What do Tanzanian Research Ethics Committees prioritise? A quantitative analysis of reviewer comments using Emanuel’s framework
摘要
Research Ethics Committees (RECs) are essential for protecting participants, yet their practical priorities in resource-limited settings remain underexplored. This study assesses how Tanzanian RECs apply Emanuel et al.'s eight-principle ethical framework during protocol review.
MethodsA quantitative content analysis was conducted on reviewers’ comments from 67 clinical trial protocols submitted between 2021 and 2023 in three Tanzanian RECs. Comments were categorized using a modified ethics framework, and frequencies were calculated to identify patterns.
ResultsRECs demonstrated a dominant focus on protocol structure (28.4% to 43.7%) and scientific validity (7.5% to 23.4%). Principles such as independent review (1.6% to 3.0%) and social value (2.4% to 6.0%) were consistently underemphasized. REC 1 and REC 2 placed greater emphasis on procedural and scientific elements, while REC 3 showed stronger attention to collaborative partnerships. However, REC 3 reviewed only two protocols; its percentages are highly unstable and should be interpreted as illustrative only.
ConclusionTanzanian RECs showed selective conformity to Emanuel et al.’s framework, prioritizing procedural and scientific elements over equity-oriented principles. This means they might approve studies that are scientifically sound but ethically inadequate. Recommendations include the implementation of balanced-review templates, enhanced reviewer training, and institutional accountability mechanisms to promote comprehensive ethical oversight.