Understanding community-based processes for research ethics review: a national study.
Understanding community-based processes for research ethics review: a national study.
复制标题
了解基于社区的研究伦理审查流程：一项国家研究。
DOI：
10.2105/ajph.2010.194340
复制
发表时间：
2011
影响因子：
12.7
通讯作者：
Sarena D. Seifer
中科院分区：
文献类型：
--
作者：
Nancy Shore;R. Brazauskas;Elaine M Drew;Kristine A. Wong;Lisa Moy;Andrea Corage Baden;K. Cyr;Jocelyn Ulevicus;Sarena D. Seifer
目标
旨在保护个体研究参与者的机构审查委员会 (IRB) 不会定期评估社区的同意、风险和收益。社区团体正在建立伦理审查流程，以确定是否以及如何在其社区中进行研究。为了加强对社区参与研究的伦理审查，我们试图识别和描述这些过程。
方法
2008 年，我们对参与人类参与者研究的美国社区团体和社区机构合作伙伴进行了在线调查。我们确定了 109 名符合参与标准并制定了道德审查流程的受访者。
结果
受访者的流程主要通过社区机构伙伴关系、社区组织、社区卫生中心和部落组织发挥作用。创建这些流程的主要目的是确保相关社区参与研究并直接受益于研究，并免受研究危害。主要过程的好处包括让社区在决定进行哪些研究方面拥有发言权，确保研究具有相关性和可行性，并建立社区能力。主要的流程挑战是支持该流程所需的时间和资源。
结论
基于社区的道德审查流程考虑社区层面的道德问题，而基于机构的 IRB 通常不会考虑这些问题。
OBJECTIVES
Institutional review boards (IRBs), designed to protect individual study participants, do not routinely assess community consent, risks, and benefits. Community groups are establishing ethics review processes to determine whether and how research is conducted in their communities. To strengthen the ethics review of community-engaged research, we sought to identify and describe these processes.
METHODS
In 2008 we conducted an online survey of US-based community groups and community-institutional partnerships involved in human-participants research. We identified 109 respondents who met participation criteria and had ethics review processes in place.
RESULTS
The respondents' processes mainly functioned through community-institutional partnerships, community-based organizations, community health centers, and tribal organizations. These processes had been created primarily to ensure that the involved communities were engaged in and directly benefited from research and were protected from research harms. The primary process benefits included giving communities a voice in determining which studies were conducted and ensuring that studies were relevant and feasible, and that they built community capacity. The primary process challenges were the time and resources needed to support the process.
CONCLUSIONS
Community-based processes for ethics review consider community-level ethical issues that institution-based IRBs often do not.