Draft Guidance – Use of a Single Institutional Review Board for Cooperative Research

Links to the Draft Guidance:

The draft guidance can be accessed at Use of a Single Institutional Review Board for Cooperative Research.

A copy of the Federal Register notice announcing the availability of the draft guidance for comment can be accessed in either HTML or PDF formats at the Government Printing Office's Federal Digital system (FDsys) website.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OHRP is announcing the availability of a draft guidance document for public comment titled “Use of a Single Institutional Review Board for Cooperative Research.”  The document is intended primarily for institutions, institutional review boards (IRBs), investigators, institutional officials, and other human research protection staff.

The draft guidance document applies to activities that are conducted or supported by HHS.  It is intended primarily to help entities implement the requirement for use of a single IRB for cooperative research (subpart A of 45 CFR part 46.114).  In particular, the draft guidance addresses the following topics:

1. What is cooperative research?
2. When must an institution rely on a single IRB for approval of cooperative research?
3. Who decides which IRB will be the IRB of record for the purposes of regulatory compliance?
4. Can an institution that is not required to comply with 45 CFR 46.114(b)(1) for a particular study still choose to rely on a single IRB for review of cooperative research?
5. Can an institution involved in cooperative research choose to conduct its own IRB review of the research even though review is required by a single IRB that is located elsewhere?
6. Are there documentation requirements for use of a single IRB in cooperative research?
7. What are some of the operational capacities an IRB should have in order to serve as a single IRB?
8. What are the responsibilities of the reviewing IRB with respect to information pertaining to sensitivity to community attitudes and the local context for proposed research?
9. What are the responsibilities of the reviewing IRB pertaining to applicable State and local laws?

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-2022-0011 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 30, 2022.

You may submit comments, identified by docket ID number HHS-OASH-2022-0011, by one of the following methods:

• Federal eRulemaking Portal: http://www.regulations.gov. Enter the docket ID number and click on “Search.” On the next page, click the “Comment Now” action and follow the instructions.
• Mail/Hand delivery/Courier [For paper, disk, or CD-ROM submissions]: Natalie Klein, Ph.D., Office for Human Research Protections, 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:

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.