Harraseeket会议-重新审视人类参与研究的伦理监督系统

IF 2.1 Q2 ETHICS
S. Rosenfeld, G. Shaler, Ross Hickey
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引用次数: 2

摘要

美国目前的伦理监督体系是基于机构审查委员会(IRB)的审查。该系统的建立是为了应对生物医学、社会和行为研究中对受试者的众所周知的、令人震惊的虐待。自研究条例颁布以来的几十年里,对IRB监督负担的反应导致该系统将重点放在合规上,并将其积极监督不成比例地限制在可能带来身体伤害风险的研究上。与此同时,研究企业的特点发生了变化,方法现在呈现出法规中没有预见到的新风险。我们召集了一组IRB专业人员、学术领袖和其他人来讨论当前系统的局限性,如何改变该系统以识别不断变化的风险,并日益关注参与者和社区的声音,以及它如何更好地满足研究人员的需求,并支持作为公共产品的科学社会项目。建议包括呼吁重新审视学术激励结构,建立一套从研究设计开始就考虑伦理原则的系统,并明确为高风险的干预性试验和低风险的生物医学和社会行为研究提供不同的伦理支持和监督。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
The Harraseeket Conference – Revisiting systems for ethics oversight of research with human participants
The current system of ethical oversight in the United States is based on Institutional Review Board (IRB) review. The system was established in response to well-known and egregious mistreatment of subjects in both biomedical and social and behavioral research. In the decades since the research regulations were enacted, reaction to the burden of IRB oversight has led the system to focus on compliance and limit its active oversight disproportionately to studies that could present the risk of physical harm. At the same time, the characteristics of the research enterprise have changed and methodologies now present novel risks that were not envisioned in the regulations. We convened a group of IRB professionals, academic leaders, and others to discuss limitations of the current system, how that system could be changed to recognize evolving risks and an increasing focus on participant and community voice, and how it could better serve the needs of researchers and support the societal project of science as a public good. Recommendations included a call to reexamine the academic incentive structure, to develop a system to support consideration of ethical principles from the time of study design, and to explicitly provide different ethical support and oversight for high-risk interventional trials and lower risk biomedical and social behavioral research.
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来源期刊
Research Ethics
Research Ethics Arts and Humanities-Philosophy
CiteScore
4.30
自引率
11.80%
发文量
17
审稿时长
15 weeks
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