研究者和伦理审查委员会：抑郁症和精神分裂症研究人员的调查。
The investigator and the IRB: a survey of depression and schizophrenia researchers.
机构信息
Maryland Psychiatric Research Center, University of Maryland School of Medicine, 55 Wade Avenue, P.O. Box 21247, Baltimore, MD 21228, USA.
出版信息
Schizophr Res. 2010 Sep;122(1-3):206-12. doi: 10.1016/j.schres.2009.12.019. Epub 2010 Jan 12.
Despite the integral part Institutional Review Boards (IRBs) play in U.S. research, research on IRBs is lacking. This is especially true in the area of mental health investigator-IRB interactions. It was hypothesized that schizophrenia researchers would have a different experience with IRBs as compared to depression researchers. This would include longer turn-around time and fewer protocols approved on first submission. It was also thought that schizophrenia researchers would be more hesitant to submit ethically complex protocols for IRB review. 396 NIH-funded schizophrenia and depression investigators were invited to participate in a survey study on IRBs. 108 usable responses were returned, 45 of which were from schizophrenia researchers. Schizophrenia researchers were significantly less likely to submit ethically complex protocols for IRB review than depression researchers even when controlling for academic rank, years of research experience, type of research done, and the need to submit to multiple IRBs. However, there was no significant difference between researcher groups in IRB review turn-around time or initial approval rates. As a group, respondents found IRB submission paperwork burdensome but necessary and were almost evenly split as to whether IRB comments were helpful (54.8%) or not (45.2%). Time to initial review was 3 weeks or longer for most respondents. 94.4% agreed IRBs should enforce subject privacy and 68.2% agreed they should monitor conflict of interest, but only 37.% agreed IRBs should review study design. Conclusions are that 1. the population studied may have profound impacts on the type of protocols submitted to IRBs even within the field of mental health, 2. IRBs may not draw as large a distinction between depression and schizophrenia protocols as researchers believe, and 3. facilitating IRB review by eliminating evaluation of design may be possible if the protocol has already been vetted by a credible funding agency (such as the U.S. National Institutes of Health).
尽管机构审查委员会（IRB）在美国研究中起着不可或缺的作用，但对 IRB 的研究却很缺乏。这在心理健康研究人员与 IRB 的互动方面尤其如此。有人假设，与抑郁症研究人员相比，精神分裂症研究人员与 IRB 的互动会有不同的体验。这包括更长的周转时间和首次提交时批准的协议更少。人们还认为，精神分裂症研究人员提交伦理复杂的协议进行 IRB 审查时会犹豫不决。396 名 NIH 资助的精神分裂症和抑郁症研究人员受邀参与一项关于 IRB 的调查研究。共收到 108 份有效回复，其中 45 份来自精神分裂症研究人员。即使控制学术职称、研究经验年限、所做研究类型以及是否需要向多个 IRB 提交等因素，精神分裂症研究人员提交伦理复杂协议进行 IRB 审查的可能性也明显低于抑郁症研究人员。然而，研究人员小组在 IRB 审查周转时间或初始批准率方面没有显著差异。作为一个群体，受访者认为 IRB 提交文件繁琐但必要，对于 IRB 意见是否有帮助（54.8%）或没有帮助（45.2%）的看法几乎平分秋色。大多数受访者的初步审查时间为 3 周或更长时间。94.4%的人同意 IRB 应维护受试者隐私，68.2%的人同意 IRB 应监测利益冲突，但只有 37%的人同意 IRB 应审查研究设计。研究结论是，1. 即使在精神健康领域内，研究人群也可能对提交给 IRB 的协议类型产生深远影响，2.IRB 可能不会像研究人员认为的那样在抑郁症和精神分裂症协议之间做出如此大的区分，3. 如果协议已经由可信赖的资助机构（如美国国立卫生研究院）进行了审查，那么通过消除设计评估来简化 IRB 审查是可能的。
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