HHS requests comments on new financial conflicts of interest guidelines

HHS requests comments on new financial conflicts of interest guidelines

The Department of Health and Human Services (HHS) has proposed new draft guidelines for protecting research volunteers from possible harm caused by financial conflicts of interest. "Financial Relationships and Interests in Research Involving Human Subjects: Guidance for Human Subject Protection," presents a single HHS-wide reference point for decision-making pertaining to all human subject research. It would apply to research conducted or supported by HHS and its agencies, including the National Institutes of Health and the Centers for Disease Control and Prevention, as well as to all human subject research regulated by the Food and Drug Administration.

Presented as a series of questions and "points to consider," the draft guidance is directed to investigators, research institutions, institutional review boards, and other interested parties who develop, review, and implement research proposals. The intent is to help these entities assess whether financial interests in research could affect the rights and welfare of research subjects, as well as suggest actions to manage or eliminate such conflicts of interest.

The proposed guidelines were published as a notice (pp. 15456-15460) in the March 31 Federal Register with a 60-day comment period. Go to http://fr.cos.com/cgi-bin/getRec?id=20030331a140.

Source: AAMC STAT, March 31, 2003