Reaching the goals of the AWA and HREA by reconsidering IACUC members and their roles
By Mariah Bowman| June 25th, 2026
The Animal Welfare Act (AWA) and the Public Health Service Policy on Humane Care and Use of Laboratory Animals ("PHS Policy") require research institutions to create an Institutional Animal Care and Use Committee (IACUC). The AWA covers research facilities using “any live or dead dog, cat, nonhuman primate, guinea pig, hamster, rabbit, or any other warm-blooded animal,” with the exception of “birds, rats of the genus Rattus, and mice of the genus Mus, bred for use in research.” Whereas the PHS Policy covers all animals that are vertebrates. The AWA and PHS policy both require that a chairperson, one veterinarian, and a community member serve on the IACUC; however, the PHS policy goes further and requires a scientist with experience in animal research and a member with expertise outside of science to serve as members as well. IACUCs are internal review boards that provide broad oversight of an animal research facility, its animal care and use program (including animal welfare concerns), and approves all protocols that use an animal model included in the scope of the AWA or PHS Policy. IACUCs are required to review the institution’s animal care and use program and inspect the institution at least twice a year. The IACUC then prepares reports and makes recommendations regarding the program, facility, or personnel training. However, research facilities not covered under the AWA or PHS Policy are not required to have an IACUC. These facilities may have an IACUC for the sake of best practices, but the extent as to how common this is within the industry is unknown.
IACUCs can evaluate research proposals based on the number of animals used, minimizing pain or distress and how that is done, the enrichment provided to the animals, availability of alternatives (when there is pain to the animal), and the training of the personnel involved. However, IACUCs do not provide input before the protocol has received funding. The Committee cannot create any rules or orders regarding the design or guidelines of proposed research or the performance of research. IACUCs are also not required to consider the proposed research’s use or lack of non-animal alternatives, also called new approach methodologies (NAMs), when there is no indication that the protocol will result in pain to the animal (7 U.S.C. 2143 § 13(a)(3)(b)). Moreover, the Committee does not address ethical arguments that go beyond the 3Rs (replacement, reduction, and refinement) when reviewing proposed research, for example, questioning whether the proposed protocol is overly repetitive of past research or employing a harm-benefit analysis. Interestingly,the Guide for the Care and Use of Laboratory Animals (with which the PHS Policy requires compliance) explains that the ethical considerations surrounding the 3Rs “should serve as a starting point,” and researchers “are encouraged to go beyond these provisions.”
IACUCs are required to consider a range of factors, as mentioned above, when reviewing proposed research on animals, but they are not required to consider the interests of the animals or their unique needs. For example, although the PHS Policy requires a scientist with experience in animal research to serve on an IACUC, that scientist will not have expertise in every kind of animal model that may be used at that institution. Although IACUCs do consider certain animal interests when evaluating research proposals (pain, housing, enrichment, etc.), there are other considerations not receiving the attention they deserve. This is important because animals are sentient beings, each with an interest in having fulfilling lives, just like humans and recognizing this perspective has the potential to greatly improve animal welfare and the scientific research in which they are involved. Therefore, the best way to include the interests of the animals is to require an animal advocate to be the community member serving on IACUCs.
The Courtroom Animal Advocate Program (CAAP) is one example of appointed individuals representing animal interests. This program allows animal advocates, mostly attorneys, to be the voice of the animal victim’s interests during animal cruelty matters. Connecticut was the first state to enact a CAAP in 2016, and the law allows judges to appoint an advocate to represent the “interests of justice.” Maine enacted a CAAP in 2019, and a county in New York also has its own program. These advocates provide another perspective to the court that focuses on the animal victim’s experience. This is important because without this voice animal cruelty matters in the pre-trial phase tend to focus on the defendant. Appointing an animal advocate ensures that the judge will hear about the pain or suffering the animal victim experienced. An animal-focused review could help the IACUC members better understand some of the issues involved when animals are used in research. An advocate can also supplement information to both parties based on their own expertise, which can provide valuable context.
Both the AWA and the PHS Policy already require a community member to serve on the IACUC. Therefore, IACUCs already acknowledge the value of outside voices and perspectives. This member is intended to speak for the human community that is not affiliated with the research facility. This position must also include the interests of animals, who are a vital part of the interests of the communities that the IACUCs must by law be considering. There are no restrictions on the size of the IACUC, so more members should be sought out in pursuit of the best animal welfare and the best available science. Also, this representative could be someone who satisfies the Office of Laboratory Animal Welfare’s requirement for at least one non-affiliation and at least one non-scientist member. Adding this person would ensure that the IACUC fully considers the 3Rs and other statutory, regulatory, and policy issues. Moreover, having a member solely representing the animals’ perspective on IACUCs is an opportunity for assuring that IACUC considerations surpass the bare minimum, which is crucial to making sure that the scientific research is strong.
The views expressed do not necessarily reflect the official policy or position of Johns Hopkins University or Johns Hopkins Bloomberg School of Public Health. 5
