WASHINGTON, D.C.— A focused review published in the journal Research Integrity and Peer Review has found that Institutional Animal Care and Use Committees (IACUC) provide surprisingly little protection for animals in research, that searches for alternatives to animal use are seldom conducted, and that, when performed, they are inadequate. For the first time since the publication of "The Guide for the Care and Use of Laboratory Animals" (The Guide) in 1963, research scientists are recommending a new guide that puts replacement of animals in research and IACUC member training at the forefront.
"This new guide could not come at a better time, on the heels of announcements by both the NIH and the FDA that they will largely discontinue the use of animals," says John Pippin, MD, FACC , director of academic affairs for the Physicians Committee for Responsible Medicine, a scientific and medical ethics nonprofit.
In April, the National Institutes of Health (NIH) announced its commitment to prioritize innovative, human-based methods , like organoids, tissue chips, computational models, and real-world data analyses, while reducing animal use. The Food and Drug Administration (FDA) announced it will phase out animal testing requirements for monoclonal antibodies and other drugs. These changes are popular among the public: In a recent poll , 85% of Americans agreed that "animal experimentation should be phased out in favor of more modern research methods."
The review identified these key challenges to IACUC evaluation of animal research proposals:
- There is no requirement that committee members have expertise in the research areas under review or in methods that could replace animal use.
- Investigators are expected to consider alternatives to procedures using animals if they cause more than momentary pain or distress. But they are not required to use alternatives.
- Investigators are asked whether their research is duplicative. But they are not required to verify this.
- Consideration of alternatives to painful experiments that use birds, mice, and rats (animals used in most experiments in the United States but not covered by the Animal Welfare Act) is not required.
- An alternative to animal use is not required for experiments not deemed painful.
With these challenges in mind, researchers offer a new guide, " A Way Forward: Reducing Animal Use and Sourcing Human-Relevant Research Methods. " Its key policy recommendations are that:
IACUCs should not base their operating standards on the minimal obligations and inconsistent enforcement of federal law. A meaningful research program can more effectively put principles into action through steps such as the following:
- Searches for nonanimal methods are essential regardless of species.
- Replacement considerations should focus on research methods most relevant to human biology.
- Education should be provided for IACUC members, investigators, and students sufficient to provide a solid grounding on legal requirements and best practices for replacement.
- In judging alternatives searches, IACUCs should consult with reviewers with subject matter expertise.
- Conflicts of interest should be eliminated whenever possible.
- Designated Member Reviews should be limited to annual reviews (not initial protocols), and Just-In-Time Reviews should be eliminated.
"Neither best scientific practices nor best ethics result from current IACUC practices," Dr. Pippin says. "Small wonder that more than 90% of animal research fails in clinical trials."
