Wickremsinhe Marisha, Carrecedo Sarah, Yakubu Aminu, Yusof Aimi Nadia Mohd, Kaur Sharon
London School of Hygiene and Tropical Medicine, London, UK.
Pontificia Universidad Catolica del Peru, Lima District, Lima Region, Peru.
Wellcome Open Res. 2023 Jun 2;8:231. doi: 10.12688/wellcomeopenres.19279.1. eCollection 2023.
Health-related research with human participants is governed by research ethics regulations in most jurisdictions. Globally, the 2016 International Ethical Guidelines for Health-related Research Involving Humans, published by the Council for International Organizations of Medical Sciences (CIOMS), are especially influential and widely held as an international standard. The CIOMS guidelines support the inclusion of people with psychosocial disabilities in research and offer clear guidance to promote their recruitment, including by outlining provisions for substitute decision-making. The CIOMS guidelines sit alongside the United Nations' Convention on the Rights of Persons with Disabilities (CRPD). Adopted in 2006 and ratified in 2008, the CRPD offers a robust framework for recognizing the rights of persons with disabilities, including individuals with psychosocial disabilities. Though the CRPD does not explicitly reference research inclusion, its core principles-especially pertaining to the right to universal legal capacity-have clear implications for research ethics governance, specifically with respect to the use of substitute decision-making for research participation. In this paper, we review the extent to which existing research ethics regulations across selected jurisdictions concord with each of these two frameworks, offering first a broad analysis of regulations across 26 African countries, and then exploring two country-specific case studies from Malaysia and Peru. We find that, while many countries' research ethics regulations align with key aspects of the CIOMS guidelines, core principles of the CRPD are absent. Given the shortcomings of existing regulations, we analyse a key point of tension between CIOMS and the CRPD-the right to participate in research-and offer a proposal for revised regulations that aims to bridge this tension and meet the standards of both frameworks.
在大多数司法管辖区，涉及人类参与者的健康相关研究受研究伦理法规的约束。在全球范围内，国际医学科学组织理事会（CIOMS）于2016年发布的《涉及人类的健康相关研究国际伦理准则》具有特别重要的影响力，并被广泛视为国际标准。CIOMS准则支持将患有心理社会残疾的人纳入研究，并提供明确指导以促进他们的招募，包括概述替代决策的规定。CIOMS准则与联合国《残疾人权利公约》（CRPD）并行。CRPD于2006年通过并于2008年批准，为承认残疾人权利提供了一个强有力的框架，包括患有心理社会残疾的个人。尽管CRPD没有明确提及研究纳入，但它的核心原则——特别是与普遍法律行为能力权相关的原则——对研究伦理治理有明确影响，特别是在使用替代决策来参与研究方面。在本文中，我们审查了选定司法管辖区现有的研究伦理法规与这两个框架各自的一致程度，首先对26个非洲国家的法规进行了广泛分析，然后探讨了马来西亚和秘鲁的两个国别案例研究。我们发现，虽然许多国家的研究伦理法规与CIOMS准则的关键方面一致，但CRPD的核心原则却缺失。鉴于现有法规的不足，我们分析了CIOMS和CRPD之间的一个关键紧张点——参与研究的权利——并提出了一项修订法规的建议，旨在弥合这一紧张关系并符合两个框架的标准。
