Links to the Draft Guidance and Federal Register Notice of Availability:
The draft guidance can be accessed at Scholarly and Journalistic Activities Deemed Not to be Research: 2018 Requirements.
A copy of the Federal Register notice announcing the availability of the draft guidance for comment can be accessed in either HTML or PDF formats at the Government Printing Office's Federal Digital system (FDsys) website.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:
The draft guidance explains how certain scholarly and journalistic activities that focus directly on the specific individuals about whom the information is collected are deemed not to be research under the 2018 Requirements of the regulations for the protection of human subjects (45 CFR Part 46), and consequently do not have to satisfy the requirements of those regulations. It is intended for IRB administrators, IRB chairpersons, relevant institutional officials, and investigators who may be concerned about whether scholarly or journalistic activities need to satisfy the 2018 Requirements of the regulations.
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-2018-0012 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 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 8/24/2018.
You may submit comments, identified by docket ID number HHS-OPHS-2018-0012, 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 [email protected].
