Health research ethics (HRE) training programmes are being developed and implemented globally, often with a goal of increasing local capacity to assure ethical conduct in health-related research. Yet what it means for there to be sufficient HRE capacity is not well-defined, and there is currently no consensus on outcomes that HRE training programmes should collectively intend to achieve. Without defining the expected outcomes, meaningful evaluation of individual participants and programmes is challenging. In this article, we briefly describe the evolution of formal education in HRE, articulate the need for a framework to define outcomes for HRE training programmes, and provide guidance for developing HRE competency frameworks that define outcomes suited to their contexts. We detail critical questions for developing HRE competency frameworks using a six-step process: (1) define the purposes, intended uses and scope of the framework; (2) describe the context in which practice occurs; (3) gather data using a variety of methods to inform the competency framework; (4) translate the data into competencies that can be used in educational programmes; (5) report on the competency development process and results and (6) evaluate and update the competency framework. We suggest that competency frameworks should be feasible to develop using this process, and such efforts promise to contribute to programmatic advancement.
- research ethics
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Contributors All authors contributed to the conceptual development of the article, drafting and revising the manuscript, and approved the final manuscript.
Funding The research reported in this publication was supported by National Institutes of Health (NIH), Fogarty International Center (grant #R25TW010891).
Disclaimer The funder was not involved in the creation of, or decision to submit this manuscript. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.
Competing interests JS is a member of Merck KGaA’s Bioethics Advisory Panel and Stem Cell Research Oversight Committee; a member of IQVIA’s Ethics Advisory Panel; a member of Aspen Neurosciences’ Scientific Advisory Board; a consultant for Biogen; and a consultant for Portola Pharmaceuticals. None of these activities have a direct interest in the material discussed in this manuscript.
Provenance and peer review Not commissioned; externally peer reviewed.
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