Department of Surgery, Mount Sinai School of Medicine, New York, NY 10029, USA.
Med Educ Online. 2013 Feb 25;18:1-6. doi: 10.3402/meo.v18i0.19524.
Special concerns often arise when medical students are themselves the subjects of education research. A recently completed large, multi-center randomized controlled trial of computer-assisted learning modules for surgical clerks provided the opportunity to explore the perceived level of risk of studies where medical students serve as human subjects by reporting on: 1) the response of Institutional Review Boards (IRBs) at seven institutions to the same study protocol; and 2) the thoughts and feelings of students across study sites about being research subjects.
From July 2009 to August 2010, all third-year medical students at seven collaborating institutions were eligible to participate. Patterns of IRB review of the same protocol were compared. Participation burden was calculated in terms of the time spent interacting with the modules. Focus groups were conducted with medical students at each site. Transcripts were coded by three independent reviewers and analyzed using Atlas.ti.
The IRBs at the seven participating institutions granted full (n=1), expedited (n=4), or exempt (n=2) review of the WISE Trial protocol. 995 (73% of those eligible) consented to participate, and 207 (20%) of these students completed all outcome measures. The average time to complete the computer modules and associated measures was 175 min. Common themes in focus groups with participant students included the desire to contribute to medical education research, the absence of coercion to consent, and the low-risk nature of the research.
Our findings demonstrate that risk assessment and the extent of review utilized for medical education research vary among IRBs. Despite variability in the perception of risk implied by differing IRB requirements, students themselves felt education research was low risk and did not consider themselves to be vulnerable. The vast majority of eligible medical students were willing to participate as research subjects. Participants acknowledged the time demands of their participation and were readily able to withdraw when those burdens became unsustainable.
当医学生自己成为教育研究的对象时，往往会出现特殊的问题。最近完成的一项大型、多中心、随机对照试验，研究了计算机辅助学习模块对外科实习医生的影响，为我们提供了一个机会，可以通过以下方式探讨人们对医学生作为人体研究对象的研究的感知风险水平：1）来自 7 个机构的机构审查委员会（IRB）对同一研究方案的反应；2）研究现场的学生对作为研究对象的想法和感受。
从 2009 年 7 月到 2010 年 8 月，所有参与合作的 7 所机构的三年级医学生都有资格参加。比较了相同方案的 IRB 审查模式。根据与模块交互的时间计算参与负担。在每个站点与医学生进行焦点小组讨论。通过三名独立审阅者对转录本进行编码，并使用 Atlas.ti 进行分析。
参与的 7 个机构的 IRB 分别对 WISE 试验方案给予了完全（n=1）、加速（n=4）或豁免（n=2）审查。995 名（符合条件的 73%）同意参加，其中 207 名（20%）学生完成了所有结果测量。完成计算机模块和相关测量的平均时间为 175 分钟。与参与者学生的焦点小组中的常见主题包括为医学教育研究做出贡献的愿望、没有被迫同意的情况以及研究的低风险性质。
我们的研究结果表明，IRB 对医学教育研究的风险评估和审查程度存在差异。尽管不同的 IRB 要求暗示了风险感知的差异，但学生本人认为教育研究风险较低，并不认为自己处于弱势地位。绝大多数符合条件的医学生愿意作为研究对象参与。参与者承认参与的时间要求，并在负担不可持续时随时准备退出。
