#27 Don’t write an ethics statement in your paper without Appendix 3! 

Episode Host

Lara Varpio

Episode Article

Schutte, T., Fasel, M. E., Fokkens, J. T., & Wouters, A. (2023). The reporting of ethical review and ethical considerations in articles published in medical education journals: A literature review. Medical Education, 57(9), 870–878. https://doi.org/10.1111/medu.15139

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In this episode, the hosts talk about a very short, but very important statement that should be in all our publications: the ethics statement. What do you put in that statement? What should you put in it? This discussion will make sure you know (hint: download Appendix 3)! 


The ethical review of our research is essential and is, in fact, a requirement for most peer-reviewed journals to publish your research. But, the ethical review process at different institutions are highly variable experiences! We submit our work for ethical review and ethical approval, but what does that mean? In some contexts, an “exempt” decision means the board didn’t look at it. In others, it means they did an expedited review and found nothing of concern.  

What are the ethical considerations that the board reviews? They might consider how authors mitigate potential harm to participants. They might worry about confidentiality of the data — how are you making sure nobody can access identifiable data? They might focus on remuneration as a possible for of persuasion. Or they might look at none of this and say that educational research is, by definition, so low risk as to have very minimal considerations. 

To understand current practices of ethical review decisions, these authors looked at how ethical review decisions and ethical considerations for HPE research are reported in our journals. Who are these authors? It is Schutte, Fasel, Fokkens and Wouters, all of whom hail from The Netherlands. And the paper is called “The reporting of ethical review and ethical considerations in articles published in medical eduction journals“. Published in Medical Educaiton in September of this year. 


The authors looked at papers published in 2020 — just one year — and looked across 8 HPE journals:

  • Academic Medicine
  • Advances in Health Sciences Education
  • BMC Med Ed; Medical Education
  • Medical education online
  • Medical teacher
  • Perspectives on medical education
  • Teaching and learning in medicine

They included any paper that reported on outcomes that were based on research using data derived from human participants. So, if the study has ANY data from humans, then it met inclusion criteria and so is part of the study. Therefore,  innovation reports, or perspective papers, or any of a number of kinds of papers were included, not just research papers. 

Data were extracted data in 4 areas: 

  1. Study characteristics or demographics (e.g., country where the study was done, type of article, etc.) 
  1. Information about the review process and outcome (e.g., was the study approved, or exempt; information about the type of review board; file number, etc) 
  1. Reporting structure (e.g., Was there a heading where ethical considerations are explicitly highlighted in the paper? Was it in the main text or in footnotes at the end of the paper?) 
  1. Key ethical features (e.g., was the Helsinki declaration mentioned? Was informed consent reported? Were incentives provided?) 

In terms of analysis, the authors used descriptive statistics — nothing too convoluted. 


Out of the 2004 papers they found, 955 met the inclusion criteria. Of those, 85% of the papers that reported on data from humans were research papers, leaving 15% from other columns like educational case reports. Across all the papers, 83% mentioned a review by an ethical review board, or an institutional review board, or research ethics review board. Half the papers mentioned being approved, and 18% said they were exempt. In the research papers, nearly 8% said they were reviewed but never said that that they were approved or exempt. Only 17% of the articles had a section in the paper’s methods specifically addressing ethics. But in the research articles, 84% had a section at the end in the appending declarations that reported an ethics declaration.  

The kinds of ethical considerations that were reported depended on the kind of study that was conducted in the research papers — so statements about informed consent procedure were present in 64% of research articles, most often with focus group studies (in those papers, 84% of the papers described informed consent). In contrast, in some papers voluntary participation was described — such as in survey studies where it might be inferred not explicitly reported 

One point to highlight here is how qualitative studies were noted for having detailed descriptions of the context and also having a reflexivity paragraph. That reflexivity paragraph often made note of relationships between researchers and participants and of how power dynamics in those relationships were attended to.  

The authors also noted that some articles that reported on focus groups stated that data collection was anonymous. Well, we know that’s impossible in a focus group, you’re interacting with participants in the group — that is NOT anonymous. This suggests that researchers may not really understand some of the key factors of ethical consideration like anonymity. Maybe we’re not as aware of ethical consequences of our study designs as we think we are. 


The only other thing I’d highlight is how you MUST download Appendix #3. In this appendix, the authors provide a list of the ethical considerations you would want to address in your manuscript AND they provide examples of phrasings from the literature they reviewed. Very handy! 


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