Medical students as human subjects in educational research
| Autor: | Frederick G. More, Hyuksoon S. Song, Michael W. Nick, Rachel Ellaway, Mary Ann Hopkins, Steven D. Yavner, Umut Sarpel, Adina Kalet, Martin V. Pusic |
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| Jazyk: | angličtina |
| Rok vydání: | 2013 |
| Předmět: |
Research design
Students Medical 020205 medical informatics Attitude of Health Personnel Research Subjects education Institutional review board Educational research Computer assisted instruction Learning Medical Students medical students 02 engineering and technology Risk Assessment Education law.invention 03 medical and health sciences computer-assisted instruction 0302 clinical medicine Randomized controlled trial Informed consent law 0202 electrical engineering electronic engineering information engineering Humans 030212 general & internal medicine Letter to the Editor Medical education lcsh:LC8-6691 lcsh:R5-920 learning Education Medical lcsh:Special aspects of education educational research 4. Education General Medicine Focus group 3. Good health Risk perception Research Design Risk assessment Psychology lcsh:Medicine (General) institutional review board Ethics Committees Research |
| Zdroj: | Medical Education Online; Vol 18 (2013) Medical Education Online, Vol 18, Iss 0, Pp 1-6 (2013) Medical Education |
| ISSN: | 1087-2981 |
| Popis: | Introduction: 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. Methods: 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. Results: 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. Discussion: 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. Keywords: institutional review board; educational research; computer-assisted instruction; learning; medical students (Published: 25 February 2013) Citation: Med Educ Online 2013, 18 : 19524 - http://dx.doi.org/10.3402/meo.v18i0.19524 |
| Databáze: | OpenAIRE |
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