Fogarty African Bioethics Training Program (FABTP)

Since its inception in 2001, the Johns Hopkins-Fogarty African Bioethics Training Program (FABTP) has trained 30 professionals, scientists, and senior scholars from 14 countries across sub-Saharan Africa. Prior to 2010, the program provided a one-year opportunity for qualified individuals to participate in intensive bioethics and research ethics training at Johns Hopkins Berman Institute of Bioethics and Bloomberg School of Public Health, with additional workshops, seminars, and IRB activities at the National Institutes of Health and Georgetown University [12]. Following the six month training period, trainees returned to their home countries to conduct independent projects related to research ethics.

In 2010, FABTP shifted its focus to initiate annual collaborative partnerships with African institutions in an effort to enhance research ethics capacity within selected institutions. In addition to one year of bioethics and research ethics training at Johns Hopkins University (JHU) for two individuals from the selected institution, FABTP also provides one-month tailored training opportunities in research ethics for two additional partner faculty, investigators, ethics committee members, or staff. FABTP also "sponsors a training" workshop in research ethics each year, hosted at the African institution, and co-taught by JHU and partner faculty as well as program alumni. Further, under the institutional partnership model, FABTP engages in on-site and virtual consultations with institutional leadership to assist with evaluating and enhancing the integration of research ethics into organizational structures. This also includes technical assistance with the development of research ethics centers, units or programs. Program participants are offered mentorship from JHU faculty and are provided with networking opportunities for their continued professional and institutional development.

An approach to institutional assessment

Several models for the assessment of institutional research capacity have been described [17–21]. However, most of these models have been developed from a high-income country perspective and cannot be easily adapted for evaluation of research ethics capacity in LMIC. A system for evaluating research ethics capacity in LMIC presumably would allow multiple elements of a research ethics system to be assessed; would be pragmatic in terms of timeliness for a LMIC context; and allow for empirical testing. In pursuing such an approach, we adapted the Octagon model developed by the Swedish International Development Cooperation Agency that was intended as a rapid assessment instrument for the strengths and weaknesses of non-governmental organizations [22]. The octagon assesses an organization along eight domains: basic values and identity; structure and organization; ability to carry out activities; relevance of activities to the stated goals; capacity of staff and management; administrative, financing and accounting systems; relations with target groups; and relationship of the organization with the larger environment in which it is operating. The octagon offers a simple yet deliberative, and iterative tool for institutional assessment over time.

In our adaptation of the Octagon model to the context of research ethics in LMIC, the category of basic values and identity is applied to determine whether the institution has clearly articulated aims and objectives for research ethics and whether it has formulated strategies to achieve those objectives. Highest points are awarded if these aims and objectives are available in a written form and if there are clearly articulated strategies to achieve these objectives. The Structure and management domain of the assessment deals with how the organization is structured and how its activities are organized for research ethics. Specifically it looks at whether the research ethics duties and responsibilities are clearly defined for everyone working for the organization and whether it abides by the principles of transparency, accountability and democratic rules. Highest points in this category are awarded if there is an organizational chart showing how different responsibilities are divided and the decision making for research ethics within the organization is transparent.

Under the domain of Implementation, the organization is evaluated on its ability to systematically carry out its research ethics activities through an operational plan. In addition, the organization is evaluated on whether it seeks feedback on its current operations and whether it learns from its experience. The organization’s activities are evaluated for their correspondence with the organization’s stated goals for research ethics under the fourth domain. Under this category two related issues are evaluated: whether the staff members have the requisite skills to perform their research ethics duties, and whether the management enjoys the confidence of the workers.

We also integrated a self-assessment in our approach. The octagon description along with an explanation of scoring was sent to the institution for their own ranking of performance on research ethics. This allowed for a comparative analysis of internal with external assessments and an opportunity for discussion around differences. In addition, the institutional leadership was asked to provide any written documents pertaining to policies on research ethics, application forms or checklists used by the IRB, research strategy, policies on ethical conduct, and guidelines for researchers on the kinds of research that needs to be submitted to the IRB for approval. All the documents provided by the university were then carefully examined for their content and consistency with each other and with the institution’s overall policy on research ethics and with responses made by leadership or individual respondents.

The University of Botswana case study

In 2010, our FABTP partnered with the University of Botswana (UB) in Gaborone, Botswana. UB is the premier educational and research institution of the country, with approximately 15,700 students and 800 academic staff [25]. Our evaluation of the health research ethics capacity at UB in 2010 was conducted in accordance with the approach described above. That is, two site visits were made, and the institutional survey was completed by the university leadership. We also conducted IDIs and FGDs with institutional leadership, staff, faculty members, researchers, graduate students, and IRB members. All data collection was conducted in English, audio recorded and transcribed. All transcripts were read separately by three members of our research team (AAH, WZ, and JA) and thematic analysis performed and coded along the domains of the Octagon model. The institutional survey was also read carefully by all five internal reviewers (AAH, WZ, JA, RS, and NK) and the questions mapped onto the eight domains of the Octagon. Based on all of the data including site visits, a score was given for each of the eight domains of the Octagon; these scores represented a consensus amongst our research team. These scores by our team were then also compared with the scores provided in the self-assessment by the institutional leadership of UB including the director of the Office for Research and Development, the Assistant Director for Research Ethics, and a professor in the school of medicine.

A total of 18 participants were involved in the FGDs of whom 5 were members of the UB IRB, 4 were faculty researchers, 4 were members of research staff and 5 were graduate students. The mean age of the participants was 40 years. Twelve participants were female, 7 held a bachelor's degree, 2 had a master's degree and 9 had doctorates. Below we present results pertaining to each of the eight domains of the Octagon. These results reflect University of Botswana's research ethics capacity at the time of evaluation in 2010 only. This case study was approved by the institutional review boards of the Johns Hopkins Bloomberg School of Public Health, USA and the University of Botswana as well as the research ethics committee at the Botswana Ministry of Health.

Basic values and identity

The University of Botswana has a strategic plan (updated in 2008) which addresses key policy areas including research and development, intellectual property, and ethics. In addition the university has written institution-wide policies that describe the kinds of research activities that need approval from the IRB, and what information researchers should include when submitting research protocols to the IRB. Notable strengths of UB in this regard are the formation of the Office of Research and Development (ORD), the wide range of protocols that need approval from the IRB, and the fact that policies related to research ethics are easily accessible to researchers through the university intranet. A primary goal of the university is to facilitate the development of new scientific knowledge by becoming a "research intensive" institution by the year 2021. In order to achieve this, the university has expanded its PhD program and facilitated coordination between the ORD and the graduate school.

However, while the ORD has clearly identified internal structure of authority and role regarding research ethics, the university needs to better identify how ORD relates to other departments and position the office clearly in an organizational chart. Possibly due to this lack of clarity, currently the role of ORD was not well understood by some researchers and students.

Structure and management

UB has a clearly defined internal structure of responsibility and authority for research ethics under the ORD, which is overseen by a director who answers to the Deputy Vice Chancellor for Academic Affairs. All research ethics activities are directly supervised by an Assistant Director for Research Ethics. In highlighting the role of ORD in coordinating research ethics activities across the university, one informant explained:

“[the] office is responsible for helping them [researchers] get those research permits [issued by Government] and the person responsible assists them to ensure that all the ethical issues have been clarified …. Usually when someone requests, or has an issue, they call and then we clarify those things and also have one on one session with people [researchers] who have issues and someone also goes to board and faculty meetings to have meetings with them” (IDI-research staff).

In addition, several other committees relevant to the smooth, safe, and efficient conduct of research exist under the jurisdiction of ORD, including the UB Animal Care and Use committee, Hazardous Materials Sub-Committee, Research Risk Committee, and the Institutional Review Board. A strength of the IRB structure at UB is the existence of an explicit policy for gender representation, and IRB members are drawn from a wide range of backgrounds including religious and community representation. At the time of this institutional interview, there were 8 males (67%) and 4 females (33%) serving on the IRB. However, UB did not have an organizational chart showing how the ORD relates to other departments within the university.

Implementation of Activities / Production

The teaching program at UB covers many of the substantive areas in research ethics; these are covered through specific sessions in existing research methods courses, requirements for student research, ad hoc training workshops by the ORD, and mentoring by UB faculty. However, ethics training is not an institutional requirement; rather, it is taught based on the perceived need and priorities of individual instructors. The need for more widespread and formal ethics training came up during the FGDs with graduate students as one student remarked:

“There is not anything like that [ethics training], there is not any course in our program. The lecturer talked about it, gave scenarios I think trying to prepare us but it was not a real course ….. I think it would be good to put ethics in research as a course” (FGD graduate student).

The FGD with the research staff also indicated that they felt inadequately trained in research ethics. For instance none of the staff interviewed were fully conversant with the concept of "informed consent". One participant pointed out that:

“There was not any form of training as to what one should do when one meets the [research] communities. I think the reason why they gave me the job to run the program is the fact that I have done research before when I did my Masters Degree! That's how it was”. (FGD research staff)

The IRB’s work at UB is both extensive and collaborative. In the year 2009 the IRB reviewed 50 proposals of which 33 were local, while 12 were in collaboration with other institutions. UB is registered with the United States Office for Human Research Protection and has a Federal Wide Assurance from USA. A challenge regarding the implementation of research ethics activities relates to workload and recognition for the work done by IRB members. Informants reported a perception that the load affected the quality of the review, and the turnaround period for protocols submitted. One IRB member said:

“Sometimes we are really not in a position to offer justice [to reviews]…….we have no…..special discount somewhere that we can be given some time out from our heavy academic loads so that we can develop ourselves as [IRB] members and we can contribute in a productive sense…we have to face this…it is all up to us. So we need some organizational support….we need some real support”. ( FGD- IRB members)

Respondents also pointed out that the IRB currently has no expedited review option and even simple research proposals take a “long time” before approval. The respondents also stressed the need for the IRB to properly monitor ongoing research after they have been approved.

Relevance of activities

UB’s Office of Research has stated its aims to increase capacity for ethical research among students and staff; and to ensure that human subjects research done at the university follows international guidelines for ethical research. Although the IRB at UB has been formally in existence for over five years, effectively it was reported to be functional only for the last two years. Owing to the large number of demands on committee members' time, the IRB has found it difficult to meet regularly. Some members felt that the IRB was "unconscious" in the early years since it managed to meet only twice a year. UB is working towards its goals regarding ethical research, and the constitution of the IRB and teaching of ethics to students have been ongoing for a few years. Some of the strengths of the UB IRB activities include the diversity of the committee in terms of representing different sectors and disciplines; its collaboration with outside groups and IRBs; its collaboration with other research and policy committees at UB; and good community involvement with representation of community members on the committee.

One particular challenge alluded to during several interviews was the low turnout for optional or voluntary ethics training activities. As a UB stakeholder commented:

“Maybe we need to change some particular aspects on ethics training because the people that need it [the training] do not come. Those faculties [staff] that we’ve had troubles with on matters of human subjects’ protection are the very ones who are not coming. " (IDI-Stakeholder)

This has led UB to consider instituting policies that would require researchers and graduate students to undergo some sort of research ethics training.

Right skills for activities

Interviews with UB staff suggest that hiring for the ORD is a rigorous process and effort is made to hire people with appropriate skills and experience. However, for existing personnel serving in the ORD there are no requirements for professional training. UB faculty with significant interest in bioethics research and training do have relevant qualifications (one PhD in Law, and two faculty members with Masters degrees in Medicine). Two faculty members have publications on ethics-related subjects; however, only one faculty member had primary training in public health despite UBs interest in population research.

UB has written policies promoting training of IRB members but there are no minimum training requirements. The IRB provides short workshops and seminars on research ethics to members several times a year, and in 2009 four members of the IRB received such training. There is no requirement for refresher training for IRB members. However, participants stated that the short workshops offered by the IRB are insufficient:

“It [the training workshop] is very fast and without any practical problems where you’re really given cases. Where you put your mind, your complete self, to discuss those cases to see how and what are the challenges?” (IRB member)

“I attended that [training workshop] three or four years back, but it was again a snapshot. It was not really what is going to give you a clear vision and a clear picture. It was just very fast without proper training” (IRB member)

Another challenge faced by UB is a high proportion of guest workers and expatriates among the staff. Consequently there is a high turnover of the staff, often leading to a lack of consistency in research ethics activities. Another issue participants pointed out was the absence of a clinician serving on the IRB partly due to the fact that the school of medicine at UB was new and had a lot of staff turnover.

"So what we do not have on this committee at the moment is a clinician, as such another representative who is on this committee but is absent at the moment who is not medically trained, but a basic scientist has been involved with a lot of human study" (IRB member)

Systems for financing and administration

Every year, UB allocates funds for supporting all research through its annual budget; this is a significant strength of UB and currently not reported from other African institutions. Such funds cover items such as salaries for ORD staff, internal research grants, and research support activities such as research training, research awards and others. This annual allocation is about 1.5% of UBs annual budget. UB is also able to raise funds from external sources and has research grants from for example the Wellcome Trust, the United States National Institutes of Health, and the European Union. The IRB at UB does not have an independent budget or an external source of funding. It is supported through the funds allocated for research support activities. IRB members are also not compensated for their services, however, and outreach programs or community mobilization programs by the IRB are sometimes stifled from lack of funding.

Relations with target groups

UB identified the following target groups as important to the research ethics activities: human subjects (local community), students, faculty, health researchers, the Ministry of Health, the Government of Botswana and external collaborators. The UB has established an educational scholarship program in its effort to try and give back to the local community, as stated by this participant:

“Issues of funding of course sometimes limit us, but we have done that much in terms of bringing them [community members] on board to have access to University, higher education. The research work that we are doing is to identify and see how we can reform policy and access of the course for populations or the communities we work with” (FGD research staff).

Moreover, UB staff has operationalized this concern and addressed it and also identified staff to perform outreach programs:

“I am [mentions his title], and well in terms of interaction with the people, from time to time I do what you refer to as outreach. In this I have to travel to the remote areas and meet the [names a minority group] and talk about the program and also the education of the people that we meet for our Scholarship Program and I will say well, in terms of how often I meet with the people, it also depends on the, on our budget". (FGD research staff)

The focus group discussion with research staff indicated that at least some members of an indigenous community where UB has an ongoing study have complained that "you come here often and nothing comes to us":

“There wasn’t any capacity development component. Later that came as a result of this research which showed that there are huge gaps in terms of access to resources, social services, even in education and so the University funded to put in the next component so that research was not just done on these communities." ( FGD research staff)

In addition the research staff highlighted the potential concern some of them had around undue influence when studies offer incentives for research participants. Respondents also reported that UB has good relations with the Ministry of Health, the government, and external collaborators.

Working environment

This category reflects particularly positively on the UB’s pioneering role in developing health research ethics capacity in Botswana since there are no national guidelines for professional organizations or for human subjects research. The only research law in Botswana (as of 2010) dated from 1960s covering anthropological research. And even though other institutions in Botswana have IRBs, they do not offer ethics training programs.

During focus group discussions, several participants highlighted the regulatory overlap between the UB and Botswana's national ministries, particularly the Ministry of Health. As of 2010, research protocols must be approved both by the IRB of UB and by a ministry committee which issues a permit. Consequently researchers have to fill out multiple forms to submit to the IRB and ministry. This overlap between the function of the UB IRB and the ministry was reported to often cause inordinate delays before approval for research can be obtained. Concern was also voiced that the permit from the ministry, if obtained in advance, might be seen as influencing the deliberations of the UB IRB.

Comparative assessment

Figure 1a & b shows the scored Octagons by both our team (external) and the internal UB groups – and demonstrates several interesting issues. The overall shape suggests that strengths at UB are in the areas of structure, relevance, production and identity; while UB still needs more work in the areas of systems of finance, target groups, and environment. The Octagons also show the similarities and discrepancies between the ‘external’ and ‘internal’ evaluations – which provides the opportunity to have specific discussions with UB to explore the reasons for these different assessments and why UB might be over estimating specific domains (or why we might be under estimating). For example, in this case study the score for ‘identity’ allows for an exploration of what constitutes a strong identity for research ethics at UB and how it can be strengthened and better documented. Such discussions are ongoing.