Revision of a self-assessment tool for research ethics committees in low- and middle-income countries: Incorporation of elements that safeguard participants' rights and welfare.

IF 0.9 3区哲学 Q3 ETHICS

Developing World Bioethics Pub Date : 2024-11-14 DOI:10.1111/dewb.12469

Hany Sleem, Henry J Silverman

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Abstract

Evaluating the quality of research ethics committees (RECs) is crucial but challenging due to the difficulty of developing meaningful quality measures. Recently, commentators assessed ten quality instruments for RECs, including the Research Ethics Committee Quality Assurance Self-Assessment Tool developed for RECs in the Arab Middle East. They identified several missing items in this tool regarding safeguarding participants' rights and welfare. To address these gaps, we aimed to redesign the tool. Using the Delphi method, we involved 15 REC chairs to provide feedback and recommendations for a revised tool. This process led to a modified instrument that incorporated the missing items and additional elements regarding the monitoring of research conduct (an essential oversight function of RECs), and the independence of the RECs from institutional and external influences. We conclude that the revised tool effectively addresses the quality of RECs by including elements relevant to participant outcomes, board deliberations, and participant protection. The added focus on ethics oversight enhances its robustness, significantly impacting participants' rights and welfare.

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修订中低收入国家研究伦理委员会的自我评估工具：纳入保障参与者权利和福利的要素。

评估研究伦理委员会 (REC) 的质量至关重要，但由于难以制定有意义的质量衡量标准，评估工作充满挑战。最近，评论者评估了 REC 的十种质量工具，包括为阿拉伯中东地区 REC 开发的研究伦理委员会质量保证自我评估工具。他们在该工具中发现了几个有关保障参与者权利和福利的缺失项。为了弥补这些缺失，我们打算重新设计该工具。我们采用德尔菲法，让 15 位区域选举中心主席为修订工具提供反馈和建议。在此过程中，我们修改了工具，纳入了缺失的项目，并增加了有关监督研究行为（REC 的基本监督职能）以及 REC 独立于机构和外部影响的内容。我们的结论是，修订后的工具通过纳入与参与者结果、董事会审议和参与者保护相关的要素，有效地解决了研究伦理委员会的质量问题。对伦理监督的额外关注增强了其稳健性，对参与者的权利和福利产生了重大影响。

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来源期刊

Developing World Bioethics 医学-医学：伦理

CiteScore

4.50

自引率

4.50%

发文量

审稿时长

>12 weeks

期刊介绍： Developing World Bioethics provides long needed case studies, teaching materials, news in brief, and legal backgrounds to bioethics scholars and students in developing and developed countries alike. This companion journal to Bioethics also features high-quality peer reviewed original articles. It is edited by well-known bioethicists who are working in developing countries, yet it will also be open to contributions and commentary from developed countries'' authors. Developing World Bioethics is the only journal in the field dedicated exclusively to developing countries'' bioethics issues. The journal is an essential resource for all those concerned about bioethical issues in the developing world. Members of Ethics Committees in developing countries will highly value a special section dedicated to their work.