Research ethics requirements for Medical Education

Is there any question that raises a broader array of emotions than ‘Did you secure ethics approval prior to starting your research project?’ A sample of reactions to this question includes unencumbered enthusiasm (‘Of course! Ethical review is absolutely vital!’), mild contentment (‘Why, yes I did…’), anger (‘Of what are you accusing me?!’), frustration (‘The forms are really long and they don’t fit our research area!’), smugness (‘This project was deemed exempt!’), exasperation (‘Why would we need ethics approval?’), and disappointment (‘You won’t publish my research without ethics approval?’). Each of these reactions is understandable, in part, because there is such tremendous diversity of expectations across institutions and around the globe. I know of countries where ethical review will not be performed on medical education research by most review boards because patients are not involved and, therefore, the risks are deemed too minimal. I know of departments at the other end of the spectrum where research agendas have been shut down because ethics approval had not been secured for medical education research projects. This editorial has not been written to express an opinion on where along this continuum the ideal balance lies, but, rather, to clarify and elaborate upon the policy at Medical Education with respect to requirements for research ethics review. Authors who have read the guidelines on our website will have noted that Medical Education is guided in its principles by the Uniform Requirements for Manuscripts Submitted to Biomedical Journals,1 a set of standards put forth by the International Committee of Medical Journal Editors. These standards were published in our journal in 1999, but, as they are updated regularly, we would direct readers to the committee’s website (http://www.icmje.org). The standards broadly describe expectations with regard to reporting, publication ethics and the need for ethical treatment of research participants, the last of which is the primary focus of this editorial. In this regard, they state: ‘When reporting experiments on human subjects, authors should indicate whether the procedures followed were in accordance with the ethical standards of the responsible committee on human experimentation (institutional and national) and with the Helsinki Declaration of 1975, as revised in 2000. If doubt exists whether the research was conducted in accordance with the Helsinki Declaration, the authors must explain the rationale for their approach and demonstrate that the institutional review body explicitly approved the doubtful aspects of the study.’1 Although this statement yields exceptional guidance, using it to guide policy implementation for our journal provides a challenge that requires parsing to resolve. In the following paragraphs I will try to elaborate on each section of this statement in order to make clear what researchers submitting manuscripts to Medical Education should expect. ‘When reporting experiments on human subjects…’1 Although I have not systematically quantified the prevalence of different methods in our field, I would venture a guess that the majority of our work is not experimental. Rather, it is quasi-experimental, epidemiologic, psychometric, observational or something else entirely. For this reason the opening phrase should be interpreted according to the spirit of the sentiment rather than the literal use of the word ‘experiments’. When reporting research involving human subjects would be more appropriate wording for our purposes and authors should take note that this broader phrase captures just about everything we do in this field. ‘…authors should indicate whether the procedures followed were in accordance with the ethical standards of the responsible committee on human experimentation (institutional and national) and with the Helsinki Declaration of 1975, as revised in 2000…’1 The identifying document we require authors to complete and return with the submission of each new manuscript clearly states ‘authors are required to seek ethical review for all research on human subjects’ and requires authors to indicate the authority from which ethics approval was obtained. If the authors’ institutional and national standards are such that there are no committees responsible for the review of research in medical education (or if the need for ethics approval has been waived by the responsible committee), the onus remains on the authors to demonstrate an awareness of the Helsinki Declaration2 and the principles laid out within that document by clearly and explicitly indicating how the autonomy and protection of the participants was ensured. All such statements (including those indicating the authorities from which ethics approval was sought and received) should be included in the manuscript itself as well as the identifying document so the presence of ethics approval and appropriate adherence to ethical principles are transparent to all readers. In general we expect someone outside the research team to have evaluated whether or not appropriate plans for adherence were in place prior to the study being conducted. The Helsinki Declaration notes that all investigators should be aware of regulatory requirements in their own countries and that local requirements cannot reduce those set forth in the Declaration (paragraph 9).2 Authors should make local and national regulatory requirements clear to the journal at the time of submission. In all instances, statements such as ‘We did not think ethics review to be necessary’ will be deemed insufficient. Again, for our purposes, the spirit of the Declaration is most important as the phrase ‘medical research’ should be deemed encompassing enough to include research in medical education. ‘…if doubt exists whether the research was conducted in accordance with the Helsinki Declaration, the authors must explain the rationale for their approach and demonstrate that the institutional review body explicitly approved the doubtful aspects of the study.’1 In the new reviewer form implemented at the end of last year, we ask reviewers to offer explicit comment on the adequacy of the statements pertaining to ethical review and adherence to ethical principles. Should the reviewers or the editorial team consider the evidence insufficient in this regard, Medical Education will reject the paper for publication on that basis alone. We will not argue with the judgement of ethical review committees, but will insist that authors who have not received approval from such bodies take on the onus of convincing the review team that the standards set forth in the Helsinki Declaration2 have been met. The purpose of this emphasis on ethical review is not to support mindless and tedious bureaucracy, a charge that has often been launched towards ethical review boards. On the contrary, we wish to encourage members of the medical education research community to actively engage with their local institutions to ensure that ethical review of education research is established in a way that involves individuals who are informed about the types of risks and benefits that arise when performing education research. The review process and the effort required to satisfy requirements should be proportional to the potential for risk, but the fact that risks in our community do not compare in magnitude with those to which some patient participants are exposed does not justify the act of ignoring the need to protect the rights and freedoms of our students and faculty members.3 It may one day be the case that Medical Education will implement a more stringent policy whereby formal ethical review will be required in all instances, but, for now, out of respect for cultural and institutional differences, we will strive to provide leadership in this domain through the processes outlined in this editorial. We would encourage mentors to actively engage in discussion with their protégés about how to ensure that the research protocols they design meet local and Helsinki standards and are defensible at the point of manuscript submission. This position was generated in consultation with Medical Education’s deputy editors, international editorial board, and quality and standards advisory group. As a result of that process, I am very confident that these guidelines reflect the current sentiments held by our international community as well as the direction in which leaders in the field would like the journal to move. Medical Education is committed to promoting the highest of ethical standards within our community and, as such, continues to be a member of the Committee on Publication Ethics and the World Association of Medical Editors, both of which are open to consultation by the editors of the journal and the research community at large.