About Draft on Risk Disclosure in Evaluating Standards of Care

Links to the Draft Guidance and Federal Register Notice of Availability:

The draft guidance can be accessed at Draft Guidance on Disclosing Reasonably Foreseeable Risks in Research Evaluating Standards of Care.

A copy of the Federal Register notice announcing the availability of the draft guidance for comment can be accessed in either HTML or PDF formats at the Government Printing Office's Federal Digital system (FDsys) website.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The draft guidance explains how to apply the HHS Regulations at 45 CFR Part 46 to studies that are designed to evaluate one or more standards of care.  It discusses whether risks are considered risks of research when one of the purposes of the research is the evaluation or comparison of risks associated with standards of care.  It also discusses disclosing certain reasonably foreseeable risks to prospective subjects when seeking their informed consent to participate in such research activities. It explains OHRP’s position that in general the reasonably foreseeable risks of research in a study include the already identified risks of the standards of care being evaluated as a purpose of the research when the risks being evaluated are different from the risks some of the subjects would be exposed to outside of the study.  Reasonably foreseeable risks must be described to prospective subjects when seeking their informed consent in accordance with 45 CFR 46.116(a)(2).

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-2014-0005 in the “Enter Keyword or ID” field and click on “Search.” On the next web page, click on the "View All" link at the top of the "Comments section of the page. The next web page shows a list of the comments.  Click on the "Comment on FR Doc # 2014-25318" link at the top of each comment to see the text of the comment. The list of comments extends 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 are a transmittal of an attached letter that can be opened from the page showing the comment.

When and How to Submit Comments:

Submit comments by January 22, 2015.

You may submit comments, identified by docket ID number HHS-OPHS-2014-0005, 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.