Dr. P. David Charles, assistant professor of Neurology, recently testified in front of the Senate Health, Education Labor, and Pensions Subcommittee on Public Health about protections for human research subjects.
Testifying on behalf of the National Alliance of Medical Researchers and Teaching Physicians, Charles told the subcommittee, “The challenge for the medical profession and public policy makers is to strengthen safeguards without creating new regulations so burdensome that they make it impossible to complete vital research.”
Charles outlined the Alliance’s support for a comprehensive and uniform set of federal protections; strong, informed, and independent oversight by IRBs; effective privacy protections that do not prevent important archival research; and strong guidelines governing conflicts of interest that require full disclosure of such arrangements.
Controversy arose after the deaths of two research participants in the past four years. Last year, a 24-year-old died after volunteering in a Johns Hopkins University asthma study. In 1998, an 18-year-old died after participating in a gene therapy trial at the University of Pennsylvania.
The subcommittee is chaired by Senator Edward Kennedy (D-Mass.) Senator Bill Frist (R-Tenn.) is the subcommittee’s ranking member.