Many countries in the global south are hard-pressed to identify in-country personnel with adequate training in human subjects research ethics to participate as investigators, research staff, or members of ethics review bodies. International partners have attempted to address this need by incorporating research ethics short courses and workshops into their capacity-building programs or by supporting host-country initiatives to implement training efforts of their own. While such programs generally share a common goal – that of building competency in human subjects’ protections – they can vary significantly in instructional approach and format. Some programs focus on formal guidelines, general ethical principles and historically noteworthy cases of research abuse; these programs provide researchers with information needed to meet regulatory requirements but do not necessarily prepare them to apply ethical reasoning skills to the design and conduct of research . Such programs, which emphasize compliance with national regulations and international guidelines, are easier to develop than case-based instruction, can be taught over relatively short periods of time, and can be readily compared to existing regulations to ensure that all required elements have been covered .
Studies, however, have suggested that researchers are more likely to formulate their concepts of scientific integrity and responsibilities towards others from climate, institutional social contexts, and ethical norms than from formal guidelines [3, 4]. Research ethics education programs that combine lectures with inter-collegial discussion of case-based ethical situations may be more effective in fostering recognition of ethical issues, capacity for moral reasoning, intentionality, and the ability for action [1, 5, 6].
International research ethics training programs also vary significantly in format, including on-site, in-person short courses and workshops [6–8] wholly on-line distance education courses [9–14] and hybrid programs combining face-to-face instruction with supplementary web-based materials. In addition, a number of international collaborations have produced ethics training curricula in modular form which are available in print, online, or as CD-ROMs and which can be tailored to meet the training needs, resources, and time constraints of individual programs or institutions [6, 15, 16]. Face-to-face workshops and short-courses can be valuable given the opportunity they provide for discussion, debate, and exchange of ideas, but are resource-intensive and rely on the availability of participants and faculty with dedicated time to commit to such purposes . On-line programs, which offer maximal flexibility in use and require relatively few resources once established, have the added advantage of accessibility for large numbers of people with different schedules and learning speeds. A 2009 quantitative meta-analysis of ethics program evaluation efforts, however, found that ethics courses which emphasized student engagement through highly interactive learning and practice activities promoted instructional effectiveness over those which relied more on self-directed learning . Other scholars, while they debate the extent to which Internet-based learning can contribute to skill development in ethical-decision making, acknowledge that online courses that require interaction with faculty or other students and which ask trainees to tackle ethical problem-solving in writing, can foster ethical reasoning skills . A recent randomized controlled trial comparing on-line and on-site training programs in biostatistics and research ethics, for example, found marked and similar improvements among volunteer scientists, suggesting that on-line instruction may offer a cost-effective, scalable alternative to more resource-intensive face-to-face instructional programs . Evaluators of hybrid programs combining face-to-face interaction with on-line learning emphasize the importance of the face-to-face component to establish collaborative atmospheres in which individuals can safely engage in dialog over controversial ethical issues .
Research ethics in Botswana
With one of the highest rates of HIV in the world, a stable democracy, and a national commitment to public health, Botswana has attracted global attention over the past three decades as a hub for behavioural, epidemiological, and clinical research related to HIV-AIDS and other co-morbid conditions. A number of foreign academic research universities and NGOs have established study centers in Gaborone, the capital city, in order to support on-going research activities. Post-graduate opportunities in the country’s tertiary educational institutions have also expanded during the past decade, resulting in a growing national research portfolio. The rapid increase in the volume and complexity of research activity in the country has necessitated the strengthening of the national research regulatory system and has generated a demand for a trained national workforce able to conduct ethics reviews or serve as investigators and staff at all levels of the research enterprise.
Ethics review of all health and health-related research in Botswana is currently conducted by a government-appointed national research ethics body, the Health Research and Development Committee (HRDC), which functions as an Institutional Review Board/Ethics Review Committee (IRB/REC) with administrative support from the Health Research Unit at the Ministry of Health (HRU). The HRDC increasingly relies on the IRB/REC at the University of Botswana (UB) for research conducted by its faculty and students, but retains authority for final review and approval of all international protocols. A number of IRBs have been established at the local level in hospitals and academic centers, but these, like the HRDC and the IRB/REC at UB, suffer from a paucity of staff and committee members with knowledge and skills in research ethics. Despite concerted efforts in ethics training by the Ministry of Health (MoH) and UB, supported in part by various international agencies such as the Fogarty International Center at the National Institutes of Health, the Wellcome Trust, and the European and Developing Countries Clinical Trials Partnership (EDCTP), the number of individuals in-country with adequate training in research ethics to meet growing demand remains quite small [21–23]. The same limited pool of individuals is often pressed into service on multiple projects or ethics committees. Local entities that have sponsored or endorsed their staff members’ participation in formal academic ethics training programs often lose them on completion of their training to more lucrative jobs with regional or international organizations.
Limited empirical data on the effectiveness of various instructional approaches in teaching research ethics are available to guide Botswana institutions as they expand their training efforts. The traditional practice among the Batswana people to discuss issues of importance in familial and communal settings would suggest that face-to-face small-group problem-solving would be highly effective. Wholly on-line instruction, despite its advantages as a low-cost, scalable, flexible medium, requires reliable Internet access, a rarity in Botswana where Internet service, even within government and academic centers, is sporadic. Use of email as a communication tool, however, is fairly common, particularly among Batswana professionals, although access to computers with connectivity is frequently limited to the workplace or Internet cafes.
In 2010, with support from EDCTP, the MoH launched a multi-year endeavour to create a country-wide system of ethics committees/community advisory boards in response to the growing demand for ethics review of student-initiated research in academic institutions situated outside of the capital city as well as the interest of the research community in developing new study sites in many of these same locations. Seven communities were the foci of this proposed system, selected because they were sites of satellite campuses of the Institute of Health Sciences (IHS), a tertiary educational institution responsible for the training of nurses and affiliated health professionals, as well as government-run District Health Teams (DHTs) which serve the semi-urban settlements of Batswana. The MOH proposed to create local ethics committees that would jointly serve as IRB/RECs of record for student-initiated research and as community advisory boards to the HRDC on international research situated within their communities.
In implementing this ethics capacity-building initiative, the Ministry faced a number of challenges relating to course content, appropriate teaching methodologies, and faculty. A grant from the Penn Center for AIDS Research enabled study authors FHB and JFM to work with professional ethics staff at the MOH and UB to offer training to researchers, and ethics committee members from across Botswana. The resultant training program was also used as an opportunity to study the effectiveness of an Internet based learning environment in this population.