Education Research and Human Subject Protection: Crossing the IRB Quagmire

Sullivan, Gail M.

doi:10.4300/jgme-d-11-00004.1

Cited by 19 publications

(19 citation statements)

References 12 publications

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“…Concerns may include the idea that students within the close-knit community of a medical school might feel compelled to participate (5, 6).

Students might be subject to inappropriate and undue pressure and might participate in studies in an attempt to garner better recommendations, better grades, or other favors (such as summer employment).

…”

Section: Discussionmentioning

confidence: 99%

“…Consent is not voluntary when potential subjects feel pressure to participate, whether the pressure is explicit or implied. Some authors have suggested that medical students are a vulnerable population or captive audience, observing that even though recruitment to a study is presented as voluntary, students within the close-knit community of a medical school may nevertheless feel that their lack of participation might precipitate a negative response from the faculty, or in some other way prejudice their standing or progress (5, 6). Christakis points out, ‘the same ready availability that makes medical students a desirable subject pool also makes them a captive population, a status that can only decrease their autonomy’ (7).…”

Section: Introductionmentioning

confidence: 99%

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Medical students as human subjects in educational research

Sarpel

Hopkins

et al. 2013

Medical Education Online

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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.

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“…Concerns may include the idea that students within the close-knit community of a medical school might feel compelled to participate (5, 6).

…”

Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Medical students as human subjects in educational research

Sarpel

Hopkins

et al. 2013

Medical Education Online

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“…Although educational research is considered low-risk research (Sullivan, 2011) it has its own ethical implications. This study as mentioned above is designed to explore the perception of new immigrants, however, human subjects were involved though it was not an intervention study, it is important to follow ethical guidelines (BERA, 2011).…”

Section: Measures and Covariatesmentioning

confidence: 99%

Perception of Newcomers Regarding Learning English and Culture in Canada

Khan¹,

Takkaç²

2019

ELT

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There are some factors, which are motivational, and on the other hand, there are many challenges that may cause hindrance for learning English as a second language. Therefore, the main objective is to assess perception regarding factors for learning English as a second language, especially among new immigrants. This was a cross-sectional study conducted at a Polycultural center, Canada during the period of June-2017 to July-2017. The results of the study reinforced that new immigrants face challenges while learning English. Almost more than half the participants said that they find difficulty in understanding majority words. Regarding learning culture, two-thirds mentioned that the learning about culture gives them different points of view about the world and develops their critical thoughts. However, the socio-demographic characteristics like age, native language, play an important role in learning English.

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“…If any information is collected that can directly identify a subject or when an identifier can be linked to this individual, then it is not eligible for exemption unless it meets one of the 6 exemption categories listed in the federal regulations (45 CFR 46.101). 14 Measures to protect the privacy and confidentiality of subjects should be taken and clearly described in the study.…”

Section: The Irb Review Process For Education Researchmentioning

confidence: 99%

Health Professions Education Research and the Institutional Review Board

et al. 2016

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The growth in health professions education (HPE) and a desire on the part of nurse and medical educators to disseminate their work have raised important questions about the ethical conduct of education research. At the center of the debate is the institutional review board (IRB) and its proper role in the oversight of HPE research. This article examines the IRB process and types of reviews for education research and presents an Education Project Summary Template to use for IRB reviews.

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Education Research and Human Subject Protection: Crossing the IRB Quagmire

Cited by 19 publications

References 12 publications

Medical students as human subjects in educational research

Medical students as human subjects in educational research

Perception of Newcomers Regarding Learning English and Culture in Canada

Health Professions Education Research and the Institutional Review Board

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