AAALAC FAQs Flashcards
The occupational health and safety department at our institution has recently required the use of additional equipment in the animal facility to minimize exposure of personnel to animal allergens (biosafety cabinets, cage changing stations and bedding dump stations). They cite language in the 2011 Guide that prioritizes engineering controls for allergy prevention over personal protective equipment (PPE). What is the AAALAC position regarding engineering controls for allergy prevention?
The Guide for the Care and Use of Laboratory Animals (NRC 2011) does emphasize the use of “engineering or process controls” for allergy prevention. It also states that “PPE should be used to supplement, not replace, engineering or process controls….” This guidance is made in the context of allergy prevention and early identification of personnel with emerging allergic symptoms. The Guide also cites the extensive literature indicating that laboratory animal allergy has become a significant issue for those in contact with laboratory animals. AAALAC International considers allergy prevention to be an important topic and a key component of the occupational health and safety program. The use of engineering controls to prevent exposure to allergens is preferred as the primary means to minimize personnel exposure. PPE should be used as an adjunct to engineering controls, rather than the foremost means of protection. Keeping in mind that the activities most associated with allergen exposure are handling animals and cages with bedding, cage changing and dumping soiled bedding in the cage wash area, appropriate engineering controls may include: proper animal facility design and function with separation of functional spaces; a well designed and functional HVAC system with appropriate airflow patterns; consideration of newer cage designs which minimize personnel exposure; and the use of containment equipment such as biosafety cabinets, cage changing stations and bedding dump stations.
The 2011 ILAR Guide (page 25) states that “Program review and facilities inspections should occur at least annually or more often as required (e.g. , Animal Welfare Act and PHS Policy).” Does this mean that if our institution is not subject to the Animal Welfare Act or PHS Policy that we can automatically reduce the frequency of our IACUC program reviews and facility inspections to an annual periodicity?
AAALAC International expects program reviews and facility inspections by the IACUC (or comparable oversight body) be conducted at a frequency and intensity that ensure prompt identification of program issues, with rapid correction of identified deficiencies. While national or regional regulations, policies and guidelines, as well as conditions of funding, may set a minimum frequency for such reviews, of greater importance to AAALAC is evidence of a highly engaged Committee that conducts thorough evaluations of the program and facilities, ensures corrective measures are taken in a timely manner, and that the program and facilities are adequately supporting the research, testing and teaching objectives of the institution. Because the conduct of timely program reviews and facilities inspections can be an effective component of overall monitoring and oversight, AAALAC International encourages Committees to carefully consider the frequency of their evaluations in order to ensure quality animal care and science. In certain programs and circumstances, self-assessments at frequencies greater than minimally required may be prudent.
On page 27, the Guide for the Care and Use of Laboratory Animals (NRC 2011) indicates that for studies that have the potential for unrelieved pain or distress, there are special considerations for IACUC review. Specifically, the Guide indicates that “the IACUC is obliged to weigh the objectives of the study against potential animal welfare concerns.” This seems to indicate that for studies involving the potential for pain and distress, the IACUC should conduct a “harm/benefit” analysis. What does AAALAC expect with regard to Committee evaluation of these kinds of studies?
The 2011 Guide specifies that the Committee is obliged to weigh study objectives against animal welfare concerns in accordance with the tenets of the Three R’s. This analysis is typically already performed by IACUCs in their reviews of proposed animal studies. AAALAC International expects that IACUC’s (or comparable oversight body), as part of the protocol review process, will weigh the potential adverse effects of the study against the potential benefits that are likely to accrue as a result of the research. This analysis should be performed prior to the final approval of the protocol, and should be a primary consideration in the review process. For animal use activities potentially involving pain and/or distress or other animal welfare concerns, the AAALAC International site visitors will assess how the Committee conducts this analysis.
We are considering using a former employee as our nonaffiliated member. They are no longer affiliated with our program and they are familiar with the type of research we perform. Are there any concerns with this approach?
The Guide for the Care and Use of Laboratory Animals (Guide), NRC 2011, does offer some guidance on the issue of what should be some of the traits of the nonaffiliated (public) member. The Guide states this person should represent the general community interests in the proper care and use of animals, should not be laboratory-animal users, and not be affiliated with the institution or be members of the immediate family of a person who is affiliated with the institution. The OLAW/ARENA Institutional Animal Care and Use Committee Guidebook (which is an AAALAC International reference resource) expands on this by stating that the nonaffiliated member can bring significant value to the committee by bringing a non-institutional perspective to the research endeavor. For programs with an NIH Assurance, OLAW provides some additional guidance in their frequently asked questions section of their website (http://grants.nih.gov/grants/olaw/faqs.htm#IACUC_1) by stating that “the unaffiliated member should have no discernable 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 nonaffiliated is the best way to fulfill the letter and spirit of this provision.” Using a former employee as the nonaffiliated member is certainly a gray area that might come into question during a site visit based on the above guidance, especially in context of the comments about the value of that member bringing a non-institutional perspective to the research endeavor and not having any discernable ties or ongoing affiliation with the institution. While not specifically prohibited, the Institutional Official should give special consideration to the use of a former employee as a nonaffiliated member to ensure that both the intent and the spirit of the Guide are being met.
We are an accredited institution located outside the United States. The Guide for the Care and Use of Laboratory Animals (NRC 2011) states that “continuing IACUC oversight of animal activities is required by federal laws, regulations and policies.” We don’t have any specific laws or regulations requiring an IACUC, though we have other equally effective methods of program oversight (e.g. , government inspections, animal welfare officer, etc. ). Will AAALAC require us to hire compliance staff to perform post-approval monitoring to maintain our accreditation?
The 2011 Guide notes the value of having a mechanism in place to help ensure that animal study procedures are conducted in accordance with the approved protocol. Post-approval monitoring (PAM) programs vary from reliance on existing activities performed by the IACUC (or comparable oversight body) to very extensive supplemental audits of protocols and the entire program conducted by compliance staff. Although AAALAC agrees that ensuring compliance with approved protocols is critical, AAALAC International interprets the Guide recommendation for a PAM program in the broadest sense for the international community, namely that there will be a system for ensuring animal procedures conform with the approved protocol or study plan.
At some recent meetings I have heard the terms “program-wide exception” and “global exception” used when talking about an Institutional Animal Care and Use Committee or comparable oversight body (IACUC/OB) approving exceptions to the Guide. Can you clarify these terms for me?
The Guide for the Care and Use of Laboratory Animals (Guide), NRC 2011 supports the use of performance standards in the event that acceptable alternative methods to engineering standards are available or unusual circumstances arise. With the advent of new scientific information and new technology, there are situations where new methods or procedures not described in the Guide may be available and result in equal or greater welfare for the animals involved. In most cases, these exceptions involve a specific project or are limited in scope within an animal care and use program. Occasionally, exceptions are wider in scope and may involve the entire animal care and use program or even apply globally in the case of organizations with facilities in multiple countries; these are often referred to as program wide and global exceptions, respectively. In all cases where practices deviate from Guide standards, AAALAC expects each IACUC/OB to establish an ongoing, documentable, site specific, data driven approach that allows for approval and monitoring of exceptions to the Guide. These criteria are essential to ensure that performance standards are properly developed and implemented in accordance with the intent of the Guide.
My institution is located outside the United States and there is no government requirement for our institution to develop a mechanism for reporting animal welfare concerns, though we have good lines of communication within our institution so that we are certain that any concerns would be discussed with management. The Guide for the Care and Use of Laboratory Animals (NRC 2011) describes a number of specific elements of a reporting system. Are all of these required?
AAALAC International recognizes that the regulatory requirement for a defined method for reporting animal welfare concerns is primarily limited to the United States. However, as noted in the Guide, it is the responsibility of everyone associated with the animal care and use program to ensure animal welfare. In some instances, this may involve having to make a formal report regarding a welfare concern. Providing a method by which such reports can be made anonymously and without fear of reprisal, and enhancing staff awareness of the importance and means of reporting animal welfare concerns through training, the posting of signage, and other communication modalities are critical elements of the reporting program. It is AAALAC’s expectation that such reports will be investigated by the appropriate oversight body (e.g. , the IACUC or comparable oversight body) and that any necessary corrective actions will be taken. In addition, AAALAC International should be informed of the results of the investigation and any subsequent corrective measures.
An investigator at my institution regularly performs survival surgical procedures on rodents in her laboratory. Our IACUC has reviewed and approved these activities. The recently updated Guide states that the laboratory should be dedicated only to surgical activities during the time that surgery is performed. Does this mean that all other activities in the laboratory must stop while surgery is being performed? What is AAALAC’s opinion?
The Guide for the Care and Use of Laboratory Animals (NRC 2011) states, “For most survival surgery performed on rodents and other small species such as aquatics and birds, an animal procedure laboratory, dedicated to surgery and related activities when used for this purpose and managed to minimize contamination from other activities conducted within the room at other times, is recommended.” AAALAC International acknowledges that limiting nonsurgical activities in the laboratory may help to minimize contamination of the surgical area. However, AAALAC recognizes that minimizing contamination during surgery may be achieved by considering several factors. The specific location of the surgical area within the laboratory should promote the proper conduct of sterile technique, and to the extent possible, it should be isolated from other activities in the laboratory. The surgical area should be dedicated for that purpose while surgery is performed. Other factors that may impact the risk of contamination include the invasiveness and complexity of the surgical procedure, duration of surgery, and the nature of other non-surgical activities conducted in the laboratory (i.e. their likelihood of increasing the risks of surgical contamination). For complex or long procedures, or if the layout of the laboratory does not permit a suitable dedicated surgical space, it may be advisable to temporarily stop other laboratory activities, thereby dedicating the laboratory to surgery in order to maximize the potential for a good surgical outcome. For minor surgeries of short duration, conducted in a suitable area within the laboratory, it may be acceptable to allow other laboratory activities to continue if they do not jeopardize aseptic technique. The investigator, IACUC (or comparable oversight body) and veterinarian should evaluate surgical areas to ensure they are appropriate.
Our IACUC receives protocols that require use of drugs or other chemicals not formulated for clinical use, which we understand to be characterized as non-pharmaceutical-grade compounds. We would appreciate AAALAC’s guidance on the distinction between pharmaceutical- and non-pharmaceutical- grade compounds and how to evaluate this aspect of these protocols.
A pharmaceutical-grade compound is defined as any active or inactive drug, biologic or reagent, for which a chemical purity standard has been established by a recognized national or regional pharmacopeia (e.g., the U.S. Pharmacopeia (USP), British Pharmacopeia (BP), National Formulary (NF), European Pharmacopoeia (EP), Japanese Pharmacopeia (JP), etc.). These standards are used by manufacturers to help ensure the products are of the appropriate chemical purity and quality, in the appropriate solution or compound, to ensure stability, safety, and efficacy.
AAALAC International acknowledges that in an animal care and use program non-pharmaceutical-grade compounds often are necessary for scientific research. Where the use of non-pharmaceutical-grade substances may be essential for the conduct of science, the goal of the IACUC (or comparable oversight body (OB)) should be to consider the health and well-being of the animals while aiding the researcher in minimizing potentially confounding experimental variables and maximizing reproducibility of the research. The Council on Accreditation will apply a performance approach to its assessment of the use of non-pharmaceutical-grade compounds, and will expect that the IACUC/OB has established acceptable criteria for use of such compounds within the institution and for review and approval of their use.
AAALAC distinguishes between two scenarios when considering the use of non-pharmaceutical-grade compounds:
Clinical Use - compounds used for the clinical treatment of animals and to prevent or reduce/eliminate animal pain or distress. Whenever possible, pharmaceutical-grade compounds must be used.
Research Use - compounds used to accomplish the scientific aims of the study. If available, and suitable, pharmaceutical-grade compounds are preferred.
In all cases when non-pharmaceutical-grade preparations are used, AAALAC International expects investigators and the IACUC/OB to consider the following factors:
Use must be compliant with applicable national or regional regulatory guidelines and requirements and the requirements of relevant funding agencies;
A scientific justification is provided;
The pharmaceutical-grade compound is not available in the appropriate concentration or formulation or the appropriate vehicle control is unavailable
The compound is required to generate data that are part of an ongoing study or that are comparable to previous work;
The chemical properties of the compound are appropriate for the study and the route of administration (e.g., the purity, grade, stability in and out of solution, solution vehicle properties, pH, osmolality, and compatibility of the solvent and other components of final preparation). In some cases the reagent-grade of the compound may be as or more pure than the pharmaceutical-grade; and
The method of preparation, labeling (i.e., preparation and use-by dates), administration and storage of formulations should be appropriately considered with the aim of maintaining their stability and quality (i.e., to prevent inadvertent co-administration of infectious agents or contaminants).
Our AAALAC accredited Veterinary College is struggling over whether or not there is a requirement for client-owned animals to be covered under a protocol since they are used for teaching purposes for veterinary students during their clinical rotations, or when they become part of a research study.
AAALAC International has had a long standing policy of following animal ownership as a mechanism for determining inclusion in the accredited animal care and use program. This was highlighted in the Spring 2003 Connection Newsletter that described the AAALAC International Rules of Accreditation regarding contract facilities and how ownership determines responsibility (click here to download). The concept of ownership also applies to Colleges of Veterinary Medicine where client-owned animals are brought in for care. Even though there are some teaching and research activities involved with this scenario, the animals are not owned by the institution and so therefore AAALAC does not consider them as part of the accredited program. For animals that are owned by the College of Veterinary Medicine being used for research, teaching or other purposes (e.g., blood donors), we would expect the Institutional Animal Care and Use Committee (IACUC or comparable oversight body) to provide oversight and for the animals to be covered by a standard operating procedure or protocol that is reviewed and approved by the IACUC/OB. There is nothing that prevents an institution from establishing some sort of IACUC/OB oversight mechanism for client-owned animals; on the contrary, it would reflect a high level of institutional commitment, but AAALAC does not require it. For institutions that also hold a U.S. Public Health Service Assurance, see additional information regarding this topic at http://grants.nih.gov/grants/olaw/faqs.htm#App_8.
