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News Release

FOR IMMEDIATE RELEASE
Friday, March 28, 2003

Contact: OPHS Press Office
(202) 205-1841

HHS PROPOSES NEW GUIDANCE FOR FINANCIAL CONFLICTS OF INTEREST
IN HUMAN SUBJECT RESEARCH

HHS Secretary Tommy G. Thompson today proposed draft guidance for protecting research volunteers from possible harm caused by financial conflicts of interest in the research.

The draft guidance, "Financial Relationships and Interests in Research Involving Human Subjects: Guidance for Human Subject Protection," presents a single HHS-wide reference point for decision-making that would apply to all human subject research conducted or supported by HHS and its agencies, including the National Institutes of Health and the Centers for Disease Control and Prevention. It would also apply to all human subject research regulated by the Food and Drug Administration.

"Protecting research volunteers is of paramount importance," said Secretary Thompson. "This guidance would give institutions, institutional review boards, researchers and other responsible parties a clearer framework for identifying and managing potential conflicts of interest as early as possible."

The draft guidance, presented as a series of questions and "points to consider," is directed to investigators, research institutions, institutional review boards (IRBs) and other interested parties who develop, review and implement research proposals. The guidance is intended to help these entities assess whether financial interests in research could affect the rights and welfare of research subjects and if so, what actions might be taken to manage or eliminate these conflicts of interest.

Although the draft guidance is primarily directed to the research community, the Secretary encourages the general public to comment as well.

The draft guidance suggests various points that institutions, IRBs, and researchers may use to manage any financial interests that are identified, such as the following:

  • Institutions could separate responsibility for financial decisions and research decisions, or could establish conflict-of-interest committees to verify the absence of financial interests in the research;
  • IRBs could verify that members have no conflicts of interest regarding protocols they consider;
  • Investigators could directly provide subjects with information on the source of funding and the funding arrangements for reviewing and carrying out the research; and
  • Investigators and IRBs could ensure that an independent third party is used to explain the research study to subjects and obtain subjects' consent.

The proposed guidelines will be published in the March 31 Federal Register with a 60-day comment period; they are also available at http://www.fda.gov/ohrms/dockets/GUIDANCES/DGUIDES.htm. Written comments may be submitted to the Dockets Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Room 1061, Rockville, MD 20852. Electronic comments may be sent to http://www.fda.gov/dockets/ecomments.

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Last Revised: March 28, 2003