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.
The need to understand the systems that support ethical health research has long been recognized, but there are limited descriptions of actual health research ethics (HRE) systems. Using participatory network mapping methods, we empirically defined Malaysia's HRE system. 13 Malaysian stakeholders identified 4 overarching and 25 specific HRE system functions and 35 actors internal and 3 external to the Malaysian HRE system responsible for those functions. Functions requiring the most attention were: advising on legislation related to HRE; optimizing research value to society; and defining standards for HRE oversight. Internal actors with the greatest potential for more influence were: the national network of research ethics committees; non-institution-based research ethics committees; and research participants. The World Health Organization, an external actor, had the largest untapped potential for influence overall. In summary, this stakeholder-driven process identified HRE system functions and actors that could be targeted to increase HRE system capacity.
Educational programs are integral to building health research ethics (HRE) capacity, but no outcomes framework exists to guide them. We empirically developed a competency framework for health research ethics education-the Framework for Research Ethics Studies Competencies and Outcomes (FRESCO)-using mixed methods, including group concept mapping and a survey of international experts. FRESCO includes seven competency domains: (1) Foundational Knowledge; (2) Laws, Regulations, Guidelines, and Policies for Research Oversight; (3) Ethical-Issue Identification, Analysis, and Resolution; (4) Engagement, Communication, and Advocacy; (5) Lifelong Learning, Education, Research, and Scholarship; (6) Coordination, Stewardship, and Responsiveness in HRE Systems; and (7) Impartiality, Honesty, and Responsibility. These domains are detailed in 27 subdomains. Survey respondents rated FRESCO's relevance to HRE highly. FRESCO can be adapted and implemented in educational programs to refine recruitment and selection processes, educational and assessment methods, and performance measures to ensure that HRE educational programs have their intended effects.