eNews re IRB Review

IMPORTANT NOTICE

Proposed Major Revision of Federal Human Subjects Regulations

Federal regulatory agencies recently proposed significant and wide-ranging changes in the federal human subjects regulations. This is the first overhaul of the regulations in their 40-year history. Collectively, these changes would have a truly profound impact.

The proposed changes

The proposed changes are described in documents and summaries at the Office of Human Research Protections (OHRP) site: http://www.hhs.gov/ohrp/humansubjects/anprm2011page.html

Description of the revision process

The revision process is likely to take several years.

  • The changes are posted for a 60-day public comment period.
  • The relevant federal agencies will review and consider all comments.
  • The agencies will draft the revised regulations.
  • The draft revised regulations will be posted for another 60-day public comment period.
  • The agencies will review and consider all comments.
  • The final revised regulations will be implemented.

Feedback for the federal agency

The federal Office of Human Research Protections (OHRP) welcomes anyone to submit comments directly by September 26th. Follow the instructions at the OHRP website.

Feedback for the Human Subjects Division

The Human Subjects Division (HSD) of the UW Office of Research welcomes your thoughts and comments on any of the propose changes. Your feedback will be considered for inclusion in a comment from HSD to OHRP. Please provide your feedback via email to Karen Moe, HSD Director, by September 10th. Please relate your comments to specific sections or questions as identified in the proposed changes.

HSD is developing a communication plan to ensure that the UW research community is kept fully informed at every step of this historic process. To begin with, we've set up a GoPost discussion board for conversation regarding the proposed changes. If you don't have a UWNetID, you can choose the "ProtectNetwork"option and register for a free account.

Contact Karen Moe, the Director of the Human Subjects Division, if you have any questions. Email: kemoe@uw.edu.

 

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August 10, 2011

IN THIS ISSUE

Proposed Major Revision of Federal Human Subjects Regulations

The proposed changes

Description of the revision process

Feedback for the federal agency

Feedback for HSD 





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