Magdalena Guraiib Maria, Ross Anna Laura, Frewer Andreas, Sprumont Dominique, Shamsi Gooshki Ehsan, Dzenowagis Joan, Alois Reis Andreas
Maria M. Guraiib, MPH, is a Technical Officer, in the Research for Health Department, World Health Organization, Geneva, Switzerland.
Anna Laura Ross, PhD, is Unit Head, Emerging Technology, Research Prioritisation and Support Unit, in the Research for Health Department, World Health Organization, Geneva, Switzerland.
Health Secur. 2024 Aug;22(4):281-293. doi: 10.1089/hs.2023.0095. Epub 2024 May 31.
The World Health Organization (WHO) addresses the governance of biorisks, including dual-use research, for countries. It emphasizes engaging multisectoral stakeholders such as governments, scientific bodies, health and research institutes, standard-setting organizations, funding bodies, and others. Ethics constitutes a key component of the framework. Given the high social impact of such research and the importance of trust, risk, and benefit, national ethics committees could make a valuable contribution by providing ethical guidance in the decisionmaking process. The purpose of this study was to examine the role of national ethics committees in the context of governance and oversight of dual-use research at the national level. We conducted a landscape analysis of the activities of ethics committees in dual-use research oversight. We also searched the WHO database on National Ethics Committees for publications related to dual-use research and/or misuse of life sciences research and gathered additional documentation from national ethics committees websites and through author contacts. Results showed that in the context of the wide range of oversight mechanisms for dual-use research in countries, national ethics committees have contributed to guiding policy and assessing dual-use research risks in only a limited number of countries. Recommendations from those countries include establishing a multistakeholder, coordinated oversight mechanism at the country level; strengthening international linkages to guide, harmonize, and reinforce national and international efforts; and involving ethics committees as an expert resource in the governance and oversight process.
世界卫生组织(WHO)为各国处理包括两用研究在内的生物风险治理问题。它强调让多部门利益相关者参与其中,如政府、科学机构、卫生与研究机构、标准制定组织、资助机构等。伦理是该框架的关键组成部分。鉴于此类研究具有高度的社会影响以及信任、风险和益处的重要性,国家伦理委员会可通过在决策过程中提供伦理指导做出宝贵贡献。本研究的目的是考察国家伦理委员会在国家层面两用研究治理与监督背景下的作用。我们对伦理委员会在两用研究监督方面的活动进行了全景分析。我们还在世界卫生组织国家伦理委员会数据库中搜索与两用研究和/或生命科学研究滥用相关的出版物,并从国家伦理委员会网站以及通过与作者联系收集了更多文件。结果显示,在各国对两用研究的广泛监督机制背景下,国家伦理委员会仅在少数国家为指导政策和评估两用研究风险做出了贡献。这些国家提出的建议包括在国家层面建立多利益相关者协调监督机制;加强国际联系以指导、协调和加强国家及国际努力;以及让伦理委员会作为专家资源参与治理和监督过程。