PRIM&R’s Comments on NIH OLAW Request for Information on Reducing Regulatory Burden

Elisa Hurley

PRIM&R recently submitted comments in response to National Institutes of Health (NIH)’s March 14 request for information (RFI) on how best to improve the coordination of regulations and policies with respect to research with laboratory animals as prompted by a mandate in the 21st Century Cures Act. Comments on the RFI are due June 12, and I wanted to share what PRIM&R submitted in case the comments are helpful as you consider developing and submitting your own comments to NIH, which is coordinating the RFI with the Food and Drug Administration and the Department of Agriculture (USDA). Comments must be submitted through the NIH portal, which has a text box for responding to each question asked in the RFI, so our comments reflect that constraint, and below is a summary of the key points we make. For more on the details on the RFI and the specific areas on which the agencies are seeking comment, please see my earlier blog post.

In our comments, we encourage the federal agencies to be open, in the spirit of the mandate of Cures, which is detailed at Section 2034(d), to the wide range of recommendations that the regulated community has put forth for reducing administrative burdens associated with federally funded laboratory animal research while protecting the welfare of research animals and maintaining the integrity of science, including recommendations that might exceed the scope of the specific questions asked in this RFI.

For example, we not only support the proposal to allow investigators to submit protocols for continuing review using a risk-based methodology, we also endorse a recommendation made in the recent report by the Federation of American Societies for Experimental Biology (FASEB), the Association of American Medical Colleges, the Council on Governmental Relations, with assistance from the National Association for Biomedical Research, “Reforming Animal Research Regulations: Workshop Recommendations to Reduce Regulatory Burden” (FASEB Report) calling for the USDA and NIH’s Office of Laboratory Animal Welfare (OLAW) to “amend the protocol review requirement to define types of studies involving low-risk, noninvasive, or, minimally invasive procedures.” Such studies could then be classified as “exempt” from full IACUC review, or eligible for an administrative or expedited review. PRIM&R believes such an approach would allow IACUC resources to focus on ensuring the proper care and use of animals in more invasive research. At the same time, PRIM&R recommends that regulatory policy continue to emphasize that researchers must obtain IACUC approval before making significant protocol changes.

Similarly, PRIM&R supports the RFI proposal to harmonize the guidance from the NIH and the USDA to reduce duplicative considerations of alternatives to painful and distressful procedures, on the grounds that redundant regulatory procedures do not enhance animal welfare. We also endorse a FASEB Report recommendation that USDA Animal Care Policy #12 be amended so that it no longer identifies a database search as the “most effective and efficient method for demonstrating compliance with the requirement to consider alternatives to painful/distressful procedures.” We suggest that a better approach would be for USDA and OLAW to reinforce that IACUCs have the discretion and authority to determine whether a principal investigator has adequately considered alternatives to painful and distressful procedures and detailed those considerations appropriately as part of a protocol submission. Having IACUCs determine that an investigator has adequately considered alternative procedures and provided a narrative description of the methods and sources used to make that determination will strengthen protections over the current process.

PRIM&R also highlights some of our recommendations from our recent STAT piece on the topic. For instance, we believe that, where possible, revised federal policies should clarify that IACUCs and attending veterinarians have ultimate authority for ensuring the ethical care and use of animals at an institution, and for determining whether the anticipated benefits of the particular research study justify the proposed use of laboratory animals.

In addition, we argue that a consolidated oversight system covering all vertebrate species would garner greater respect and buy in from the research community than the current system which has bureaucratically intensive regulations that do not necessarily translate to better animal welfare. The fact that funding source is a trigger for whether a species (like mice or rats) receives certain oversight and welfare considerations is ethically unjustified. To support a single oversight framework, revised policies should include funding for education so that oversight personnel and investigators are better equipped to assess whether all animals are being housed and cared for appropriately.

In response to the federal agencies’ solicitation of information on whether tools or resources like the FDP Compliance Unit Standard Procedures or the IACUC Administrators Association repository of best practices would be helpful for reducing burden on investigators, we point out that these options are already available to regulated parties and that they are designed to address “self-imposed” regulatory burden rather than burdens created by overlapping and duplicative regulations themselves. In addition, we note that the recommended repositories currently are not complete or universally accessible, thus limiting their utility to the regulated community.

We also urge the federal agencies to provide additional clarity on areas of continued uncertainty for the animal research community, including what it considers policy guidance (for instance, whether its FAQs are considered policy guidance) and on the Veterinary Verification and Consultation process.

The RFI concludes with a question about whether there should be additional IACUC training activities that focus on reducing burden on investigators. PRIM&R believes that this step will be unnecessary as long as the federal government adheres to language in the 21st Century Cures Act which calls for the federal government to “(1) identify ways to ensure [laboratory animal research] regulations and policies are not inconsistent, overlapping, or unnecessarily duplicative, including with respect to inspection and review requirements by Federal agencies and accrediting associations; (2) take steps to eliminate or reduce identified inconsistencies, overlap, or duplication among such regulations and policies; and (3) take other actions, as appropriate, to improve the coordination of regulations and policies with respect to research with laboratory animals.” If the federal government takes such steps, then IACUC training could focus instead on strategies for protecting and promoting research animal welfare rather than on reducing burden.

Comments are due June 12, and must be submitted to the NIH electronically via a form at this link: For more on how to submit your comments, see my earlier blog post. I encourage you to provide feedback to NIH and its sister agencies about how you think the agencies can best reduce regulatory burden that serves neither animal welfare nor good science.