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News Release

FOR IMMEDIATE RELEASE
Wednesday, May 12, 2004

Contact: HHS Press Office
(202) 690-6343

HHS Provides Guidance on Financial Relationships and Interests in Research Involving Human Subjects

HHS Secretary Tommy G. Thompson today released new guidance for protecting research subjects from possible harm caused by financial conflicts of interest that may arise in research studies.

The guidance, “Financial Relationships and Interests in Research Involving Human Subjects: Guidance for Human Subject Protection,” applies to all human subjects research conducted or supported by HHS agencies or regulated by the Food and Drug Administration.

“All who take part in research deserve the strongest possible protection,” Secretary Thompson said. “Openness and honesty help promote ethical research and can only strengthen the research process.”

Institutions, institutional review boards (IRBs), researchers and other responsible parties are encouraged to use this guidance to help ensure that any potential conflicts of interest stemming from financial relationships are identified and eliminated or managed with the subject’s best interests in mind. The guidance presents a series of points to consider in determining if and how specific financial interests in research can affect the rights and welfare of human subjects, and if so, what actions can be considered to protect those subjects.

As institutions, IRBs and researchers consider potential financial conflicts of interest, they can refer to the guidance for possible mechanisms to manage such conflicts. These mechanisms include:

  • Separating institutional responsibility for research activities from management of the institution’s financial interests;
  • Establishing conflict of interest committees (COICs) or identifying other bodies or persons and procedures to address financial interests in research;
  • Using independent organizations to hold or administer the institution's financial interest;
  • Determining whether current methods for managing conflicts of interest are adequate for protecting the rights and welfare of human subjects and whether other actions are needed to minimize risks to subjects;
  • Determining the kind, amount, and level of detail of information to be provided to research subjects regarding funding and financial interests; and
  • Using special measures to modify the informed consent process when a potential or actual financial conflict exists.

In preparing this guidance, the Department considered public comments on an earlier draft guidance published in March 2003. The guidance is available at http://ohrp.osophs.dhhs.gov/humansubjects/finreltn/finalguid.pdf.

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Last Revised: July 26, 2004