The Department of Health and Human Services will hold a two-day public meeting August 15-16, 2000, to discuss the issue of financial conflict of interest and human subject protections in clinical research.

The meeting will emphasize the informed consent process and how it might be clarified and enhanced in dealing with issues related to financial conflict of interest. This conference responds to one of the five main actions outlined by HHS Secretary Donna E. Shalala in her May 23 announcement of steps being taken to strengthen human subject protection during clinical trials.

The conference will provide information on current Public Health Service and Food and Drug Administration regulations, guidelines and guidance, and will include examples of how the issue of financial conflict of interest has been handled by a number of institutions, Institutional Review Boards, and clinical investigators. The conference also will solicit public comment on the issues surrounding financial conflict of interest and human subject protections. The input received during the meeting will provide information for HHS to develop additional guidance to implement current regulatory requirements.

The meeting will be held in the Natcher Conference Center on the Bethesda, Md., campus of the National Institutes of Health.

The Office of the Secretary, HHS, NIH, the Food and Drug Administration, and the Centers for Disease Control and Prevention are the sponsors of the meeting. Additional information about the conference is available at the following Web site: http://www.aspe.hhs.gov/sp/coi/index.htm. You may register online at the Web site, or you may contact Mark Brown
by phone at 240-632-0519,
by fax at 240-632-0519,
or by e-mail at mbrown@masimax.com.