[Federal Register Volume 68, Number 62 (Tuesday, April 1, 2003)]
[Notices]
[Page 15731]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-7957]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 03N-0014]


Draft Guidance on Human Subject Protection; HHS Request for 
Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of solicitation of comments by HHS.

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SUMMARY: The Food and Drug Administration (FDA) is announcing that in 
the issue of the Federal Register published March 31, 2003, the 
Department of Health and Human Services, Office of the Secretary, 
Office of Health and Science is soliciting public comment on a draft 
guidance document for Institutional Review Boards, investigators, 
research institutions, and other interested parties, entitled 
``Financial Relationships and Interests in Research Involving Human 
Subjects: Guidance for Human Subject Protection.'' This draft guidance 
document raises points to consider in determining whether specific 
financial interests in research affect the rights and welfare of human 
subjects, and if so, what actions could be considered to protect those 
subjects. This draft guidance applies to human subjects research 
conducted or supported by HHS or regulated by FDA.

DATES: HHS is accepting written or electronic comments on the draft 
guidance until 4:30 p.m. on May 30, 2003.

    Dated: January 21, 2003.
Margaret M. Dotzel,
Assistant Commissioner for Policy.
[FR Doc. 03-7957 Filed 3-28-03; 2:22 pm]
BILLING CODE 4160-01-S