4-1 Considerations for Research Ethics in HPE

Overview

In this chapter you will explore research and scholarly ethics. While not all health professions education scholarship is research, it is important to understand the inherent challenges that are unique to the HPE scholarship scene.

Vignette

As the capstone project for her educator’s certificate, Dr. Carmen Diego-Nunez had developed a curriculum weekend bootcamp on clinical skills in the virtual world. Now, after half a year of planning, her program had finally been approved to be delivered by the undergraduate curriculum committee and would be placed as an optional workshop in the curriculum in a few months’ time.

“Congratulations on getting this program designed and started Carmen! This is going to be very exciting,” stated her mentor Dr. Mary Park-Edwards. “But have you considered whether this study will require ethics approval? I think this could qualify as an exemption, but we still have to run it by our institutional review board…”

Carmen paused. She hadn’t thought about that. Most of the courses and programs she attended in her schooling had a survey at the end of the program. Did they have to get ethics approval each time for each program evaluation survey? What about the patient experience surveys that she always had to translate and help her mom fill out? Did the ethics board govern all of those surveys too?

“I’m not sure,” she replied. “Is there a place where I could learn more about this process?”

Mary replied: “Definitely. Let me find that link to the HPER chapter and send you that to read before our next meeting…”

A Deeper Dive into the Concept

Broadly speaking, all research should be done in an ethically sound manner. There are multiple precedents in the history of research that will be known to most researchers. The Tuskgeekee Syphilis experiments, World War II experiments on prisoners, research on nutrition in Canadian residential schools, these are well known to most scientists as the impetus for institutional review boards or research ethics boards (1,2).

The general premise of research ethics is to protect those who are subject to the research protocols, and to ensure that they do not experience undue hardship or complications. Research is meant to ultimately serve society as a whole – and there are many groups involved in these processes ranging from granting agencies/funders to students or patients. At times there may be ties to industry and/or governmental policy-makers too. However, regardless of the stakeholders, all research should be conducted ethically and soundly to ensure that the stakeholders do not negatively impact others (e.g. pharmaceutical company unduly influencing the results reported in a clinical trial). For more about general principles of Canadian research ethics check out this page from the Canadian Institutes of Health Research (1).

Ethical Considerations in Health Professions Education Research

While we are not usually conducting invasive experiments such as testing a new vaccine on our study participants, we must still bear in mind that there can be the potential for harm when conducting research in the health professions education domain. In Canada, our shameful history around nutritional research in residential school children (2) specifically drives home the importance of all researchers (especially those who are educators) to fulfil their moral and ethical obligations in safeguarding and protecting those who participate within our research.

For the purposes of our discussions, the Tri-Council Policy Statement 2 (2022) [Article 2.1] defines the following as research:

1. living human participants;
2. human biological materials, as well as human embryos, fetuses, fetal tissue, reproductive materials and stem cells. This applies to materials derived from living and deceased individuals.

There are also some forms of research that are deemed exempt from research ethics board (REB) review in Canada. The Tri-Council Policy Statement 2 (2022) [Article 2.2-2.4] (3) defines the following as research:

1. “Research does not require REB review when it relies exclusively on information that is a. publicly available through a mechanism set out by legislation or regulation and that is protected by law; or b. in the public domain and the individuals to whom the information refers have no reasonable expectation of privacy.” (2, Article 2.2)
2. “REB review is not required for research involving the observation of people in public places where: a. it does not involve any intervention staged by the researcher, or direct interaction with the individuals or groups; b. individuals or groups targeted for observation have no reasonable expectation of privacy; and c. any dissemination of research results does not allow identification of specific individuals.” (2, Article 2.3)
3. “REB review is not required for research that relies exclusively on secondary use of anonymous information, or anonymous human biological materials, so long as the process of data linkage or recording or dissemination of results does not generate identifiable information.” (2, Article 2.4)

The following are some considerations that can be important to consider when designing studies:

• Power Dynamics – Power dynamics (or the perception of these) can often be a source of this problem within certain populations. In clinical research or biochemical research, it is often clear that the participants in research often feel there is a power differential between them and the researcher (e.g. their treating physician or nurse who may be part of a clinical trial). Similarly in health professions education, researchers may have power over their potential participants. If a residency program director is seeking to study a group of potential student-applicants to their specialty, one might imagine how there may be some ethical issues that might have to be navigated to minimize the impact of this power on the applicants? In response to issues around power within HPER, many institutions will have secondary review panels that include student stakeholders in reviewing potential research projects in tandem with the formal research ethics board. Within the McMaster University landscape, there is a specific secondary review panel that is run within the Michael G. DeGroote medical school that must sign off on all HPER that includes medical students.
• Relationship to Clinical Environments – While many HPER projects may not directly impact upon clinical care, if the work is done within a clinical learning environment, there may be indirect effects of introducing that research (or sometimes the researcher) to an environment. For instance, if an ethnographer wished to be embedded within a clinical team to observe how trainees interact with patients, this researcher may need to adhere to all the typical procedures and policies of any other healthcare provider (e.g. immunizations, workplace hazard training, patient confidentiality modules) to ensure that they do not breach protocols in place within the hospital.
• Confidentiality – In all research, confidentiality is very important for the conduct of any research – but in HPER, there can be multiple layers of confidentiality that may need to be considered. For instance, when studying excellence or shame within a nursing student population in a qualitative project, the students may be led via the interviews and disclose their own personal health information to contextualize their stories. Similarly, they may feel like the only way to explain how they felt was in the context of a specific patient encounter. In both cases, the participant may disclose identifiable attributes that could lead to a breach of confidentiality. As a HPE researcher, it is important to then be on the lookout for the way that your knowledge elicitation or data collection tools might influence your participants to tell their stories.

Exemptions to Research Ethics Board governance

In Canada, research ethics governance is determined by the Tri-Council Policy Statement (TCPS2), which is in its second iteration (3). There are some notable exemptions that impact health professions educators that are worth exploring in this section.

Before we do so, however, it is important for us to review the nature of education scholarship and note that not all studies that a health professions educator may conduct will be “research”. In TCPS2, ’“research” is defined as an undertaking intended to extend knowledge through a disciplined inquiry and/or systematic investigation (3). This means that the primary intent for embarking on a particular project will be to extend what we know about a specific area or domain. However, as defined previously in other parts of the HPER curriculum, education scholarship will include other forms of scholarship such as literature reviews/knowledge syntheses, needs assessments, program evaluation, narrative medicine, and knowledge translation.

As you may recall from earlier in this chapter Article 2 of TCPSC2 (2022) identifies several areas of research that are allowed that do not require ethics oversight (3). These are:

1. Public data (Article 2.2);
2. Data in the public domain with no reasonable expectation of privacy (Article 2.2);
3. Observation in Public Places (Article 2.3);

Secondary use of anonymous information or anonymous human biological materials (so long as the data linkage does not generate identifiable information) (Article 2.4).

Quality improvement

Specifically relevant to educators, Article 2.5 of TCPS2 (2018) highlights the following:

Quality assurance and quality improvement studies, program evaluation activities, and performance reviews, or testing within normal educational requirements when used exclusively for assessment, management or improvement purposes, do not constitute research for the purposes of this Policy, and do not fall within the scope of REB review.

Under Article 2.5, this means that program evaluation activities (such as surveys regarding courses or routine testing that exists for students in your classes) does not require an REB review. Certainly, this is an important clause for you to know as an educator, since it is important to know that checking to see if your specific program (or curriculum or product) is functioning well (either by surveys, focus groups, or interviews) is not considered “research”. However, it is very important to ensure that such program evaluation activities stay within the bounds of evaluating a specific program and do not to stray into generalities and inferences about new insights gained.

Often this grey area is where HPE researchers can get into trouble. Researchers may wish to explore more deeply some ideas that come out of a specific program evaluation, but waltz into an problematic ethical zone if the project becomes more about the general pursuit of truth rather than a specific project. Broadly speaking, program evaluation activities should be used for the purposes of improving the project – it just might be that the story of your project will be useful to others seeking to embark on a similar project, and hence publishable as a work of quality improvement scholarship. In the clinical realm, there are whole journals that focus on quality improvement (e.g. BMJ Quality and Safety, Journal of Evaluation in Clinical Practice), and many of these projects may include some educational components or be focused entirely on the educational aspects of a given project. Similarly, many HPE journals have innovation reports (4) or other formats that allow educators to publish their educational improvement projects (e.g. needs assessment for a new project, evaluation of an innovative curriculum/program).

The duality of some HPE researchers as being those in power over curricula can also create an ethically grey zone. For instance, if you were a program director and you chose to introduce a new curriculum purely for the purposes of finding out new things about a particular learner population (e.g. a one-off workshop on growth mindset with a pre/post survey including demographics and prior exposure to growth mindset), this could very well be seen as a research endeavour. However, if you were that same program director and determined that a workshop for new trainees on growth mindset would be beneficial, then the development, implementation and the evaluation of this new workshop would not be seen as research. If in doubt, it is always advisable to check with your local research ethics board. In Alberta, they have created an online tool [The ARECCI Tool] (5) that walks you through the thinking process for a given project. Locally, for instance at McMaster University, our REB prefers to review each project individually.

Creative Endeavours

Finally, for those engaged in narrative or creative endeavours, Article 2.6 of TCPS2 (2022) states:

“Creative practice activities, in and of themselves, do not require REB review. However, research that employs creative practice to obtain responses from participants that will be analyzed to answer a research question is subject to REB review.”

This clause is important because some individuals may seek to engage in narrative medicine or arts-based techniques for teaching and learning. These materials may become a work of scholarship unto itself, e.g. an anthology of stories from medical students. However, as the statement above articulates, if you use arts-based or creative practice techniques to answer a research question, then the study would require REB review and approval. An example of this might be a healthcare improv session with physiotherapy students that is recorded, to be analyzed later for interactions between teachers and learners by a group of individuals interested in novel teaching techniques – such a project would require REB review and approval before proceeding. Another example would be a study where midwifery students are asked to draw rich pictures and engage in graphical elaboration of their experiences with bullying in the workplace, with these pictures being analyzed later to answer questions that teachers might have about student experiences within the clinical learning environment.

Summary on Research Ethics

To summarize, the following table (4.1.1) shows some of the types of education scholarship that might qualify for exemptions, but if in doubt, your local research ethics board is the go-to place to review.

Of note, the determination of what is and isn’t research, however, is usually done at the level of a given institution. Although not governed directly by the TCPS2 documents, most journals will expect that you have confirmed with the research ethics board or your institutional review board that your project is deemed exempt per their perspective.

Authorship & Contributorship Ethics

Separate from research ethics but related still to HPER practices is the domain of authorship ethics. Although this is not within the boundaries of this particular HPER chapter, we would invite you to recall that there are some standards around authorship conduct that should be reviewed and respected by the members of your team. Please see the next HPER primer chapter (Working Collaboratively: Building a Research Team) to ensure that you have a good handle on this topic as well.

Vignette Conclusion

After a discussion with Dr. Park-Edwards, Carmen embarks on a deep dive into program evaluation techniques and literature – emerging with a plan for a very robust program evaluation that specifically seeks to answer questions about her particular curricular innovation.

After developing the program evaluation protocol documents (including a survey tool and a follow-up stakeholder interview guide), Mary helps Carmen to submit the documents for a formal exemption review from their local Research Ethics Board chairperson. After some correspondence and a short phone conversation, the REB chairperson agrees that this falls well within the auspices of a robust and scholarly approach to a curricular program evaluation and writes Carmen a formal exemption letter that she can keep on file.

5 years later…

After several iterations of her curriculum have passed, Carmen is now a junior faculty member still running this program. Over the course of the past 5 years, Carmen has overseen the expansion and growth of this novel curriculum, and her Department Chair highlights to her that she has seen nothing like this at other institutions. She encourages her to consider writing an article that describes the program.

Taking her exemption letter back to the REB (since the REB Chairship has changed), confirms that they still consider her program evaluations to be exempt per the most recent version of the Tri-Council Policy Statement. Carmen sifts through her program evaluation surveys and old curricular improvement reports to assemble the story of her workshop. She is amused by her early interviews with participants, noting that many of them are senior residents at this juncture. She assembles an article featuring some of the evaluation data for an article at a top journal within the health professions education field. She invites Mary to participate as a co-authors in this article, even though she has now moved to a different centre to become Vice Dean of Education. Mary politely declines as she is quite busy, but graciously thanks Carmen for including her as a collaborator on the project and is happy to be listed in the acknowledgements.

On the day that Carmen uploads the article for submission, she smiles and wistfully remembers those early conversations she had with her former mentor. She is especially thankful for all the guidance that she received from Mary back in the day since one of the first things that the journal asks for is a letter attesting to the exemption for this project.

References

1. Tri-Council Policy Statement: Ethical Considerations About Health Research. Canadian Institutes for Health Research. Published January 11, 2023. Last accessed August 30, 2021.February 4, 2023. Available at: https://ethics.gc.ca/eng/policy-politique_tcps2-eptc2_2022.html
2. MacDonald NE, Stanwick R, Lynk A. Canada’s shameful history of nutrition research on residential school children: The need for strong medical ethics in Aboriginal health research, Paediatrics & Child Health, 2014;19(2);64. Available at: https://doi.org/10.1093/pch/19.2.64
3. Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans – TCPS 2 (2018). Last accessed August 30, 2021. Available at: https://ethics.gc.ca/eng/policy-politique_tcps2-eptc2_2018.html
4. Hall AK, Hagel C, Chan TM, Thoma B, Murnaghan A, Bhanji F. The writer’s guide to education scholarship in emergency medicine: education innovations (part 3). Canadian Journal of Emergency Medicine. 2018 May;20(3):463-70. https://doi.org/10.1017/cem.2017.28

Additional Resources

If you are interested in finding out more about Program Evaluation, you can check out this podcast MacPFD Spark Podcast episode with Dr. Michelle Howard, Associate Professor, Department of Family Medicine, McMaster University:

About the Author

name: Teresa Chan

institution: McMaster University

Teresa Chan (she/her) is an Associate Professor in the Department of Medicine within the Division of Emergency Medicine and cross-appointed to the Division of Education & Innovation. She is an associate member of the Department of Health research methods, Evidence, and Impact. She is also the Associate Dean, Continuing Professional Development Office (CPD) and a Clinician Scientist, McMaster Education Research, Innovation & Theory (MERIT) Program, Faculty of Health Sciences, McMaster University.