The paradox of human subjects protection in research: some thoughts on and experiences with the Federalwide Assurance Program.
The paradox of human subjects protection in research: some thoughts on and experiences with the Federalwide Assurance Program.
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研究中人类受试者保护的悖论：对联邦保障计划的一些思考和经验。
DOI：
10.1111/j.1553-2712.2002.tb01615.x
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发表时间：
2002
期刊：
影响因子：
--
通讯作者：
Lewis,RogerJ
中科院分区：
文献类型：
--
作者：
Newgard,CraigD;Lewis,RogerJ
保护参与医学研究的人类受试者，就其本质而言，是一种平衡行为。历史表明，保护不足，特别是对弱势群体的保护不足，会导致潜在的虐待、剥削和伤害。相反，对医学研究的过度限制性监管，即使仅仅是出于保护人类受试者的愿望，也可能成为旨在使受保护人群受益的研究的障碍。适当的平衡并不总是一开始就显而易见的，但随着我们对各种人类受试者保护方法的经验积累，可能必须使用迭代过程来找到。在美国，美国卫生与公众服务部（DHHS）下属的人类研究保护办公室（OHRP）是负责保护人类研究受试者的机构。随着联邦研究资金水平的不断提高以及联邦政府支持的研究项目数量的增加，旨在确保保护人类受试者的法规的实施在过去几年中发生了重大变化。多年来，联邦对人类研究保护的监督是通过各种不同的保证提供的。“保证”是一份文件或协议，规定了机构遵守管理研究行为的联邦法规的义务。多项目协议（MPA）被颁发给参与大量研究的机构，这些机构拥有机构审查委员会（IRB）和系统，以确保保护人类受试者和研究的道德行为，通常是学术中心。单一项目咨询（SPA）是针对特定项目的（即，每个项目需要不同的SPA），并发放给不定期参与研究或没有自己的IRB的机构（例如，社区医院、疗养院）。合作项目Asphalt（CPA）用于参与多中心试验的机构，通常在联邦机构（例如，美国国立卫生研究院或疾病控制和预防中心）的指导或支持下进行。每种类型的保险-
Protecting human subjects who participate in medical research is, by its very nature, a balancing act. History has shown that inadequate protection, especially of vulnerable populations, leads to potential abuse, exploitation, and harm. 1, 2 Conversely, overly restrictive regulation of medical research, even when motivated solely by the desire to protect human subjects, may be a barrier to the conduct of research that is intended to benefit the very population being protected. The appropriate balance is not always initially apparent, but may have to be found using an iterative process as we gain experience with various approaches to human subjects protection.In the United States, the Office for Human Research Protections (OHRP), under the auspices of the US Department of Health and Human Services (DHHS), is the agency assigned to protect human research subjects. In response to increasing levels of federal research funding and a resulting increase in the number of federally-supported research projects, the implementation of the regulations designed to ensure protection of human subjects has changed significantly over the last several years. For many years, federal oversight of human research protection was provided through a variety of different assurances. An ‘‘assurance’’is a document or agreement that defines an institution’s obligation to comply with the federal regulations governing the conduct of research. Multiple Project Assurances (MPAs) were issued to institutions participating in larger volumes of research that had Institutional Review Boards (IRBs) and systems in place to ensure the protection of human subjects and the ethical conduct of research, typically academic centers. Single Project Assurances (SPAs) were project-specific (ie, a different SPA was required for each project) and were issued to institutions that did not regularly participate in research or that did not have their own IRB (eg, community hospitals, nursing homes). Cooperative Project Assurances (CPAs) were used for institutions participating in multicenter trials, usually under the guidance or support of a federal agency (eg, the National Institutes of Health or the Centers for Disease Control and Prevention). Each type of assur-