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Draft Guidance on Important Considerations for When Participation of Human Subjects in Research is Discontinued

December 1, 2008

Background:

The Office for Human Research Protections (OHRP), Office of Public Health and Science, is seeking comment on a draft guidance document entitled, “Guidance on Important Considerations for When Participation of Human Subjects in Research is Discontinued.” The draft guidance document, when finalized, would provide OHRP’s first formal guidance on this topic. The draft document is intended primarily for institutional review boards, investigators, and funding agencies that may be responsible for the review or oversight of human subject research conducted or supported by the Department of Health and Human Services. The proposed guidance document would provide guidance on important considerations for when participation of human subjects in research is discontinued, either because a subject voluntarily chooses to discontinue participation during the course of the research, or because an investigator terminates a subject’s participation in the research without regard to the subject’s consent. OHRP will consider comments received before issuing the final guidance document.

Submit written or electronic comments by January 30, 2009. Comments may be submitted by any of the following methods: (1) E-mail todiscontinueparticipation@hhs.gov and include “Guidance on Discontinuation of Subject Participation” in the subject line; (2) Fax: 301-402-2071; (3) Mail/Hand delivery/Courier [For paper, disk, or CD-ROM submissions]: Michael A. Carome, M.D., Captain, U.S. Public Health Service, OHRP, 1101 Wootton Parkway, Suite 200, Rockville, MD 20852.

Comments received, including any personal information, will be made available to the public upon request.

The draft guidance can be accessed at:
http://www.hhs.gov/ohrp/documents/200811guidance.html or
http://www.hhs.gov/ohrp/documents/200811guidance.pdf.

A copy of the Federal Register notice announcing the availability of the draft guidance for comment can be accessed at:
http://edocket.access.gpo.gov/2008/E8-28369.html or
http://edocket.access.gpo.gov/2008/pdf/E8-28369.pdf.

FOR FURTHER INFORMATION CONTACT: Michael A. Carome, M.D., Captain, U.S. Public Health Service, OHRP, 1101 Wootton Parkway, Suite 200, Rockville, MD 20852, 240-453-6900; e-mail Michael.Carome@hhs.gov