A framework for the ethics review of education research

Health professions education is a rapidly growing domain of research.1 Along with this rapid growth comes an increased concern for quality. One element of quality refers to the ethical conduct of researchers towards research participants. Recently, editors of major medical education journals formulated criteria for research ethics, including the condition that experimental research must be approved by an ethics committee if one is available.2,3 In some countries, including the Netherlands, health professions education research is not habitually reviewed, usually because it is not recognised policy for ethics review boards (ERBs) to include such research in their considerations. However, in other countries, ERBs for biomedical research do accept education research projects for review. Legislation governing ERBs usually reflects the Nuremberg Code and the Declaration of Helsinki, which were designed to ensure the protection of patients in medical research and were not specifically intended for application in education research. Education research bodies, such as the American Educational Research Association (AERA) Janet and the Australian Association for Research in Education (AARE), have developed codes of research conduct, but in the medical domain much more stringent and legal procedures apply.4 One element of quality refers to the ethical conduct of researchers towards research participants Invited by the Netherlands Association for Medical Education (Nederlandse Vereniging voor Medische Onderwijs [NVMO]), we developed a specific framework for the ethics review of education research. Pugsley and Dornan5 voiced a need for evaluation by specialists in education research as a powerful motivator to improve health professions education and enthuse researchers. We support their view that the specific conditions of education research and the specificity of the expertise needed to review such studies warrant the creation of a dedicated ERB for the ethics review of health professions education research. The aim of this commentary is to discuss a new framework for the ethics review of health professions education research that specifically takes into account the characteristics of research in this domain and that can be applied by a national ERB. Given the importance of this issue, we believe this will be of interest to an international audience. The specific conditions of education research warrant the creation of a dedicated ERB for the ethics review of health professions education research Ethically justified research must comply with several terms. There is no universally accepted framework, but several elements have been suggested.6,7 From these and other sources, we have identified four principles.8 The justification of research is to advance knowledge and understanding. This requires valid research designs and a reasonable prospect that the research will generate valuable knowledge; this is the first principle.6 Respect for participants is the second principle. Participation in research should be voluntary and informed consent should be sought. Voluntary participation implies that neither coercion nor manipulation of choice by others has taken place. Gaining informed consent obliges researchers to provide participants with sufficient and appropriate information in an understandable form6 and to exert reasonable effort to ensure participants understand this information.7 Protection of privacy and confidentiality reflects respect for the autonomy of participants6 as ethical conduct does not end when participants have signed a consent form.7 Beneficence, the third principle, implies a need to maximise benefit for participants (if possible) and for society and to minimise any risk for physical or mental harm to participants, including any disadvantages for participants. All research can potentially involve harm, however minimal, and this should be proportionate to the benefit of advancing knowledge.7 The fourth principle, of justice, refers to the equitable treatment of research participants and to distributive justice, which requires an equitable distribution of burdens and benefits over populations and the special protection of vulnerable persons.9 Ethics review boards must protect potential research participants in these respects. The legitimacy and authority of their evaluations are derived from a process of expert and reasoned deliberation.10 Distributive justice requires an equitable distribution of burdens and benefits over populations and the special protection of vulnerable persons Health professions education research and medical research have similarities and differences. In both, human beings may be involved and interventions may be applied. However, students are, in some respects, not equivalent to patients and there may be a difference in how harm and autonomy are weighed.11 Students are usually less dependent on teachers than patients are on doctors. Harm and disadvantage may differ as the risks involved in education research are arguably often less severe than those associated with medical research. The vulnerability of participants is likely to differ too. Disease can threaten patients in their very existence, whereas education seldom has such existential impact on students. With this in mind, the four principles can be nuanced for education research. Valuable knowledge is important in all research. Education research applies designs and methods12 that differ from those used in medical research and the ethics review of health professions education research therefore requires specific expertise. Disease can threaten patients in their very existence, whereas education seldom has such existential impact on students Respect for persons refers to participants in education research, who are usually students or teachers. Their autonomy is less threatened and they are better equipped to make decisions about participation than patients in medical research. Health professions education research usually involves topics and questions that are familiar to and comprehensible by all participants. Participants can weigh arguments and considerations. This obviously requires adequate provision of information. Pertaining to the beneficience principle, the risks associated with education research are usually low and physical harm is exceptional. Harm can pertain to negatively affected study results and study progress, or to enforcing an experimental condition that would not have been a primary choice. Health professions education research usually involves topics that are familiar to all participants The vulnerability of participants in education research is lower than in medical research. Justice is a particular issue of interest in education research as many studies pertain to groups of participants who are more aware of one another’s experimental treatment than are patients. Particularly with assessments, employed in many education studies, the equal and just treatment of students within cohorts is a critical issue. Based on this evaluation of the characteristics of education research, we propose a procedure for the ethics review of medical education research, containing four levels of consideration. Level A applies to research outside the relevant domain, in which the research is either not eligible for review or may be referred to a regular biomedical ERB. Level B applies to proposed research that uses existing data. We believe that this type of research does not require debated ethics review, provided that data are stored and handled properly and used anonymously and there are no issues concerning autonomy, privacy or risk.13,14 Fully protocolised approval in response to solicited procedural statements from the researcher should suffice. Level C involves research that raises autonomy issues only and does not imply harm or risk. Ensuring the provision of proper informed consent is the focus of review. We believe that a limited expert review can suffice and in many cases can be handled by only one or two members of a review board, who can decide whether a full review is indicated. If not, approval can be given without delay. Level D review applies to all other research that requires full review by a properly composed review board. Particularly with assessments, the equal and just treatment of students within cohorts is a critical issue We developed a web-based procedure that automatically generates responses for research considered at Levels A and B. The researcher’s responses to a web-based, self-administered questionnaire determine the appropriate level of review. The questionnaire includes a statement that questions are answered truthfully. The review board that administers this protocol should include experts in education, law and ethics, and a student among its members. The NVMO ERB operates nationally and is not linked with a specific university. We think this ensures objectivity, independence and equality in evaluations.