January 29, 2018

Reducing Regulatory Burden Related to Animal Use in Research

Reducing Regulatory Burden Related to Animal Use in Research

by Michael Azain

ASAS Public Policy Committee

December, 2017

A report, entitled “Reforming Animal Research Regulations: Workshop Recommendations to Reduce Regulatory Burden” was recently released: Animal Regulatory Report. The workshop, held in April, 2017, included representatives from:  The Federation of American Societies for Experimental Biology (FASEB), the Association of American Medical Colleges (AAMC), the Council on Governmental Relations (COGR), and the National Association for Biomedical Research (NABR).  The primary goal of the workshop was to identify animal care and use requirements that “demand significant administrative effort but do not enhance animal welfare” and to prioritize steps that NIH, USDA and Congress can take to reduce these requirements.    Part of the incentive for the workshop and recommendations was a 2012 survey that indicated that a large portion (42%) of principal investigator time was being spent on administrative requirements rather than on conducting research.  There are a number of recommendations put forward in the report. Those of particular relevance to animal science researchers include:

  1. Consolidation of animal research oversight into one federal agency with a single set of regulations and guidance documents.
  2. Amend the Animal Welfare Act (AWA) to require only one annual inspection of research facilities by the IACUC.
  3. Amend the AWA to remove the requirement for an annual USDA inspection of facilities and allow for inspection frequency that is based on compliance history.   In addition, AAALAC accreditation of a facility could be used in a risk-based manner to determine frequency of USDA visits.
  4. All current Public Health Service and USDA regulations, policies and other documents related to animal research should be reviewed by an external panel consisting of experts engaged in animal research to determine that these documents emphasize issues that are of core importance to animal welfare and are consistent with current scientific understanding.
  5. Revise the USDA Animal Care Policy to allow for multiple survival surgeries with approval from the IACUC and as justified by scientific and animal welfare reasons. 
  6. Amend the USDA policy on keyword / literature searches to be more consistent with the AWA language which charges the IACUC to determine that the investigator has considered alternatives to painful procedures and has provided a written description of the methods to be used in the protocol.  This change would eliminate the requirement for a literature search.

Some of the recommendations from the panel would require legislative action by the president or congress, while others could be implemented through administrative action by USDA or the NIH.  The report notes that there have been similar recommendations to reduce administrative burden over the last 20 years, but little action has been taken.   The 21st Century Cures Act (December,2016) directs NIH,USDA, and FDA to review regulations and policies related to animal care and identify ways to reduce the burden on investigators without compromising animal welfare.   In addition, with the current administration’s emphasis on regulatory reform, the committee felt that the timing of their report was advantageous.