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Office for Human Research Protections (OHRP)

Requests for Public Comment

OHRP invites public comments on the following guidance documents and topics:

November 6, 2009 Draft Guidance on IRB Continuing Review of Research
November 6, 2009 Draft Guidance on IRB Approval of Research with Conditions

Public comments on any OHRP guidance document are welcome at anytime. For any comments not submitted during an identified comment period, please email comments to ohrp@hhs.gov and insert the title of the specific guidance document in the subject field, or submit comments by mail to:

Division of Policy and Assurances
Office for Human Research Protections
1101 Wootton Parkway
Suite 200
Rockville, MD 20852

Prior Requests for Comments

March 5, 2009 Request for Information and Comments on IRB Accountability (comment period 3/5/09 to 6/3/09)
December 1, 2008 Draft Guidance on Important Considerations for When Participation of Human Subjects in Research is Discontinued (comment period: 12/1/08 to 1/30/09)
July 2, 2008 Request for Information and Comments on the Implementation of Human Subjects Protection Training and Education Programs (comment period: 7/1/08 to 9/29/08)
October 26, 2007 Request for Comments on Categories of Research That May Be Reviewed By the Institutional Review Board (IRB) Through an Expedited Review Procedure (comment period: 10/26/07 to 12/26/07)
September 5, 2007 Request for Information and Comments on Research That Involves Adult Individuals With Impaired Decision-making Capacity (comment period: 9/7/07 to 1/14/08)
December 8, 2006 Draft Guidance on OHRP Guidance on Engagement of Institutions in Human Subjects Research (comment period: 12/8/06 to 2/6/07)
OHRP's viewpoint on conflicting interests for NCI Pediatric Central IRB members (comment period: 9/15/05 to 12/15/05)
October 11, 2005 Draft Guidance on Reporting and Reviewing Adverse Events and Unanticipated Problems Involving Risks to Subjects or Others (comment period: 10/13/05 to 1/13/06)

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Last Updated: November 6, 2009

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