Ethics approval for health professions education research: Necessary and beneficial.

Abstract

Editor - Recently, Schuwirth and Durning1 advocated for liberal and limited ethical review for health professions education (HPE)research. They question the value and process of ethical reviewing because of its supposed incapability to ‘detect harm’ and to ‘cure the disease’ of identifying non-merit research. Moreover, they doubt the prevalence of harmful studies in HPE research and believe that the benefits of ethical reviewing are minimal compared to the effort. We understand their concerns, but do not recognise all of them. Therefore, in this response, we underline the potential and necessity of ethical reviewing of HPE research. Potential harm of HPE research is not limited to physical harm that Schuwirth and Durning refer to.1 This harm (should) also include explicit or hidden pressure and risks for autonomy and privacy. For example, if sensitive data (eg, grades or motivation profiles) are not sufficiently anonymised or even public, this could have serious consequences for participants. Similarly, psychological impact can be significant when participants are insufficiently informed (eg, about a dual educator-researcher role or access to sensitive data without explicit consent). We agree that the capability to detect harm in an HPE research proposal depends on the ethical review board (ERB) itself (general and HPE) and its members, processes and support. In particular, the composition with different (HPE-oriented) members and distinct expertise (education, law and ethics), increases the ability to detect harm because of multidisciplinary feedback. For low-risk proposals, an expedited, decentralised, review seems sufficient, but for higher-risk proposals, it is useful to consult a centralised (expert) group with a high sensitivity and specificity to identify harm or pressure and to detect proposals without merit. We agree with Schuwirth and Durning that ethical reviewing can be a lengthy procedure, and should be as concise as possible. However, asking researchers to adjust their protocol, and not simply rejecting it, ensures a dynamic process. Moreover, this process can be shortened by pre-emptively influencing proposed research; for example, by providing templates and formulating minimal requirements. In our experience, the majority of proposals contain issues needing amendments to better protect and inform participants and/or improve methodology. Altogether, we consider ethical review in HPE research valuable. However, differentiating high- and low-risk protocols seems vital for efficiency and to prevent an onerous, lengthy process. Low-risk protocols can benefit from expedited (possibly decentralised) review, thereby preserving time for higher-risk protocols to be assessed by a centralised (expert) group, securing multidisciplinary feedback and ultimately ethical approval.