TAG ARCHIVES FOR NIH

19
Oct2018

PRIM&R recently submitted comments in response to the NIH’s proposal to amend its Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules, which was published in the Federal Register on August 17, 2018. Although the title of the announcement is a mouthful, we encourage readers to read our comments, as the proposal has important implications for public engagement around the ethical and social implications of emerging genetic research. The NIH is asking for comments by October 25, 2018. In our comments, we agree that the federal government should eliminate redundant regulatory requirements that add nothing to the protection of human research subjects. However, we take significant issue with the proposed changes to the mandate, purpose, and scope of the Recombinant DNA Advisory Committee (RAC). Read more

24
May2018

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). Read more

10
Apr2018

One of the most illuminating sessions from PRIM&R’s 2017 SBER Conference was “Clinical Trials in the SBER Context” by Melissa W. Riddle, PhD (Chief, Behavioral and Social Sciences Research Branch, National Institute of Dental and Craniofacial Research) and Cindy S. Shindledecker, CIP (Director, Health Sciences and Behavioral Sciences Institutional Review Board, University of Michigan). Dr. Riddle was absent, but her colleague Wendy Webber, ND, PhD, MPH (Acting Deputy Director, National Center for Complementary and Integrative Health) was able to do an impromptu presentation on behalf of NIH. She offered guidance on how to interpret the NIH definition of clinical trials by breaking down its various components.   Read more

29
Mar2018

On March 14, 2018, the National Institutes of Health (NIH), in coordination with USDA and FDA, published a 90-day request for comments “seeking information to improve the coordination of regulations and policies with respect to research with laboratory animals as required by the 21st Century Cures Act, Section 2034(d).” The animal research community now has an important opportunity to address long-standing concerns about regulatory burden—requirements that add administrative work without enhancing animal welfare or good science—and to help shape the future of animal research regulations. I urge you to take this opportunity to share with the federal regulators your ideas about how we can best streamline regulatory and administrative inefficiencies that don’t promote animal welfare or good science.  Read more