Requests for Comments
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
Open Requests for Comments
- No requests are currently open
Prior Requests for Comments
- June 12, 2012 Draft Guidance on Considerations in Transferring a Previously- Approved Research Project to a New IRB or Research Institution, [PDF 85KB]
- September 7, 2011 Draft Guidance on Exculpatory Language in Informed Consent or [PDF 118KB]
- September 23, 2010 Draft Revised Federalwide Assurance (FWA) Form and Terms of Assurance
- Revised Form [PDF 56.7KB] but use on-line submission at http://ohrp.cit.nih.gov/efile/FwaStart.aspx
- Revised Terms of Assurance [PDF 48.4KB]
- November 6, 2009 Draft Guidance on IRB Continuing Review of Research (comment period 11/6/09 to 1/5/10)
- Final guidance issued November 10, 2010 [PDF 52KB]
- November 6, 2009 Draft Guidance on IRB Approval of Research with Conditions (comment period 11/6/09 to 1/5/10)
- Final guidance issued November 10, 2010 [PDF 63KB]
- 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- December 1, 2008 Draft Guidance on Important Considerations for When Participation of Human Subjects in Research is Discontinued (comment period: 12/1/08 to 1/30/09)
- Final Guidance issued September 21, 2010 [PDF 121KB]
- 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)
- OHRP's viewpoint on conflicting interests for NCI Pediatric Central IRB members (comment period: 9/15/05 to 12/15/05)