Studies involving human volunteers, or the use of data derived from living people, are necessary to answer some questions of importance in our world. Human studies are beset with ethical challenges and risks, however, and there are innumerable examples of the exploitation of vulnerable individuals and groups in the context of research (e.g., the U.S. Public Health Service syphilis study at Tuskegee, the Cold War human radiation experiments, the pattern of unrecognized ethical violations in medical publications that were uncovered by Henry Beecher). 1–4 In this editorial, I reflect briefly on aspects of advancing ethically sound human studies in education research in the health professions.
Human studies in the United States have been guided by the principles of respect for persons, beneficence, and justice as articulated in the Belmont Report 5 more than 40 years ago. These ethical principles are expressed through professional standards and regulatory safeguard practices. Investigator expertise and integrity, institutional oversight, informed consent, conflict of interest management, confidentiality protections, and community-based participatory procedures are examples of these professional standards and regulatory safeguard practices as they have evolved over many years. 6 These standards and safeguards apply to all investigations that meet criteria for human research (see 45 CFR 46.101 7 and 45 CFR 46.102 8). In general, these standards and safeguards are calibrated to become more stringent as the potential for exploitation of study volunteers and populations increases, as study procedures become more invasive or burdensome, and when investigations entail a higher degree of biological and/or psychosocial risks. 6
As a subset of human research, education research in the health professions poses ethical challenges and ambiguities related to broader research safeguard principles and standards. For example, there is little consensus on the potential vulnerability of learners as study volunteers/subjects in research. Traditionally, vulnerability in the context of research is tied to constraints on autonomy, susceptibility to influence or coercion, or inability to derive sufficient protection or benefit from usual safeguards. 4–6,9 For learners who are research volunteers/subjects, potential vulnerability to exploitation depends on a number of factors, including whether the researcher also serves in an evaluative role, whether the question under study is of genuine significance to the learner or learner populations, to what extent the individual learner-volunteers/subjects are identifiable, and how findings may be shared or used. 10–12
Ethical ambiguities arise in educational research because research activities may resemble or overlap with usual educational experiences. 13,14 This resemblance and overlap create a lack of clarity around what constitutes adequate safeguards. Consider the case of an additional analysis of data that are collected routinely from learners in educational settings. Such an analysis is considered human research if the objective is to develop an empirical report for publication, contributing to generalizable knowledge in the field (see 45 CFR 46.102(l) 15). Such an analysis is not considered human research, however, if it is conducted strictly as a quality improvement effort. If a quality improvement effort proves valuable and inspires a new goal of sharing findings broadly with others, the effort that previously had been usual education or quality work suddenly meets the criteria for human research. 16 The quality improvement project now falls under research regulatory standards and entails appropriate safeguards. Thus, depending on intention, which may change over time, activities that are otherwise identical are held to different expectations. It is no wonder that journals such as ours commonly receive submissions based on quality improvement projects that should have been approved or formally deemed exempt by local institutional review boards but were not.
The need for safeguards for education research also may be unclear to investigators when study procedures are not invasive, burdensome, or biologically risky. Nevertheless, education research may introduce significant psychosocial risks that may be underappreciated. 12 Research projects on trainee burnout, mistreatment, disparities, or health concerns are vital to our field and yet involve the collection and interpretation of highly sensitive personal information. Psychosocial risks associated with education research thus include the potential for inadvertent disclosure of personal or academic performance information that may contribute to stigma, discrimination, or other threats to the well-being of clinical trainees.
In this issue, a collection of articles has been assembled on the topic of ethical issues in health professions education research and closely related ethics topics. 17–20 Klitzman 17 provides an overview of ethical issues in education research, and ten Cate 18 situates education research ethics and safeguard practices in an international frame. Stiles et al 19 describe what they learned in managing human subjects research during a global pandemic, and Kasperbauer et al 20 provide insights on ethical complexities arising in the process of collecting biospecimens and obtaining consent for biobanking.
These articles are thoughtful and thought-provoking, building on the contributions of articles appearing in our journal in the past. Maggio et al 21 and Johansson et al 22 describe best practices in education research, and DuBois et al 23 outline how to create a climate of research integrity as informed by stakeholder engagement. Readers may find an early publication that I co-authored 14 to be of interest, as it illustrates distinctions between usual practice, innovation, and research in education settings and necessary safeguards. Keune et al 13 describe the steps for seeking institutional review when conducting research studies involving graduate medical trainees. Schwartz et al 24 and Gillespie et al 25 comment on new issues arising with large education research networks and “bigger” longitudinal data projects. Finally, elevating trainee voices, I encourage our readers to look at the work of Devine et al 26 characterizing residents’ experiences as education research participants.
This collection and past articles highlight the need for greater attention to ethical challenges faced in health professions education research and academic medicine more broadly. These works just scratch the surface. They do not explore in-depth complexities related to equity in education research, 27 constraints on the autonomy and potential vulnerability of learner-volunteers/subjects, 9,11,12 authorship and publication issues, 28 or research misconduct. 29 The collection also does not cover optimal participatory practices that advance knowledge of importance as defined by learners themselves. 30 The collection does not address the ethical questions that arise when health professions students are recruited to participate in clinical research as healthy comparison subjects or members of a convenient, local population. 31 Engagement of health professions students as research volunteers can lead to unexpected and impactful incidental findings, confidentiality breaches, and tragedy, as observed in the deaths of Nicole Wan and Ellen Roche. 4,31
Education research helps us to become better teachers, mentors, and leaders. Education research nurtures the strengths, capabilities, skills, and knowledge of our early career colleagues who have chosen to enter the health professions. Education research helps us to be publicly accountable for our efforts while helping us to answer significant questions related to our overarching responsibility of improving human health through health professions education. Answering such questions, on the other hand, may require the involvement of learner-volunteers/subjects who may be exposed to underappreciated risks. Further, learner-volunteers/subjects may have constraints on their autonomy, may encounter undue influence or coercion in the research situation, and may not be adequately protected by research safeguards. Clearly, these reasons compel us to carry out systematic and intensive inquiry into the ethics of education research in the health professions.
1. Beecher HK. Ethics and clinical research. N Engl J Med. 1966;274:1354–1360.
2. Centers for Disease Control and Prevention. The U.S. Public Health Service Syphilis Study at Tuskegee. https://www.cdc.gov/tuskegee/timeline.htm
. Updated April 22, 2021. Accessed October 14, 2021.
3. Advisory Committee on Human Radiation Experiments. Final Report. 1995. Washington, DC: U.S. Government Printing Office; https://bioethicsarchive.georgetown.edu/achre/final/
. Accessed October 14, 2021.
4. Resnik DB. The Ethics of Research With Human Subjects: Protecting People, Advancing Science, Promoting Trust. 2018.Cham, Switzerland: Springer;
5. National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. The Belmont Report. https://www.hhs.gov/ohrp/regulations-and-policy/belmont-report/read-the-belmont-report/index.html
. Published April 18, 1979. Accessed Oct 14, 2021.
6. Roberts LW. A Clinical Guide to Psychiatric Ethics. 2016.Washington, DC: American Psychiatric Association Publishing;
7. Basic HHS Policy for Protection of Human Research Subjects, To What Does This Policy Apply? 45 CFR §46.101 (2018).
8. Basic HHS Policy for Protection of Human Research Subjects, Definitions for Purposes of This Policy. 45 CFR §46.102 (2018).
9. Resnik DB. Employees as research participants: Ethical and policy issues. IRB Ethics and Hum Res. 2016;38:11–16.
10. Roberts LW. Ethical dimensions of psychiatric research: A constructive, criterion-based approach to protocol preparation. The Research Protocol Ethics Assessment Tool (RePEAT). Biol Psychiatry. 1999;46:1106–1119.
11. Leentjens AF, Levenson JL. Ethical issues concerning the recruitment of university students as research subjects. J Psychosom Res. 2013;75:394–398.
12. Levine RE, Breitkopf CR, Sierles FS, Camp G. Complications associated with surveying medical student depression: The importance of anonymity. Acad Psychiatry. 2003;27:12–18.
13. Keune JD, Brunsvold ME, Hohmann E, Korndorffer JR Jr, Weinstein DF, Smink DS. The ethics of conducting graduate medical education research on residents. Acad Med. 2013;88:449–453.
14. Roberts LW, Geppert C, Connor R, Nguyen K, Warner TD. An invitation for medical educators to focus on ethical and policy issues in research and scholarly practice. Acad Med. 2001;76:876–885.
15. Basic HHS Policy for Protection of Human Research Subjects, Definitions for Purposes of This Policy, Research. 45 CFR §46.102(l) (2018).
16. Boileau E, Patenaude J, St-Onge C. Twelve tips to avoid ethical pitfalls when recruiting students as subjects in medical education research. Med Teach. 2018;40:20–25.
17. Klitzman RL. Understanding ethical challenges in medical education researchAcad Med. 2022;97:18–21.
18. ten Cate O. The ethics of health professions education research: Protecting the integrity of science, research subjects, and authorship. Acad Med. 2022;97:13–17.
19. Stiles DF, Ruotolo BL, Kim H, Cho J, Appelbaum PS, Green NS. Managing human subjects research during a global pandemic at an academic center: Lessons learned from COVID-19. Acad Med. 2022;97:48–52.
20. Kasperbauer TJ, Waltz A, Hudson B, et al. Collecting biospecimens and obtaining biobank consent from patients in an academic health care setting: Practical and ethical considerations. Acad Med. 2022;97:62–68.
21. Maggio LA, Artino AR Jr, Picho K, Driessen EW. Are you sure you want to do that? Fostering the responsible conduct of medical education research. Acad Med. 2018;93:544–549.
22. Johansson AC, Durning SJ, Gruppen LD, Olson ME, Schwartzstein RM, Higgins PA. Perspective: Medical education research and the institutional review board: Reexamining the process. Acad Med. 2011;86:809–817.
23. DuBois JM, Chibnall JT, Tait R, Vander Wal JS. The professionalism and integrity in research program: Description and preliminary outcomes. Acad Med. 2018;93:586–592.
24. Schwartz A, King B, Mink R, Hicks PJ. The emergence and spread of practice-based medical education research networks. Acad Med. 2020;95(suppl 11):S12–S13.
25. Gillespie C, Zabar S, Altshuler L, et al. The Research on Medical Education Outcomes (ROMEO) Registry: Addressing ethical and practical challenges of using “bigger,” longitudinal educational data. Acad Med. 2016;91:690–695.
26. Devine LA, Ginsburg S, Stenfors T, et al. Professional responsibilities and personal impacts: Residents’ experiences as participants in education research. Acad Med. 2019;94:115–121.
27. Fernandez A. Further incorporating diversity, equity, and inclusion into medical education research. Acad Med. 2019;94(suppl 11):S5–S6.
28. Roberts LW. Addressing authorship issues prospectively: A heuristic approach. Acad Med. 2017;92:143–146.
29. Artino AR Jr, Driessen EW, Maggio LA. Ethical shades of gray: International frequency of scientific misconduct and questionable research practices in health professions education. Acad Med. 2019;94:76–84.
30. Roberts LW. Community-Based Participatory Research for Improved Mental Healthcare: A Manual for Clinicians and Researchers. 2013.New York, NY: Springer;
31. Bonham VH, Moreno JD. Emanuel EJ, Grady C, Crouch RA, et al, eds. Research with captive populations: Prisoners, students, and soldiers. In: Oxford Textbook of Clinical Research Ethics. 2008Oxford, UK: Oxford University Press; 461–474.