Comparison of Research Ethics Committees (RECs) review of protocols reviewed by multiple ethics review committees.
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Date
2016
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Abstract
As high-impact diseases have increased, so have the collaborative efforts to alleviate their effects. These collaborative efforts have gone beyond borders, resulting in collaborative research between low- and middle-income countries (LMICs) and high-income countries (HICs). This collaborating factor has resulted in protocol review between the sponsor and host countries, resulting in multiple ethics review of a single site protocol.
This study discusses the issue of using a multiple research ethics committee (REC) model in ethics review. The study objectives were to investigate the similarity and/or variability in ethics review for a single-site protocol reviewed by multiple research ethics committees and to determine if protocols reviewed by both developing and developed countries were reviewed according to the ethical framework for clinical research proposed by Emanuel, Wendler, Killen, and Grady (2004). The study employed an exploratory qualitative design. For data collection, retrospective document review was used to review and compare REC responses.
Key findings were that there are major similarities in the ethics review process of RECs in developed and developing countries. Where variability was noted, this was negligible. The study highlighted that RECs in both developed and developing countries followed common research ethics principles and benchmarks as laid out in the ethical framework by Emanuel et al. Most researchers did not deviate from the protocols when carrying out their proposed studies as determined in the subsequent publishing of results.
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Master Social Science in Psychology. University of KwaZulu-Natal, Pietermaritzburg 2016.