Payment of trial participants can be ethically sound: Moving past a flat-rate

The South African Medicines Control Council (MCC) policy that trial participants be paid a flat-rate of R150 per visit in clinical trials has been criticised in the press1,2; its affordability by non-industry funded trials questioned3; that it is an excessive or inappropriate reward4; or that it neglects critical factors like the design or nature of the study.3, 4 It might also be argued that this amount will act as an “undue inducement” for participants to enrol. In our view the principal problem with the MCC policy is that it violates justice in that participants are paid the same amount but do not do the same things or make the same financial sacrifices.5 It has been argued that it would be more appropriate to have a broad contextualised policy6 and that participants should be paid for their time and expenses.4 However, these recommendations have not been specified in the South African literature. To take these recommendations forward we apply two theoretical models of payment (Wage Payment and Reimbursement models) to operationalise payments for time, inconvenience and expenses (TIE). We recommend that participants be paid for their time at a rate similar to national unskilled labour rates, with increments for inconvenient procedures (set nationally), and that they be refunded their direct expenses. This is operationally complex but ethically sound. Our recommendations for stakeholders include that the NHREC assume control of payment norms and endorses payment for TIE. A new payment approach will struggle to overcome the legacy of a flat rate because of community expectations and researchers who have enjoyed a simple administrative procedure

ACCESS TO TREATMENT IN HIV PREVENTION TRIALS: PERSPECTIVES FROM A SOUTH AFRICAN COMMUNITY: Access to Treatment: Community Perspectives

Access to treatment, in HIV vaccine trials (HVTs), remains ethically controversial. In most prevention trials, including in South Africa, participants who seroconvert are referred to publicly funded programmes for treatment. This strategy is problematic when there is inadequate and uneven access to public sector antiretroviral therapy (ART) and support resources. The responsibilities, if any, of researchers, sponsors and public health authorities involved in HVTs has been hotly debated among academics, scholars, representatives of international organizations and sponsors. However, there is little published on community perceptions. Recent guidance asserts that communities should make inputs into treatment and care decisions. This qualitative study explored a South African community’s perceptions of who should provide what to HVT participants as well as how and why this should be done. Twenty-nine adults working at or attending five primary health care clinics in two rural areas in KwaZulu-Natal participated in in-depth interviews. Respondents expressed that researchers should ‘help participants to access’ treatment and care ‘because they are in a position to do so’ and ‘are in a relationship with’ trial participants. Respondents suggested that researchers could help by ‘facilitating referral’ until such time that participants can access care and treatment on their own. We highlight a series of implications for researchers in HVTs, including their need to be aware of prospective participants’ considerable trust in and respect for researchers, the responsibility that this places on them, and the need for clear communication with communities so as not to erode community trust

The Structure and Function of Research Ethics Committees in Africa: A Case Study

Kass and colleagues explore the strengths and weaknesses of research ethics committees in Africa

South Africa’s Duty to Support Health Research for the Global Poor

This thesis provides the first account of the duties middle-income countries have to the global poor. More specifically, it argues for South Africa’s duty to support health research for the global poor. In 1999 the South African AIDS Vaccine Initiative (SAAVI) was given the task of developing and testing an affordable, effective and locally relevant HIV vaccine for southern Africa. This mandate appears to imply that South Africa has an obligation to support health research for the broader African region i.e. an obligation beyond its borders. South Africa has the means to fulfil, at least part of, this obligation, since it is a hub for both internally and externally sponsored health research. This prompts two questions. First, does South Africa really have an obligation to support health research whose intended beneficiaries lie beyond its borders? After all, South Africa is not a rich country but a middle-income country. Second, if there is an obligation, how far does it extend? Many theories of global justice accept that very rich countries have some obligation to those who are poor. The global justice literature has, however, been silent on the duties of middle-income countries. South Africa, and countries like it, occupies a unique position that has been neglected in the global justice literature. A middleincome country might have significantly more resources and research capacity than low-income countries, but still struggles to meet internal needs that high-income countries have largely addressed. It is therefore not immediately apparent what the global justice duties of middle-income countries should be. To address this question, I first defend the assumption that, in most cases, prioritising investment in the worstoff1 is the fairest way to allocate scarce health research resources, since, in most cases, adhering to this principle also serves to maximise total health benefits and increase global health equality. I then argue that when fulfilling duties to the worstoff, neither political boundaries nor national allegiances are morally important, and should not be used to prioritise the needs of some over those of others. This is because the duty to the worst-off is a specific duty of rescue. This rescue duty is so pressing that it trumps justice duties and special duties to co-nationals. Recognizing this rescue duty essentially moves the worst-off outside our political borders inside our scope of moral concern. As a result, South Africa has equal duties to the worstoff both within and beyond its borders. Given that a middle-income country, with limited resources, is not able to assist all the worst-off, I suggest a morally defensible way to prioritise within this set. Prioritising the worst-off in sub-Saharan Africa is morally permissible because it will, in most cases, produce a larger overall benefit. South Africa’s duties to the worst-off in the region are therefore equal to its duties to its own citizens who are among the worst-off, and can be prioritised over duties to the worst-off elsewhere. My account offers a morally sound way for South Africa to prioritise limited health research resources while fulfilling its duties to the global poor. Further, to inform how South Africa can begin to fulfil its duties, I identify gaps in global health spending, with a focus on the poor. I outline which populations are likely to be representative of the world’s worst-off. I identify what types of health research, in which disease categories, are priorities for these populations, and which of these are the most underfunded. This evidence base informs how South Africa can begin to focus its health research activities and resources. I recommend “next steps” for South Africa; offer suggestions for data collection, and insights on the duties of middleincome countries more generally. Finally, since most of the time the fairest way to allocate scarce health research resources, is to prioritise investment in the worst-off, I analyse a selection of the World Health Organisation’s global health research priority-setting exercises to establish whether they adhere to this prioritarian principle. I recommend that future global health research priority setting exercises narrow the scope of their recommended health research priorities

Racial differences in public perceptions of voluntariness of medical research participants in South Africa

The reign of apartheid in South Africa was characterized by systematic violation of the human rights of the Black population. Ruling institutions of the country perpetuated and enforced such violations. Consequently, Black South Africans may be apprehensive of scientific research in which the Black population is targeted for participants, regardless of the reason for their being selected. This exploratory study aims to (1) contribute to the relatively limited body of empirical research on the concept of voluntariness and (2) assess racial differences in public perceptions of the voluntariness of medical research participants. We sampled 111 employees from two companies. The sample consisted of 39 Black, 37 Indian, and 38 White participants. A structured questionnaire was used to interview respondents. Results showed that Black respondents scored significantly lower on scores of perceived voluntariness than both Indian and White respondents. These racial differences in perceptions of voluntariness were found to be independent of level of education, knowledge of medical research procedures, and close or personal experience of medical research. Perceptions of voluntariness did not however appear to impact on participants' personal willingness to participate in future research. Implications for recruitment of future health research participants in South Africa are discussed.Voluntariness Race Research participants Consent South Africa

Exploring the ethics of global health research priority-setting

CITATION: Pratt, B., et al. 2018. Exploring the ethics of global health research priority-setting. BMC Medical Ethics, 19:94, doi:10.1186/s12910-018-0333-y.The original publication is available at https://bmcmedethics.biomedcentral.comBackground: Thus far, little work in bioethics has specifically focused on global health research priority-setting. Yet features of global health research priority-setting raise ethical considerations and concerns related to health justice. For example, such processes are often exclusively disease-driven, meaning they rely heavily on burden of disease considerations. They, therefore, tend to undervalue non-biomedical research topics, which have been identified as essential to helping reduce health disparities. In recognition of these ethical concerns and the limited scholarship and dialogue addressing them, we convened an international workshop in September 2015. The workshop aimed to initiate discussion on the appropriate relationship between global and national levels of health research prioritysetting and to begin exploring what might be ethically required for priority-setting at each of those levels. Main text: This paper comprises our reflections following the workshop. Its main objective is to launch a research agenda for the ethics of global health research priority-setting. We identify three domains of global health research priority-setting—scope, underlying values and substantive requirements, and procedural considerations. For each domain, specific research questions are highlighted and why they need to be explored is explained. Some preliminary thoughts and normative arguments as to how the research questions might be answered are also offered. For example, we provide initial ideas about the appropriate relationship between different priority-setting levels and what values and substantive considerations should guide or underpin global health research priority-setting as a matter of justice. Conclusion: We anticipate that framing a new research agenda for the ethics of global health research priority-setting will spur ethicists, researchers, and policymakers to refocus their efforts on developing more rigorous and ethically sound approaches to priority-setting.https://bmcmedethics.biomedcentral.com/articles/10.1186/s12910-018-0333-yPublisher's versio

Perceived enablers and constraints of motivation to conduct undergraduate research in a faculty of Medicine and Health Sciences : what role does choice play?

CITATION: Marais, D. L., et al. 2019. Perceived enablers and constraints of motivation to conduct undergraduate research in a Faculty of Medicine and Health Sciences : what role does choice play?. PLoS ONE, 14(3):1-23, doi:10.1371/journal.pone.0212873.The original publication is available at http://journals.plos.org/plosonePublication of this article was funded by the Stellenbosch University Open Access Fund.Background: Enhancing evidence-based practice and improving locally driven research begins with fostering the research skills of undergraduate students in the medical and health sciences. Research as a core component of undergraduate curricula can be facilitated or constrained by various programmatic and institutional factors, including that of choice. Self-Determination Theory (SDT) provides a framework for understanding the influence of choice on student motivation to engage in research. Aim: This study aimed to document the enablers and constraints of undergraduate research at a South African Faculty of Medicine and Health Sciences (FMHS) and to explore how the presence or absence of choice influenced students’ engagement with research in this context. Methods: An exploratory descriptive design was adopted. Undergraduate students who had conducted research and undergraduate programme staff were recruited through purposive sampling. Semi-structured interviews were transcribed and thematically analysed. Findings were interpreted using SDT, focusing on how choice at various levels affects motivation and influences research experiences. Results: Many of the programmatic and institutional enablers and constraints–such as time and supervisory availability–were consistent with those previously identified in the literature, regardless of whether research was compulsory or elective. Choice itself seemed to operate as both an enabler and a constraint, highlighting the complexity of choice as an influence on student motivation. SDT provided insight into how programmatic and institutional factors–and in particular choice–supported or suppressed students’ needs for autonomy, competence, and relatedness, thereby influencing their motivation to engage in research. Conclusion: While programmatic and institutional factors may enable or constrain undergraduate research, individual-level factors such as the influence of choice on students’ motivation play a critical role. The implication for curriculum development is that research engagement might be enhanced if levels of choice are structured into the curriculum such that students’ needs for autonomy, competence, and relatedness are met.https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0212873Publisher's versionAuthors retain copyrigh