Student Projects in Medicine: A Lesson in Science and Ethics

Abstract

Regulation of biomedical research is the subject of considerable debate in the bioethics and health policy worlds. The ethics and governance of medical student projects is becoming an increasingly important topic in its own right, especially in the U.K., where there are periodic calls to change it. My main claim is that there seems to be no good reason for treating student projects differently from projects led by qualified and more experienced scientists and hence no good grounds for changing the current system of ethics review. I first suggest that the educational objectives cannot be met without laying down standards of good science, whatever they may be. Weak science is unnecessary for educational purposes, and it is, in any case, unlikely to produce good researchers in the future. Furthermore, it is curious to want to change the system of ethics review specifically for students when it is the science that is at stake, and when the science now falls largely outside the ethics remit. I further show that ethics review is nevertheless important since students carry a new potential conflict of interests that warrants independent oversight which supervisory support does not offer. This potential conflict may become more morally troublesome the greater the risks to the subjects of the research, and students may impose greater risks on their subjects (relative to professional researchers) by virtue of being inexperienced, whatever the nature of the project. Pragmatic concerns may finally be allayed by organizing the current system more efficiently at critical times of the university calendar.

Keywords:

• ethic committees
• medical students
• research ethics
• student projects

Acknowledgments

I would like to thank Jonathan Wolff, James Wilson, David Hunter, and my reviewers for their comments on this article.

Notes

¹In 2004, NRES (then COREC), set up a working group chaired by Professor Len Doyal, which concluded that student projects should be reviewed by an entirely separate system of review. The underlying rationale for creating a new system specifically for student work was that: 1) students should be given more encouragement to do projects to secure academic medicine in the long run; 2) they should be regulated in a way that puts greater emphasis on the educational rather than the scientific objectives of the projects, and 3) any regulatory framework should be more university-friendly and more able to cope with the increase in demand at certain times during the university calendar. The system proposed by the Working Group was ethics review by special new committees called Student Projects Ethics Committees (SPECs) which would be jointly managed and funded by the National Health Service and the relevant universities. However, the Doyal review was not adopted by the Department of Health which commissioned it. Since then, the proposals have changed twice, and still no new policy has been agreed suggesting that the question of student work has not been successfully answered. A year or so later, COREC as was, proposed to review students' projects by more frequently convened “subcommittees” of any existing committee which had no special regard for students although the subcommittee members may have an interest in student work and also have an eye on university requirements. By 2007, the proposals had changed yet again probably as a result of other changes in the ethics system, and the idea then was to review student projects by specially “flagged” committees whose members accumulate collective experience and expertise over time in the area of reviewing student projects simply in virtue of sitting on that said committee.

²In economic theory, opportunity costs are associated with choosing the best option, all things considered, and forgoing the benefits the next best alternative option would have bestowed had it been chosen. Here, I am using the term more loosely and more colloquially to mean any missed opportunity and so require the prior evaluation of missed benefits. However, these could be endless.

³It is also worth noting that the requirement for committee review may itself have opportunity costs, and there is much discussion of the resources and time taken and how these may be reduced and the system “streamlined.” Partly with this in mind, some projects which pose minimal risk or “no material ethical issues” may now be fast-tracked. However, I am interested in whether students are special and so require a different form of governance rather than what system of governance research generally should be subject to, however burdensome.

⁴It is worth pointing out that many students look at their peers or even themselves or their families as a convenient study population, and so the particular issue of wasting patient resources may collapse. It is worth noting that the National Health Service (NHS) system of ethics review is relevant only for students wanting to use human tissue, NHS patients, staff or resources for their study, so the universities should also be alert to how their students are using friends and families. However, this issue of course is not critical to the overall position presented in this article.

⁵This would make the best option weak science, and the next best strong science, as economic theory intended.

⁶It is perfectly possible to have two sets of interests at stake while pursuing one objective. That is to say, the student could have a single objective that is both educational and scientific while having an extra potential conflict of interests (on top of what a professional researcher might have) because of the need to meet the requirements of their degree. However, requiring students to do good science may conflict with the logistic requirements of the course, as it may take longer, require more input from supervisors, but which does not conflict with the intrinsic educational value of the project.

⁷It would be possible to dream up potentially conflicting interests which, when combined, do not compound each other and could even pull in different directions if not cancel each other out. For example, a researcher could be paid not to recruit patients in his research at the same time as striving to gain career advantage by recruiting them.