December 19, 2014
The public comment period for submitting comments, on the Office for Human Research Protections’ (OHRP) Draft Guidance on Disclosing Reasonably Foreseeable Risks in Research Evaluating Standards of Care, is extended for an additional 30 days, until January 22, 2015. OHRP announced the availability of the draft document on October 24, 2014 and requested that written comments be submitted by December 23, 2014. Since October 24, 2014, the Department received requests to extend the comment period to allow sufficient time for a full review of the draft guidance document. We have elected to extend the comment period an additional 30 days to afford the public a meaningful opportunity to comment on the draft guidance document. The notice announcing a 30-day extension that is available today for public inspection can be obtained here: https://www.federalregister.gov/articles/2014/12/22/2014-29915/disclosing-reasonably-foreseeable-risks-in-research-evaluating-standards-of-care-guidance. The notice will be published in the Federal Register on Monday, December 22, 2014.
We welcome comments on the draft document. You can find directions on how to submit comments on the OHRP website: http://www.hhs.gov/ohrp/regulations-and-policy/requests-for-comments/about-draft-guidance-risk-disclosure-in-standards-of-care/index.html.
