Financial Relationships and Interests in Research Involving Human Subjects: Guidance for Human Subject Protection, March 31, 2003. Draft Guidance
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Office of Public Health and Science, Department of Health and Human Services (HHS) is soliciting public comment on a draft guidance document for Institutional Review Boards (IRBs), investigators, research institutions, and other interested parties, entitled "Financial Relationships and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" as announced in Federal Register, Vol.68, No. 61, Monday March 31, 2003, Page 15456. The notice can be viewed as a pdf document at: http://www.hhs.gov/ohrp/references/fr03-7691.pdf.
This draft guidance raises points to consider in determining whether specific financial interests in research affect the rights and welfare of human subjects, and if so, what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 (FDA). Comments on the draft guidance document (Docket Number 02N-0475) must be received on or before May 30, 2003 and should be submitted to: http://www.fda.gov/dockets/ecomments. Received comments may be viewed on the FDA website at: http://www.fda.gov/ohrms/dockets/default.htm .