On August 28, 2019, the National Institutes of Health (NIH) released an interagency plan of action, Reducing Administrative Burden for Researchers: Animal Care and Use in Research. The plan is a joint project of NIH’s Office of Laboratory Animal Welfare (OLAW); the Animal and Plant Health Inspection Service (APHIS) at the U.S. Department of Agriculture; and the Food and Drug Administration (FDA). This report is available on the OLAW website.
These three agencies each have their own regulations and/or policies governing the care and use of animals in research and testing. Many of the policies are similar, but differences between the requirements make regulatory compliance challenging for institutions subject to oversight from more than one agency. In addition, the ways the agencies have sometimes interpreted their own rules have made compliance burdensome. In light of this, Congress included a section in the 21st Century Cures Act calling upon these agencies to review these regulations and make appropriate revisions. The objectives of this review are reducing administrative burden for researchers while maintaining the integrity and credibility of research findings and protecting research animals.
Most of the report consists of an overview of recommendations from various sources that the agencies considered before developing their plans of action. The plans themselves are summarized on pages 5-8 of the report. In terms of implementation, the agencies said they “intend to make progress” over the next two years on the specific items listed. One of those items is to allow public comments before finalizing new regulations or policy guidance. Therefore, most of the changes the agencies would like to make will be published for a period of public comment before they are implemented. In addition, the agencies said they will continue to identify areas where their regulations can be simplified.
Proposed OLAW and APHIS actions include:
- OLAW will allow at least a 60-day comment period for significant policy guidance such as new interpretations of the Public Health Service Policy on the Humane Care and Use of Laboratory Animals (PHS Policy); the National Academies of Science Guide for the Care and Use of Laboratory Animals (the Guide); or the American Veterinary Medical Association (AVMA) Guidelines for the Euthanasia of Animals.
- OLAW will update its disclaimer concerning its guidance to emphasize that “unless specific statutory or regulatory requirements are cited,” such guidance should be viewed as “recommendations in that an institution may use an alternative approach if the approach satisfies the requirements of the PHS Policy.” OLAW will seek public comment on its revised disclaimer.
- OLAW will review its current guidance for how Institutional Animal Care and Use Committees (IACUCs) should ensure congruence between NIH grant proposals and IACUC-approved animal use protocols. OLAW will clarify the requirements for grant-to-protocol congruence and seek public comment on the revision.
- APHIS will allow public comments before implementing significant new policies or revising its current policies on the use of animals in research, teaching, testing, experiments, or surgery.
- APHIS will also “include a statement in its policies to explain that such policies are clarifications or interpretations of the AWA [Animal Welfare Act] and Animal Welfare Regulations, which are the only legally binding requirements.”
- OLAW will continue to require IACUCs to “review the care and treatment of animals in all animal study areas and facilities of the research entity, at least semiannually.” This is a statutory requirement, and OLAW believes that discontinuing this practice would likely have a negative impact on animal welfare. However, OLAW indicated that the PHS Policy “affords flexibility in the designation of IACUC inspectors and the conduct of inspections.” Consequently, OLAW will develop guidance on options available to IACUCs and seek public comment before finalizing the new guidance.
- The AWA also has a statutory requirement for semiannual inspections and reviews, with some exceptions granted when animals are studied in their natural habitats. However, APHIS pointed out that the AWA regulations allow IACUCs to “determine the best means of conducting evaluations of the research facility’s programs and facilities.” The agency also noted that AAALAC, Intl. site visits may be counted as semiannual inspections.
- OLAW and USDA plan to “review and enhance current resources to support [the] IACUC’s use of existing options for streamlining protocol review and review of significant changes to approved protocols.” This will include “updating resources to encourage the use of DMR [Designated Member Review] for low-risk activities and for three-year complete review.” The agencies underscored their shared view that “DMR and FCR [Full Committee Review] are equally acceptable methods for use by IACUCs when conducting protocol review” as long as IACUCs follow the procedures set forth in the PHS Policy and AWA regulations.
- The agencies will provide updated resources on exemptions from IACUC review and seek public comment on these resources.
- NIH will consult with the FDA to review and update guidance on the use of non-pharmaceutical grade substances to “further clarify the options for IACUC review.” OLAW will then seek public comments on this guidance.
- APHIS will undertake formal rulemaking to align its continuing review requirement with OLAW’s. The AWA regulations currently require “continuing review” of covered activities “at appropriate intervals…but not less than annually.” APHIS will propose to revise this regulation to require IACUCs to conduct a “complete review” of activities every three years.
- OLAW will clarify its guidance on situations where IACUCs are required to report departures from the Guide to the Institutional Official. The revised guidance will be posted for public comment.
- OLAW will revise its current guidance on reporting noncompliance and will include refined examples of reportable situations as well as ones that would not normally be reported. OLAW also will clarify the timeframe for reporting and what information to provide. In addition, OLAW will reevaluate whether grant numbers should continue to be provided in these reports. All of these revisions will be posted for public comment.
- OLAW and APHIS will allow institutions to submit annual reports to both agencies on the same schedule. They will also explore the development of a single reporting portal with the goal of increase efficiency. This portal would not merge the information contained in the two reports.
- OLAW will change the instructions for what should be included in domestic Animal Welfare Assurances to permit the incorporation of elements from AAALAC, Intl. Program Descriptions. OLAW will also coordinate with AAALAC on “options for harmonizing documents to meet both organizations’ requirements.” However, OLAW does not intend to collect or review institutions’ actual AAALAC Program Descriptions.
- APHIS will seek a regulatory change to eliminate the requirement for research institutions to submit a new registration every three years. It will also continue to enhance the online portal it created for the submission of annual reports.
- OLAW and APHIS will work with the Departments of Defense and Veterans Affairs to develop options for harmonizing research oversight requirements across the agencies.
- OLAW and APHIS will support efforts to improve training and resources with a “focus on improving IACUC function to ensure animal welfare, enhancing IACUC communication with investigators, and recognizing pitfalls that increase burden.”
- OLAW and APHIS will continue efforts to create a repository of best practices for IACUCs and for standard procedures with animals. The agencies will also support the development of a sample animal study protocol focusing on elements necessary to ensure animal welfare and facilitate IACUC review. This sample protocol will be provided for the convenience of IACUCs, but its use will be optional.
- OLAW and APHIS will consider developing new web resources for the implementation of updated policy guidance on topics such as reporting departures from the Guide; identifying non-animal alternatives; grant-to-protocol congruence; non-pharmaceutical grade substances; statistics; literature searches; and writing protocols for lay audiences.
Stay Connected
Get Advocacy Alerts and the latest news by connecting with the Society’s Science Policy Team around the web