Requests for Comments
Draft Guidance on Exculpatory Language in Informed Consent
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
- September 7, 2011 Draft Guidance on Exculpatory Language in Informed Consent or [PDF 118KB]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- November 6, 2009 Draft Guidance on IRB Continuing Review of Research (comment period 11/6/09 to 1/5/10)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- November 6, 2009 Draft Guidance on IRB Approval of Research with Conditions (comment period 11/6/09 to 1/5/10)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- December 1, 2008 Draft Guidance on Important Considerations for When Participation of Human Subjects in Research is Discontinued (comment period: 12/1/08 to 1/30/09)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)