Ethics of medical education research

In 2015, Sanjai, a student and I conducted a research study on altruism among medical students. We wrote a protocol, had it reviewed by our institutional ethics committee, obtained proper informed consent from the participants and carried out the study. The questionnaire had some statements which the participants had to read and respond in agreement or disagreement and that would capture their level of altruism. After we finished the study, we published it in the Indian Journal of Medical Ethics. You can read the article in this link. Sanjai and I were thrilled when a reporter from local press contacted us after reading the article and wanted to cover the piece in the newspaper. She wrote up a piece with a rather scathing headline "Chennai medical students unlikely to be altruistic doctors". This led to a cascade of problems for us. Firstly our institutional authorities came down on me heavily for allowing such a harsh report of our study to appear in the news, showing our institution in a bad light. Secondly fights started happening between the medical colleges in Chennai where some students blamed us for portraying all the Chennai city medical students as selfish. I can never forget the amount of mental trauma and disturbance that this study caused us. It was a benign and innocent research on medical education, but had the potential to rake up serious controversy. 

Several years down the line, recently I carried out a research study on reflective writing as a method of learning and evaluation of learning of medical ethics. I asked a batch of 150 students to watch the movie Miss Ever's Boys in which the Tuskegee Syphilis trial is depicted. After watching the movie, I asked each of them to write a reflective essay on whether they see parallels to the unethical research carried out on Black Americans, in India. Within a week, I received 150 essays and started reading them with full excitement. I noticed that 14 of the students had written identical essays. One of them must have written and shared it with the others who had just copied it. I was disturbed by it and noted down the names of these students and called them separately to talk to them. Of the 14, 8 were from schools where their medium of instruction was Tamil, the local language and they did not know how to write a reflection in English. The other 6 were sincere but did not enjoy writing and so were scared that what they write would not be good. All 14 of them expressed remorse. Many of them mentioned that they experienced significant distress because they were driven to cheat in the assignment. This research proposal was exempted from review by our ethics committee. Many ethics committees routinely waive the review of medical education research. I also did not obtain informed consent from the students. I did explain that it was a study and that I will use the data for analysis and publishing the findings. But I did not make it explicit that they can opt out of the activity. If I had made it clear that it was voluntary, these students need not have gone through the mental trauma. After talking to them, I gave them an option to write the reflection in Tamil or to record a voice note and share it with me. 

These are just two examples of how medical education research is not necessarily low risk. There are numerous other examples on how research involving medical students can lead to harms. I wrote another blog recently in which I have reflected on how medical education itself is oppressive and non inclusive in many ways. The one size fits all approach of medical education which fails to consider the diverse aptitudes, interests and learning styles of the students, and imposes mandatory attendance in boring lectures and innumerable internal assessment examinations on them itself can be quite oppressive and push students to the fringes. Over and above this, when research is imposed on the students without proper ethical oversight and ensuring respect for the students, it becomes a serious problem.

The National Ethical Guidelines for Biomedical and Health Research Involving Human Participants was published by the ICMR in 2017. It provides guidance on ethical conduct of research. According to this guidelines, "comparison of instructional techniques, curricula or classroom management methods" in other words medical education research, may be exempted from ethical review. Such research are classified as "research with less than minimal risk without any linked identifiers". In my opinion this is a very myopic view of medical education research. The examples of both the research that I have pointed out earlier are medical education research, but they led to substantial harms. But usually medical education researchers bypass the rigor of ethical review by an ethics committee. It gives a free pass to medical education researchers to carry out research without ethical oversight thus placing the participants in harms way. 

Many ethics committees also have standard operating procedures where they waive the requirement of obtaining an informed consent while conducting classroom research or research on instructional designs. They argue that such classroom research does not go beyond what is routinely done in a classroom setting. But educational practice and educational research are different, despite the line separating them being very fine. A student may not have a choice but to undergo classroom teaching that is provided by the teacher, but they must have a choice whether to participate in a classroom research or not. This is the sense of voluntarism, in which no student should be coerced or forced to participate in a research if they are not interested in it. Therefore, informed consent should not be waived, even if the research is of 'not more than minimal risk' and even if it is nothing more than routine classroom activity. This is particularly important when the research is conducted by the teacher on students because there is an inherent power differential between the teacher and students in the classroom. The teacher wields power within the class and the students are often compelled to listen to their instructions, thus violating the spirit of voluntary participation. 

The ICMR ethical guidelines are quite vague when it comes to waiver of informed consent. It mentions that "the researcher may apply to the ethics committee for waiver of consent if the research involves less than minimum risk to the participants and the waiver will not adversely affect the rights and welfare of the participants." This is highly problematic and subject to misinterpretation. It seems to imply that informed consent is only required when the research has more than minimum risk and when the participant welfare will be affected. This undermines the autonomy and right to self determination of potential participants in research that is low risk. Why should the voluntariness of participants be assumed if the research is of 'no risk' or 'low risk' category? In public health there are some situations where informed consent may not be feasible. For example when the intervention such as spraying an insecticide to control mosquitoes happens at the community level, a single household may not be able to refuse the intervention. Other than these situations and situations where obtaining informed consent is not feasible, the need to ensure voluntariness and full understanding of the research before getting into it cannot be undermined. 

In conclusion, I think medical education research should not be taken lightly. It is associated with its own set of risks and harms. Medical education research must be subject to the same rigor of ethical review as any other research and must not be exempt from informed consent requirement to protect the best interests of the students and other stakeholders in the research.