NIH has, for many years, been concerned about the increasing burden of applying for, reporting on, and the costs faced by researchers when complying with requirements on federally-funded research grants— so much so that it is even called out in our strategic plan as an area to address. Today, as we continue to implement the 21st Century Cures Act, NIH is requesting public feedback on some proposed approaches to reduce administrative burden on investigators use of laboratory animals in biomedical research (NOT-OD-18-152 and Federal Register Notice 2018-05173). Together with our colleagues at the U.S. Department of Agriculture (USDA) and the Food and Drug Administration (FDA), we are looking for constructive and thoughtful feedback on this topic from individuals, research institutions, professional societies, animal advocacy organizations, and other interested parties. Input will be accepted electronically during a 90-day comment period, that is until June 12, 2018.
Through your participation, we hope to gain insights into how we can best improve the coordination and harmonization of regulations and policies with respect to research with laboratory animals. This call will help shed further light on where the community feels that regulations and policies are inconsistent, overlapping, or unnecessarily duplicative.
Using animals in research is critical to scientific understanding of biomedical systems leading to useful drugs, therapies, and cures. It is important to note that, even as we strive to identify ways to reduce administrative burden on our supported investigators, we simultaneously aim to maintain the highest standards of integrity and credibility within the biomedical research enterprise. This further extends to NIH continuing to ensure the greatest commitment to the welfare of laboratory animals involved in our supported research endeavors.
As part of examining existing regulations, staff within the NIH, USDA, and FDA have conducted listening sessions on the topic and diligently reviewed published materials aimed at reducing burden faced by investigators within the research community. Such resources span findings from a workshop held last April, National Academies of Science recommendations from 2016, the National Science Board’s considerations from 2014, and a survey about faculty workload published in 2012.
Ideas have been collected and analyzed for their relationship to existing statutes, regulations, and policies, as potential approaches to implement in support of the 21st Century Cures Act requirements to reduce regulatory burden on investigators in their use of animals. Some examples include:
- Allow investigators to submit protocols for Institutional Animal Care and Use Committee continuing review using a risk-based methodology.
- Allow institutional annual reporting to the NIH Office of Laboratory Animal Welfare (OLAW) and USDA on the same reporting schedule and as a single report through a shared portal.
- Harmonize the guidance from NIH and USDA to reduce duplicative considerations of alternatives to painful and distressful procedures.
- Provide a minimum 60-day comment period for new OLAW policy guidance.
We hope to hear from you during this process. Insights from the community are critical to helping us refine and ensure the final recommendations and implementation plans are appropriate to reducing administrative burden while maintaining our long-standing commitment to the humane care and use of animals in research.