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Financial Relationships and Interests in Research Involving Human Subjects: Guidance for Human Subject Protection

Federal Register, May 12, 2004, Page 26393-26397

Agency

Office of Public Health and Science, HHS.

Action

Notice.

Summary

The Office of Public Health and Science (OPHS), Department of Health and Human Services (HHS) announces a final guidance document for Institutional Review Boards (IRBs), investigators, research institutions, and other interested parties, entitled ``Financial Relationships and Interests in Research Involving Human Subjects: Guidance for Human Subject Protection.'' This guidance document raises points to consider in determining whether specific financial interests in research could affect the rights and welfare of human subjects, and if so, what actions could be considered to protect those subjects. This guidance applies to human subjects research conducted or supported by HHS or regulated by the Food and Drug Administration.

Dates

The guidance is effective as of the date of publication.

Addresses

Office for Human Research Protections, The Tower Building, 1101 Wootton Parkway, Suite 200, Rockville, MD 20852, (301) 402-4994, facsimile (301) 402-2071.

Further Information

Submit requests for single copies of the guidance document to the address identified below for further information. Requests may be made by mail or e-mail. Persons with access to the Internet also may obtain the document at http://ohrp.osophs.dhhs.gov/humansubjects/finreltn/finreltn.htm. Glen Drew, Office for Human Research Protections, Office of Public Health and Science, The Tower Building, 1101 Wootton Parkway, Suite 200, Rockville, MD 20852, (301) 402-4994, facsimile (301) 402-2071; e-mail gdrew@osophs.dhhs.gov.

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