Reforming the Oversight of Multi-Site Clinical Research: A Review of Two Possible Solutions

The current system for the ethical oversight of clinical research suffers from structural, procedural, and performance assessment problems. Initially conceived primarily to handle local investigator-initiated single-site studies, the system of institutionally-based committee review has become progressively more inefficient given the increased prevalence of commercially or federally sponsored multi-center trials. To date, proposed solutions do not adequately address these problems.

Beginning with a review of these structural, procedural, and performance assessment problems, this article will then consider two proposals for addressing these deficiencies: (a) regional ethics organizations; and (b) IRBNet™, a newly developed web-based program for cooperative IRB review. The strengths and weaknesses of these two approaches will be evaluated in light of recent experience with centralized review. The proposal to establish a system of regional ethics organizations presents a comprehensive approach to many of the problems faced by the current system. However, IRBNet™ offers an immediate and feasible solution to many of the problems faced by the review of multi-site clinical studies.

IRBNet™ has been developed by Elizabeth A. Bankert, MA and Robert M. Nelson, MD, PhD through a cooperative venture of Dartmouth College and The Children’s Hospital of Philadelphia, funded by the National Institutes of Health through a Human Subjects Research Enhancement Award (1 S07 RR18181). IRBNet™ has subsequently been transferred to a private entity for commercial development.

Keywords:

• clinical research
• Institutional Review Board
• regional ethics organization
• multi-site research
• pharmaceutical research

Notes

IRBNet™ has been developed by Elizabeth A. Bankert, MA and Robert M. Nelson, MD, PhD through a cooperative venture of Dartmouth College and The Children’s Hospital of Philadelphia, funded by the National Institutes of Health through a Human Subjects Research Enhancement Award (1 S07 RR18181). IRBNet™ has subsequently been transferred to a private entity for commercial development.

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Brown, J. G. (1998). Institutional Review Boards: A Time for Reform. Department of Health and Human Services (ed.). Washington, DC: Office of the Inspector General.

Human Research Subject Protections Act of 2002. H.R.4697. Sponsored by Representative Diana DeGette. U.S. House of Representatives. 107th Congress

Research Revitalization Act of 2002. Senate Bill 3060. Sponsored by Senator Edward M. Kennedy. 107th Congress