Research ethics board approval for an international thromboprophylaxis trial

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• 作者：Kristina Lutz^a ; Kelly Wilton^a ; Nicole Zytaruk^a ; Lisa Julien^c ; Richard Hall^c ; Johanne Harvey^d ; Yoanna Skrobik^d ; Nicholas Vlahakis^e ; Laurie Meade^e ; Andrea Matte^f ; Maureen Meade^a ; ^b ; Karen Burns^f ; Martin Albert^d ; Bronwyn Barlow Cash^a ; Shirley Vallance^g ; James Klinger^h ; Diane Heels-Ansdell^b ; Deborah Cook^a ; ^b ; ^{debcook@mcmaster.ca} ; For the PROTECT Investigators in collaboration with the CCCTG ; ANZICS-CTG
• 关键词：Research ethics board ; Randomized trial ; Clinical research ; Ethics
• 刊名：Journal of Critical Care
• 出版年：2012
• 期刊代码：167_08839441
• 类别：med
• 出版时间：June, 2012
• 卷：27
• 期：3
• 页码：225-231
• 文件大小：148 K

摘要

Background

Research ethics board (REB) review of scientific protocols is essential, ensuring participants' dignity, safety, and rights. The objectives of this study were to examine the time from submission to approval, to analyze predictors of approval time, and to describe the scope of conditions from REBs evaluating an international thromboprophylaxis trial.

Methods

We generated survey items through literature review and investigators' discussions, creating 4 domains: respondent and institutional demographics, the REB application process, and alternate consent models. We conducted a document analysis that involved duplicate assessment of themes from REB critique of the protocol and informed consent forms (ICF).

Results

Approval was granted from 65 REB institutions, requiring 58 unique applications. We analyzed 44 (75.9%) of 58 documents and surveys. Survey respondents completing the applications had 8 (5-12) years of experience; 77%completed 4 or more REB applications in previous 5 years. Critical care personnel were represented on 54%of REBs. The time to approval was a median (interquartile range) of 75 (42, 150) days, taking longer for sites with national research consortium membership (89.1 vs 31.0 days, P = .03). Document analysis of the application process and ICF yielded 5 themes: methodology, data management, consent procedures, cataloguing, and miscellaneous. Protocol-specific themes focused on trial implementation, external critiques, and budget. The only theme specific to the ICF was risks and benefits. The most frequent comments on the protocol and ICF were about methodology and miscellaneous issues; ICF comments also addressed study risks and benefits.

Conclusions

More studies on methods to enhance efficiency and consistency of the REB approval processes for clinical trials are needed while still maintaining high ethical standards.