Protecting Learners As Part of Research Protocols

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As an academic healthcare system, we have a large number of trainees (including students, residents and fellows) as part of our internal teams and research population. In addition, MedStar Health includes a dedicated cohort of investigators focused on research of education in healthcare and learning in clinical settings. As researchers, it is important to consider the requirements of the Common Rule and ethical guidance for the protection of research participants when designing and conducting research involving Human Subjects. Trainees may be part of a research participant population and may provide valuable data on field-specific research as learners. In order to protect trainees that are also research participants, it is important to be aware of aspects of recruitment, consent and the conduct of research that can impact study participation in additional to protections for their safety and privacy.

One concern for trainees as research participants is the potential for coercion or undue influence. Some have referred to trainees as “captive participants” that may be in a dependent or restricted relationship with a researcher. In this context, the participants ability to consent may be compromised by vulnerability to the power of the researchers if the research also serves in some supervisory capacity over the trainee. Consider the power dynamic between trainees and their program director, preceptors, attending, or professors. This dynamic could also be extended to employees that may serve as research participants if the researcher is in a supervisory role, either directly or indirectly, for the employees.

This dynamic can create unintended pressure for potential participants and may result in individuals agreeing to participate in research when they would otherwise decline consent or to continue when they would otherwise withdraw consent.  In one publication, the authors state that 10-25% of university students report feeling coerced to participate in research and 33% report they would feel coerced if asked to participate in their own professor’s research (Leentjens & Levenson, 2013). Some incentives to research participation (ex.: extra credit for course work, required course credit, promise of letters of reference or excessive research stipends) may also lead trainees to agree to research participation when they would otherwise decline.

Researchers should also consider the generalizability of research conducted with only trainees as participants. Results from these studies may not generalize to the larger population.   Even generalization within student populations may be difficult and may be influenced by incentives to participate. For example, if students receive extra credit for research participation this may serve as a self-selecting element for students with lower scores or those that need the extra credit to improve to the next grade (improve from an C to a B average).

The Common Rule does not provide special protections for students or trainees as it does for children, pregnant women or prisoners. However, it does state “The IRB should be particularly cognizant of the special problems of research that involves a category of subjects who are vulnerable to coercion or undue influence, such as children, prisoners, individuals with impaired decision-making capacity, or economically or educationally disadvantaged persons.”  While students, trainees and employees are not specifically mentioned as potentially vulnerable to coercion or undue influence in the regulations it is important to understand the dynamic that can exist between researchers and potential research participants based on relationships outside of the research context. Researchers should consider these dynamics when developing research protocols and build in protections to avoid. It is best whenever possible to avoid even the proception of coercion or undue influence in research.

Below are some recommendations for Participant Safeguards that should be considered when designing research protocols. While this is a good start for items to consider this is not an exhaustive list.

  • Ensure that students / trainees are essential to the research population, not just a convenient sample for the research team.
  • Engage multiple researchers/staff for consent process. This allows for removal of direct relationship between one professor / supervisor / mentor & students / trainees as part of the consent process.
  • Have an explicit and stated process in the protocol for voluntary/informed consent.
  • Ensure that there are explicit protections for the privacy of data. Consider what demographic information is required for the research. In small programs, it may be easy for professors to identify students / trainees based on the broadest of demographic information. Is this information necessary? If yes can some researchers be blinded to some of the data so that they are not aware of participation of individuals they supervise?
  • All research involving human subjects must have IRB approval

 

Please contact the MedStar Health Research Institute, Office of Research Integrity for additional guidance.

 

 

Reference

Leentjens, A. F. G., & Levenson, J. L. (2013). Ethical issues concerning the recruitment of university students as research subjects. Journal of Psychosomatic Research, 75(4), 394–398. https://doi.org/10.1016/j.jpsychores.2013.03.007