Public health and research ethics education: the experience of developing a new cadre of bioethicists at a Ugandan institution | BMC Medical Education

A PubMed search was made using “research ethics training”, bioethics, and Africa, generating 117 articles. From these, we searched for literature on long-term training of African scholars to develop research ethics capacity, the priority areas, and best practices of bioethics or research ethics education programs. Long-term training was defined as postgraduate training in bioethics or research ethics education program with a duration of at least 3 months culminating in the award of a certificate, diploma, or degree [39]. Our analysis was from 2000 to 2017, spanning the time before the MUREEP, to identify existing training programs meeting our local needs, namely to develop research ethics capacity in a region with a high disease burden that is attracting biomedical and public health research. The Strengthening Bioethics Capacity and Justice in Health program, a collaboration between the University of North Carolina and the University of Kinshasa in the Democratic Republic of Congo, implemented a MPH curriculum with a concentration in research ethics for francophone countries in Africa [6], but we did not find detailed literature about the program. Of particular interest were the first five institutions that received the NIH FIC’s grants for research ethics education and curriculum development programs for LMICs in 2001 as they shaped bioethics education in Africa. For the five institutions, we used two other sources of data in addition to what is published: the NIH RePORTER and program websites. Relevant missing information about the program at CWRU and the SARETI was obtained via email to the official contacts.

Data about MUREEP are for 5 years (April 2018 to January 2023). We used curriculum materials, trainees’ post-training evaluations, applications to the program, annual reports, and the external evaluation for this paper. The MPH-RE curriculum described in this paper was accredited by the National Council for Higher Education in Uganda. We use the term “curriculum” broadly in view of the purpose of this paper to refer to the academic courses and activities of a program in an institution and the key inputs to guide teaching for students to gain proficiency in the expected knowledge and applied learning skills. Additional information was gathered from the MUREEP records and annual reports.

Description of the Mbarara University research ethics education program (MUREEP)

With funding from the National Human Genome Research Institute and the Fogarty International Center (FIC) of the US National Institutes of Health in 2018, MUST in southwestern Uganda, collaborating with Case Western Reserve University (CWRU), Cleveland, Ohio, in the USA rolled out the MUREEP. The main aim of the MUREEP is to build multi-level research ethics capacity in Uganda, specifically by: 1) developing and implementing a curriculum for research ethics education and training, leading to (a) a Master of Public Health degree with a focus on research ethics and (b) a repertoire of short courses to build research ethics capacity of Ugandan investigators, REC members and administrators; 2) create a critical mass of teachers and mentors for sustainable research ethics training in southwestern Uganda; and 3) strengthen the expertise and functioning of Research Ethics Committees (RECs) at MUST and other local institutions. Implementation of aim 1 (a) would produce 12 students, and a minimum of 525 short course trainees for aims 2 and 3. The collaboration covered strategic planning, program leadership, with MUST being the primary awardee, curriculum development and implementation, faculty, and mentoring.

MUREEP MPH-research ethics curriculum

We are implementing a well-structured curriculum designed to lead to the award of a Master’s degree in Public Health with a concentration in Research Ethics (MPH RE). Specifically, MUREEP added a new track, Research Ethics, to an existing Master of Public Health program offered in the Department of Community Health, Faculty of Medicine at MUST.

The MPH research ethics program structure

Our two-year MPH-RE curriculum is broadly structured into five major components: 1) MPH core courses; 2) MPH-Research Ethics courses; 3) non-degree short courses; 4) practicum and externships, and 5) research and dissertation.

MPH core courses

The curriculum has 9 core MPH courses of 60 contact hours each and fundamentals of clinical trials of 45 contact hours (Table 1) to develop the competences of public health bioethicists for a high-disease burdened country (Table 1). The goal is, first, to equip students with knowledge, skills, and attitudes to be sensitive and responsive to health inequalities among populations, and secondly, to bring to light the reasons underlying research, especially in rural communities.

To equip students with skills to design epidemiological studies, we begin by introducing the fundamental concepts of epidemiology and the scientific methods of investigation and problem-solving that are used to get to the root problem of disease in populations. Students learn how to critically appraise study designs (research methods; 60 contact hours); how to use statistical software to analyze the generated data, interpret it, and make practical recommendations. In biostatistics (60 contact hours), emphasis is put on various forms of data, scales of measurement, and data conversion between different scales. Research methods and biostatistics courses, which are covered in semester 1, provide a strong foundation for the development of research proposals. Students have a ‘skills application’ one-week residential placement in the community for health promotion and community involvement.

The second year of study is a practical immersion experience, working with RECs, practicing teaching research ethics, developing skills for grantsmanship, and conducting mentored research in research ethics.

Mode of delivery

In keeping with the inter-professional education approach in the Faculty of Medicine at MUST, MPH-RE students study epidemiology, biostatistics, research methods and survey design with other health profession students (Master of Medicine, Master of Nursing in Critical Nursing, Master of Pharmacy in Clinical Pharmacy Practice, and Master of Medical Laboratory Sciences). This combined class provides a unique setting for learning. Given the diversity of education backgrounds for ‘traditional MPH’ and MPH-RE students, sufficient time is dedicated to lectures, self-reading, journal clubs, small group discussions, and presentations.

MPH research ethics courses

The courses carry three credits (45 contact hours) each. Course material is adapted for local context and culture, and for -resource-limited settings. We begin with the philosophical foundations of research ethics. Given the increasing genetic/genomic and infectious disease research on the African continent, ethical issues are extensively covered under public health research ethics, regulation of genomic research, and controversial ethical issues in biomedical and biotechnology research. We use case scenarios from ongoing local and published investigations in addition to didactic lectures, pre-recorded videos, and group discussions.

Foundations of research ethics

The course introduces students to philosophical theories, fundamental ethical principles and theoretical approaches to bioethics, and their application in clinical, biomedical, and public health research. Relevant international guidelines pertaining to ethical issues and legal aspects in the context of Uganda are covered. To have a connection between theories and practice, we use readings and cases to explore professionalism, ethical challenges associated with review of research protocols by RECs, informed consent, notions of risks and benefits, the distribution of health resources nationally and internationally, and justice in global health research. Trainees in the health science professions discuss scenarios for group discussions, to learn how to balance physician expertise and respect for patient autonomy and ethical clinical decision-making among vulnerable populations. Cultural underpinnings of ethical principles are addressed with special attention to both western and non-western approaches to conceptualizations of ethical theory. As noted by others, applying bioethics in sub-Saharan Africa still remains challenging given the diverse cultural values, beliefs, indigenous faiths, different religions with those of the Christian faith residing in the same settings as Muslims, and the conflicting perception of the international principle of identity and authenticity [2] and healthcare practices. Our method is to contextualize the case studies to settings and cultural values and incorporate the essential two dimensions of bioethics (western and non-western) so that ethical values are not viewed as paternalistic but also avoid the extremes of community and solidarity ethics, the ubuntu ethics [40].

Public health research ethics

The course (45 contact hours) builds on the concepts covered in the MPH core courses of first semester. This course puts emphasis on ethical issues in infectious disease research, which is our biggest challenge; genomics and genetic studies among populations in resource-limited settings who often have a limited understanding of the concept of research; and vaccine research from the community point of view. Ethical challenges in maternal and child health research, and research ethics with sexual minorities are covered. One of the senior MPH-RE student’s research focused on understanding the community’s and research participants’ perceptions and knowledge of vulnerability in research – in the Ugandan context. Ethical challenges in community engagement for public health research, and research conducted during outbreaks, which are recurring in Uganda [29,30,31,32] are covered while emphasizing a social justice approach.

Critical reasoning in research ethics

For the MPH-RE graduate, the ability to think clearly and reason well about ethical issues is a fundamental aspect of training to be able to deal with ethical dilemmas and arrive at morally acceptable answers and decisions. This course examines three important aspects of critical thinking: namely, the ability to understand and evaluate arguments; the ability to make well-reasoned decisions; and the ability to be open-minded. The goal is to develop students’ skills for critical reasoning applied to theoretical and empirical literature addressing ethical concerns in scientific research, with particular interest in genomics and biotechnology.

Non-degree short courses

The MUREEP offers four short courses for faculty, graduate students, research staff, REC members, and administrators at MUST and other institutions, mostly in southwestern Uganda. The short courses (regulation of research and policy, responsible conduct of research, skills for teaching research ethics, and grant writing) are mandatory for MPH-RE students, each covering at least 30 hours. A previous evaluation of the curricula of 13 Fogarty research ethics training programs showed that similar topics are covered, although in some cases not as courses, while for some, like grant writing and teaching skills, the duration is not specified [37]. At the time of writing this paper, 609 trainees had completed various short-term research ethics courses offered by the MUREEP (Table 2). The majority of trainees (382, 62.7%) attended the Responsible Conduct of Research (RCR) course, followed by regulation of research and policy (68, 11.2%).

Regulation of research and policy

This is primarily important for the promotion of ethical research and the protection of research participants, and it details the roles and responsibilities of various committees and bodies involved in research oversight and regulation. MPH-RE students critique international and national guidelines for ethical conduct in research with human subjects to identify gaps that need policy development or revision. The course is also open to REC members, administrators, graduate students, and other interested persons. Trainees role-play ethics committee deliberations and discuss case scenarios.

Skills for teaching research ethics

This course targets those involved in teaching research ethics or bioethics at MUST and other local institutions of higher education as science faculty transition from an ethics compliance mindset to promoting an ethics learning to enhance and advance science [41]. The course is mandatory to MPH-RE trainees. Participants are introduced to methods and resources for teaching bioethics as well as teaching trends, challenges, and opportunities in that field [42]. Trainees are first introduced to the theories that influence teaching and learning [43] before tackling the learning environment, planning and teaching sessions, teaching skills, forms of teaching, and assessment. As a practicum experience, MPH-RE trainees participate in teaching research ethics at MUST and other institutions and make presentations in seminars and research ethics conferences.

Responsible conduct of research

The course is open to graduate students, investigators, faculty, REC members, staff, and anyone involved in research at MUST and other institutions in south western Uganda. It builds on other courses in research ethics with additional modules on bioethics in the Ugandan and sub-Saharan African (SSA) contexts. The course covers 16 broad areas including the mandatory topics provided in the NIH guidelines on instruction in RCR [44]. Didactic lectures are complemented with case study discussions, education videos, and field visits to research institutions and laboratories, clinical research sites, the MUST Animal Research Facility, and the MUST REC Office.

Grant writing

This 5-day course provides an overview of the core elements of grant writing as part of the overall research enterprise. The expected learning outcome is the preparation of a standard and competitive grant proposal for submission to a funder. It is an inclusive inter-professional education activity that promotes student-initiated collaborations among themselves and with faculty.

Practicum and externship

The MPH-RE students take part in three types of practical and externships to apply the knowledge obtained from the foundational bioethics and research ethics courses to develop skills needed to serve on RECs. First, students join the MUST REC to observe meetings and participate in mentored reviews of research protocols. Human research participant issues in resource-limited settings are unique in many ways including working with illiterate, poor populations which increase their vulnerability. We believe that the “public health research ethics” and “clinical trials” courses of the program will enable students develop capacity to review protocols of international research, and genomic and genetic studies because of issues such as complexity of genetic concepts and implications of study findings for family members and communities [45]. Second, students undertake externships either with a high-load REC or at national regulatory offices. Third, students participate in study site monitoring visits. Fourth, the students have online observership of CWRU Institution Research Board deliberations. The approach is to build their competence to lead and serve on RECs [34].

Research project and dissertation

Research proposal development begins in the recess of the first year, followed by a mentor-guided research project in research ethics in the second year. Students must write a dissertation for examination and publish or present their findings at a conference relevant to the field of research ethics. The Program provides the students with a research stipend and ethics review fees, in addition to a laptop to support their journey in becoming responsible research ethics experts.

Research seminar

One important component of a research project is the successful defense of the dissertation. This is mandatory for all postgraduate students and is assessed. The research seminar for the MPH RE students aims at imparting methods and techniques for how information obtained from literature review, research project and dissertation is condensed and written in PowerPoint and manuscript.

MPH-RE students

Trainees who are awarded the MUREEP fellowship are competitively selected to ensure that the knowledge and acquired skills are quickly put to use for the early success of the program. We selected applicants using pre-determined scoring criteria. Between October 2018 and November 2022, 20 trainees (14 full scholarships, 04 partial scholarships, and 02 self-sponsored) with diverse professional backgrounds were admitted to the MUST MPH-RE program (Table 3). The targeted number of enrolled students was 12 over the five-year period of funding. As of the writing of this paper, MUREEP has graduated 3 Masters students, while 4 submitted dissertations for examination; the rest are at different stages of their mentored research projects (Table 3). One alumnus and two MPH-RE students are serving on institutional RECs; six are faculty members in four institutions; others are in clinical and public health research and community work. While the MUREEP MPH-RE program does not have any drop-outs, the completion rate has been low in the first 5 years of program implementation. However, existing literature shows that evaluations of bioethics training programs have been, on average, after 12 years [1, 6, 37], so it may be premature to draw conclusions on the training outcomes of MUREEP in the first 5 years. The pioneer MPH-RE class and one student of cohort 2 graduated in 2021, following the reopening of institutions, and were met with high demand on the job market. They either received new appointments or were promoted and assigned higher-level tasks at their places of work (on REC, university faculty, leadership positions on a clinical trial, and in a research collaborative in Uganda). All were supported to present their research findings at international conferences, and their manuscripts are undergoing peer review in international journals. With disruptions of training and suspension of research activities 14 months after the commencement of the program to contain the coronavirus disease 2019 (COVID-19) pandemic, it is difficult to determine what more would have been achieved by individual students or by the program.

Faculty

The interdisciplinary nature of the public health and research ethics curriculum demands faculty from different disciplines. In addition to the existing human resources for the MPH program, the MUREEP faculty in Uganda and our collaborators at CWRU have specializations in the fields of bioethics, medicine, social sciences, law, similar to other programs in HIC and LMIC [37] in addition to biochemistry, epidemiology, pharmacology, pharmacy, biotechnology, genetics and genomics, anthropology, divinity, psychology, and education.

Other training activities

Journal club

This is the single most important academic activity that provides regular interaction between students, alumni, and faculty. Every 2 weeks during semester time, students have a hybrid journal club lasting 60 to 90 minutes. Three-month schedules are drawn for the journal club to allow students to look for relevant articles, either in line with their research project or a topic of interest. The journal clubs are intended to sharpen students’ critiquing skills, appraise research in research ethics, and improve presentation and communication skills.

Mentorship and career development workshop

While this is not part of the research ethics education curriculum at MUST, MUREEP conducts a five-day mentorship and career development workshop to improve the skills of MUST faculty to mentor colleagues and students while achieving professional success. There is demand for the workshop, but attendance is capped. Forty-three individuals have attended the two workshops that have been conducted.