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| Titel: |
Reforming the Oversight of Multi-Site Clinical Research: A Review of Two Possible Solutions |
| Auteur: |
Nowak, Kristin S. Bankert, Elizabeth A. Nelson, Robert M. |
| Verschenen in: |
Accountability in research |
| Paginering: | Jaargang 13 (2006) nr. 1 pagina's 11-24 |
| Jaar: |
2006-04 |
| Inhoud: |
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. |
| Uitgever: |
Taylor & Francis |
| Bronbestand: |
Elektronische Wetenschappelijke Tijdschriften |
Details van artikel 5 van 6 gevonden artikelen
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