforcement to make certain that responses to illegal activities are prompt and adequate.
  • Develop a crisis management plan that safeguards the institution, prepares it to respond with openness about the research being conducted, and educates employees on how to protect their families and their personal property.

Inform the program/scientific staff of the NIH funding component of threatening or potentially threatening situations, as they arise. (If activist activities result in conditions that jeopardize the health or wellbeing of animals or result in actual harm or death to animals, the conditions must be reported to OLAW in accordance with NOT-OD-05-034.)

How can institutions and their IACUCs best prepare for a pandemic?

Institutions must adhere to provisions of the PHS Policy, the Guide, and the commitments detailed in their Animal Welfare Assurance with OLAW. This includes advance planning for conditions that could arise as a result of a human pandemic (e.g., influenza) or outbreaks of novel infections (e.g., coronavirus disease 2019) that could jeopardize the health and wellbeing of animals because of a lack of personnel to care for the animals and/or to conduct IACUC official business.

Pandemic plans developed by institutions and IACUCs should include consideration of the following:

  • Animal facilities must be maintained at a level to ensure animal welfare. Plans should consider appropriate staffing levels, cross-training to cover critical operations, and adequate inventories of essential supplies (e.g., feed, bedding, personal protective equipment, cagewash supplies).
  • The IACUC should develop a plan for conducting official business during a pandemic event, taking into account the following:
    • The IACUC must continue to be properly constituted.
    • A quorum is required to conduct official business at a convened meeting.
    • The IACUC must ensure that protocol approvals are not allowed to expire or if they do expire, that no further animal activities (e.g., data collection) are conducted.
    • Appointment and training of IACUC members (including nonscientific members and alternates) should be considered as a part of the plan. (See NOT-OD-01-017)

    In devising a pandemic plan, the institution may wish to consider using options provided in the PHS Policy that it does not choose to use in the normal operation of its animal care and use program. Social distancing means focused measures to reduce contact among people. The PHS Policy contains some provisions that can be instituted as social distancing measures to prevent the spread of disease, including:

    • The IACUC may institute alternatives to face-to-face meetings such as teleconference or video conferencing (NOT-OD-06-052).
    • The number of IACUC meetings may be reduced to as few as one every six months.
    • The IACUC may choose to expand their use of designated member review.

    For information about coronavirus disease 2019 (COVID-19), see:

    For resources that may be helpful in developing an institutional pandemic plan, see:

    Additional guidance will be developed and posted on the OLAW website if an emergency situation is sufficiently severe and long-lasting that OLAW determines that the above suggestions do not meet the needs of the research community and funding components. OLAW is the only entity authorized to make determinations regarding waivers to provisions of the PHS Policy.

    What is OLAWs position on performance standards?

    OLAW encourages the cooperative application of diverse expertise to develop outcome-based performance standards that enhance the quality of animal care and use programs. OLAW does not consider a performance standard to be a departure from the Guide. A well-developed performance standard meets the following criteria:

    • supports scientific objectives
    • supports the health and welfare of the animal
    • includes a justified performance index and
    • has associated outcome criteria.

    IACUCs are able to meet their responsibility to ensure humane animal care and use while advancing quality scientific research through the use of performance standards.

    May cost be used as justification for not implementing animal welfare standards?

    Animal welfare and the integrity of research findings, rather than cost alone, should be the primary factors in decisions related to assuring compliance with the recommendations in the Guide in PHS-funded research. (See U.S. Government Principles for the Utilization and Care of Vertebrate Animals Used in Testing, Research, and Training Principle II.) The PHS Policy and the Guide define the minimum standards (&ldquomusts&rdquo) and performance standards (&ldquoshoulds&rdquo) that OLAW expects of Assured institutions. In many instances, institutions and IACUCs elect to exceed the standards described in the Guide. This is not required and can add expense to the program. OLAW does not discourage or encourage institutions from exceeding the standards.


    More Information About Comments

    Grantee adherence to the PHS Policy on Humane Care and Use of Laboratory Animals (PHS Policy) is a term and condition of all PHS grant or contract awards that include use of live, vertebrate animals. These questions and answers provide guidance for institutions and IACUCs as they implement the PHS Policy. Institutions with species regulated by the USDA must also comply with the Animal Welfare Act and Regulations. Institutions have the discretion to establish more stringent requirements as matters of institutional policy.

    References are to previously published guidance or commentary in Dear Colleague Letters, Lab Animal Magazine, Contemporary Topics, and ILAR News which may provide additional elaboration or commentary. The information in these FAQs is updated and supersedes previous guidance or commentary.

    OLAW will update this page with new FAQs as necessary.

    OLAW welcomes comments on any of its policy guidance. Comments may be submitted to OLAW by email at: [email protected] (please insert the title of the specific guidance document in the subject field).

    All relevant comments will be considered in OLAW decisions on timing and content of revisions to guidance documents, or development of new guidance documents. Comments generally will not result in direct responses from OLAW.


    Conflict Management Strategies

    Conflict management strategies have typically comprised lethal weapons, translocation, culling and regulation of population size, and – ultimately – the combined, if often clumsy efforts to effect the preservation of endangered species. With improved scientific research and regulatory policies and laws, recent management approaches are increasingly facilitated by various coping strategies, to be discussed later on. Yet, retaliatory killings, poaching, illegal hunting, trappings and snares, poisoning, and game hunting remain common practices that go unheeded despite serious consequences in largely pristine ecosystems. Many national parks, from Alaska to Italy to South Africa, allow forms of hunting. As human-wildlife conflicts continue to escalate, inflicting direct, indirect and opportunity costs -against a current backdrop showing the biomass weight of all wildlife on Earth to be but 1%, versus 32% human weight, and 67% domesticated livestock weight (a precise percentage reversal for wildlife versus humans, from the end of the last Ice Age, roughly 9500 years ago) - preventive and mitigation measures of human-wildlife conflict is a crucially important intervention sector in the management of biodiversity and protected areas, particularly in light of ever-escalating studies that emphatically have raised the rallying cry by the global scientific community of the severity of the current sixth extinction spasm and massive losses of wildlife.


    Is treatment different for criminal justice populations?

    Scientific research since the mid-1970s shows that drug abuse treatment can help many drug-using offenders change their attitudes, beliefs, and behaviors towards drug abuse avoid relapse and successfully remove themselves from a life of substance abuse and crime. Many of the principles of treating drug addiction are similar for people within the criminal justice system as for those in the general population. However, many offenders don’t have access to the types of services they need. Treatment that is of poor quality or is not well suited to the needs of offenders may not be effective at reducing drug use and criminal behavior.

    In addition to the general principles of treatment, some considerations specific to offenders include the following:

    • Treatment should include development of specific cognitive skills to help the offender adjust attitudes and beliefs that lead to drug abuse and crime, such as feeling entitled to have things one’s own way or not understanding the consequences of one’s behavior. This includes skills related to thinking, understanding, learning, and remembering.
    • Treatment planning should include tailored services within the correctional facility as well as transition to community-based treatment after release.
    • Ongoing coordination between treatment providers and courts or parole and probation officers is important in addressing the complex needs of offenders re-entering society.

    Challenges of Re-entry

    Drug abuse changes the function of the brain, and many things can "trigger" drug cravings within the brain. It’s critical for those in treatment, especially those treated at an inpatient facility or prison, to learn how to recognize, avoid, and cope with triggers they are likely to be exposed to after treatment.


    Conclusions

    The application of disease surveillance and reporting to diseases of aquatic organisms and aquaculture health management is complicated by many factors such as the wide ranges of socio-economic and technological development in many countries, diversity of species cultured, range and complexity of environments, nature of containment, intensity of production, variety of culture systems and types of management. Although there are still problems with respect to accuracy, consistency and timely submission of reports, the system is evolving, and reporting governments are starting to realize the benefits of such a system.

    Knowledge of the aquatic species biology, aquaculture systems and practices, interaction with wild aquatic species and many aspects of aquaculture health management are needed for a multidisciplinary approach to aquatic disease control. Monitoring and surveillance activities for diseases of aquatic organisms conducted by governmental offices often remain unpublished or published in domestic languages, thus limiting the transfer of scientific and field information between developed and developing aquatic health surveillance programmes. Publication of design, implementation and results is strongly encouraged. An international/regional network to enhance the communication, training and collaboration in surveillance of diseases of aquatic organisms will greatly facilitate the knowledge sharing and technology refining.

    Surveillance, whether passive (reactive and general in nature) or active (proactive and targeted), must be supported by adequate reporting mechanisms so that suspected cases of serious diseases are quickly brought to the attention of the CA. Surveillance and monitoring efforts must be supported by adequate diagnostic capability (including appropriately trained expertise, competent laboratory and rapid-response field diagnostics, and standardized field and laboratory methods), information system management (i.e. a system to record, collate, and analyse data and to report findings), legal support structures, transport and communication networks and linked to national, regional (e.g. NACA/FAO/OIE QAAD) and international (e.g. OIE) disease reporting systems (e.g. pathogen list or list of diseases of concern, disease notification and reporting procedures).

    Surveillance is a resource-demanding endeavour and allocation of such resources, and government commitment are essential. Projects may be able to provide the start-up costs in terms of training however, governments need to find resources for surveillance implementation. Besides knowledge and understanding, surveillance programmes require significant financial support, not usually easily available and mobilized in developing countries. The combined principle of co-financing, support by international development agencies and donors with national contribution and strong government commitment is necessary. If political will and commitment from responsible authorities and cooperation at all levels (especially primary production) can be achieved, surveillance has great potential to effectively minimize the spread of diseases of aquatic organisms and enhance trade.

    The 12-point surveillance checklist presented in this paper offers a good starting point for addressing the issues and needs identified during our work in developing countries. The stepwise and pragmatic approach can be used as a model to build targeted surveillance competency (capacity/capability) and a basic reference when starting surveillance or to improve existing surveillance programmes. This approach, according to our knowledge, is not presented or discussed in this form in any peer-reviewed literature, and can be used as an educational tool for multidisciplinary groups involved in aquatic animal health efforts in developing countries and will assist in the development and application of surveillance to manage and control diseases in aquaculture. This 12-point checklist could also benefit other multidisciplinary teams dealing with AMR surveillance in aquaculture and also for integrated ‘One Health’ surveillance approaches that are presently being conceptualized in many countries covering animal, human and environmental health.

    Two important steps planned in the future include the following: (1) development of a detailed manual of procedures for the 12-point checklist and training as one of the toolkits to support the PMP/AB, and (2) surveillance evaluation.

    For the former, several countries are now testing the 12-point checklist targeting EHP, EUS and TiLV outcomes of these initial applications will provide further insights for refinement and hopefully can contribute to the dearth of publications available on comprehensive surveillance for aquatic animal and aquatic plant diseases.

    For the latter, the OIE Tool for the Evaluation of Performance of Veterinary Services (OIE PVS Tool), the audit conducted by the Food and Veterinary Office of the EU, and the Surveillance Evaluation Tool (SET), launched by FAO in 2017 (http://www.fao.org/ag/againfo/programmes/en/empres/tools_SET.html), have been widely used in capacity assessments of national surveillance for terrestrial animals. Aquaculture and the aquatic environment provides unique disease challenges as compared to terrestrial systems. However, general principles of epidemiology still apply in the context of aquaculture, and surveillance design and evaluation methodologies can be used with some minor adaptation. In fact, SET was successfully used in 2019 to evaluate and compare freshwater and marine fisheries systems in Spain with minimal adaptive changes (publication in preparation). The OIE has developed a PVS Tool specific for aquatic animal health (OIE PVS Tool: Aquatic) based on their original PVS Tool (OIE, 2020 ), and this can be a useful tool for surveillance evaluation.


    Aseptic technique: a single technique, or any technique fulfilling criteria, or collection of said techniques? - Biology

    Þ This module provides information and techniques for planning participatory training in the context of natural resource management. The main target group of this module is people who are familiar with participatory methods and tools but may have less practical experience with providing participatory training.

    To plan and facilitate training workshops in the context of participatory processes towards co-management of natural resources.

    Development of training objectives, outputs, topics, contents and inputs of a training workshop

    Training Shedules and Aendas

    Organising the framework of a workshop

    Designing a training session

    Basic approaches, techniques and skills

    Facilitatine and debriefing of training activities

    Monitoring and evaluation of training workshops

    Creating awareness of attitudes and behaviour

    Processes of changing attitudes and behaviour

    Facilitation in the field

    - Experience in planning and preparing a training workshop
    - Techniques and skills for a lively and positive atmosphere during a training workshop
    - Experience in the processes of providing a training session (e.g. lecturing and facilitating )
    - Development of self-critical awareness about personal training/facilitation style
    - Techniques for monitoring and evaluating the success of a workshop

    Initiating a participatory process in co-management of natural resources requires sensitivity and flexibility. Facilitators and trainers need to offer as much support guidance and encouragement as necessary while still maintaining a low profile, in the process. Enhancing a process of discussion, negotiations, agreements, planning and implementation amongst a number of stakeholders from different backgrounds is a challenging task. In order to enhance such activity, this source book focuses on:

    providing information to those who do not have it moderating group processes and discussions amongst different interest groups

    facilitating joint analysis and decision making

    providing training to new trainers, moderators and facilitators organising workshops

    SECTION A - Preparing a Training Workshop

    Session 1: Exploring training needs

    This session introduces future trainers to the necessity of adapting training materials to their trainees' needs. It provides some pointers on how to assess these needs and on how to use the information gathered as a basis for planning workshop.

    • importance of knowing training needs
    • methods of assessing training needs
    • ways to incorporate findings into the planning of the workshop

    Proposed Training Strategy:

    A. Discussion: Importance of Knowing Training Needs

    The first step in determining the requirements of a training workshop is derived from the expression of such a need by the respective target group.

    It often happens, that a training workshop is organised by a higher level of administration, by an implementing agency or by outsiders, while the group that is to receive training has not expressed a need for the training nor has been involved into the decisions on the content. Such a situation requires additional sensitivity from you as a trainer, because you will have to find a common level between the officially imposed training topic and the needs of your trainees.

    Whatever are the initiating and determining factors concerning the training, you will have to conduct, at least a rough analysis of the basic professional and personal characteristics of your trainees as well as their working circumstances (see "Proposed List of Factors" below). This kind of information will serve you as a basis to plan your workshop. It influences the focus, structure and timing of the workshop, the depth and theoretical background you provide, the exercises you offer and the examples you use. It is relevant in helping you design a successful training workshop which is tailor-made for the situation of your trainees and responds to their needs and interests.

    If you have a chance to contact your trainees beforehand, find out what they require directly from them. If not, contact the initiator of the training request and ask for as much information as possible about the trainees, their wishes, knowledge and experience.

    Introduce the cloud-dreamer (or another culturally adapted cartoon which has the same message) to participants and ask them first, what they see. Let them talk about different aspects and different ways of interpreting the cartoon. Then ask them, what is their interpretation of the cartoon in the context of providing training. Among the topics which could be raised is: inappropriate measures, appropriate measures but applied in an inappropriate way, appropriate activity does not meet the "target group", waste of time, energy and resources.

    From these observations lead the discussion towards the trainees' own experiences with inappropriate training or teaching measures. Let them describe, what went wrong in those situations and what might have been the causes. Invite them to think about what would have been different, if the trainer/teacher had given them a chance to influence the training/learning situation. Summarise the discussion together with the participants by establishing a list of reasons of why it is important to undertake a ‘needs assessment’ before planning for a training workshop.

    B. Exercise: Training Needs and Trainees’ Background

    Divide participants into groups of 5-7 persons and spread a proposal list of factors (see below) concerning training needs and context, which should be part of a rough background assessment. Invite them to put themselves into the situation of trainers who are preparing for a training workshop and to work on the following tasks:

    1. Discuss the listed factors and add more, if they feel some are missing

    2. Go through the list and decide, which of them could be used with which methods

    3. Decide, which ones could be assessed with the help of a questionnaire filled in by the trainees, and establish an example questionnaire concerning these factors

    4. Decide, which factors would require different methods and think of ways and means to assess these remaining ones

    Þ produce a synthesis list of all factors, which are important to the participants

    Þ before getting into a discussion on possible sources of information, reflect briefly, what kind of information

    - is needed at an individual level (e.g. previous knowledge on a topic, level of education, wishes concerning the training etc.),

    - is sufficient to assess at a general level (e.g. seasons of heavy workload),

    - might be too sensitive to ask for in a questionnaire (e.g. taboos, traditions)

    - may be beyond the self-assessment of trainees (e.g. training need in soft skills)

    Þ when starting the debriefing on questionnaires, make sure, that the problem of illiteracy and the potential need of alternative methods is addressed

    Þ discuss the different approaches for questionnaires, and have them typed and copied as example handouts for all participants talk about proposed sources of information/methods for the assessment of different factors and, if necessary, give your participants additional hints.

    - wishes, interests, knowledge, and training needs

    - education levels, working environment customs, traditions and taboos

    - homogeneity/heterogeneity/tensions/conflicts amongst the participants

    - times and seasons of heavy workload amongst your target

    Invite participants to split up into small groups of about four persons each. Ask each group to choose one person who will have to take the role of the ‘guess - person’. Give each group a list, naming some topics (e.g. preferred food, song etc.) and ask the "guess-persons" to guess, what are the other three persons in the group might feel concerning the topics mentioned. Let them note down, how many times, the ‘guess person’ succeeded in guessing right. Most probably, the ‘guess-person’ will have a number of failures. In the debriefing, compare the task of the ‘guess-person’ to that of a trainer who has to prepare a training session without knowing anything about his trainees’ previous knowledge, experiences or preferences.

    Examples of Questions to Explore Knowledge, Training Needs and Wishes of Participants

    - have you ever heard about XY?

    - if so, in which context - have you practised XY - would you describe yourself as newcomer, practitioner or expert concerning XY?

    - who decided that you take part in this workshop?

    - do you want to learn (more) about XY, and if so why do you? In what sense do you feel it could be helpful for you?

    - what is important for you concerning XY?

    - what are you looking forward to and what do you fear about this training workshop?

    - other comments/ideas/wishes concerning the training

    D. Transferring: Applying Information on Training Needs and Trainees

    Use the list of factors resulting from the debriefing of Exercise B as a basis for this exercise. Pin up the written results of the list, go through the factors one by one and discuss with your participants, which field within a training workshop would/could be influenced by each respective factors. Establish a matrix showing the fields to be influenced in connection with the respectively influencing factors to summarise the results of this exercise.

    At the end of the session, place emphasise on the fact that, even if you have done a careful training needs and context assessment, it is still important to start the workshop itself with a session on expectations, wishes and fears of your participants (see also session x, section y), in order to be able to be more responsive to needs, which may be relevant but not as closely related to the training contents.

    Session 2: Development of training objectives, outputs, topics, contents and inputs of a training workshop

    This session provides an introduction to focusing a workshop towards certain training objectives and to planning and designing training inputs.

    • training objectives
    • planning the contents of a training workshop
    • elaborating the schedule of a training workshop

    Proposed Training Strategy:


    This is a complex session. It may be useful to repeatedly refer back to the outline of the session to help the participants stay on track.

    A. Introduction The Walk Example

    It is probably best to begin this session with a brief introduction about the importance of having an ‘objective’. The text below may be a good opener.

    "You may wonder, why it is important to clearly define the objectives of a training workshop. Try to compare the workshop with a walk that somebody has to take in order to reach a particular place. As long as the person does not know what particular place to aim for, he or she will not know in which direction to walk. The same applies to the workshop - as long as you don't know what you want to achieve, you and your trainees may work for some time without reaching what you wanted to reach."

    B. Exercise: What are Objectives

    Participants are divided into three groups. Each group is asked to come up with their definition of the term ‘objective’ and three reasons each why it is important to define the objectives of a training workshop. The working results are presented in a plenary session, discussed briefly, and if necessary complemented by the trainers.

    Make sure, that you don't get bogged down in semantic details. The important point is that participants have grasped the idea of an objective being a kind of guiding direction. Introduce your own definition only if the main ideas of what is an objective are not covered by the participants' proposals or if participants express the need to have an additional definition.

    Collect all ideas and create a synthesis chart on a flipchart: "why it is important to clarify objectives of a training session".

    Example of a definition of "Training Objectives":

    The objectives of a training workshop describe the desired changes which the participants hope to achieve in the training programme the purpose for which the training is conducted.

    Examples of reasons why it is important to clarify objectives of a training workshop:

    objectives are the basis for determining a training strategy

    objectives help to determine the necessary outputs and contents of the training

    objectives provide a direction for all training activities

    objectives help give a structure to the training

    objectives help trainers and participants to stick to their common goal

    C. Input Formulation of objectives

    Once participants have a common understanding of what objectives are and why they are important, they face the problem of how to formulate them. This can be more difficult than one might think. One way to define the objectives is by asking "What is going on now?" and "What should be different after the training?". If this method is too abstract, you may introduce the "Helpers" for the formulation of objectives listed below.

    "Helpers" for the Formulation of Objectives (Source: adapted from PL&A)

    There are some questions which make it much easier to make oneself clear about formulating the objectives.

    - Why is the training conducted?

    e.g. in order to encourage co-management of the natural reserve

    e.g. the staff of the national nature reserve

    - What is the primary content to be communicated in the training?

    e.g. participatory processes and tools

    Objective formulated out of the example answers:

    The staff of the national nature reserve is able to apply participatory tools and enhance participatory processes in order to encourage co-management of the national nature reserve.

    Remind participants to be aware of the information they have on their trainees and the present level of knowledge these trainees possess. The objectives they can realistically reach in a training workshop depend upon on the level they start from.

    D. Input: Introduction of an example on outputs, topics, contents, inputs

    Summarise, what your participants have learned about how to assess training needs and how to formulate objectives of a training workshop. The next step in preparing a training workshop is to think about how to fulfil training needs and how to reach the training objectives. In other words, one has to plan for the content and the procedure of the training workshop.

    Explain in simple words to your participants what this means. They have to think about:

    - what results their training workshop should achieve (produce) in order to meet the objective they have decided upon ( outputs ),

    - the problems they have to address ( topics ) during the training in order to get these results

    - the exact information they have to provide ( contents ) in order to cover the topic and fulfil the training needs of their trainees

    - the form in which they want to present this information ( training input )

    E. Exercise: Elaborating outputs, topics, contents, inputs

    Participants are spread into groups of not more than five persons. Each group has the task of elaborate training outputs, topics and contents for a fictive training workshop. They receive a pre-formulated objective of a training example, a rough description of a ‘made-up’ target group and a sample of a pre-prepared matrix.

    In order to understand these different steps, it will be helpful for your participants to do an exercise on a topic, which is a less complex and easier to manage than the planning of an entire training workshop. The example should refer to a simple topic, which does not distract attention from the actual planning steps. It may be best to chose an objective referring to a simple procedure which a common part of the daily life of the participants, e.g. The tourist from Europe is able to ride a camel after training in the art of camel riding.

    It can be very enlightening to give the same example to all work groups and alternate only the description of the target group. The differences appearing in the results (or not) will help your participants to develop greater sensitivity for adapting training contents to the training needs of their target group.

    Example for a training's planning matrix

    The tourist from Europe is able to ride a camel after training in the art of camel riding.

    (the results which your training has to produce)

    (the problems which must be addressed in order to have the desired effects)

    (the exact information you want to provide during the training)

    (the form in which you want to transport the information)

    Which steps do you have to introduce to the tourist in order to enable him to ride a camel

    What does he have to know for that?

    Which details do you want to give him?

    How do you provide this information?

    1. distinguish the camel from a goat

    Its general shape & height

    e.g. photo show plus flipchart

    knowing the right words of command

    e.g. real life presentation with the camel

    knowing the right command

    balancing in the saddle so as to stay on

    e.g. real life presentation with the camel

    Conclude the session by discussing the complexity of planning a training workshop. Encourage your participants to undergo this process nevertheless, because it is the basis for the success of the training effort. It will save trainers a great deal of trouble during the implementation of a workshop, if they have properly planned it beforehand.

    Despite the importance of sound planning, emphasise also the fact that a training agenda and the connected training contents should never be used in a dogmatic fashion. Good trainers always remain open and flexible and respond to the mood, feedback and interests of their trainees.

    Session 3: Training Schedules and Agendas

    This session is aimed at introducing participants to the difficulties of setting up a training schedule and provides examples of training agendas.

    Proposed Training Strategy:

    A. Introduction: The pressure of limited time

    Emphasise at the beginning of this session the one major problem of scheduling training sessions: Time is never enough! Begin this section with a few introductory sentences such as:

    "The last step in planning a training program is the task of designing an appropriate training schedule. This means looking at the training inputs you want to provide, the time which you will need for each session and the overall timeframe of the workshop. It is often difficult to match up these elements. In most cases, the number of inputs envisaged is far too ambitious for the time given. The few days set aside for the workshop seem to be insufficient for all the topics one may want to offer to the trainees. In this context, it is better to reduce the number of topics than to overload the workshop. In either situation you will eventually have to leave out certain inputs, which you might feel are important. If you do this during the planning of the schedule, you have control over what gets left out. If however, you create an overcrowded schedule, you will simply have to leave out which ever inputs fall at the end of your programme when you run out of time".

    B. Brainstorming Points to remember when designing a workshop schedule

    Sit together with your participants and hold a brainstorming exercise on what you will have to remember when setting up a training schedule. Put all the responses up on flipcharts and discuss whether they need to be expanded. Add to the participants ideas whichever of the following points are not raised by the group:

    - daytime/hours of the training

    which times of day might exclude a certain group of potential participants (e.g. daytimes, when women have to do a certain types of work), which times should be dedicated to breaks (e.g. when participants usually have their meals/prayers/siesta etc.)

    - time dedicated to each of the sessions

    inputs, exercises, energisers, monitoring, breaks (e.g. make test-presentations and try exercises and energisers out with the preparation team remember that exercises generally take twice the time you think they will)

    - time dedicated to unforeseen events

    in any training workshop there will be unforeseen events, such as e.g. the trainees' wishes to have additional inputs, longer discussions on certain topics or additional exercises. Add on an additional 10% of the workshop time for such events.

    C. Exercise: Guessing time requirements

    This exercise is meant to sensitise trainers to the topic of time requirements and improve their capacity to guess the duration of certain sessions. Prepare a list of activities such as energizers, exercises and common tools with a multiple choice set of possible answers concerning the duration of the activity. Give each participant a copy of the list and ask them to guess which answer is most likely.

    Prepare an flipchart of the list and the answers and go through it with the group. If there are answers where participants have guessed very unrealistic time requirements for certain sessions, work jointly with the group to think of all the different steps involved in that session. Give them examples which clarify how long simple procedures like "Let's all sit down" may take. Invite participants to talk about their own experiences with planning workshop schedules and the lessons they have learned from them.

    To give your participants further guideline, hand out copies of sample schedules from other workshops. Examine these schedules together and look at the various durations of different sessions. Invite questions, or comments related to these schedules.

    Discussing your personal experiences during past training workshops is often a very effective means of putting the message across

    D. Input Trainers' and Trainees' Agenda

    Give a brief description of what a trainers' and a trainees' agenda are and what needs they have to fulfil. Mention, for example, that a trainers' agenda is (G&F) minutely detailed, includes the outputs of every session, and is for the trainers' use only. A trainees' agenda, however, is limited to general topics and approximate time allocations in order to offer an overview and to allow for greater flexibility. Examples of both are found below.

    Example of a Trainer’s Agenda

    Opening and Introductions

    Trainer notes for opening

    "Climate setting". (a) warm, friendly atmosphere (b) stimulate interest and curiosity (c) enable trainees to begin thinking about gender analysis (d) encourage trainees to get to know each other

    Objective clarification: (a) present statements or questions to the trainees which clarify the purposes of the workshop (b) provide an opportunity for trainees to add objectives.

    Method clarification: (a) Discuss role of trainees and trainers in participatory workshop (b) Explain Case Study method

    What is Gender Analysis? Small group exercise or role play

    Questions or role play descriptions

    Issues clarification: (a) take mystery out of "gender analysis" (b)clarify one or two key concepts (c) facilitate participatory exchanges, e.g. One group to represent village women whilst others represent village man, city man or city woman.

    Overview of Gender Analysis and forestry Plenary Session

    Framework presentation notes plus slides or overheads

    Problem identification: overview of the problems or issues with respect to gender roles and forestry

    Introduction to methods and skills, clarify key concepts in gender analysis, and give overview of how to use the Gender Analysis Framework.

    Make it relevant: explore reasons why learning about gender analysis may be important and useful to this specific group of trainees

    Introduction to Case Study

    Slide show Projector Screen

    Provide information: (a) review facts on gender roles in case study forestry project area (b) reinforce learning from written case study (c) visually transport trainees to project area, making issues meaningful (d) visual relief

    Introduction to small group work

    (a) objective clarification

    Small group analysis of Case Study for Context Profile

    Increase information, understanding and skill:

    (a) Gender Analysis Framework (b) Produce information that can be analysed (c) engage trainees in learning.

    Example of a trainee’s agenda (source: G&F)

    Opening and introductions

    Workshop Objectives and Methods

    Overview on Gender Analysis and Forestry

    Introduction to Case Study: Slide Show

    Small Group Analysis of the Case Study

    Plenary Discussion of Case Study Findings

    Small Group Analysis of Case Study

    Plenary Discussion of Case Study Findings

    Day One Summary and Closure

    E. Exercise Spreading tasks out and agreeing on a team contract amongst trainers

    Ask all participants to brainstorm about the process of distributing tasks when once there is more than one trainer. Make sure that formal criteria such as competence for the topic, balance of trainers' inputs, and availability of trainers are raised. Informal criteria must also be raised and include, for example, who likes or dislikes certain topics, who is more amusing when presenting certain inputs, and who works more effectively in the morning or in the afternoon.

    For the second part of the exercise, divide participants into groups of 5-7 persons and ask them to imagine they are working together as trainers in a big workshop for the next 3 weeks. Ask them to collect their ideas on which agreements should be included in a team contract amongst trainers. In the course of the debriefing, prepare a list of all the topics mentioned. Have them typed out, copied and distributed to the trainees. These are important handouts.

    Emphasize that it is very useful for trainees to have the agenda of a training workshop given to them at the same time that they receive an invitation to attend. This is not just a matter of politeness. It also generally informs participants about what the workshop will be about and how long it will take. Thus it helps trainees to organise their own daily activities. It can also be the basis for considering, before the beginning of the workshop, any necessary changes in the schedule or its agenda.

    Session 4: Organising the framework of a workshop

    In order to guarantee the smooth running of a workshop many things which need to be organised and a number of issues need to be clarified. As a trainer you will most probably not be responsible for general organisational issues. Nevertheless, it is useful to be aware of crucial issues so that you can offer support to the organisers.

    organisational and logistic preparation

    Proposed Training Strategy:

    A. Brainstorming: Organisational and Logistical Issues

    Invite your participants to come up with ideas about what they think has to be organised before and during a workshop. Use a flip chart and write down all the suggestions, allowing for inputs, which may not seem to be the direct responsibility of a trainers. You may put each idea on a card or a ‘post-it’ and then cluster the cards according to whether or not they appear to be the direct responsibility of the trainer.

    Add your own experiences to the brainstorming session if that seems necessary (for list of examples see below). Produce a synthesis list. Go through the list with the participants and discuss the implications of each point.

    List of Examples of Things to Organise and Remember

    Decision on the timing of the training

    It is important to know which hours, days, weekdays, seasons, times of the year are convenient to the target participants (e.g. seasons of low workload), and which ones periods should be avoided. (e.g. religious fasting periods/festivities, general holidays, harvesting season, seasons of herd movements).

    Decision about selection of workshop participants

    Let the target group take part in the decision about who should be invited , but try to ensure that the decision is based on objective criteria (beware of jealousies and hidden interests).

    For preliminary training in participatory approaches and methods, it is useful to have a heterogeneous group of participants (different levels of education, different professional backgrounds, different living conditions). If possible try to have a gender-balanced group, but be aware of the fact that, in certain contexts the presence of men may be a hindrance for women to take part in the workshop in such a case it may be advantageous to provide single gender training.

    Keep control over the number of participants - 10-20 people in a workshop is a good number. This is big enough to ensure a variety, opinions, and attitudes, but still small enough to give space for each trainee to actively participate. There is, however, no absolute rule. Each workshop has its own focus and dynamics. Some workshops may work well with well with double the number and others may be very challenging with as small a group as of 5. If you have had little experience with providing training, it is better to start with a smaller rather than a larger group.

    Getting permission from groups affected by the workshop

    All people affected by the training workshop should be informed in advance and their permission sought. These may include people in the neighbourhood where the workshop is going to be held, local leaders and/or government authorities in whose regions you plan to run the exercises, and local people who might inadvertently be used in some way during workshop activities.

    Make sure that the location of the workshop is convenient for all the participants you want to invite. That means, for example, that transport to and from the location should be available. There should be adequate space for plenary sessions as well as small group work. The physical environment, temperature, light, sitting arrangements, and general atmosphere should be of a standard which maintains good working conditions.

    Invitations to attend should be sent out early. It is also useful if each participant is given a workshop programme and some organisational information (how to get to the workshop site, who are the other participants, which facilities are provided for, etc.).

    Make sure that all technical facilities, workshop materials and equipment are available and fully functional during the duration of the workshop.

    Session 5: Designing a training session

    This unit is about how compose a training session.

    Proposed Training Strategy:

    A. Role Play: Setting up a ‘Bad Presentation’

    Often a negative example is very useful as a learning tool. In this exercise the trainer will purposefully set up a bad presentation. To do so, you need to select a page of text, which is badly structured and full of detailed information on a technical topic. Prepare one or two charts related to this information and make them as confusing as possible. Ask for three volunteers from among the participants. Explain to them what you intend to do and ask them to listen carefully to participants comments and to observe the reactions of their colleagues. When they have returned to their seats, start the ‘poor’ presentation with the remark that the information you are going to introduce is not very important, but that you are providing it as an ‘extra’. Then start reading out the text at high speed in a low monotonous voice, with no intonation, and no breaks. When you have finished reading the text, ask your participants some detailed questions on the content of the text. Most probably, they will have difficulties in answering your questions.

    Ask your trainees to imagine that the whole of workshop was designed like this poor presentation. Ask them why they had problems in answering the questions and what they felt was difficult about the overall training approach of this session. Make sure that problems like "lack of motivation", "difficulties to keep listening", "difficulties in remembering", "poor presentation" are mentioned.

    Discuss the reasons for these problems.

    Ask the observers to describe the comments and mood of their colleagues during the test. Hopefully they will come up with inputs like "felt bored", "were confused", "got slightly angry", "did something else". If they don’t make these comments, ask the participants if any of them felt bored, or was confused. Conclude the debriefing with few remarks about how destructive a bad presentation can be for both training success and for the attitude of the participants.

    B. Transferring: Challenges for a good training approach

    Divide participants into small groups and invite them to refer back to the ‘poor presentation’. Ask each group to deal with one of the problems in the poor training approach and to think about possible ways to avoid the respective problem in a training situation. Let them come up with examples of strategies for concrete learning situations. For example, if the group is dealing with the problem "lack of motivation", they should not just come up with solutions like "motivate for the topic", but with proposals such as: "start with an energiser on the topic" or "invite participants to talk about their own experiences" etc.

    C. Input: How to compose a training session

    Give a brief introduction to the important characteristics of successfully designed training sessions. This should include discussion about how to combine different sorts of inputs and how to pace the contents.

    Designing a Training Session

    When introducing a new topic, it is important to grab your trainees' interest and to clarify the relevance of the topic for them personally. It is very helpful to start each session differently, and thus attract the attention of your trainees by making them wonder what is going to happen next.

    Try to design your training sessions in as interesting and lively fashion as possible. This does, not necessarily imply that you have to play the full-time entertainer. But you have to aim for a good balance between concentration and relaxation, serious work and some fun, passive learning and active participation, theoretical discussions and practical application. This means you will need to use a multi-sensorial training approach (let participants see, hear, speak, do) which integrates trainees' knowledge and experiences as much as possible.

    what you hear - you forget
    what you see - you remember
    what you do - you can replicate

    Pace and Content of Sessions ( Source: PL&A )

    It is important to structure each session carefully. Always ask yourself

    How much do they already know?
    What do they need to learn?
    How much time do you have to cover the material?

    To help in the selection of material, think about what the participants:

    The day after a ten-minute talk, the average member of the audience is unlikely to remember more than one or two major points. It is natural to want participants to learn everything we teach them. But too much detail covered too quickly will hinder the success of a presentation. For a 30-minute talk you should select no more than five main points, or ‘golden nuggets’. The rest is detail to keep everyone interested.

    The session should then be structured around the key points you think they MUST know by the end of the session. Always repeat the golden nuggets or central ideas. Repetition reinforces memory. If you are trying to communicate five main points to the group, then try to save the most important for last. Begin by capturing the interest of the group, and then give a taste of what is to come. Deliver the detailed message in the main body of the presentation and build up the most important point. Then summarise everything by restating the purpose and the major points.

    Whether you are giving a lecture or facilitating a group exercise, planning a session around these three stages will help to ensure that the key issues are remembered. If you are planning to give a lecture, then it will be more effective if you follow these stages:

    • tell them what you are going to tell them
    • tell them
    • tell them what you have just told them.

    Allow plenty of time for the preparation of notes and materials. A safe rule of thumb is to allow double the time of the presentation for preparation. But if you are presenting a topic for the first time, it may take much longer. Do not forget to plan anecdotes and jokes as part of your presentation. A good speaker or trainer makes jokes or remarks which appear unrehearsed but are likely to have been prepared. A trainer may well have said the same thing several times before. But a well-planned joke or story can sound spontaneous and can reinforce the learning points. For each training session, it is very helpful to prepare a planning sheet which clearly lays out what it is you intend to do and achieve.

    Try to introduce new topics with a balanced combination of fun, attracting attention, information and application. Such a combination could look like this:

    Example for a combination of training inputs concerning topic XY:

    Þ to have fun, create awareness for the problem XY and so attract the attention of the trainees for further information on XY

    Þ collecting trainees' ideas and knowledge on the topic XY

    3. Short theoretical input

    Þ information, providing an overview of what is important to know about the topic XY, always referring back to the trainees' former contributions on the topic

    Þ application - collect trainees experience and elaborate on topic XY

    Þ create a common level of understanding by resolving remaining problems and open questions establish further connections between the working/living situation of the trainees and XY

    6. Closing down the session

    Þ summarise the content of the session, put it into the context of other sessions or the whole workshop or give additional hints which go beyond the actual content of the session

    Note : Even when you like the example combination or another combination of training inputs, try not to stick to rigidly to it - otherwise the sequence of training inputs becomes a routine as well.

    In considering the presentation of the topic you want to work about, as yourself:

    • what may be difficult for the participants.
    • what could be of special interest for them.
    • where and how could they apply it.

    Then try to integrate involve these factors when designing the training inputs for the specific topic.

    D. Discussion: Providing theoretical inputs

    Refer back to the ‘Poor Presentation’, role play. Point out that most training workshops require theoretical input. Ask the participants to come up with their experiences of good and bad lectures and invite them to express their ideas about what makes a "good" lecture. Use a flipchart and write down their ideas adding to them, if necessary.

    Providing theoretical inputs

    It is hard to imagine a training workshop which has no theoretical introductions or explanations. Moreover, no matter how important such theoretical inputs might be, they are the most difficult parts of a workshop to manage.

    Research has shown, that after listening for more than 15-20 minutes to a lecture, most people have difficulties maintaining their concentration and tend to drift away. Try to keep this in mind when you want to introduce a topic.

    Restrict yourself to a few main points. Your input is more successful, if your trainees remember 5-7 general points, than if they only remember 1-2 very detailed ones.

    Help the trainees to remain concentrated and to follow your inputs by providing good and clear visual aids or flip charts (see also VIPP) in combination with well-structured handouts which summarise the contents of your input.

    SECTION B - Conducting the Workshop

    Session 6: Basic approaches, techniques and skills

    This session introduces basic approaches, techniques and skills which help create a positive training atmosphere and learning process.

    Proposed Training Strategy:

    A. Discussion: Participatory versus top-down training

    Ask participants to discuss differences between participatory training and top-down teaching. Encourage them to express their opinions and get them to discussion the advantages and disadvantages of both approaches. Introduce the overhead "traditional teaching and participatory training".

    Participatory Training versus Traditional Training ( Source: G&F )

    teacher’s role is to tell students what they need to know

    trainer’s role is to ask questions, and to facilitate discussions

    teacher is more knowledgeable and experienced than students

    both trainers and trainees are knowledgeable and experienced

    teacher shares her/his knowledge with the students by lecturing

    everyone must reflect on her/his own, then share their ideas, experiences, and expertise

    students are passive, just listening and taking notes

    trainees are active and analytical, asking questions and exploring alternatives

    students learn the right answer from their teachers

    trainees develop their own answers - indeed, there may be many different answers

    Ask the participants to discuss what kind of skills and personality traits make a good participatory trainer. Distribute handouts with background information on good trainers, on participatory training, and on the stages of control in the training process (see" Background Materials at the end of this session").

    B. Exercise: Positive working atmosphere

    Start a discussion about which features influence the atmosphere of a training workshop and how to create a positive working atmosphere. Use a flip chart to write up the ideas and encourage additional inputs, if you feel that important points are missing. Introduce some tools and techniques to help create a positive working atmosphere (see example no.5 in the "Background Materials" section). Let participants decide on their own activities as trainers, i.e. which of the features listed they would want to control or influence and at which stages of a workshop. Organize the suggestions into a useful sequence. In this way you will have created a hypothetical checklist. Have it typed and distributed to the participants

    C. Brainstorming: Learning support

    Ask participants to come up with their own experiences in learning situations. Which activities and techniques from their trainers made it easier to follow the training content. Which ones made it more difficult while remaining committed to the training process. Use a flip chart to write up the results. Supplement this list, if necessary with additional points such as:

    - having a visual training agenda within the training room and repeatedly referring back to the outline/greater context (Þ helps trainees maintaining an overview )

    - handouts (Þ avoids trainees losing their concentration trying to write notes )

    - visualisation of working steps and results on charts or cards (Þ helps trainees follow a working process and maintain an overview )

    - open questions board (Þ prevents distraction from the actual )

    - debriefing and Closing down (Þ helps to keep the main lessons learned in mind )

    - monitoring and evaluating the learning process (see session x) (Þ allows trainees to reflect their learning status and helps trainers to react and tailor-make their inputs )

    - Variety of training techniques (Þ makes the training more interesting and thus helps to maintain attention of trainees )

    D. Input: Variety of training techniques

    Give a brief introduction as to the advantages of a wide variety of training techniques and give a number of examples.

    As all of us know, routine activities become boring after a while. The same applies to training inputs: if the training is always using the same kind of methods, trainees will lose their interest. Therefore it is very helpful to use a wide range of methods and techniques in order to introduce different topics, such e.g. eye-openers, energisers, brainstorming, short inputs, pre-elaborated reports from trainees, exchange of experiences, group exercises, case studies, slide shows, films, brain-training-games, creativity techniques, drawings, guests' talks etc.

    Emphasise the importance of good training conditions and encourage your participants to reflect on their own good and poor training experiences before they attempt to set up any workshop themselves. This will help them to develop a better idea about their trainees' perceptions of the workshop approach and adapt it accordingly.

    1. "Participatory training"
    2. "What makes a good trainer"
    3. "Stages of control in the training process" (PL&A, page 9)
    4. Example list on tools and techniques to create a conducive working atmosphere
    5. Summary paper on training approaches
    6. Energisers as Training Support
    7. Background paper on seating arrangements

    1. Participatory Training ( Source: G&F )

    Participatory training is "participatory" because learning occurs through the active involvement of the trainees. They are the ones who develop the answers. It is "training" because learning opportunities are created by presenting new information together with analytical methodologies for trainees to discuss and consider in light of their own work experiences. Participatory training is very different from traditional "teaching".

    Many of the principles of participatory training draw on theories of adult learning. Adults learn more by doing, than by listening. Adult learning theory stresses that adult learners need opportunities to think , to understand , and to apply .

    To learn by thinking , trainees need to have responsibility to work out their own conclusions

    To learn by understanding , trainees need to relate the learning experience to their own values, beliefs, and previous experiences.

    To learn by applying , trainees need to use and test new skills and receive feedback on their performance.

    Learning is accompanied by change - changes in behaviour, knowledge, understanding, skills, interests, values, awareness, and attitudes. To facilitate these changes in adult learners, experiential activities, during which participants work out their own conclusions, are more effective than lectures. Thus, participatory workshop trainers need to match learning activities with learning outcomes. Good training courses include a broad variety of learning activities, including presentations, games, and role play, each with its merits and uses.

    During participatory training, activities are selected specifically to encourage trainees to engage with the materials and become active and animated - trainees offer ideas, raise questions, build on one another’s statements and challenge one another’s opinions. They learn from, and with, other participants and work together on a collective analysis.

    The trainers are also active and mobile. During participatory training, the trainers’ job is to structure and facilitate rather than deliver information, explain, or provide answers. Trainers initiate discussion and then draw in the trainees. They amplify some trainees’ comments and summarize others’ they compare and connect separate remarks and point out opposing views. They draw the threads of discussion together and relate them to the workshop’s objectives.

    Participatory training is structured around the ability of the trainees to reason, to analyse problems, and to work out their own solutions. It emphasizes the process of inquiry, and therefore participatory training workshops often end with questions as well as conclusions.

    2. What makes a good trainer ( Source PL&A )

    Many of the problems that appear in groups are ultimately related to the personality and skills of the trainer or facilitator. Jenny Rogers put it this way:

    "Thinking back to my own schooldays and to the teaching I have encountered since, the outstanding teachers all shared an enthusiastic, open, relaxed style while teaching."

    To be a good facilitator requires time and experience, and learning by doing is the best way. The most effective trainers and facilitators have a range of key characteristics (adapted from Jenny Rogers, 1989):

    • a warm personality, with an ability to show approval and acceptance of trainees
    • social skill, with an ability to bring the group together and control it without damaging it
    • a manner of teaching which generates and uses the ideas and skills of participants
    • organising ability, so that resources are booked and logistical arrangements smoothly handled
    • skill in noticing and resolving participants’ problems
    • enthusiasm for the subject and capacity to put it across in an interesting way
    • flexibility in responding to participants’ changing needs
    • knowledge of the subject matter

    Some of these characteristics can be attributed to people’s personality. Others can be learned or improved through experience and practice. Still others can be developed by using specific exercises which are structured to provide some of the conditions for learning by participation. Most importantly, though, good facilitation requires you to be self-critical about your performance at each stage of the session or workshop. Rather than asking yourself whether you could have done better, ask what and when you could have done better. Constructive criticism from colleagues or peers is an important addition. When doing this do remember that you will never be able to fully satisfy every participant. If you have managed to encourage learning amongst the majority of your participants, then you have done your job well.

    3. Stages of control in the training process (Source: PL&A)

    FIGURE 1:1 STAGES OF CONTROL IN THE TRAINING PROCESS

    4. Examples of tools and techniques to create a conducive working atmosphere

    - actively support the process of knowing each others

    - assess expectations of trainees and respond accordingly

    - training-team-contract (e.g. leave your title outside)

    - working environment and sitting arrangement (see background text)

    - basic rules of collaboration, e.g. "every idea counts"

    - granting of mutual respect (give everybody a right and space to express his/her opinion, protect this right against others who try to interrupt, shout down or joke about contributions

    - social observation (induce a process of awareness for mutual respect, try to point out, when a comment is destructive or constructive without blaming participants for their behaviour

    - sufficient breaks and energisers

    - monitor trainees' mood (see session x) and react accordingly

    5. Summary of Training Approaches

    It is more conducive for learning and more exciting for trainees to have participatory training instead of top-down frontal teaching. This is particularly the case in the context of promoting participatory processes. Participatory training reduces lectures to a minimum and gives broad space to learning situations. Trainees are actively involved and contribute to the learning process.

    2. Self-image of the trainer

    Your self-image as a trainer is closely connected to the approach of providing training in a participatory way. Try to see yourself as a service provider instead of a teacher. Your role is not to push certain facts into the heads of your trainees, but to encourage and facilitate a mutual process of exchanging knowledge and experience amongst your trainees and between them and you. Acknowledge that their contributions to the training are as important as yours, and interact accordingly.

    3. Conducive Training Atmosphere

    A conducive working atmosphere ensures that trainees are committed to the training process and that they concentrate completely on the training contents. Distraction through negative feelings as well as through uncomfortable working and sitting arrangements can be minimised, if the trainers apply a number of simple tools and techniques. Prepare a checklist of important points and go through it repeatedly during a training workshop.

    Some trainers, unwittingly act in a way which confuses trainees instead of helping them to follow the training process. However there are some basic training activities, institutions and techniques, which when applied help in avoiding some of the major sources of confusion.

    5. Variety of Training Techniques

    Routine activities become boring after a while. The same applies to training inputs. Therefore it is very helpful to use a wide range of methods and techniques in order to introduce different topics, such e.g. eye-openers, energisers, brainstorming, short inputs, pre-elaborated reports from trainees, exchange of experiences, group exercises, case studies, slide shows, films, brain-training-games, creativity techniques, drawings, guests' talks etc.

    6. Energisers as Training Helpers

    Energisers are small games, tasks or exercises which usually bring together a high "fun-factor" with a number of important physical, social and didactical functions at the same time. They are often helpful, as well, as a break or interruption between two sessions or as introduction to a new one.

    Possible functions of Energisers:

    A relax
    B move the body and muscles
    C refresh and awaken the person

    C. build a feeling of equality and break down hierarchies
    D. break the ice within a group
    E. improve a heavy atmosphere by having fun together

    - introduce to a new topic
    - create awareness of a problem
    - awaken interest for the following inputs

    7. Seating Arrangements ( Source: PL&A )

    Seating arrangements have a big influence on a workshop session. Although these can vary greatly, there are six main types (see illustrations):

    1. Rows of tables and/or chairs
    2. Hollow U-shape
    3. Banquet or fish-bone style
    4. Conference table
    5. Circle of chairs
    6. Table trios

    Each arrangement has particular advantages and disadvantages. In general, the more group work you have planned, the better it is to use the banquet or fish-bone style. This does not require the moving of chairs, and therefore limits the disruption as you shift from a presentation or lecture to a ‘ buzz’ group. Think about the type of chairs. Are they so comfortable that your participants might doze off in the middle of a slide presentation? Is it a room that the participants know well and if so, are they likely to sit in familiar seats of their own? Many people are used to sitting in rows, knowing that they may be able to daydream or fall asleep at the back. If you decide not arrange them in rows, then you should explain to your participants why you have made these arrangements. If you have the time, you could initiate a session to explore the relative advantages and disadvantages of each arrangement. Be creative with seating arrangements. They should not be seen as static, and rearranging them can help to keep participants active. Robert Chambers describes how he continually changes the seating: "I use sequences a lot. For a one day workshop, I start with participants sitting in threes at tables. Then after a few buzz groups, I join tables for a chart exercise (such as participatory mapping on the ground or paper). Then for fruit salad all the tables are moved to the wall, leaving space for circles and much else with practical work, ending the day with no chairs at all."

    Session 7: Facilitating and debriefing of training activities

    This session provides a theoretical understanding of what is meant by the term facilitation. It also gives participants an idea of the role of facilitators within the context of training activities.

    Proposed Training Strategy:

    A. Introduction: the term "Facilitation"

    Invite participants to recall their own practical experiences with participatory research tools and ask them for their interpretations of the term "facilitation". Collect all ideas on a flip chart and ask the participants to compose a definition of facilitation which covers as many of these ideas as possible.

    Example for a definition of the term "Facilitation":

    Facilitation, in the context of participatory processes, means the provision of support and, if necessary, guidance in different situations. These may include, for example, doing analysis procedures, undergoing social processes, applying certain tools, conducting participatory workshops, enhancing medium or long-term processes towards increased participation.

    Having composed a definition of facilitation, then discuss with the participants the role and performance of the person who undertakes the facilitation, that is, the facilitator.

    The facilitator takes a central role in guaranteeing the smooth, goal-oriented and successful running of training activities, as well as the involvement of all participants in such a process. Additionally she/he has the task of creating a positive atmosphere in which participants experience and exercise attitudes and behaviours appropriate to participapotry engagement. Some traits common to good facilitators include:

    - being neutral

    - keeping personal opinions out of the dynamics of the process.

    - being a good observer (keeping an eye on social interaction and content of the work)

    - encouraging participants to exercise fair and respective behaviour towards each others - reminding them as often as necessary of the key-principles and attitudes of participatory processes

    - being a kind of instrument, maintaining a balance between letting the group work on their own and assisting actively in order to avoid unnecessary detours and friction

    B. Input: Facilitation of Training Activities

    Facilitation of training activities is less complex than that of ‘real life activities’. It also has a slightly different focus. The latter is primarily goal-oriented. Facilitating training activities, however, is mainly oriented towards achieving an understanding amongst trainees of certain tools and the processes.

    Facilitation of training activities

    Facilitation in a training context has a special focus. Instead of being mainly output-oriented (like facilitation in real-life situations), the facilitation of training activities is mainly focused on participants' understanding of certain activities, tools and exercises. It is also concerned with connected processes and the lessons to be learned from them.

    The first step towards successful facilitation of training activities is the provision of clear working instructions. Visual aids and handouts repeating the tasks of an exercise are very helpful.

    When you facilitate an exercise, encourage your trainees to organise the process of working together as team. That means, for example, clarifying the task and the working steps which are necessary to fulfil an objective. It also means setting a realistic time management plan. Remind participants to think about whether or not they want to chose a moderator and assign other roles to the team members. Encourage them to write out their working steps and processes. And ask them to prepare their work for presentation to the group.

    During exercises remain with the group, but keep a low profile. Let the group start on their own. Mix in only when you feel that the working process has not started, or the group is lost and needs your support, or alternatively, when the group asks you for additional inputs.

    Give participants enough space for discussions. It is more important for them to be clear about where there are difficulties and problems in mapping than for them to create a perfect map exercise.

    Within a training situation you should allow a group to take unusual working steps (e.g. interrupt the working process to discuss with a resource person), deviations or even decisions which may be problematic in terms of fulfilling the task they were given. Such experiences can turn out to be very useful learning experiences and trainees may remember them much more clearly than had you simply talked about them.

    C. Discussion: Importance of having a debriefing

    Invite participants to discuss what they feel is helpful/needed from the trainer at the end of an exercise or a training session. Ask them to consider why it may be important to have some kind of final evaluation. Collect their ideas and list them on a flip chart as a reminder for your trainees.

    Closing down a session ( Source: adapted from G&F )

    The closing down part of a session is the momentum to:

    - summarise key findings of the training session

    - link the findings of the session to the training objectives

    - link the findings of the session to those of past sessions

    - add additional important points, hints, or warnings, which are going beyond the actual message of the session

    Concerning the overall-flow of the training, the closing down of the session has similar functions as the debriefing of a training activity - it is an official conclusion of the respective session, which prepares trainees for the following ones.

    D. Input: How to debrief and close down a session

    Build on trainees' remarks during the discussion and present a flip chart or other visual aid on closing down a training session and debriefing. Introduce the ‘helpful questions for a debriefing’ (see below) and invite participants to add others.

    The debriefing is the final part of a training activity and a way to:

    - recapitulate and reflect on the process of work

    - analyse and explain experiences and results

    - answer open questions and clarify difficulties and problems

    - draw conclusions and formulate lessons learned from training activities (e.g. exercises, brain-storming, role games, eye openers, etc.).

    A debriefing is a vital part of any training activity, which has a message. Through the use of debriefings, you can provide a guarantee that there will be a common understanding among a group of trainees and that the activity has a positive impact on the training success. Even if an exercise did not achieve its intended results, many lessons can be learned from it through a professional debriefing. In the didactic sense, a debriefing helps help trainees to conclude certain learning step, to understand their role in the course of the training session and to clear their minds for the following one.

    A debriefing should be given after each activity. However there can be no rigid rule. Sometimes sub-activities within a session may constitute a logical entity and can be debriefed separately or jointly at the end of a sequence of steps.

    The trainer has the responsibility of setting up and managing a useful debriefing. Once participants have understood the role of a debriefing, they can do it on their own. However even with experienced trainees, the facilitator can support the process by asking guiding questions and leading the stream of discussion to key-points and lessons. See below some examples of introductory guiding questions.

    Helping questions for a debriefing

    - what happened?
    - what did you feel?
    - what was your impression of the collaboration?
    - how was the atmosphere and why was it so?
    - which were the activities/persons that influenced the process?
    - what have you learned and what do you feel, you still ought to learn?

    - was the task clear?
    - which were your working steps?
    - which are your results and how did they come up?
    - which steps were easy?
    - where did you meet difficulties?
    - what have you learned and what do you feel, you still ought to learn?

    During the process of debriefing, the trainer/facilitator should try to keep a low profile. Questions should not be answered immediately, but be reflected back to the group. The solution of a problem should come from the group itself, while the facilitator supports the participants with guiding questions.

    Facilitators should encourage trainees to freely participate,. He/she should also keep trainees from making general judgements such as "this is wrong" or mutual accusations such as "it was just your fault, that. ". The facilitator should point out what has been done well and emphasise on the fact. Even deviations or tensions during group work can be pointed out to have a value within the training context, because one can always learn and improve from such situations.

    In ending a session record on flip-chart the important lessons learned during the activities of the unit and make them part of the final wrap-up of the session as well as the workshop documentation.

    Session 8: Monitoring and Evaluation of Training Workshops

    This session provides tools to monitor the run of training workshops with an eye to adapting training activities to the actual requirements of the workshop. It also provides techniques to evaluate the results of a workshop so as to make improvements in future training measures.

    • Importance of Monitoring and Evaluation
    • Monitoring tools
    • Evaluation techniques
    • Follow up

    Proposed Training Strategy:

    A. Introduction: "Cloud Dreamer"

    Refer back to the "Cloud Dreamer" (in session no. 1) and ask participants why the performance of the man is so poor and what could have been done to improve the situation. Ask them to think of parallels between the "Cloud Dreamer" and the trainers within a training workshop. Solicit their thoughts and encourage them to talk about the importance of observing and reflecting upon training processes.

    Relevance of monitoring and evaluation in a training context

    Monitoring and evaluation techniques are an important and vital part of any successful and professionally conducted training workshop. These tools help trainers to constantly check and adapt:

    • whether the training meets the needs of the participants
    • whether the mood of the trainees is conducive to a positive a learning process

    The earlier you know whether or not your training is what the participant are hoping, the better your chances of reacting to the situation and adapting the training context accordingly

    Furthermore, the feedback from trainees can be a precious source of information to improve your own capacities as a trainer. If you receive critical remarks, try to avoid taking a defensive, offended stance. Deal with these comments openly and honestly. You will find, in most cases, that the feedback you received was right-to-the-point, and offers you the chance to learn from your mistakes.

    Using a flip chart, work out with the participants a common definition for "monitoring" and for "evaluation".

    Definitions: Monitoring and Evaluation

    Monitoring a training workshop means to constantly observe and analyse what is happening during the workshop in terms of learning and social processes. This is vital in order to be able to react and adapt as early as possible to tensions or problems. It can also be used to become aware of particularly successful phases in the workshop, where the mood and learning processes are especially good in order to replicate them in the future.

    Evaluation is an activity which is carried out ‘ex post facto’, after the event. It can help to establish:

    - what was good or bad within the workshop (for example, your performance as trainer, the topics discussed, the atmosphere, etc).

    - an analysis of why it turned out as it did.

    - conclusions about what has been learned and how it can be applied in future work

    B. Brainstorming: "How to do it"

    Ask participants to come up with ideas on how to monitor and evaluate the success of training workshops. Encourage them to talk about their own experiences in training workshops they have attended in the past. Allow them also to be creative in their suggestions. Collect all their ideas together on a flip chart and come up with a brief description.

    C. Input: Tools and Techniques

    Add to the results of the brainstorming exercise by introducing additional tools and techniques for monitoring and evaluation. Mention, that there are many informal ways of monitoring and evaluating. Among them are sorrow observation of trainees, informal chats during breaks, and critical self-assessment.

    Critical Self-Assessment ( Source: PL&A )

    Conducting training sessions or workshops in participatory methods is always exhausting. If you are new to training, then you will be surprised at how tired you feel at the end. Make sure that you have space and time to recover.

    Do not organise workshops back to back. Immediately after the workshop is a critical time to learn from the experience, even though you will be tired. If you wait, you will forget many learning points. You can learn through self-reflection or by asking participants for comments.

    It is an excellent habit to make notes on your performance as soon as possible so you can improve next time. Analyse the good and bad points by reviewing each session thoroughly. How could it be done better next time? How accurate was the time-keeping? Were you able to maintain the interest of the trainees?

    Focus in particular on the weak points of your performance. It is from mistakes that we can learn most. Why did some parts not work well? Would a change of style or substance have helped? Were you responding to the participants’ needs? Or were there peculiar conditions or factors involved? Think carefully about the detail. Your audience was learning from you and you can now learn from them how to do an even better job next time.

    Make a list of the things you know you do not do well. This is not easy. For many people, it is easier to focus only what went well. Did you, for example:

    make sure that you did not mumble to yourself?

    allow sufficient time for questions to be raised?

    show too much material on overhead transparencies?

    include too many games/exercises/practical sessions at the cost of reflection and discussion?

    become irritated with the organisers before the session started because of the bad room, lack of chalk, broken slide projector, etc.?

    talk too long and too quickly?

    try to make the breaks too short?

    A good way to learn from your trainees is to ask them to evaluate you. This can be done formally with a written evaluation of their overall training experience. Do not ask more than one or two pages of questions. You could ask them specific questions about the content and organisation of the overall workshop, relevance of the content for their work, the trainer’s style and preparedness and the logistical arrangements and adequacy of the venue.

    Another way to evaluate a workshop would be to ask them to comment on each of the major sessions in terms of its organisation, content and style. Still another approach would be to ask open questions:

    "What did you find most useful about the training?
    What did you dislike about it?
    If you were organising a training of this kind, then what would you do differently?
    What would you do the same way?"

    You may also want to leave space for any additional comments people would like to make.

    However you structure the evaluation form, ensure that you leave sufficient time for the participants to consider and respond to the questions. It is generally advisable to distribute the forms a day or two before the end of training. If you wait until the very end, the responses will be hastily written and less thoughtful. Ask them to fill it in the forms before they leave, otherwise you may never see their comments.

    Remember that only you and a selected group of other people (typically the organisers) will have the opportunity to read the written evaluations once they have been completed. Therefore, in addition to asking the trainees to complete a formal evaluation, you may want to set aside time for an informal plenary discussion to receive comments about any aspect of the training. This gives each person the opportunity to express his or her views, whether positive or negative, so that the other participants can hear them. This need not take more than 20 minutes, but it is advisable to leave some time for a free-ranging evaluation.

    Another way to make evaluations is through public exhibitions. You can prepare a set of questions, written up on a chart and stuck up on a wall. Each participant then enters his/her comments under the appropriate question. These questions are useful for rapid feedback:

    • Which of your expectations or fears were met?
    • What did you find most useful?
    • What did you find least useful?
    • How could this be done better another time?
    • How will you use participatory methods in your work?

    The following tools and techniques (see the annex) have been shown to be very helpful for monitoring and evaluation in the context of participatory training workshops:

    • Knowledge Cycle
    • Mood Barometer
    • Flashlight
    • Grumble Box
    • Evaluation Questionnaire

    Emphasise the point to your participants, that neither monitoring nor evaluation have any value if the results are not followed up. If you analyse the successes and weaknesses of your workshop with input of your trainees and then don't respond as the results demand, participants will most probably feel aggrieved. This is quite understandable, because you would be giving the impression that you care, but in reality doing nothing would indicate that you are not interested in their opinion.

    SECTION C - Attitudes & Behaviour in Participatory Processes

    Session 9: Creating awareness of attitudes and behaviour

    This session introduces information on attitudes and behaviour which can help or hinder the participatory processes. It shows, how training workshops can create awareness and enhance the first initial process of positively changing attitudes and behaviour.

    • positive attitudes and behaviour
    • personal level challenges
    • enhancing processes of changing attitudes and behaviour

    Proposed Training Strategy:

    A. Role-Play: Recognising Different Attitudes and Behaviours

    The trainers perform 6 different short role-plays. They should show six different attitudes and behaviours:

    intolerance,
    inflexibility,
    top-down-attitude,
    passive attitude,
    dominant communication behaviour
    poor listening behaviour.

    Divide participants into three observing groups, and assign each to analyse 2 of the role-plays each. Hand out the pre-prepared task-sheets for exercise B. One group should act as specialists for "perception" (intolerant attitude & inflexible attitude), a second should assess "oneself and others" (top-down-attitude & passive attitude), and the third, "communication" (dominant communication behaviour & poor listening behaviour). Chose as an example a situation which is well known from the personal and cultural context of your trainees. For example, the trainees could role play a discussion between a sheepherder and a government official concerning the possibilities of gaining access to government controlled grassland (plantations).

    B. Exercise: Analysis of Attitudes and Behaviours

    This exercise is aimed at getting the participants to analyse the role-play. Prepare a task sheet, showing the following questions:

    - how would you characterise the behaviour of person x?
    - what could be the reasons/root causes for such a behaviour?
    - why could such behaviour be a hindrance within a participatory process?
    - which behaviour would be more positive instead?

    Hand out the sheets before the presentation of the role-plays in order to give the an opportunity to read and be clear about the task analysis expected of them. Let the sub-groups work on their analysis separately and then hold a common debriefing.

    C. Input: Approaches to Change Attitudes and Behaviours

    Prepare a presentation showing factors, which can influence attitudes and behaviour in the context of participatory processes. Introduce the relevant information to create awareness about obstacles to changes of attitudes and behaviours together with the respective tools to do so. Combine this with the introduction of approaches how to implement and experience changes of attitudes and behaviours.

    Background text on challenges in changing attitudes

    Enhancing a change of attitudes is fundamental in order to encourage participatory processes among persons and groups who are not used to working and acting together in a co-operative and non-hierarchical way.

    A small number of fundamental attitudes provide the basis for all participatory processes:

    - mutual respect

    - acknowledgement of each others' needs, rights, and abilities

    - validity of each others opinions as well as the connected behaviour

    This sounds like a very trite remark, but in reality, the lack of such attitudes seems to be the biggest problem hampering participatory processes.

    Therefore it is vital to encourage attitude and behavioural changes rather than introducing as many participatory tools as possible during a training workshop on participation.

    Personal Level Challenges

    Changes of attitudes and behaviour are processes which take much longer than the duration of a workshop. But the workshop is the framework within which you can create awareness and start developing new attitdues and behaviour. Once your trainees are sensitised to such changes and have agreed to implement them permanently, there are some tools and techniques, which allow for a continuous development towards new attitudes (see session 10).

    There are 3 major factors of attitude and behavioural patterns which strongly influence a person's ability and readiness to get involved in participatory processes:

    Factors influencing attitudes and behaviours in participatory processes

    These factors are intimately connected the persons involved in participatory processes. They can buildup or destroy the basis of the participatory process. They should therefore be addressed thoroughly in any participatory training workshop.

    When you provide training to enhance participation, make sure that you dedicate at least a quarter of your training time to changing attitudes and behaviour. Ensure sure that this topic comes up again and again during the workshop introduce techniques to sensitise participants to each others’ behaviour and repeat them as often as possible. In your presentation on the factors which can influence attitudes and behaviour, use some of the relevant particpatory tools found in the annex, such as the eye openers.

    Discuss the content of your presentation with the participants. Ask them to tell you about their own experiences concerning attitudes and behaviours and ask them to suggest tools which may be useful. Then put forward those tools, which they may not have mentioned. Emphasise again the importance of repeatedly returning to these attitude and behaviour changing tools.

    Tools and Approaches to Induce Attitude and Behavioural Changes in a Workshop

    Many trainers have difficulties in concretely addressing attitudes and behaviours within training workshop. They feel, that they can't do much about it and hope that changes will arise automatically, once participants are confronted with participatory philosophies and tools. However, there are concrete tools and approaches to create awareness about attitudes and behaviour (see table).

    Observed Attitude/ behaviour

    assessment of oneself and others

    - selective perception due to personal background

    - different perceptions due to unequal selection

    - different rationality behind actions or decisions

    - legitimacy of these differences

    - enrichment of processes resulting from these differences

    - worth of each and every person participating

    - feelings of inferiority/superiority due to age, social status, wealth, education etc.

    - different perceptions and their legitimacy

    - taking each others and each others ideas serious

    - communication problems (interrupting, wrong listening, neglecting ideas)

    - learners' types (visual, audio)

    - greeting in unknown language

    - discussion and debriefings

    - monitoring and discussing about processes

    - basic rules, e.g. "every idea counts"

    Session 10: Processes of changing attitudes and behaviour

    This session provides an overview of different phases in changing attitudes and behaviour. It proposes some approaches on how to start creating an awareness and rethinking of attitudes and behaviour. It also promotes a further process of enhancing such changes beyond a training workshop.

    • phases of changing attitudes and behaviour
    • supporting the process beyond the training

    Proposed Training Strategy:

    A. Input: Phases of Changing Attitudes and Behaviour

    Introduce the ‘phases’ model (see below) to your participants and describe the characteristics of the different phases. Ask participants to adopt this model

    Phases of Changing Attitudes and Behaviour

    As a trainer you have to be aware that a workshop alone will not be sufficient to sustain attitudes and behaviour change towards greater participation. Such a process of change consists of different phases and you have to think of how you can best support the proceedings from phase to phase, and beyond the workshop.

    Phase 1: Awareness Creation/"Eye Opening"

    This is the first contact of the trainees with a certain topic/problem. Give them the chance to have an emotional response - a chance to be surprised and curious about the topic - before you give further information. Good tools to do so are Eye-openers, Role Plays, Energizers.

    Phase 2: Information Phase

    Once your trainees have had preliminary exposure and are curious about the topic, they will probably be interested in hearing some theoretical input about it. In connection with such input, you can also provide some tools or guidelines, which can help them to deal with the respective topic in a working situation.

    Phase 3: Experience/Application

    Make your whole training workshop a context that allows your trainees to experience the advantages of participatory processes again and again. Let them feel how positive it is with:

    every idea counting,
    people listening to each others
    mutual respect expressed for each others opinions
    work taking place successfully in a team.

    You can greatly influence these experiences. Try to observe processes carefully and sensitise your trainees (without blaming them) to behaviours and expressions of attitudes which are not conducive to participatory processes.

    Phase 4: Institutionalisation/Further Process

    It should be quite straightforward to agree on a certain code of behaviour among all the participants during a training workshop. Many ideas are new to your trainees, the atmosphere is positive, and they are open and curious. However, the task of maintaining the newly acquired behaviour and attitudes after the end of the workshop - when people get back to their usual daily working environment - is much more challenging.

    Give them instruments and tools to monitor and evaluate their own behaviour and attitudes after the training workshop. Encourage them to create institutions such as monthly meetings to exchange experiences and to distribute clear responsibilities among themselves concerning these institutions. If possible, provide them with further supervision within their working environment and organise follow-up training.

    B. Exercise: Approaches to Support the Different Phases

    Refer back to the discussion of personal level challenges (see session 9). Divide participants into four groups and invite them to deal with one phase each. Let them think of additional approaches on how a trainer/process facilitator could support the changes within the respective phases. Ask them also to talk about the appropriate frame to implement the respective approaches. Discuss the different ideas and, if necessary, add to these with further proposals on tools and techniques.

    Approaches and Frame for the process of changing attitudes and behaviour

    C. Application: Strategies to Work on own Attitudes and Behaviours

    Clarify first, that this step is neither a game nor an exercise, but an activity, which is leading over to the "real life after the workshop". Ask participants to come up with proposals, how to divide themselves into groups for this activity. The criteria for persons being together in one group should be, e.g. that they are working together or that they are working in the same region. Ask the groups to develop a strategy on how they want to institutionalise their personal efforts of maintaining and further improving attitudes and behaviour, which are conducive for participatory processes. Ask them to define a set activities and responsibilities with this in mind. Emphasise the importance of coming up with a realistic plan, which is feasible even after everyone has returned to their original work. Consider carefully the feasibility of their plans during the debriefing, adding practical hints to encourage participants to adopt and implement these plans outside of the workshop setting.

    SECTION D - Facilitation in the Field

    Session 11: Facilitation in the Field

    This session provides a brief overview of the many different tasks a trainer has to fulfil when facilitating group work in the field. Unlike the facilitator of training exercises (see session 7), the field work facilitator is under pressure to support the respective group in producing concrete results. Additionally the facilitator has to aim to guarantee a positive working atmosphere for, sometimes, very large groups of people.

    • Tasks of a facilitator in the field
    • Critical self-awareness
    • Sensitising observation skills

    Proposed Training Strategy:

    A. Exercise: Comparing Tasks and Challenges

    Divide participants into groups, let them have a look at the responsibilities and challenges of a training facilitator and invite them to elaborate on the differences between them and those of a facilitator in the field. Encourage them to think especially about tasks and responsibilities which are not so obvious. Use a flipchart to record the group’s findings and synthesise these points into a common list, adding further points, if necessary.

    B. Brainstorming: What Makes a Good Field Facilitator

    Invite participants to remember situations where they facilitated a group process or saw other persons facilitating them in the field. Ask them to give their ideas on what makes a good field facilitator and also what a good facilitator should avoid.

    Basic Rules For Facilitators ( Source: FAO Participation Website )

    There are some basic steps which can help in fulfilling the complex task of a facilitator (they must be adapted each time to the respective on situation):

    1. Make sure that there is a positive working environment (e.g., enough space and light, appropriate temperature, minimal outside disturbances, necessary equipment readily available, well-prepared agenda, visual materials, handouts etc).

    2. Try to get prior information on all participants in order to be able to assess their strengths and weaknesses thus providing optimal support to each of them.

    3. At the beginning of a working session, ask participants to introduce themselves (if time/group size does not allow for that, give an overview of which groups/professional backgrounds are represented). Then present the agenda/purpose/goal and timeframe of the meeting in a visual form and allow time for questions, followed by comments, contributions, and suggestions for additions and changes.

    If you are dealing with a group that is going to work together for more than one session, introduce team work rules (see module IV, session on team work) and propose that group members decide upon a team contract. This would be a set of rules decided upon by the group which regulates how they want to be treated, how they will behave with each other and so on. (Such a " team-contract " is a very helpful tool to refer back to in the event of conflict or friction).

    4. If the group is not familiar with VIPP ( Visualization In Participatory Processes, see xy ), briefly explain the advantages and introduce the (visual) VIPP-rules. Then let the group decide, whether or not they want to use VIPP.

    5. Invite the participants to discuss, and if necessary adapt a proposed agenda and then start work according to this agenda - offer proposals on working procedures and tools to be used, but do not insist or feel offended if the group decides on something else. Encourage quieter persons to contribute and tactfully restrict those who tend to talk too much. Continue to guide the group from a distance checking that they stick to the subject, to their way of dealing with each other, and to their timeframe. If necessary assist them in taking common decision to change any of the above.

    6. At the end of the session, give a (visual) summary of achievements and pending issues . If necessary, let the participants decide on the next steps and those who will be responsible to initiate them. If they wish to do so and if time allows, let participants talk about their perception of the process and how it might be improved during another working session.

    C. Application: Trainees Facilitate Tools

    This part of the learning process is the hardest, as participants will have to put into practice what they have learned and then they will be confronted with a feedback situation. They should now, one after the other, facilitate their colleagues use of different PRA-tools. They should each receive feedback on their performance. Ideally the contents of the exercises should refer to the real-life, working situations of the participants and result in practical outputs, which may be used in the future.

    Although this is a very time-consuming activity, it is worthwhile since newcomers learn to observe themselves and to recognise their strengths and weaknesses as facilitators. It makes sense to offer this exercise as part of intermittent training, perhaps one such exercise day per week.

    Emphasise that these applications have a second objective: they will train participants in sensitivity and observation skills as well as skills in giving constructive feedback. This is of great value in their role of future trainers.

    The feedback should consist of three parts:

    Prepare a guide list of points to be observed (see example below). If you have the technical possibility to use videos, it can be of great help for the participants to see themselves facilitate and for you as trainers to do debriefings.

    Invite the respective participant to sit down in a quiet corner after his/her facilitation experience and write down everything he/she observed during the process. This first summery should be a rough draft (what was good - what was bad). Then he/she should go through the detailed observation guide list and repeat the exercise. The last step might be the video - if the exercies was taped - and refining the written observations.

    2. Feedback from other group members

    Avoid holding an open feedback round, as it can be hurtful and embarassing for the person in question. Rather let all group members read through the guide list for observation and note down their comments on a piece of paper during the process and additionally after the session. Emphasise that positive comments are as important as negative ones. Collect all comments, check them for fairness and keep them for the feedback discussion with the participant.

    3. Feedback from the trainers

    Sit together in a quiet place, just you and the person to receive the feedback. Mention first, that no facilitator starts off as a good facilitator. To be a good facilitator requires along process of practice, evaluation, and critical self-reflection. Emphasise, that in this context, no mistake is a bad mistake, as long as one is prepared to learn from it.

    Invite the participant to offer his/her own observations, starting with what has been good. Then add the observations of other group members as well as your own. If there is a large discrepancy between self-assessment and the perception of others, try to discuss, why this is so (if there is a video of the event, have a look at it together). Discuss the negative observations in the same sequence. Then invite the participant to come up with his/her lessons learned and add to these, if necessary.

    Guidelines for Observation

    Observation as a basis for feedback should address facilitators' performance in supporting: a positive group process and working atmosphere a well-structured working process (keep the group on track and reach certain results within the given time)

    Guide Questions for Observation of Group Processes

    - was the working environment/sitting arrangement positive - if not, did the facilitator try to improve it?

    - do you have the impression that all group members were clear about the task/exercise/tool they were to carry out?

    - did all group members participate equally?

    - Did the facilitator try to encourage quieter participants?

    - were there persons dominating the discussion - did the facilitator try to reduce their influence?

    - were all ideas taken up and discussed - were they all equally taken into consideration?

    - Was their tensions within the group - was there a sense of achievement or disappointment, or frustration?

    - did the group look after the less experienced/less well informed persons?

    - were there factions emerging or opposing subgroups? - did the facilitator attempt to bring about a general rapprochement?

    - did all participants seem to be following the topics being discussed?

    - did the facilitator succeed in balancing guidance with low profile managment? How?

    Guide Questions for Observing the Working Process

    - how did the facilitator explain the activities to be undertaken?

    - was there an agreement on the steps to be taken and the timeframe?

    - did participants start work immediately or was there some reluctance - if so, how did the facilitator respond?

    - what did the facilitator do to enhance progress (e.g. technical hints, examples)?

    - were there deviations or side-discussions which did not contribute to the actual objectives of the task - if so, how did the facilitator resolve the situation?

    - where there problems within the working process - if so, what kind of solutions did the facilitator offer?

    - did the facilitator help participants to keep an overview on the process, e.g. by summarising different opinions or common achievements?

    · feedback is preferably just between two persons

    · if you provide feedback, imagine yourself in the position of the receiver

    · watch the other person carefully and try to make sure that you are not upsetting him/her

    · give personal messages, so called "I-messages". In other words, make it clear that what you say is just your personal opinion. Start your statements with "I have the impression that. " or "It seems to me, as if. "

    · avoid statements like "you always do. " - refer to concrete situations instead. For example "when you were talking about xy, you did. "

    · try to avoid adjectives which have a strong negative connotation, like " bad ", " boring ", " wrong " as they will probably hurt the feelings of the other person and thus distract attention or create a defensive reaction. Rather talk about effects on yourself. For example instead of saying " Your presentation was boring " you could say " In my opinion , your presentation could have been more lively - therefore, it was difficult for me to concentrate at times "

    · adapt your feedback to the personality of the other. For example, a very self-confident person may tolerate stronger words and clearer messages, while a person who is already very critical and unsure about his/her own style of facilitation, might feel a complete "loser" if you come up with strongly adverse comments.


    Scientific Research in Education (2002)

    In Chapter 2 we present evidence that scientific research in education accumulates just as it does in the physical, life, and social sciences. Consequently, we believe that such research would be worthwhile to pursue to build further knowledge about education, and about education policy and practice. Up to this point, however, we have not addressed the questions &ldquoWhat constitutes scientific research?&rdquo and &ldquoIs scientific research on education different from scientific research in the social, life, and physical sciences?&rdquo We do so in this chapter.

    These are daunting questions that philosophers, historians, and scientists have debated for several centuries (see Newton-Smith [2000] for a current assessment). Merton (1973), for example, saw commonality among the sciences. He described science as having four aims: universalism, the quest for general laws organization, the quest to organize and conceptualize a set of related facts or observations skepticism, the norm of questioning and looking for counter explanations and communalism, the quest to develop a community that shares a set of norms or principles for doing science. In contrast, some early modern philosophers (the logical positivists) attempted to achieve unity across the sciences by reducing them all to physics, a program that ran into insuperable technical difficulties (Trant, 1991).

    In short, we hold that there are both commonalities and differences across the sciences. At a general level, the sciences share a great deal in common, a set of what might be called epistemological or fundamental

    principles that guide the scientific enterprise. They include seeking conceptual (theoretical) understanding, posing empirically testable and refutable hypotheses, designing studies that test and can rule out competing counterhypotheses, using observational methods linked to theory that enable other scientists to verify their accuracy, and recognizing the importance of both independent replication and generalization. It is very unlikely that any one study would possess all of these qualities. Nevertheless, what unites scientific inquiry is the primacy of empirical test of conjectures and formal hypotheses using well-codified observation methods and rigorous designs, and subjecting findings to peer review. It is, in John Dewey&rsquos expression, &ldquocompetent inquiry&rdquo that produces what philosophers call &ldquoknowledge claims&rdquo that are justified or &ldquowarranted&rdquo by pertinent, empirical evidence (or in mathematics, deductive proof). Scientific reasoning takes place amid (often quantifiable) uncertainty (Schum, 1994) its assertions are subject to challenge, replication, and revision as knowledge is refined over time. The long-term goal of much of science is to produce theory that can offer a stable encapsulation of &ldquofacts&rdquo that generalizes beyond the particular. In this chapter, then, we spell out what we see as the commonalities among all scientific endeavors.

    As our work began, we attempted to distinguish scientific investigations in education from those in the social, physical, and life sciences by exploring the philosophy of science and social science the conduct of physical, life, and social science investigations and the conduct of scientific research on education. We also asked a panel of senior government officials who fund and manage research in education and the social and behavioral sciences, and a panel of distinguished scholars from psychometrics, linguistic anthropology, labor economics and law, to distinguish principles of evidence across fields (see National Research Council, 2001d). Ultimately, we failed to convince ourselves that at a fundamental level beyond the differences in specialized techniques and objects of inquiry across the individual sciences, a meaningful distinction could be made among social, physical, and life science research and scientific research in education. At times we thought we had an example that would demonstrate the distinction, only to find our hypothesis refuted by evidence that the distinction was not real.

    Thus, the committee concluded that the set of guiding principles that apply to scientific inquiry in education are the same set of principles that

    can be found across the full range of scientific inquiry. Throughout this chapter we provide examples from a variety of domains&mdashin political science, geophysics, and education&mdashto demonstrate this shared nature. Although there is no universally accepted description of the elements of scientific inquiry, we have found it convenient to describe the scientific process in terms of six interrelated, but not necessarily ordered, 1 principles of inquiry:

    Pose significant questions that can be investigated empirically.

    Link research to relevant theory.

    Use methods that permit direct investigation of the question.

    Provide a coherent and explicit chain of reasoning.

    Replicate and generalize across studies.

    Disclose research to encourage professional scrutiny and critique.

    We choose the phrase &ldquoguiding principles&rdquo deliberately to emphasize the vital point that they guide, but do not provide an algorithm for, scientific inquiry. Rather, the guiding principles for scientific investigations provide a framework indicating how inferences are, in general, to be supported (or refuted) by a core of interdependent processes, tools, and practices. Although any single scientific study may not fulfill all the principles&mdashfor example, an initial study in a line of inquiry will not have been replicated independently&mdasha strong line of research is likely to do so (e.g., see Chapter 2).

    We also view the guiding principles as constituting a code of conduct that includes notions of ethical behavior. In a sense, guiding principles operate like norms in a community, in this case a community of scientists they are expectations for how scientific research will be conducted. Ideally, individual scientists internalize these norms, and the community monitors them. According to our analysis these principles of science are common to systematic study in such disciplines as astrophysics, political science, and economics, as well as to more applied fields such as medicine, agriculture, and education. The principles emphasize objectivity, rigorous thinking, open-mindedness, and honest and thorough reporting. Numerous scholars

    For example, inductive, deductive, and abductive modes of scientific inquiry meet these principles in different sequences.

    have commented on the common scientific &ldquoconceptual culture&rdquo that pervades most fields (see, e.g., Ziman, 2000, p. 145 Chubin and Hackett, 1990).

    These principles cut across two dimensions of the scientific enterprise: the creativity, expertise, communal values, and good judgment of the people who &ldquodo&rdquo science and generalized guiding principles for scientific inquiry. The remainder of this chapter lays out the communal values of the scientific community and the guiding principles of the process that enable well-grounded scientific investigations to flourish.

    THE SCIENTIFIC COMMUNITY

    Science is a communal &ldquoform of life&rdquo (to use the expression of the philosopher Ludwig Wittgenstein [1968]), and the norms of the community take time to learn. Skilled investigators usually learn to conduct rigorous scientific investigations only after acquiring the values of the scientific community, gaining expertise in several related subfields, and mastering diverse investigative techniques through years of practice.

    The culture of science fosters objectivity through enforcement of the rules of its &ldquoform of life&rdquo&mdashsuch as the need for replicability, the unfettered flow of constructive critique, the desirability of blind refereeing&mdashas well as through concerted efforts to train new scientists in certain habits of mind. By habits of mind, we mean things such as a dedication to the primacy of evidence, to minimizing and accounting for biases that might affect the research process, and to disciplined, creative, and open-minded thinking. These habits, together with the watchfulness of the community as a whole, result in a cadre of investigators who can engage differing perspectives and explanations in their work and consider alternative paradigms. Perhaps above all, the communally enforced norms ensure as much as is humanly possible that individual scientists&mdashwhile not necessarily happy about being proven wrong&mdashare willing to open their work to criticism, assessment, and potential revision.

    Another crucial norm of the scientific &ldquoform of life,&rdquo which also depends for its efficacy on communal enforcement, is that scientists should be ethical and honest. This assertion may seem trite, even naïve. But scientific knowledge is constructed by the work of individuals, and like any other enterprise, if the people conducting the work are not open and candid, it

    can easily falter. Sir Cyril Burt, a distinguished psychologist studying the heritability of intelligence, provides a case in point. He believed so strongly in his hypothesis that intelligence was highly heritable that he &ldquodoctored&rdquo data from twin studies to support his hypothesis (Tucker, 1994 Mackintosh, 1995) the scientific community reacted with horror when this transgression came to light. Examples of such unethical conduct in such fields as medical research are also well documented (see, e.g., Lock and Wells, 1996).

    A different set of ethical issues also arises in the sciences that involve research with animals and humans. The involvement of living beings in the research process inevitably raises difficult ethical questions about a host of potential risks, ranging from confidentiality and privacy concerns to injury and death. Scientists must weigh the relative benefits of what might be learned against the potential risks to human research participants as they strive toward rigorous inquiry. (We consider this issue more fully in Chapters 4 and 6.)

    GUIDING PRINCIPLES

    Throughout this report we argue that science is competent inquiry that produces warranted assertions (Dewey, 1938), and ultimately develops theory that is supported by pertinent evidence. The guiding principles that follow provide a framework for how valid inferences are supported, characterize the grounds on which scientists criticize one another&rsquos work, and with hindsight, describe what scientists do. Science is a creative enterprise, but it is disciplined by communal norms and accepted practices for appraising conclusions and how they were reached. These principles have evolved over time from lessons learned by generations of scientists and scholars of science who have continually refined their theories and methods.

    SCIENTIFIC PRINCIPLE 1Pose Significant Questions That Can Be Investigated Empirically

    This principle has two parts. The first part concerns the nature of the questions posed: science proceeds by posing significant questions about the world with potentially multiple answers that lead to hypotheses or conjectures that can be tested and refuted. The second part concerns how these questions are posed: they must be posed in such a way that it is

    possible to test the adequacy of alternative answers through carefully designed and implemented observations.

    Question Significance

    A crucial but typically undervalued aspect of successful scientific investigation is the quality of the question posed. Moving from hunch to conceptualization and specification of a worthwhile question is essential to scientific research. Indeed, many scientists owe their renown less to their ability to solve problems than to their capacity to select insightful questions for investigation, a capacity that is both creative and disciplined:

    The formulation of a problem is often more essential than its solution, which may be merely a matter of mathematical or experimental skill. To raise new questions, new possibilities, to regard old questions from a new angle, requires creative imagination and marks real advance in science (Einstein and Infeld, 1938, p. 92, quoted in Krathwohl, 1998).

    Questions are posed in an effort to fill a gap in existing knowledge or to seek new knowledge, to pursue the identification of the cause or causes of some phenomena, to describe phenomena, to solve a practical problem, or to formally test a hypothesis. A good question may reframe an older problem in light of newly available tools or techniques, methodological or theoretical. For example, political scientist Robert Putnam challenged the accepted wisdom that increased modernity led to decreased civic involvement (see Box 3-1) and his work has been challenged in turn. A question may also be a retesting of a hypothesis under new conditions or circumstances indeed, studies that replicate earlier work are key to robust research findings that hold across settings and objects of inquiry (see Principle 5). A good question can lead to a strong test of a theory, however explicit or implicit the theory may be.

    The significance of a question can be established with reference to prior research and relevant theory, as well as to its relationship with important claims pertaining to policy or practice. In this way, scientific knowledge grows as new work is added to&mdashand integrated with&mdashthe body of material that has come before it. This body of knowledge includes theo-

    BOX 3-1
    Does Modernization Signal the Demise of the Civic Community?

    In 1970 political scientist Robert Putnam was in Rome studying Italian politics when the government decided to implement a new system of regional governments throughout the country. This situation gave Putnam and his colleagues an opportunity to begin a long-term study of how government institutions develop in diverse social environments and what affects their success or failure as democratic institutions (Putnam, Leonardi, and Nanetti, 1993). Based on a conceptual framework about &ldquoinstitutional performance,&rdquo Putnam and his colleagues carried out three or four waves of personal interviews with government officials and local leaders, six nationwide surveys, statistical measures of institutional performance, analysis of relevant legislation from 1970 to 1984, a one-time experiment in government responsiveness, and indepth case studies in six regions from 1976 to 1989.

    The researchers found converging evidence of striking differences by region that had deep historical roots. The results also cast doubt on the then-prevalent view that increased modernity leads to decreased civic involvement. &ldquoThe least civic areas of Italy are precisely the traditional southern villages. The civic ethos of traditional communities must not be idealized. Life in much of traditional Italy today is marked by hierarchy and exploitation, not by share-and-share alike&rdquo (p. 114). In contrast, &ldquoThe most civic regions of Italy&mdashthe communities where citizens feel empowered to engage in collective deliberation about public choices and where those choices are translated most fully into effective public policies&mdashinclude some of the most modern towns and cities of the peninsula. Modernization does not signal the demise of the civic community&rdquo (p. 115).

    The findings of Putnam and his colleagues about the relative influence of economic development and civic traditions on democratic success are less conclusive, but the weight of the evidence favors the assertion that civic tradition matters more than economic affluence. This and subsequent work on social capital (Putnam, 1995) has led to a flurry of investigations and controversy that continues today.

    ries, models, research methods (e.g., designs, measurements), and research tools (e.g., microscopes, questionnaires). Indeed, science is not only an effort to produce representations (models) of real-world phenomena by going from nature to abstract signs. Embedded in their practice, scientists also engage in the development of objects (e.g., instruments or practices) thus, scientific knowledge is a by-product of both technological activities and analytical activities (Roth, 2001). A review of theories and prior research relevant to a particular question can simply establish that it has not been answered before. Once this is established, the review can help shape alternative answers, the design and execution of a study by illuminating if and how the question and related conjectures have already been examined, as well as by identifying what is known about sampling, setting, and other important context. 2

    Donald Stokes&rsquo work (Stokes, 1997) provides a useful framework for thinking about important questions that can advance scientific knowledge and method (see Figure 3-1). In Pasteur&rsquos Quadrant, he provided evidence that the conception of research-based knowledge as moving in a linear progression from fundamental science to applied science does not reflect how science has historically advanced. He provided several examples demonstrating that, instead, many advancements in science occurred as a result of &ldquouse-inspired research,&rdquo which simultaneously draws on both basic and applied research. Stokes (1997, p. 63) cites Brooks (1967) on basic and applied work:

    Work directed toward applied goals can be highly fundamental in character in that it has an important impact on the conceptual structure or outlook of a field. Moreover, the fact that research is of such a nature that it can be applied does not mean that it is not also basic.

    We recognize that important scientific discoveries are sometimes made when a competent observer notes a strange or interesting phenomenon for the first time. In these cases, of course, no prior literature exists to shape the investigation. And new fields and disciplines need to start somewhere. Our emphasis on linking to prior literature in this principle, then, applies generally to relatively established domains and fields.


    Customer behavior patterns

    Buying behavior patterns are not synonymous with buying habits. Habits are developed as tendencies towards an action and they become spontaneous over time, while patterns show a predictable mental design.

    Each customer has his unique buying habits, while buying behavior patterns are collective and offer marketers a unique characterization. Customer behavior patterns can be grouped into:

    1. Place of purchase

    Most of the time, customers will divide their purchases between several stores even if all items are available in the same store. Think of your favorite hypermarket: although you can find clothes and shoes there as well, you’re probably buying those from actual clothing brands.

    When a customer has the capability and the access to purchase the same products in different stores, they are not permanently loyal to any store, unless that’s the only store they have access to. Studying customer behavior in terms of choice of place will help marketers identify key store locations.

    2. Items purchased

    Analyzing a shopping cart can give marketers lots of consumer insights about the items that were purchased and how much of each item was purchased. Necessity items can be bought in bulk while luxury items are more likely to be purchased less frequently and in small quantities.

    The amount of each item purchased is influenced by the perishability of the item, the purchasing power of the buyer, unit of sale, price, number of consumers for whom the item is intended, etc.

    3. Time and frequency of purchase

    Customers will go shopping according to their feasibility and will expect service even during the oddest hours especially now in the era of e-commerce where everything is only a few clicks away.

    It’s the shop’s responsibility to meet these demands by identifying a purchase pattern and match its service according to the time and frequency of purchases.

    One thing to keep in mind: seasonal variations and regional differences must also be accounted for.

    4. Method of purchase

    A customer can either walk into a store and buy an item right then and there or order online and pay online via credit card or on delivery.

    The method of purchase can also induce more spending from the customer (for online shopping, you might also be charged a shipping fee for example).

    The way a customer chooses to purchase an item also says a lot about the type of customer he is. Gathering information about their behavior patterns helps you identify new ways to make customers buy again, more often, and higher values.

    Think about all the data you’ve already collected about your customers. The purchase patterns are hiding in your e-store’s analytics and you can either look for insights manually or integrate a tool with your eCommerce platform to get automated insights about behavior patterns.


    Watch the video: Σίτιση μέσω γαστροστομιας (August 2022).