Experiences of research ethics committee members and scientists of the research protocol review process in Uganda: a case study.

Agnes Ssali,Janet Seeley,Fiona Poland

doi:10.1093/inthealth/ihaa047

Abstract

BackgroundWe investigated how relevant and responsive scientists and research ethics committee (REC) members considered the research protocol review processes for health research practice in Uganda.MethodsInterviews were conducted with five scientists and five REC members. Data were analysed thematically.ResultsHow much to compensate for time, the amount of study information shared with volunteers and sample storage for future unknown research were areas of concern for REC members. Delays in getting feedback concerned scientists.ConclusionsResearchers and REC members need to hold regular discussions to ensure the review process is relevant and responsive.

Highlights

Scientists and research ethics committee (REC) members have expressed concerns that the review process does not factor in certain aspects of trial conduct among vulnerable populations, such as compensation for time, amount of study information and future sample storage
Each committee member was tasked with reviewing the whole protocol, a few members with expertise in the given study topic area and discipline would take the lead in the discussion
REC members reported a number of challenges: ensuring information sheets and consent forms were clear and could be understood by the targeted study populations; decisions about appropriate compensation to study participants; researcher requests for sample storage without clear reasons for the purpose being explained; managing the response from scientists who disputed the REC feedback on reviewed protocols; funding limits in the field of ethics, which meant the training of committees and researchers in research ethics was limited; and the absence of national policy guidelines on research ethics

Summary

Introduction

Scientists and research ethics committee (REC) members have expressed concerns that the review process does not factor in certain aspects of trial conduct among vulnerable populations, such as compensation for time, amount of study information and future sample storage. This may lead to some friction between the two groups if not discussed.[1] We investigated how the ethics review process might become more relevant and responsive to health research practice in Uganda and in the wider field of applied research ethics. Conclusions: Researchers and REC members need to hold regular discussions to ensure the review process is relevant and responsive

Methods

Results

Discussion

Conclusion