TAG ARCHIVES FOR PRIMR comments

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

11
Jul2017

Recently, PRIM&R submitted comments to the National Institutes of Health (NIH) in response to a Request for Information (RFI): Invitation to Comment on Inclusion in Clinical Research Across the Lifespan. Read more

25
Apr2016

Recently, PRIM&R submitted comments to the International Committee of Medical Journal Editors (ICMJE) in response to their proposed requirements for sharing clinical trial data. PRIM&R stated that we fully support initiatives to promote data sharing on the grounds it enhances the value of clinical research and the participation of human research subjects. Read more

4
Feb2016

PRIM&R submitted comments to the Department of Health and Human Services’ (DHHS) Office for Human Research Protections (OHRP) and the Food and Drug Administration (FDA) in response to their jointly released draft guidance on meeting minutes for institutional review boards (IRBs) who oversee human subjects research under the FDA and/or DHHS regulations. Read more