Merchant Raina M, Rubright Jonathan D, Pryor John P, Karlawish Jason H T
Department of Emergency Medicine, Leonard Davis Institute of Health Economics, University of Pennsylvania School of Medicine, Philadelphia, PA, USA.
Acad Emerg Med. 2008 Jun;15(6):581-3. doi: 10.1111/j.1553-2712.2008.00134.x.
The Food and Drug Administration (FDA) requires researchers to consult with the community prior to conducting research with exception from informed consent, but little is known about whether people support this and, if they do, who researchers should consult. We sought to determine if people could identify communities and leaders of those communities who researchers should consult with to represent their views about research that requires an exception from informed consent.
We conducted a cross-sectional interview study using a convenience sample of patients seeking care in an urban emergency department (ED) to determine if people belonged to specific communities and, if they did, if they could identify communities and leaders appropriate for consultation. Descriptive statistics were used to represent our findings.
Most of the 262 participants approached for the study completed the interview (199; 76%). Of those interviewed, 122 (61%) were African American, 54 (27%) were white, 83 (42%) were male, and the mean (+/-standard deviation [SD]) age was 36.2 +/- 14.4 years. Most, (194; 97%), identified that they belonged to a community and most (177; 89%), said that researchers could consult at least one of their communities for consultation about an exception from informed consent study. Participants typically named geographic and religious-affiliated communities and leaders as appropriate for consultation.
Most participants identified a community and a leader of that community who researchers could consult about research with exception from informed consent. Geographic and faith-based organizations could play an important role in consultation.
美国食品药品监督管理局（FDA）要求研究人员在开展免除知情同意的研究之前与社区进行协商，但对于人们是否支持这一点以及如果支持的话研究人员应该与谁协商，我们知之甚少。我们试图确定人们是否能够识别出研究人员应该与之协商以代表他们对需要免除知情同意的研究的看法的社区及其领导者。
我们使用便利抽样法，对在城市急诊科寻求治疗的患者进行了横断面访谈研究，以确定人们是否属于特定社区，如果属于，他们是否能够识别出适合进行协商的社区及其领导者。描述性统计用于呈现我们的研究结果。
参与该研究的262名参与者中，大多数（199名；76%）完成了访谈。在接受访谈的人中，122人（61%）是非裔美国人，54人（27%）是白人，83人（42%）是男性，平均年龄（±标准差[SD]）为36.2±14.4岁。大多数人（194人；97%）表示他们属于某个社区，大多数人（177人；89%）表示研究人员可以就免除知情同意的研究向他们所属的至少一个社区进行咨询。参与者通常提名地理和宗教相关社区及其领导者为适合咨询的对象。
大多数参与者识别出了一个社区及其领导者，研究人员可以就免除知情同意的研究向他们进行咨询。地理和基于信仰的组织在咨询过程中可以发挥重要作用。
