The Importance of Context and Organization of Ethical Review in Health Professions Education Research.

Abstract

To the Editor: In ten Cate’s Invited Commentary on the ethics of health professions education (HPE) research (HPE-R), 1 he provides 27 lessons in HPE ethics and states the importance of discussions to develop ethical integrity. We believe some issues he addresses could benefit from further discussion and clarification, including (1) context and organization of HPE-R ethical review (ER), and (2) meaning of ER decisions. Although ten Cate states that “international variations in habits, rules, and regulations do not strike the author as being substantially different,” there are significant differences in context and organization of HPE-R. 2 These differences can result in differing ER processes (i.e., review time, required changes) and decisions (i.e., exempt or approval after full or expedited review) of the exact same protocol, even within one country. 3 Moreover, the meaning of the ER decision “exempt” varies considerably between countries. 4 Given the differences in context and organization, terminology matters. Twice ten Cate refers to ER requirements. First, writing, “Most grant funders and HPE journals require ethical review of empirical studies,” and second, writing, “obtaining ethical approval has become standard for most research in HPE.” 1 There are differences between “requiring ethical review” and “obtaining ethical approval,” and these differences are not only linguistic, but they have significant implications. Requiring review does not necessarily mean approval is granted, implying “exempt” decisions may be accepted. Actually, “exempt” decisions could encompass no review at all, not falling under the scope of applicable rules/regulations in some countries. Reporting only the ER decision “exempt,” without considerations, is a shortcut that creates ambiguity and hampers critical reflection on research practice both by the researchers and for the HPE community to assess the quality of the work. This was illustrated by Hally and Walsh who reviewed publications in 4 main HPE journals and revealed dubious statements indicating unrequired/exempted ER, often without further explanation. 5 A key lesson is that ethical considerations and procedures, such as recruitment, informed consent, prevention of pressure to participate, data handling/management, and protection should be described for the HPE community to be able to assess whether the research meets our common ethical standards. HPE-R is reviewed in context—in different countries and committees with different rules/regulations. To ensure ethical integrity, it is essential to make considerations of researchers explicit to overcome differences in terminology.