Navigating federalwide assurance requirements when conducting research in community-based care settings
Navigating federalwide assurance requirements when conducting research in community-based care settings
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DOI：
10.1111/j.1532-5415.2004.52424.x
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发表时间：
2004-09-01
影响因子：
6.3
通讯作者：
Shupert, CL
中科院分区：
文献类型：
--
作者：
Cartwright, JC;Hickman, SE;Shupert, CL
迫切需要对生活在社区护理环境中的老年人的生活质量和医疗保健提供进行研究，但在这些环境中实施当前的联邦范围保险(FWA)要求可能是一个挑战。本文讨论FWA对参与联邦资助研究的要求，因为这些要求与基于社区的护理环境有关。阻碍社区设施获得FWA批准的因素包括：缺乏对研究道德行为进行监督的组织结构，管理者对获得FWA相关的潜在责任感到担忧，缺乏完成所需文书工作的资源，以及工作人员缺乏关于人类受试者保护和参与研究的联邦要求的知识。自由贸易协定程序对调查人员的影响包括为支持以社区为基础的设施获取自由贸易协定所需的额外时间负担，以及担心研究可能仅限于那些拥有完成自由贸易协定程序的资源的社区设施。由调查员发起的在社区环境中开展研究的战略包括考虑豁免FWA程序的研究设计，以及积极协助社区机构获得FWA地位。调查人员需要与潜在的研究网站和人类研究保护办公室合作，以确保受试者得到保护，而不会将保护负担转移到准备不足的社区管理员身上。
There is an urgent need for research on quality of life and healthcare delivery for older adults living in community-based care settings, yet implementing current federalwide assurance (FWA) requirements can be a challenge in these settings. This paper discusses FWA requirements for engagement in federally funded research as the requirements pertain to community-based care settings. Factors that impede community facilities in achieving FWA approval include lack of organizational structure to provide oversight for the ethical conduct of research, administrator concerns regarding potential liability associated with obtaining the FWA, lack of resources to complete required paperwork, and lack of staff knowledge about human subjects protection and federal requirements for participating in research. Effects of the FWA process on investigators include the burden of extra time needed to support community-based facilities to acquire a FWA and concerns that studies may be limited to only those community facilities with the resources to complete the FWA process. Investigator-initiated strategies for conducting research in community-based settings include considering study designs that are exempt from the FWA process and proactively assisting community-based facilities to acquire FWA status. Investigators need to work with potential research sites and the office for human research protections to ensure that subjects are protected without shifting the burden of protection to ill-prepared community administrators.