SPECIAL SECTION: ETHICAL LIMITS IN HUMAN SUBJECTS RESEARCH
The Poster Child for the Need for Central Review of Research
Protocols: The Children's Oncology Group
and ANITA F.
a1 Rebecca D. Pentz, Ph.D., is Associate
Professor of Hematology and Oncology in Research Ethics at the Winship
Cancer Institute of Emory University, Atlanta, Georgia
a2 Anita F. Khayat, Ph.D., M.B.A., is Executive
Officer at the Children's Oncology Group in Arcadia,
Multiple groups, including the National Bioethics Advisory Commission,
the American Society of Clinical Oncology (ASCO), the National Coalition
of Comprehensive Cancer Centers (Personal communication with Robert B.
Catalano, PharmD, Vice President for Regulatory Affairs, Coalition of
National Cancer Cooperative Groups), Workgroup 6 of the Summit Series on
Cancer, PRIM&R, the Bell Report, and prominent ethicists have called
for replacing the current system of local institutional review with central
review for multisite national trials. We argue that this need is particularly
acute in pediatric oncology, as shown by the experience of the
Children's Oncology Group (COG).