Health Systems and Research Ethics Department, KEMRI-Wellcome Trust Research Programme, Kilifi, Kenya
Mary Ann & J. Milburn Smith Child Health Outcomes, Research, and Evaluation Center, Stanley Manne Children's Research Institute, Ann & Robert H Lurie Children's Hospital, Chicago, Illinois, USA.
BMJ Glob Health. 2024 Aug 25;9(8):e015233. doi: 10.1136/bmjgh-2024-015233.
A data monitoring committee (DMC) is an independent group of experts who assess the ongoing scientific and ethical integrity of a study through periodic analyses of study data. The objective of this study was to explore the extent to which the structure, membership and deliberations of DMCs enable them to address ethical issues.
We conducted qualitative individual interviews (n=22) with DMC members from countries across Africa, the Americas, South Asia and the UK. We selected interview respondents through purposive sampling, managed data using NVivo (Release V.1.7) and analysed data thematically.
All respondents were highly experienced professionals; many (18/22) had received training in medicine and/or statistics. One respondent had academic qualifications in ethics, and four indicated that they served on DMCs as ethicists. While respondents generally felt DMCs should be required for studies that were high-risk or enrolled vulnerable populations, some were concerned about the overuse of DMCs. There were divergent views on the necessity of geographical and disciplinary representation in DMC membership, including about whether ethicists were helpful. Many respondents described a DMC member recruitment process that they felt was somewhat exclusive. While one respondent received DMC-specific training, most described learning on the job. Respondents generally agreed that study protocols and DMC charters were key guiding documents for addressing ethical issues and described DMC deliberations that often, but not always, involved consensus-building.
This study is one of the first to consider the ethical implications of DMC structure, membership and deliberations. The potential overuse of DMCs, DMC member recruitment processes that seem somewhat insular, limited training for DMC members, and divergent approaches to deliberation may limit the capacity of DMCs for addressing ethical issues. Further research on DMC structure and processes could help enhance the ethical preparedness of DMCs.
数据监测委员会（DMC）是一个独立的专家组，通过定期分析研究数据，评估研究的科学和伦理完整性。本研究的目的是探讨 DMC 的结构、成员和审议程序在多大程度上能够解决伦理问题。
我们对来自非洲、美洲、南亚和英国的 DMC 成员进行了定性的个人访谈（n=22）。我们通过目的抽样选择访谈受访者，使用 NVivo（版本 V.1.7）管理数据，并进行主题分析。
所有受访者都是经验丰富的专业人士；许多人（18/22）接受过医学和/或统计学培训。一名受访者拥有伦理学的学术资格，四名受访者表示他们作为伦理学家在 DMC 任职。虽然受访者普遍认为对于高风险或招募弱势群体的研究应该要求成立 DMC，但也有人担心 DMC 的过度使用。对于 DMC 成员的地理和学科代表性是否有必要存在分歧意见，包括伦理学家是否有帮助。许多受访者描述了他们认为有些排外的 DMC 成员招聘流程。虽然一名受访者接受了特定于 DMC 的培训，但大多数受访者描述了在职学习。受访者普遍认为研究方案和 DMC 章程是解决伦理问题的关键指导文件，并描述了 DMC 审议，这些审议通常但并非总是涉及建立共识。
这项研究是首次考虑 DMC 结构、成员和审议程序的伦理影响的研究之一。DMC 的过度使用、DMC 成员招聘流程似乎有些孤立、DMC 成员培训有限以及审议方法的分歧可能会限制 DMC 解决伦理问题的能力。进一步研究 DMC 的结构和程序可以帮助提高 DMC 的伦理准备水平。
