TAG ARCHIVES FOR PRIMR comments

9
Jun2022

On April 14, 2022, the FDA released draft guidance that aims to diversify the population of participants in clinical trials. Because the guidance is a draft, its content is open for public discussion and comment. Earlier this week, PRIM&R submitted comment to the FDA explaining how the guidance, while welcome, might be improved. Comments are due June 13, 2022, and we encourage others to submit their own comments (and feel free to borrow from ours)! Read more

30
Mar2020

PRIM&R is generally very pleased with the breadth and aims of the framework. The framework’s third objective, which emphasizes integrity, accountability, and social responsibility in the conduct of science, demonstrates NIH’s clear commitment to the idea that good science is responsible science. Read more

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the National Institutes of Health (NIH) released its Draft NIH Policy for Data Management and Sharing and Supplement Draft Guidance as part of its continuing efforts to ensure public access to research the government conducts and pays for.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