Links to the Draft Guidance and Federal Register Notice of Availability:
The draft guidance can be accessed at Elimination of Institutional Review Board Review of Research Applications and Proposals.
A copy of the Federal Register notice announcing the availability of the draft guidance for comment can be accessed in either HTML or PDF formats at the Government Printing Office's Federal Digital system (FDsys) website.
The draft guidance provides guidance on the elimination of the requirement in the pre-2018 Requirements (45 CFR 46.103(f)), that each application or proposal for research undergo IRB review and approval as part of the certification process. This guidance also affirms the requirement in the 2018 Requirements for certification of each proposed research study prior to initiation. It is intended for Institutions, IRBs, investigators, HHS funding agencies, and others that may be responsible for the review, conduct, or oversight of nonexempt research involving human subjects conducted or supported by HHS.
How to Access Comments that Have Been Submitted:
With your Web browser, go to the Federal eRulemaking Portal: https://www.regulations.gov. Enter the docket ID number HHS-OPHS-2018-0014 in the "Enter Keyword or ID" field and click on "Search." On the next web page, click "Open Docket Folder", on next page, click "View all documents and comments in this Docket". The list of comments may extend over more than on page, and additional comments can be accessed by clicking the forward or back buttons at the bottom of the page. Note that some comments include attachments that can be opened.
When and How to Submit Comments:
Submit comments by 8/24/2018.
You may submit comments, identified by docket ID number HHS-OPHS-2018-0014, by one of the following methods:
- Federal eRulemaking Portal: https://www.regulations.gov. Enter the above docket ID number in the "Enter Keyword or ID" field and click on "Search." On the next web page, click on the "Submit a Comment" action and follow the instructions.
- Mail/Hand delivery/Courier [For paper, disk, or CD-ROM submissions]: Irene Stith-Coleman, Ph.D., OHRP, 1101 Wootton Parkway, Suite 200, Rockville, MD 20852.
OHRP strongly encourages commenters to submit comments via the Federal eRulmaking Portal. Comments received, including any personal information, will be posted without change to the docket at https://www.regulations.gov as they are submitted, usually within 1 week after submission. While the comment period remains open, individuals may also provide comments in response to already submitted comments that have been posted to the docket.
For Further Information Contact:
Irene Stith-Coleman, Ph.D., OHRP, 1101 Wootton Parkway, Suite 200, Rockville, MD 20852, 240-453-6900; e-mail Irene Stith-Coleman@hhs.gov