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

Federal Register, March 31, 2003, Page 15456

Agency

Office of the Secretary, Office of Public Health and Science, HHS

Action

Notice

Summary

The Office of Public Health and Science, Department of Health and Human Services (HHS) is soliciting public comment on a draft guidance document for Institutional Review Boards (IRBs), investigators, research institutions, and other interested parties, entitled "Financial Relationships and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 This draft guidance document raises points to consider in determining whether specific financial interests in research affect the rights and welfare of human subjects, and if so,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 guidance applies to human subjects research conducted or supported by HHS or regulated by the Food and Drug Administration.

Dates

Submit written or electronic comments on the draft guidance on or before 4:30 p.m. on May 30, 2003. Comments on HHS guidance documents are welcome at any time.

Addresses

Submit written comments to the Dockets Management Branch (HFA-305), Docket Number 02N-0475, Food and Drug Administration, 5630 Fishers Lane, Room 1061, Rockville, MD 20852. Submit electronic comments to http://www.fda.gov/dockets/ecomments. All comments submitted should be identified with the docket number found in brackets in the heading of this notice. Comments received may be viewed on the Food and Drug Administration (FDA) Web site at http://www.fda.gov/ohrms/dockets/default.htm or may be seen in the FDA Docket Management Branch at 5630 Fishers Lane, Room 1061, Rockville, MD 20852 between 9 a.m. and 4 p.m., Monday through Friday. Submit requests for single copies of the draft guidance document to the address identified below for further information.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://www.fda.gov/ohrms/dockets/GUIDANCES/DGUIDES.HTM.

Further Information

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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