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 [email protected] 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
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".
- On the next web page, click "Open Docket Folder."
- On the next web page, click "View all documents and comments in this Docket."
- 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.
Open Requests for Comments
- There are no current open requests for comments.
Prior Requests for Comments
- July 1, 2022 Draft Guidance – Use of a Single Institutional Review Board for Cooperative Research (Comment period 7/1/2022 to 8/30/2022)
- January 10, 2019 Draft Guidance – The Revised Common Rule Compliance Dates and Transition Provision (45 CFR 46.101(l) (comment period 1/10/2019 to 2/11/2019)
- November 19, 2018 Draft Guidance – Activities Deemed Not to Be Research: Public Health Surveillance, 2018 Requirements (comment period 11/19/2018 to 12/19/2018)
- July 19, 2018 Draft Guidance – Scholarly and Journalistic Activities Deemed Not to be Research: 2018 Requirements (comment period 7/25/2018 to 8/24/2018)
- July 19, 2018 Draft Guidance – When Continuing Review Is Not Required During the 6-Month Delay Period of July 19, 2018 through January 20, 2019 (comment period 7/25/2018 to 8/24/2018)
- July 19, 2018 Draft Guidance – Elimination of Institutional Review Board (IRB) Review of Research Applications and Proposals: 2018 Requirements (comment period 7/25/2018 to 8/24/2018)
- August 2, 2016 Draft Guidance - Institutional Review Board (IRB) Written Procedures: Guidance for Institutions and IRBs (comment period 8/2/2016 to 10/3/2016)
- November 5, 2015 Draft Guidance - Minutes of Institutional Review Board (IRB) Meetings: Guidance for Institutions and IRBs (comment period 11/05/2015 to 2/03/2016)
- November 25, 2015 Notice Extending Comment Period an additional 30 days (comment period 09/08/2015 to 01/06/2016)
- September 8, 2015 Notice of Proposed Rulemaking, Federal Policy for the Protection of Human Subjects (comment period 09/08/2015 to 12/07/2015)
- 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)
- 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)
