FW: Good Clinical Practice Update (December 2008)

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You are a subscriber to the Good Clinical Practice/ Human Subject

Protection e-mail update service provided by the U.S. Food & Drug

Administration (FDA). We thought you might be interested in receiving

the following information that was recently sent by the Office for Human

Research Protections (OHRP).

" On December 1, 2008, the Office for Human Research Protections (OHRP)

announced, in the Federal Register, the availability of a draft guidance

document entitled " OHRP 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

maybe 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 efore issuing the final guidance document.

OHRP requests that written comments on the draft guidance document be

submitted by January 30, 2009. Comments may be submitted by any of the

following methods: (1) E-mail to discontinueparticipation@... and

include " Guidance on Discontinuation of Subject Participation " in the

subject line; (2) Fax: ; (3) Mail/Hand delivery/Courier [For

paper, disk, or CD-ROM submissions]: A. Carome, M.D., Captain,

U.S. Public Health Service, OHRP, 1101 Wootton Parkway, Suite

200,Rockville, MD 20852.

The draft guidance can be accessed at:

http://www.hhs.gov/ohrp/requests/200811guidance.html or

<http://www.hhs.gov/ohrp/requests/200811guidance.pdf>

http://www.hhs.gov/ohrp/requests/200811guidance.pdf

<http://www.hhs.gov/ohrp/requests/200811guidance.pdf.A> .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.htm or

http://edocket.access.gpo.gov/2008/pdf/E8-28369.pdf. "

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