The issue of financial conflicts of interest in research is one of the five main issues identified by the Secretary of Health and Human Services in her announcement of steps being taken to strengthen human subject protection during clinical trials. (Ref. Press Release and Backgrounder, 5/23/00). In that announcement, the Secretary stated that HHS would hold public discussions this summer to find new ways to manage conflicts of interest so that research subjects are appropriately informed, and to further ensure that research results are analyzed and presented objectively. In addition, these public discussions also will focus on clarifying and enhancing the informed consent process.
A conference was held August 15-16, 2000 at the National Institutes for Health in Bethesda, Maryland in order to
- Implement one of the Secretary's five initiatives to strengthen human subject protection in clinical research.
- Remind participants of current PHS/FDA regulations, guidelines and guidance through documents and presentations.
- Present examples of how the issue of financial conflict of interest is dealt with at the level of: Institutions, IRBs, and Clinical Investigators.
- Receive public comments on questions posed in the Federal Register announcing the conference.
- Receive public comments on the NIH guidance on Financial Conflicts of Interest.
- Provide information for the Department of Health and Human Services to develop more useful and detailed guidance to implement current regulatory requirements.
Comments were addressed to our email box at coi@osaspe.dhhs.gov or otherwise addressed to
Stuart Nightingale, M.D.
Office of the Assistant Secretary for Planning and Evaluation
Hubert H. Humphrey Bldg., Room 447D
200 Independence Ave., S.W.
Washington, D.C. 20201
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Updated July
16,
2001