The goal of federal oversight is to ensure animal welfare, but over the years the increasing complexity of regulatory compliance has become a source of frustration for researchers and institutions alike. In some cases institutions have adopted procedures to fulfill the regulatory mandates that actually exceed what the regulations themselves require and do not enhance animal welfare. While such expansive policies are intended to protect the institution against non-compliance, they can have a deleterious effect on both the research itself and on staff morale.
In March, 2019, the FASEB Office of Public Affairs and AAU’s Council on Governmental Relations held two webinars to clarify what federal regulations and policy actually require to enable institutes to decide whether there is a good reason to exceed these requirements. Representatives of NIH’s Office of Laboratory Animal Welfare (OLAW), and USDA’s Animal Plant and Health Inspection Service (APHIS) were featured at the first webinar (1), held on March 18, 2019. The second webinar (2), held on March 25, 2019, featured representatives of research institutions. Recommendations for alleviating self-imposed burden in the design and review of protocols noted in these webinars are summarized below. The webinar recordings, slides, and Q & A document are available on FASEB’s website.
The Institutional Animal Care and Use Committee (IACUC) can use its own discretion to determine an appropriate animal range for a protocol within the following parameters: “An infinite upper limit is not acceptable” and “The low end of the range should ensure statistical significance.” (Streamlining Webinar, question #38).
For NIH grants, the same number should be reported in the Vertebrate Animal Section in the grant application, the protocol and in the statistical analysis. If this number is later found to be too low or too high, the protocol can be amended. (Streamlining Webinar, question #3).
USDA pain category E applies to animals that undergo procedures involving more than momentary pain or distress in cases where drugs cannot be used to alleviate pain or distress. Such protocols must include a justification for withholding these drugs. USDA recommends only classifying protocols that fit this description as Category E. This streamlines inspections since “Having to explain that there was no procedure which caused more than momentary pain or distress would be confusing and more time consuming than correctly classifying the animal,” according to an USDA official. (Streamlining Webinar, question #21)
The PHS Policy does not require literature searches to demonstrate that the Principal Investigator (PI) has considered alternatives to painful or distressful procedures. However, an NIH representative noted that PIs typically conduct literature searches anyway in planning studies and preparing grant applications. (Streamlining Webinar, question #13).
Animal use protocols do not have to be re-written every three years. The PHS Policy requires the IACUC to conduct “continuing review” triennially using the criteria outlined in PHS Policy IV.C.1. a-g. (Understanding Requirements Webinar, question #18).
USDA currently requires that continuing review take place no less than annually, but it allows IACUCs latitude to determine how best to conduct this review. (Streamlining Webinar, question #26) (Note: In an interagency plan of action to reduce regulatory burden released on August 28, 2019, USDA indicated that it would undertake rulemaking to align its review requirement with that of the PHS Policy.)
According to an NIH representative, continuing review may be accomplished in various ways, including post-approval monitoring; semiannual reviews; laboratory visits by an IACUC coordinator or veterinarian; or by having technicians, animal care staff and investigators provide feedback to the IACUC. (Streamlining Webinar, question #29). Since continuing review can be accomplished using one of these options, it need not be conducted as a separate review. (Streamlining Webinar,¹ slide 9).
According to NIH OLAW’s Guidance on Significant Changes to Animal Activities (NOT-OD-14-126), “Consultation with the veterinarian must be documented.” However, it does not prescribe specific ways to do this. According to an institutional representative at the second webinar, one way to fulfill this requirement is by having both the PI and the veterinarian send follow-up emails or reports. (Understanding Requirements Webinar, question #14).
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