Managing Ethical Issues in Medical Education Research Dr. Cheryl Cline, PhD Dr. Mala Joneja, MD
Today s Objectives Review existing policies and practices at Queen s and elsewhere Identify key ethical considerations Reflect on analogies between patients, healthy volunteers and students Share experiences
Number of Medical Education Articles Since 1950 250000 200000 150000 100000 50000 0 1950 1960 1970 1980 1990 2000 2010 2020 Medline Search
Why this Topic Now Increasing demand on QUEEN S Medicine students and residents to participate in educational research studies need for evidence-informed educational practices broader definition of research to include education scholarship accreditation reliance on student performance data academic reward system for faculty non-sponsored clinician-educator research* potential risks of research not always visible to researchers or subjects minimal published literature on the topic journal submission requirements research is being carried out in close-knit communities and intimate professional environments protection of student (and faculty) rights and welfare faculty obligations as role models improved quality of research
Medical Students as Research Subjects Students are captive groups, not as prisoners of war are but, nonetheless, subject to certain kinds of subtle coercion.
Using a Sledgehammer to Crack a Nut? Let health ethics panels concentrate their scrutiny on research involving toxic drugs, radiation and new technologies, but let them stay away from research in medical education. - Using a Sledgehammer to Crack a Nut: Clinical Ethics Review and Medical Education Research Projects, Pugsley and Dornan (2007) 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. - Research Ethics Requirements for Medical Education [Journal], Kevin Eva (2009 Editorial)
Variability in Ethics Review Medical Student Quality of Life Survey Study 4 expedited reviews 2 full reviews 7-19 requests for changes The majority of requested changes related to informed consent letter Medical Education Research and IRB Review: An Analysis and Comparison of the IRB Review Process at Six Institutions, Dyrbye et al., Academic Medicine, 2007 Surgical Clerks Supplementary On-Line Module Study 1 full review 4 expedited reviews 2 exemptions from review considerable interinstitutional variability in the perception of risks to students Medical Students as Human Subjects in Educational Research, Sarpel et al., Medical Education, 2013
National Ethics Requirements US CODE OF FEDERAL REGULATIONS 45 CFR 46.101(b) Categories of Exempt Human Subjects Research* 1. Research conducted in established or commonly accepted educational settings, involving normal educational practices, such as (a) research on regular and special education instructional strategies or (b) research on the effectiveness of or the comparison among instructional techniques, curricula or classroom management methods. 2. Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures or observation of public behavior, unless: a. information obtained is recorded in such a manner that subjects can be identified, directly or through identifiers linked to the subjects and b. any disclosure of the human subjects' responses outside the research could reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects' financial standing, employability or reputation.
Professional Association Policies and Processes American Educational Research Association Code of Ethics British Educational Research Association Ethical Guidelines for Education Research Scottish Educational Research Association Ethical Guidelines for Educational research Netherlands Association for Medical Education NVMO Ethical Review Board
University Policies and Guidelines University of Victoria Guidelines for Ethics in Dual-Role Research for Teachers and other Practitioners University of Manitoba Practitioner Research Guidelines for Researchers and Research Ethics Boards at the University of Manitoba University of Alberta Guidelines on Conducting Research in Class (Students as Participants) Mount Royal University Ethical Considerations for Dual Role Research: Conducting Research with Students in Your Own Classroom Lakehead University Guidelines on the Use of Students as Research Subjects McMaster University Research on Teaching and Learning Guidebook University of Waterloo Conducting Research in Classes or with Students as Participants Queen s University Quality Assurance/Quality Improvement Guidelines University of Toronto Teacher- Researcher Conflicts of Interest University of Ottawa In-Class Research
Medical School Policies and Processes University of Alberta Educational Research Procedure: Trainee Access Committee University of British Columbia MD Program Research Access Committee Dalhousie University The RAC, which meets monthly as needed, reviews, approves and monitors all the Guidelines for Researchers Applying for Access to Medical Students studies before they are presented to the medical students and residents. The RAC provides the forum for discussion and decision-making on the studies to be offered to Yale School The of Curriculum Medicine Committee of the Undergraduate medical students and residents. Policy on Medical Access Education to Students Program as Research is responsible Subjects for approving Studies that may yield benefits to the current and/or future medical students or all applications from researchers who wish to access residents will be given priority. The committee will ensure that the timing of survey Keele University medical students as research participants. studies does not interfere with the demands of the education program and conflict with School educational of Medicine research Ethics studies Committee already underway. SOMEC must Queen s be satisfied University that Undergraduate the aims, design Medicine and analysis Program of the project reach an acceptable scientific standard.staff research projects will require independent peer review.
Starting Point: Tri-Council Policy Statement (2 nd Ed) Canadian guidance document for REBs Examples of Areas for Ethical Consideration scientific merit harm-benefit assessment recruitment privacy and confidentiality informed consent authorship ethics
1. Consent to Participate in Research 1. Informed The researcher must provide an explanation to the prospective participant of the nature and purpose of the proposed study, the risks and benefits of participating, how the information will be used, how the subject s privacy will be protected etc. 2. Voluntary (Article 2.2) consent must be voluntarily given, without manipulation, undue influence or coercion Undue influence may take the form of inducement the exercise of control, or authority over prospective subjects. Voluntariness is especially relevant in research involving restricted or dependent subjects For example, voluntariness of students may be restricted because their institutional context implies undue pressure. Students can be convenient, captive, and/or necessary
QUESTION 1a. Balancing Dual Roles: Education and Research TCPS Article 7.4 Article 3.2e reminds researchers of relevant ethical duties that govern real, potential or perceived conflicts of interest as they relate to consent of participants. To preserve the trust on which many professional relationships rest, researchers should be fully cognizant of conflicts of interest that may arise from their dual or multiple roles.and how they can manage the conflict. When acting in dual or multiple roles, the researcher should disclose the nature of the conflict to the participant in the consent process. Pre-Clinical Students YES Clinical Students YES Should med ed research be conducted to improve your medical training? 95% 90% Do you have a vested interest in participating in med ed research? 46% 33% Would you feel coerced to participate because of a faculty member s position of authority? Do you believe that your participation would result in better grades, recommendations or other favours? 5% 14% 20% 28% Medical Students Perceptions of Medical Education Research and their Roles as Participants, Forester and McWhorter, 2005.
Factors Influencing Voluntariness TCPS Article 3.1 Sdfsdfdsfsdfsdfsdfsdfsfsdfsdfsdf sdfssdfsdfsdfsffffff Undue influence and manipulation may arise when prospective participants are recruited by individuals in a position of authority. Coercion is a more extreme form of undue influence, involving a threat of harm or punishment for failure to participate. Incentives are anything offered to participants, monetary or otherwise, for participation in research (incentives differ from reimbursements and compensation for injury, which are discussed in Article 3.2 (j)
Examples of Ways to Manage Dual-Role Conflicts Seek alternatives to using your own students/trainees Be at arms length by person (e.g. a neutral third party introduces study and completes consent process; collects and annonymizes data first) Be at arms length by time (e.g. identifying data be available to researcher only after education-related relationship ends) Recruit using general announcements Disclose conflict of interest (e.g. dual-roles) and mitigation plans to potential research subjects (e.g. in informed consent form and study introductions)
2. Balancing the Risks and Benefits of Medical Education Research Potential Harms undue pressure to participate social penalties and reputational risks opportunity costs (e.g. time away from educational activities) intrusions on privacy performance in a study could impact evaluation of performance outside the study psychological or emotional advancement/employment Educational Potential Benefits
Managing Risks From Twelve Tips for Ethical Approval for Research in Health Professions Education Egan-Lee et al., 2010
3. Safe Guarding Privacy and Confidentiality: Qualitative Research TCPS 5 (Key Concepts): Privacy refers to an individual s right to be free from intrusion or interference by others. It is a fundamental right in a free and democratic society. Individuals have privacy interests in relation to their bodies, personal information, expressed thoughts and opinions, personal communications with others, and spaces they occupy. Ethical concerns regarding privacy decrease as it becomes more difficult (or impossible) to associate information with a particular individual. These concerns also vary with the sensitivity of the information and the extent to which access, use or disclosure may harm an individual or group. subjective perspective is important goal is articulation of phenomena from a particular explicit perspective(s). Seeking understanding, depth, richness. - N. Walton Giving a voice Lived experience
3. Privacy and Confidentiality Challenges can be difficult to remove indirect identifiers while maintaining authenticity of data for analysis by researcher who is otherwise blinded to subjects identities identification may still be possible even when not using names. For example, use of direct quotations is common. In small communities or with small numbers of participants, this may be problematic The possibility of privacy breaches exist not just for research subjects but also for other parties whom they are describing (fellow students, residents, physicians, patients and families) who know nothing about the research confidentiality breaches may occur through other research subjects and not only through the research team (e.g. focus group research)
Research in Postgraduate Medical Education - Ethics Close to my heart Motivation in researching residency education Recent article in Academic Medicine: Keune et al. Acad Med 2013
Research in Postgraduate Medical Education - Ethics Research in PGME is fueled by: New knowledge and technology Educational theory Emphasis on hospital efficiency Focus on interface between education and patient safety Questions around limits on work hours
Research in Postgraduate Medical Education - Ethics Challenges in this research: Small, dispersed group Limited funding Ethical and methodological issues
Research in Postgraduate Medical Education - Ethics Informed Consent Coercion Hierarchy in med ed Loss of privacy/confidentiality Can residents say no? Junior vs. Senior residents? Benefit for residents?
Looking Ahead: Possible Win-Win Initiatives Internal how to instructions (e.g. forms, guidelines, decision-trees) and descriptions of the process of REB review for this type of research specifically Establish student-subject protection standards for some components of medical education research projects Additional level of internal institutional review Faculty-scholar development research ethics module
Acknowledgements Leslie Flynn Libby Alexander Elaine VanMelle Jackie Duffin Albert Clark Andrea Winthrop