TAG ARCHIVES FOR PRIMR comments

10
Jan2020

On November 8, 2019, the National Institutes of Health (NIH) released its Draft NIH Policy for Data Management and Sharing and Supplement Draft Guidance as part of its continuing efforts to ensure public access to research the government conducts and pays for. Today, PRIM&R submitted comments applauding the NIH for taking steps to accelerate data sharing efforts while also offering a few constructive suggestions primarily centered around privacy and funding issues. The comment period closes today, and we encourage interested parties to consider submitting their own comments. Read more

14
Feb2019

The Office for Civil Rights (OCR) within the Department of Health and Human Services (HHS) recently put out a "Request for Information on Modifying HIPAA Rules to Improve Coordinated Care." PRIM&R submitted comments encouraging HHS to take this opportunity to harmonize the HIPAA Rules with the Common Rule to improve it's use in the research context. The research community has long argued that HIPAA is confusing, awkward, inconsistent, and unnecessarily burdensome as applied to human subjects research. Read more

5
Feb2019

PRIM&R recently submitted comments in response to the Food and Drug Administration (FDA)’s proposed rule "Institutional Review Board Waiver or Alteration of Informed Consent for Minimal Risk Clinical Investigations," which was published in the Federal Register on November 15, 2018. Comments are due February 13. 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

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