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社区参与研究的人体受试者保护计划的九项关键功能:需考虑的要点。

Nine key functions for a human subjects protection program for community-engaged research: points to consider.

作者信息

Ross Lainie Friedman, Loup Allan, Nelson Robert M, Botkin Jeffrey R, Kost Rhonda, Smith George R, Gehlert Sarah

机构信息

Department of Pediatrics, University of Chicago, IL 60637, USA.

出版信息

J Empir Res Hum Res Ethics. 2010 Mar;5(1):33-47. doi: 10.1525/jer.2010.5.1.33.


DOI:10.1525/jer.2010.5.1.33
PMID:20235862
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC2963647/
Abstract

The ethical conduct of Community-Engaged Research (CEnR), of which the Community-Based Participatory Research (CBPR) model is the partnership model most widely discussed in the CEnR literature and is the primary model we draw upon in this discussion, requires an integrated and comprehensive human subjects protection (HSP) program that addresses the additional concerns salient to CEnR where members of a community are both research partners and participants. As delineated in the federal regulations, the backbone of a HSP program is the fulfillment of nine functions: (1) minimize risks; (2) reasonable benefit-risk ratio; (3) fair subject selection; (4) adequate monitoring; (5) informed consent; (6) privacy and confidentiality; (7) conflicts of interest; (8) address vulnerabilities; and (9) HSP training. The federal regulations, however, do not consider the risks and harms that may occur to groups, and these risks have not traditionally been included in the benefit: risk analysis nor have they been incorporated into an HSP framework. We explore additional HSP issues raised by CEnR within these nine ethical functions. Various entities exist that can provide HSP---the investigator, the Institutional Review Board, the Conflict of Interest Committee, the Research Ethics Consultation program, the Research Subject Advocacy program, the Data and Safety Monitoring Plan, and the Community Advisory Board. Protection is best achieved if these entities are coordinated to ensure that no gaps exist, to minimize unnecessary redundancy, and to provide checks and balances between the different entities of HSP and the nine functions that they must realize. The document is structured to provide a "points-to-consider" roadmap for HSP entities to help them adequately address the nine key functions necessary to provide adequate protection of individuals and communities in CEnR.

摘要

社区参与式研究(CEnR)的伦理行为,其中基于社区的参与式研究(CBPR)模式是CEnR文献中讨论最广泛的合作模式,也是我们在本次讨论中主要借鉴的模式,需要一个综合全面的人体受试者保护(HSP)计划,该计划要解决CEnR中突出的其他问题,即社区成员既是研究伙伴又是参与者的情况。如联邦法规中所规定的,HSP计划的核心是履行九项职能:(1)将风险降至最低;(2)合理的利益风险比;(3)公平的受试者选择;(4)充分的监测;(5)知情同意;(6)隐私和保密;(7)利益冲突;(8)应对脆弱性;(9)HSP培训。然而,联邦法规并未考虑可能发生在群体身上的风险和危害,这些风险传统上既未包含在利益风险分析中,也未纳入HSP框架。我们在这九项伦理职能范围内探讨CEnR提出的其他HSP问题。有各种实体可以提供HSP,包括研究者、机构审查委员会、利益冲突委员会、研究伦理咨询计划、研究受试者倡导计划、数据和安全监测计划以及社区咨询委员会。如果这些实体能够协调一致,以确保不存在漏洞、尽量减少不必要的冗余,并在HSP的不同实体及其必须实现的九项职能之间提供制衡,那么就能最好地实现保护。该文件的结构旨在为HSP实体提供一个“要点考虑”路线图,以帮助它们充分履行在CEnR中为充分保护个人和社区所必需的九项关键职能。

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[8]
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