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 firstname.lastname@example.org 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
Rockville, MD 20852
How to View Posted Public Comments
- Click on the link for the Federal Register notice requesting comments
- In another tab or window, access www.regulations.gov:
- Copy and paste, or just retype, the docket number given in the Federal Register notice, into the regulations.gov box that is labeled “Search”.
- The first answer should say “Featured Result.”
- Click on “Open Docket Folder” at the upper right corner of that result.
- There should be a heading labeled “Comments” in the middle of the page.
- Click on “View All” next to Comments.
- Now you should have access to all of the comments, and can use the search box at the top to search among them.
- Also, a list of comments received and posted should display, and can be opened one at a time.
- For many comments , the substance of the comment is in an attachment, which can be opened by clicking on the "View Attachment" PDF icon on the right side of the screen
Open Requests for Comments
- No requests for comments are currently open.
Prior Requests for Comments
- March 9, 2015 Draft Guidance for Industry, Clinical Investigators, and Institutional Review Boards—Use of an Electronic Informed Consent in Clinical Investigations— Questions and Answers; Availability (comment period 03/9/2015 to 5/7/2015)
FDA’s FR Notice with instructions on how to submit comments to FDA can be accessed at: http://www.gpo.gov/fdsys/pkg/FR-2015-03-09/pdf/2015-05377.pdf. (comment period 3/9/2015 to5/7/2015)
FDA’s Draft Guidance document can be accessed at: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM436811.pdf.
- October 24, 2014 Draft Guidance on Disclosing Reasonably Foreseeable Risks in Research Evaluating Standards of Care (comment period 10/24/2014 to 01/22/2015)
- June 26, 2013 Notice of a Department of Health and Human Services Public Meeting and Request for Comments on Matters Related to the Protection of Human Subjects and Research Studying Standard of Care Interventions (comment period 6/6/13 to 9/9/13)
- June 12, 2012 Draft Guidance on Considerations in Transferring a Previously- Approved Research Project to a New IRB or Research Institution, [PDF 85KB] (comment period 6/12/12 to 8/13/12)
- September 7, 2011 Draft Guidance on Exculpatory Language in Informed Consent or [PDF 118KB] (comment period 8/19/11 to 11/7/11)
- September 23, 2010 Draft Revised Federalwide Assurance (FWA) Form and Terms of Assurance (comment period 9/23/10 to 10/25/10)
- November 6, 2009 Draft Guidance on IRB Continuing Review of Research (comment period 11/6/09 to 1/5/10)
- November 6, 2009 Draft Guidance on IRB Approval of Research with Conditions (comment period 11/6/09 to 1/5/10)
- 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)
- OHRP's viewpoint on conflicting interests for NCI Pediatric Central IRB members (comment period: 9/15/05 to 12/15/05)