Medical students as human subjects in educational research

Abstract

IntroductionSpecial 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.MethodsFrom 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.ResultsThe 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.DiscussionOur 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.

Estudiantes de la Salud como Sujetos de Estudio en Investigación: Una Revisión Acerca de su Incorporación e Implicancias Éticas

“…Todos los artículos vinculan algún ámbito de la ética científica al involucrar estudiantes como SE en investigación. De los dieciséis autores que se refieren respecto a las presiones indebidas, voluntariedad o coerción (Shannon, 1979;Christakis;Diamond & Reidpathd, 1992;Dalziel, 1996;Clark & McCann, 2005;Forester & McWhorter;Ferguson et al, 2006;Ridley, 2009;Voo, 2009;Bradbury-Jones & Alcock, 2010;Sykes & Dullabh, 2012;Leentjens & Levenson, 2013a;Aycock & Currie;Sarpel et al, 2013;Vaidya et al, 2016;Boileu et al, 2017) Vaidya et al), uno es una carta al editor (Voo) y uno es un estudio cualitativo (Sarpel et al).…”

“…Diez artículos se refieren a temas de confidencialidad y anonimato para disminuir los riesgo de la participación de los estudiantes (Shannon El último tema abarcado es sobre la "responsabilidad de las instituciones de revisión o comités éticos" con ocho de los veintidós articulos (Henry & Wright, 2001;Forester & McWhorter;Ferguson et al;Scheppler & Kolar, 2008;Sarpel et al;Leentjens & Levenson, 2013a,b;Boileau et al), donde cinco son revisiones narrativas (Henry & Wright;Ferguson et al;Scheppler & Kolar;Leentjens & Levenson, 2013a;Boileau et al), una encuesta (Forester & McWhorter), un estudio cualitativo (Sarpel et al), y una carta al editor (Leentjens & Levenson, 2013b).…”

Lights, Camera, Empathy: A Request to Slow the Emergency Medicine Standardized Video Interview Project Study

“…We worry that this itself presents a serious ethical dilemma. Students are considered a special class of vulnerable populations due to three broad areas of concern: the risk for coercion given the undue pressure they will have to participate in research, the compromised relationship between students and educators due to the research, and the fact that research on medical students may pose risks that are not readily apparent to either the students or investigators . The EMSVI second‐phase design presents several concerns related to participant coercion: The desire to have 100% of applicants complete the EMSVI and the score advertisement to all programs seemingly puts participants in a position where lack of an SVI score may be perceived as a “red flag” on their application.…”

Medical students as human subjects in educational research – the importance of responder bias

“…Sarpel and her colleagues should be praised for bringing much-needed evidence to the debate about the degree of rigor required when conducting research on medical students (1). Their study explored ‘the perceived level of risk of studies where medical students serve as human subjects’ (1).…”

“…Their study explored ‘the perceived level of risk of studies where medical students serve as human subjects’ (1). They evaluated the response of review boards to the same study protocol and the feelings of students about being research subjects.…”