Background <p>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.</p> Methods <p>A 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.</p> Results <p>RECs 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.</p> Conclusion <p>Tanzanian 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.</p>

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What do Tanzanian Research Ethics Committees prioritise? A quantitative analysis of reviewer comments using Emanuel’s framework

  • David Machaku,
  • Bruno Sunguya,
  • Elizabeth Bukusi,
  • Richard Waddell,
  • Connie M. Ulrich

摘要

Background

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.

Methods

A 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.

Results

RECs 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.

Conclusion

Tanzanian 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.