An Institutional Animal Care and Use Committee (IACUC) is by its nature a focal point (fig. 1) for communication among all parties who have a stake in the use of animals in biomedical research. While each group may seek resolutions that favor its own interests, the guidepost for IACUC members, when evaluating animal use proposals, must be the ethical use of animals in research and testing.
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Figure 1. IACUC communication pathways.
During a typical review process, IACUC members are accustomed to hearing, "You can't do that," "You don't know the science," "You have no authority," "I've done this so many times already," "That will take too long," "You are an impediment to research." (8) When a frustrated investigator says, "Just tell me what I need to do," an IACUC member may be tempted to respond, "You want me to do your animal use protocol for you?" Of course, that is not the intent of the process. The goal of this communication is to describe a review process by which all participants may expedite approval of an animal care and use proposal.
The IACUC form and the review process will vary according to local organizational needs and constraints. Ideally, the IACUC forms should be available on the computer (best practice) as well as in hard-copy editions. Computer editions must be tamper-proof to prevent errors of omission or commission.
The idea of a standardized animal care and use proposal form has been adopted by the Department of Defense (DoD) and may be considered by others nationwide. Standardization would enhance collaboration between organizations that share animal resources. Likewise, an institution that follows a national standard would be less open to criticism by the United States Department of Agriculture and animal rights groups.
An IACUC, according to the DoD general counsel (6), is a decisionmaking body, not an advisory committee. Hence, appropriate attention should be given to member selection. At the Armed Forces Radiobiology Research Institute (AFRRI), service on the IACUC is voluntary. Members and alternates who represent the scientific departments are appointed by the chief laboratory officer, as are a statistician and clinical veterinarians. Two high school biology teachers represent the community (9). All IACUC members serve at the discretion of the laboratory director, and the scientific department representatives usually serve for 2 or 3 years. There are no paid administrative and secretarial staffs.
A significant strength (best practice) of the Institute's American Association for the Accreditation of Laboratory Animal Care (AAALAC)-accredited animal care and use program is the participation of IACUC members, executive, administrative, scientific and veterinary departmental staff, and community representatives in seminars offered by the Public Responsibility in Medicine and Research (PRIM&R), Applied Research Ethics National Association (ARENA), American Association of Laboratory Animal Science (AALAS), and Scientist's Center for Animal Welfare (SCAW). Many scientific and veterinary staff members have trained at the Animal Welfare Information Center (AWIC), in Beltsville, Maryland, to increase their computer-based bibliographic search skills. Participation at these meetings is open to all staff members and does not replace in-house training mandated by the Animal Welfare Act.
Figure 2. Pathway for successful scientific and animal care and use proposal review at the Armed Forces Radiobiology Research Institute.
The IACUC proposal review process commences when an investigator conceptualizes a research idea for which internal or extramural research funds will be requested (fig. 2). Generally, a rigorous and relevant literature search (problem area) is conducted in order to generate a grant or scientific proposal to acquire research funds. If literature searches are limited to the National Library of Medicine CD-ROM's (Medline, Toxline, etc.) and the investigator's own holdings, the IACUC cannot be assured that the proposed use of animals is not unduly redundant. Therefore, it is recommended that the investigator work with a local librarian or the AWIC staff to determine which computer-based bibliographic services should be used. Because the numerous electronic databases can be expensive to use, it is incumbent on the investigator to work with a librarian to develop a strategic approach to the bibliographic search.
At AFRRI, the scientific review process is administratively separated from the IACUC review process. Thus, two documents the scientific proposal and the animal use proposal must be prepared. Unfortunately, an investigator may try to make parts of the scientific proposal also function as the animal care and use proposal by embedding scientific rationale and literature citations into the nontechnical explanation of the purpose in the animal use proposal and in the nontechnical description of the experimental design (problem area). This approach routinely causes IACUC community members to defer the proposal until only nontechnical language and selected references are used to describe the work. Furthermore, it provokes in-depth discussion that should be reserved for a specific scientific review.
At our institute, the scientific proposal must be approved by a hierarchy of scientific administrators. This arrangement, in addition to providing a review of the science, serves as a check on the duplication of effort relative to animal use (best practice). This process, however, takes time because the approval authorities are also involved in other administrative activities (problem area). Therefore, it is incumbent on all reviewers (especially those at the lowest supervisory level) to detect animal welfare issues that should be corrected before the animal use proposal is submitted for IACUC review.
When the investigator completes the IACUC form, it is submitted to the departmental representative for initial review. Since the representative may be familiar with the proposed research, input on fundamental scientific issues can be provided to the investigator in a diplomatic manner (2, 5). The review is provided as hard-copy, and the investigator adjusts the animal use proposal.
The investigator must realize that the animal use proposal is submitted into a process and is not evaluated against a static checklist of requirements. Each IACUC representative should also acquire the skill to teach an investigator about the animal welfare requirements as set forth in the IACUC form or ensure that the investigator knows where to find pertinent information.
The departmental representative submits the animal care and use proposal to the IACUC chairperson once he/she is satisfied with the investigator's adjustments in response to his/her comments. The IACUC chairperson, who evaluates all animal care and use proposals, distributes copies to a subcommittee composed of a clinical veterinarian, a statistician, two IACUC committee members acquainted with the subject species (5), and other IACUC members (7), if any, who wish to evaluate the proposal. So, including the departmental representative, the animal use proposal is reviewed by at least six different IACUC members.
Professionalism and respect for all parties during the animal care and use proposal review is maintained in the following way. Each IACUC subcommittee member evaluates the proposal and submits to the IACUC chairperson a written unsigned critique like that for a peer-reviewed manuscript. Further, the IACUC chairperson inspects all critiques to ensure the fair and impartial application of animal welfare requirements. All unsigned critiques are then turned over to the investigator's IACUC representative who in turn releases all of them at one time to the investigator (best practice). If the investigator has serious concerns relative to fairness and impartiality of the critiques, he can appeal to the IACUC chairperson for adjudication and relief.
The failure to provide all critiques to the investigator at one time (problem area) can cause significant frustration. Although the IACUC reviewer may intend to save time for the investigator by providing an individual critique, the investigator could end up revising the proposal six times instead of once.
The review process described above is reasonably straightforward. Even so, proposals reviewed by the IACUC are often returned for additional information. When this happens, an investigator may view the IACUC and the IACUC chairperson as authoritarian (problem area), a critical situation that requires the utmost diplomacy and expert guidance on how to respond to the concerns documented in the critiques. It is important to explain to the investigator that specific scientific merit is not questioned and that the IACUC's concerns are with animal welfare and proper documentation (3) that satisfies all concerned parties indicated in figure 1. Common reason for rejection of the animal care and use proposal is the lack of strong and thorough assurance documentation relative to duplication of research and alternatives for painful procedures. Investigators, in an effort to save time, may use the literature search used to establish the research proposal rationale (problem area). The IACUC must insist on a literature search that establishes whether pain can be alleviated or reduced and, if applicable, why less painful procedures cannot be used. As stated previously, valuable assistance in the performance of literature searches can be provided by the local librarian or the staff at AWIC.
The astute investigator responds to all the critiques and indicates in some manner to his/her IACUC departmental representative that all concerns of all IACUC reviewers were addressed. The departmental representative reviews the revised document (best practice) for compliance with adjustment requests and, if it is satisfactory, indicates to the IACUC chairperson that the animal care and use proposal is ready for full committee review. The animal care and use proposal is then placed on the IACUC agenda, which is distributed several days prior to the meeting.
The fully adjusted animal care and use proposal must meet with the approval of the departmental representative. At the meeting of the full IACUC membership, the chairperson again offers to all IACUC members the opportunity to review the adjusted animal use proposal. If there are no requests, the departmental representative (best practice) provides an oral review of the proposal and stands for questions from the whole committee. The investigator may be invited and may request to present the review. If not presenting the review, the investigator is alerted to be in the vicinity of the meeting area to answer technically difficult questions. Based on the relationship that develops during the review process, most investigators trust their departmental representative to present the review. Likewise, many investigators are uncomfortable or even intimidated by a committee of their peers who reviewed their work.
When all concerns have been addressed by the investigator, the animal care and use proposal is brought to a vote. If present, the investigator and anyone with a vested interest is invited to leave the room. Voting by secret ballot or by voice is offered. An "approved" decision is justified if all parties have been attentive to the IACUC role of oversight of the animal welfare rules and regulations. If the proposal is approved, the decision is documented in the meeting minutes, the proposal is stamped, signed, and dated by the IACUC chairperson, the investigator is notified, and the original document is kept in the permanent IACUC files. If disapproved, the proposal is returned to the investigator via the IACUC representative for additional information or revision.
Figure 3. Sources of continuing education leading to knowledge in animal welfare issues.The Animal Welfare Act mandates that the IACUC is the formal overseer of animal welfare in the local research environment. However, this does not release any participant from ensuring that animals are humanely used and that integrity (1) is central to all research and testing endeavors. Education relative to animal welfare, inside and outside of the IACUC, is a continuing process (fig. 3). Enlightened staff realize that there are many avenues to this knowledge and that, once achieved, produces better research products.
(The figures were presented in part at the 46th Annual American Association for Laboratory Animal Science Oct 15-19, 1995, Baltimore, MD.)
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U.S. Department of Agriculture
Agricultural Research Service
National Agricultural Library
10301 Baltimore Ave.
Beltsville, MD 20705-2351
Phone: (301) 504-6212
FAX: (301) 504-7125
E-mail: awic@nal.usda.gov
