Research ethics board approval for an international thromboprophylaxis trial

Kristina Lutz, Kelly Wilton, Nicole Zytaruk, Lisa Julien, Richard Hall, Johanne Harvey, Yoanna Skrobik, Nicholas Vlahakis, Laurie Meade, Andrea Matte, Maureen Meade, Karen Burns, Martin Albert, Bronwyn Barlow Cash, Shirley Vallance, James Klinger, Diane Heels-Ansdell, Deborah Cook

Producción científica: Contribución a una revistaArtículorevisión exhaustiva

5 Citas (Scopus)

Resumen

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.

Idioma originalEnglish
Páginas (desde-hasta)225-231
Número de páginas7
PublicaciónJournal of Critical Care
Volumen27
N.º3
DOI
EstadoPublished - jun. 2012

Nota bibliográfica

Funding Information:
We are grateful to all research coordinators and investigators who participated in this study. We thank Mary Jane Sayles for her help with the logistics of this project. We thank Drs Michael Walsh and Gordon Guyatt for their analysis suggestions and anonymous peer reviewers. Dr M. Meade is a mentor of the Canadian Institutes of Health Research. Dr K. Burns holds a Clinician Scientist Award from the Canadian Institutes for Health Research. Dr D. Cook is a research chair of the Canadian Institutes for Health Research. This work was supported by the Canadian Institutes for Health Research.

ASJC Scopus Subject Areas

  • Critical Care and Intensive Care Medicine

Huella

Profundice en los temas de investigación de 'Research ethics board approval for an international thromboprophylaxis trial'. En conjunto forman una huella única.

Citar esto