Open Mike

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Final Report on Reducing Administrative Burdens Associated with Research Involving Laboratory Animals

We are pleased to announce that last month the National Institutes of Health (NIH), the Animal and Plant Health Inspection Service of the United States Department of Agriculture (USDA), and the Food and Drug Administration (FDA) published their final report on Reducing Administrative Burden for Researchers: Animal Care and Use in Research (NOT-OD-19-136). This report, called for in the 21st Century Cures Act, is the culmination of more than two years of diligent work to address inconsistent and overlapping policies governing oversight of research involving animals, while ensuring research findings remain credible and research institutions safeguard animal welfare. 

Regulations and policies overseeing federally-sponsored research help ensure NIH remains a responsible steward of public funds. This extends to properly enforcing the public’s expectation on how laboratory animals will be used in biomedical research, teaching, and testing. Many stakeholders have pointed out, rightfully so in some cases, that with federal regulations comes increasing reporting requirements which adversely affect research productivity without necessarily improving animal welfare.  

Experts from the USDA, the FDA, and the NIH undertook much collaborative, thoughtful, and rigorous deliberation to get us to this point. More on their process can be found here, here, and here. Their final report reflects, incorporates, and analyzes diverse perspectives of more than 1,300 researchers, animal welfare advocacy organizations, scientific professional societies, members of the public, and others who commented on an earlier draft version. Investigators, generally speaking, supported the report’s recommendations to reduce various administrative hurdles. But, importantly, they were also balanced with concerns raised by animal welfare organizations and the public to not lessen requirements in such a way that adversely effects the humane care and use of laboratory animals.  

Well, what did they find? Below are some highlights. I encourage everybody to read the report for the full details and recommendations.  

Opportunities exist to reduce duplicative regulations and policies. These focus generally around areas such as inspections, animal protocol review, and institutional reporting. For example, we will consider flexibilities in how and by whom semiannual inspections by Institutional Animal Care and Use Committees (IACUCs) are conducted.  It may be possible to streamline some IACUC animal protocol reviews, such as by using Designated Member Review for low-risk activities. And, NIH and USDA will establish a process allowing annual reporting to both agencies on the same reporting schedule (such as through a streamlined data submission on a shared portal).

We recognize the importance and value of better coordination across federal funders. We will allow public comments for at least sixty days for all new significant policy guidances. Building on that, guidances from NIH, USDA, and other federal funders will be harmonized as appropriate to reduce duplicative and inconsistent requirements. We concur with the suggestion to enhance training and resources across federal agencies. One way to achieve this will be continuing to work with our USDA colleagues to develop new industry-led training and web resources to strengthen IACUC activities that focus on reducing burden on investigators.

Keep an eye out for our next steps. We are currently looking at all of the recommendations and thinking about possible ideas, guidance, and resources to address them. Any planned changes will be implemented over the next couple years, along with a strategy that considers how effective they were. This timeframe affords ample opportunity for your voice to still be heard along the way.

I would like to congratulate and thank my colleagues Dr. Patricia Brown and Ms. Lori Hampton (both of the NIH Office of Laboratory Animal Welfare) for their leadership in helping to prepare the report and for their help in writing this summary.

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