Introduction
Medical education research was emerged since the late 1950s to expand scientific knowledge in the field of academic [
1]. The transition of the type of studies in medical education has been observed over the decades. Initially, research studies were mainly focused on descriptive nature including the implementation of teaching learning strategies in the field of medical education [
2]. It has been shifted to “justification studies” focused on the comparison of interventions in the field of medical education or health professionals’ education such as comparison of different curriculum [
2]. Lately, a highly valuable transition was observed which focused on “clarification studies.” Clarification studies incorporated the influence of different variables on the educational outcomes and the underlying process of intervention workflow [
2].
In line with the growing interest of health professionals’ education research, paying attention to basic ethical principles and specific challenges in the field of medical education research is needed.
Methodology
This paper adopted the narrative review design to synthesize and present ethical considerations and challenges in conducting medical education research. Relevant literature was searched through Medline, Scopus, and Google Scholar. Keywords used in databases search included “medical education research, ethics, autonomy, beneficence, justice, and confidentiality.” Articles that discussed ethical principles, considerations, or challenges related to medical or health professions education research were selected and critically reviewed. The main concepts related to ethical principles (beneficence, respect for persons, and justice) and the strategies to address the potential ethical challenges were summarized and synthesized to develop the narrative discussion.
1. Ethical principles in conducting medical education research
1) Beneficence
Beneficence is empirically defined as a duty to serve the best interests of patients in the clinical setting [
3]. The beneficent principle in medical education research refers to the ethical obligation to maximize benefits and minimize harm for participants, students, educators, and the broader medical community. In medical education research, the strategies, interventions, and implementation should be targeted to the best interests in the field of health professions education.
Minimizing harm to participants is an essential consideration in conducting medical education research. In health professional students training, it is crucial to balance of risk and benefits for involving inexperience students and providing efficient training in health professions education.
Many studies have been conducted regarding technological advancement in health professions education and training. A study conducted among internal-medicine trainees revealed that simulation training could improve the adherence of protocol for central venous catheter placement [
4]. Therefore, planning and conducting research in medical education should be beneficial for students by enhancing learning efficiency, refining instructional methods, and promoting patient safety as an ultimate aim.
Researchers in health professions education could be cautious that the benefits of conducting research outweigh potential risk to the students. This key principle is important to adhere to improve ethical rigor in health professions education research projects [
5].
2) Respect for person
A principal concept of human research including medical education research is respect to the participants. Paying respect to study participants include allowing them to decide with freedom of decision making, voluntary participation, seeking informed consent, and respect for dignity in the study process [
6].
Autonomy is fundamental in ethical consideration of conducting research with human subject participants. Autonomy implies to the fact that human beings have the right to make their own decision to being involved in biomedical and educational research as well as in making their own decision for medical treatment, procedures, and management [
7].
Research participants’ understanding on the purpose of research study, process or procedure, potential benefits and risk is essential in making the decision. Therefore, researchers must provide relevant and adequate information to the participants to make the informed decision [
8]. Securing the informed consent process upon recruitment is necessary to respect autonomy of participants [
8]. Maintaining privacy and confidentiality are under the scope of the principle of autonomy. Privacy and keeping information confidential to the greatest extent is paying respect to the study participants.
3) Justice
Justice is an ethical component that is fair, equitable, and appropriate treatment of persons or patients [
9]. In the context of health research, it could be related to avoiding bias when taking samples from a larger population. Moreover, it is crucial to avoid exposing the study participants that could lead to disadvantage or negative or unfair consequences to participants in any way [
10].
Ethical concepts of justice can be categorized into distributive justice and social justice. Distributive justice is related to equal treatment to individuals regardless of gender, ethnicity, age, culture, and any other characteristics. While social justice is considered as every individual should have access to the same treatment or intervention that might improve their health [
11].
While in consideration of justice in medical research, there is an obligation to be fair with the intervention or treatment to the study participants.
2. Addressing potential ethical challenges in conducting medical education research
Medical education research is unique as it focuses on students, educators, and educational environment with the application of knowledge and findings in educational practice.
1) Autonomy and vulnerability
In research, “vulnerable population is defined as a disadvantaged community subgroup unable to make informed choices, protect themselves from inherent or intended risks, or keep their own interests safeguarded [
12].”
It is important to be aware that power and hierarchy in the workplace or education might influence the decision-making capacity of participants. As examples, the relationship as teacher-student and employer-employee might have an effect in the recruitment process due to the position of authority as teacher and employer. Informed consent process will ascertain the autonomy of participants [
13]. The hierarchy usually established in the education field between those who conduct assessments (teachers) and those who are assessed (students) may affect the autonomy of the latter. If the student participants are recruited by their own teachers, it might influence the autonomy and informed consent provision of the students [
14].
To overcome this challenge, it would be beneficial to assign another research collaborator or research assistant to inform about study information, obtaining informed consent, and recruitment process. It will ensure that the informed consent process is solely the decision of student participants [
14].
2) Maintaining confidentiality in medical education research
Researchers must ensure the confidentiality of students’ participants’ personal data in conducting medical education research. Data should be anonymized whenever possible to protect participants’ privacy.
Furthermore, confidentiality of consent forms should be considered in medical education research as well. If the teacher and researcher roles are performed by a single individual, the participants might have a concern that their teacher could identify the participants, and non-participants list in the project. Assigning a research assistant or project member, who are not the teacher of students, to monitor and maintain the consent form and not to be related with the data will help to overcome this challenge [
14]. This protective measure should be clearly explained to the students in the recruitment process.
Collecting the data (variables) only if they are relevant to the research question, de-identifying the data before analysis, and protecting data with password-protected computers or a locked cabinet in the office or institution could be done to maintain the confidentiality and data security in education research [
14].
3) Maintaining justice and fairness in medical education research
In medical education research, it must be ascertained that participants—students, educators, or institutions—are selected fairly, avoiding bias based on gender, ethnicity, socioeconomic status, or academic standing. Overburdening certain groups or excluding marginalized populations from research opportunities violates the principle of justice.
In medical education research, justice is essential in intervention studies. For example, if the intervention (class activities or after class activities) is assigned to a group of students, while the other group did not receive the intervention, it would create unfair distribution of study related activities [
10]. Another example could be evaluating the effectiveness of different educational interventions in different groups. Careful consideration is needed when comparing the interventions as they might yield different effects and outcomes to the study participant groups [
10].
The benefits of medical education research, such as improved teaching learning strategies, curriculum enhancements, and assessment tools, should be accessible to all students, not pertaining to the privileged subset. Similarly, no student group should bear a disproportionate risk or burden in participating in medical education research. Lastly, the beneficial findings of medical education research should be disseminated widely and made accessible to all stakeholders, including students, educators, institutional managements, and policymakers.
Conclusion
In conclusion, medical education research must adhere to the three core principles of research ethics (beneficence, respect for persons, and justice). When researchers design educational related research, especially for intervention research, various aspects of ethical consideration must be carefully integrated into the research framework. Education researchers should consider the benefits and potential risks of intervention to ensure that participants were not exposed to harm or burden. Study design must follow the principles of justice and fairness to ensure that intervention and control groups are not compromised in the teaching-learning process. Furthermore, power differentials between teachers and students pose ethical challenges, which should be fully aware and education researchers must promote autonomy to the students’ participants. By addressing the above challenges, education researchers could conduct the research in a responsible manner and ultimately contribute to the advancement of medical education.
Acknowledgements
None.
Funding
The authors received no financial support for the research, authorship, and/or publication of this article.
Conflicts of interest
No potential conflict of interest relevant to this article was reported.
Author contributions
ML and RRM conceptualized and drafted the manuscript. ALA critically revised the manuscript. All authors reviewed and approved of the final version for submission.
References
- 1. Kuper A, Albert M, Hodges BD. The origins of the field of medical education research. Acad Med. 2010;85(8):1347-1353. https://doi.org/10.1097/ACM.0b013e3181dce9a7
- 2. Dolmans DH, van der Vleuten CP. Research in medical education: pratical impact on medical training and future challenges. GMS Z Med Ausbild. 2010;27(2):Doc34. https://doi.org/10.3205/zma000671
- 3. Bernat JL, Beresford R. Ethical and legal issues in neurology. Amsterdam, The Netherlands: Elsevier; 2013.
- 4. Peltan ID, Shiga T, Gordon JA, Currier PF. Simulation improves procedural protocol adherence during central venous catheter placement: a randomized controlled trial. Simul Healthc. 2015;10(5):270-276. https://doi.org/10.1097/SIH.0000000000000096
- 5. Klitzman RL. Understanding ethical challenges in medical education research. Acad Med. 2022;97(1):18-21. https://doi.org/10.1097/ACM.0000000000004253
- 6. Pieper IJ, Thomson CJ. The value of respect in human research ethics: a conceptual analysis and a practical guide. Monash Bioeth Rev. 2014;32(3-4):232-253. https://doi.org/10.1007/s40592-014-0016-5
- 7. Manda-Taylor L, Masiye F, Mfutso-Bengo J. Autonomy. In: Have H, editor. Encyclopedia of Global Bioethics. Cham, Switzerland: Springer; 2016. p. 218-225. https://doi.org/10.1007/978-3-319-05544-2_460-1
- 8. Stoljar N. Autonomy: relational conceptions. In: Laurie G, Dove E, Ganguli-Mitra A, et al., editors. The Cambridge Handbook of Health Research Regulation. Cambridge, UK: Cambridge University Press; 2021. p. 27-36
- 9. Varkey B. Principles of clinical ethics and their application to practice. Med Princ Pract. 2021;30(1):17-28. https://doi.org/10.1159/000509119
- 10. Maheux-Pelletier G, Frake-Mistak M, Popovic C. SoTL Research Ethics Guide: justice. https://ethicsguide.info.yorku.ca/second-page/respect/. Published 2016. Accessed June 2, 2025.
- 11. OpenLearn Create. Health management, ethics and research. https://www.open.edu/openlearncreate/mod/oucontent/view.php?id=225§ion=1.4.5. Published 2024. Accessed June 2, 2025.
- 12. Manti S, Licari A. How to obtain informed consent for research. Breathe (Sheff). 2018;14(2):145-152. https://doi.org/10.1183/20734735.001918
- 13. Pugh J. Autonomy, rationality, and contemporary bioethics. Oxford, UK: Oxford University Press; 2020.
- 14. Elgie S, Childs R, Fenton NE, et al. Researching teaching and student outcomes in postsecondary education: a guide. Toronto, Canada: Higher Education Quality Council of Ontario; 2012.
