Draft Guidance – The Revised Common Rule Compliance Dates and Transition Provision (45 CFR 46.101(l)

Links to the Draft Guidance:

The draft guidance can be accessed at The Revised Common Rule Compliance Dates and Transition Provision (45 CFR 46.101(l).

Background:

The draft guidance document pertains to research conducted or supported by HHS and subject to 45 CFR part 46. It discusses the regulatory implications of institutional decisions to voluntarily transition research studies initiated before January 21, 2019 to the 2018 Requirements (as described in the transition provision). It discusses when and how an institution may transition a study initiated before January 21, 2019 to the 2018 Requirements and describes the regulatory impact that transitioning a study will have on the administration of that study. Depending on when a transition determination is made, it may be necessary, for example, for investigators to revise informed consent forms. The draft document also discusses logistical issues, in the form of Q&As, that pertain to the transition of a study from the pre-2018 Requirements to the 2018 Requirements. It is intended for IRBs, investigators, research administrators and other relevant institutional officials, and funding agencies that may be responsible for review or oversight of human subjects research conducted or supported by HHS, and the general public.

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-2019-0001 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 2/11/2019.

You may submit comments, identified by docket ID number HHS-OPHS-2019-0001, 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]: Lauren Hartsmith, J.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:

Lauren Hartsmith, J.D., OHRP 1101 Wootton Parkway, Suite 200, Rockville, MD 20852, 240-453-6900; e-mail Lauren.Hartsmith@hhs.gov.