Reforming the Oversight of Multi-Site Clinical Research: A Review of Two Possible Solutions
Authors: NOWAK, KRISTIN1; BANKERT, ELIZABETH1; NELSON, ROBERT2
Source: Accountability in Research: Policies and Quality Assurance, Volume 13, Number 1, January-March 2006 , pp. 11-24(14)
Publisher: Taylor and Francis Ltd
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Abstract:
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.Keywords: clinical research; Institutional Review Board; regional ethics organization; multi-site research; pharmaceutical research
Document Type: Research article
DOI: 10.1080/08989620600588845
Affiliations: 1: Dartmouth College, Hanover, New Hampshire, USA 2: Center for Research Integrity, The Children's Hospital of Philadelphia, Philadelphia, Pennsylvania, USA
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