包容、参与和负责的机构审查委员会。

IF 2.8 1区 哲学 Q1 MEDICAL ETHICS
Emily E Anderson, Ann Johnson, Holly Fernandez Lynch
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引用次数: 0

摘要

2023 年 2 月,美国政府问责局(GAO)发布了另一份报告,承认我们仍然缺乏有意义的、经过验证的、被广泛接受的措施来评估机构审查委员会(IRB)的质量和有效性。推进有效研究伦理监督联合会(www.AEREO.org)深知这一挑战,该联合会由人类研究保护(HRP)专业人士、研究人员和研究伦理学家组成,成立于 2018 年,目的正是为了实现 GAO 的建议:研究衡量 IRB 在保护人类受试者方面有效性的方法,并酌情实施这些方法。AEREO 在思考 IRB 的质量和有效性时,有两个基本原则是其核心:(1)IRB 的存在是为了保护参与者,因此参与者的视角应该是 IRB 所做的一切的核心;(2)由于 IRB 的任务是应用主观的伦理和监管标准,而人们对这些标准可能存在分歧,因此他们的方法和决定至少应该满足合理性的基本标准,即考虑相关视角、考虑关键因素并提供站得住脚的理由。对于上述每一条原则而言,IRB 都应在其审议过程中纳入不同的观点,想方设法与相关社区进行有意义的接触,了解他们对伦理研究和适当的参与者保护的看法,并对公众负责。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Inclusive, engaged, and accountable institutional review boards.

In February 2023, the U.S. Government Accountability Office (GAO) released another report acknowledging that we still lack meaningful, validated, widely-accepted measures for evaluating institutional review board (IRB) quality and effectiveness. This challenge is well known to the Consortium to Advance Effective Research Ethics Oversight (www.AEREO.org), a collaborative group of human research protection (HRP) professionals, researchers, and research ethicists founded in 2018 to do precisely what GAO recommends: examine approaches for measuring IRB effectiveness in protecting human subjects, and implement the approaches as appropriate. Two underlying tenets have been central to AEREO's as approach to thinking about IRB quality and effectiveness: (1) IRBs exist to protect participants and thus the participant perspective should be central to all IRBs do; and (2) because IRBs are tasked with applying subjective ethical and regulatory standards about which people may disagree, their approach and decisions should at least meet the basic standard of reasonableness in terms of accounting for relevant perspectives, considering key factors, and providing defensible justifications. Critical to each of these tenets, IRBs should include diverse perspectives in their deliberations, find ways to meaningfully engage with relevant communities about their views regarding ethical research and appropriate participant protections, and be accountable to the public.

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来源期刊
CiteScore
4.90
自引率
14.70%
发文量
49
审稿时长
>12 weeks
期刊介绍: Accountability in Research: Policies and Quality Assurance is devoted to the examination and critical analysis of systems for maximizing integrity in the conduct of research. It provides an interdisciplinary, international forum for the development of ethics, procedures, standards policies, and concepts to encourage the ethical conduct of research and to enhance the validity of research results. The journal welcomes views on advancing the integrity of research in the fields of general and multidisciplinary sciences, medicine, law, economics, statistics, management studies, public policy, politics, sociology, history, psychology, philosophy, ethics, and information science. All submitted manuscripts are subject to initial appraisal by the Editor, and if found suitable for further consideration, to peer review by independent, anonymous expert referees.
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