TAG ARCHIVES FOR NIH

8
May2019

I could never have guessed just how large and life changing a venture creating a two-way, system-wide IRB infrastructure would be when I received exactly that project in late 2010. Now, as we approach the single IRB mandate, I wanted to share a little bit about the efforts that I was fortunate to lead and participate in for the benefit of all the organizations not only contemplating this step, but being required to implement it at this juncture. I can only hope this brief effort to capitulate our successes and failures will lead you and your organization to even grander aspirations and achievements than my own. Read more

19
Feb2019

Last week, PRIM&R submitted comments in response to a request for information (RFI) on a draft report issued by the federal Working Group on Reducing Administrative Burden to Researchers for Animal Care and Use in Research. Comments on the draft report are due February 20, 2019, and we encourage you to consider submitting your own comments. The community is welcome to cite PRIM&R’s comments or borrow any of the points we make Read more

4
Dec2018

On October 10, the National Institutes of Health (NIH) published a Request for Information (RFI) from the public on Proposed Provisions for a Draft Data Management and Sharing Policy for NIH Funded or Supported Research. According to the NIH, it will take into account the feedback received as it develops a draft of a new NIH policy for data management and sharing. That draft will also be open for public comment, at a future date. Comments on this first stage of policymaking, the proposed provisions, are due December 10, 2018. Read more

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