Draft Guidance – Frequently Asked Questions: Limited Institutional Review Board Review and Related Exemptions

Links to the Draft Guidance:

The draft guidance can be accessed at https://www.hhs.gov/ohrp/regulations-and-policy/requests-for-comments/draft-guidance-frequently-asked-questions-limited-institutional-review-board-review-related-exemptions/index.html

A copy of the Federal Register notice announcing the availability of the draft guidance for comment can be accessed in either HTML or PDF formats at the Government Printing Office's Federal Digital system (FDsys) website.

Background:

OHRP is announcing the availability of a draft guidance document for public comment titled “Frequently Asked Questions: Limited Institutional Review Board Review and Related Exemptions.”  The draft guidance document applies to research activities involving human subjects that are conducted or supported by HHS.  It is intended primarily to help entities implement the requirement for limited review of research by an IRB to meet the conditions of four exemptions found at 45 CFR 46.104(d) of the 2018 Requirements (the Common Rule).  The draft guidance discusses the concept of limited IRB review, which appears in these exemptions, and provides information about how limited review may be conducted.  When finalized, this will provide OHRP’s first formal guidance on this topic. 

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-OASH-2022-0014 in the "Enter Keyword or ID" field and click on “Search.” On the next web page, click "View all documents and comments in this Docket." The list of comments may extend over more than one 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 August 15, 2023.

You may submit comments, identified by docket ID number HHS-OASH-2022-0014, by one of the following methods:

• Federal eRulemaking Portal: https://www.regulations.gov.  Follow the instructions for submitting comments. 
• E-mail: OHRP@hhs.gov 
• Fax: 240-453-8420
• Mail/Hand Delivery/Courier: Division of Policy and Assurances, Office for Human Research Protections, 1101 Wootton Parkway, Suite 200, Rockville, MD 20852. 

Instructions: All submissions received must include the docket number.  All comments received, including attachments and any personal information, will be posted without change to https://www.regulations.gov. 

For Further Information Contact:

Natalie Klein, Ph.D., Office for Human Research Protections, 1101 Wootton Parkway, Suite 200, Rockville, Maryland 20852; telephone: 240-453-8141; fax: 240-453-6909; e-mail address: natalie.klein@hhs.gov.