Ethical considerations in using a smartphone-based GPS app to understand linkages between mobility patterns and health outcomes: The example of HIV risk among mobile youth in rural South Africa.

Smartphones with Global Positioning System (GPS) apps offer simple and accurate tools to collect data on human mobility. However, their associated ethical challenges remain to be assessed. We used the Emanuel framework to assess the ethical concerns of using smartphone GPS to record mobility patterns of young adults in rural South Africa for a larger study on mobility and HIV risk (Sesikhona). We conducted four focus groups (FGDs) with individuals eligible for the Sesikhona study. FGD data were coded using the Emanuel framework. Participants perceived use of smartphone GPS to study human mobility and HIV risk as valuable. They raised concerns about invasion of privacy and confidentiality. Also mentioned were risk/benefit ratio, informed consent and ongoing respect. Concerns expressed provided a useful evidence-base for the development of a guide to inform future participants about ethical issues arising in the use of GPS technology to track mobility and health-related issues.

Mental health and COVID-19 in South Africa.

COVID-19, the disease caused by severe acute respiratory syndrome coronavirus 2, has affected most parts of the globe since its first appearance in the city of Wuhan, China, in December 2019. As a result, the World Health Organization declared the virus a global public health crisis and a pandemic within 2 weeks, after the virus had spread to 114 countries with 118 000 recorded cases and 4291 deaths due to the virus and related complications. The World Health Organization declaration is indicative of the enormous impact of the pandemic on human life globally. South Africa has not been exempted from that impact. While the pandemic has affected all South Africans in various ways, the poor have been most affected due to structural inequality, poverty, unemployment, and lack of access to quality health care and other services. Furthermore, public mental health has also been negatively affected by the pandemic, and this comes against a backdrop of an ailing mental health care system. We argue that the psychology profession, as a mental health profession and behavioural science, working as part of a multidisciplinary team, ought to play a significant role in addressing the mental health ramifications of the pandemic. In so doing, lessons can be drawn from other countries while establishing contextual immediate and long-term interventions.

Standard of care for social harms in HIV prevention trials: A South African perspective.

BACKGROUND: The prevention of HIV remains an ongoing global concern. The safety and welfare of participants in these trials are imperative. Research Ethics Committees (RECs) review all reports of serious adverse events, adverse events and social harms arising in the course of such trials. There is little guidance for RECs on how to respond appropriately to social harm reports. METHODOLOGY: This paper reviews the literature on social harms in HIV prevention trials and offers suggestions for RECs on how to respond appropriately to such reports. RESULTS: This review confirms that social harms are reported in clinical trials in South Africa and that specific guidance on managing these is minimal. CONCLUSION: Social harms in South African HIV prevention trials need to be more systematically researched so that ethical evidence-based prevention, care and treatment strategies can be developed. This review makes specific suggestions for further research on social harms that can inform further consultations to develop more specific guidance for stakeholders on appropriate responses to such social harms. Such future work may also inform future versions of relevant local and international ethics guidance on HIV prevention trials.

Ethical issues associated with HIV molecular epidemiology: a qualitative exploratory study using inductive analytic approaches.

BACKGROUND: HIV molecular epidemiology is increasingly recognized as a vital source of information for understanding HIV transmission dynamics. Despite extensive use of these data-intensive techniques in both research and public health settings, the ethical issues associated with this science have received minimal attention. As the discipline evolves, there is reasonable concern that existing ethical and legal frameworks and standards might lag behind the rapid methodological developments in this field. This is a follow-up on our earlier work that applied a predetermined analytical framework to examine the perspectives of a sample of scientists from the fields of epidemiology, public health, virology and bioethics on key ethical issues associated with HIV molecular epidemiology in HIV network research. METHODS: Fourteen in-depth interviews were conducted with scientists from the fields of molecular epidemiology, public health, virology and bioethics. Inductive analytical approaches were applied to identify key themes that emerged from the data. RESULTS: Our interviewees acknowledged the potential positive impact of molecular epidemiology in the fight against HIV. However, they were concerned that HIV phylogenetics research messages may be incorrectly interpreted if not presented at the appropriate level. There was consensus that HIV phylogenetics research presents a potential risk to privacy, but the probability and magnitude of this risk was less obvious. Although participants acknowledged the social value that could be realized from the analysis of HIV genetic sequences, there was a perceived fear that the boundaries for use of HIV sequence data were not clearly defined. CONCLUSIONS: Our findings highlight distinct ethical issues arising from HIV molecular epidemiology. As the discipline evolves and HIV sequence data become increasingly available, it is critical to ensure that ethical standards keep pace with biomedical advancements. We argue that the ethical issues raised in this study, whether real or perceived, require further conceptual and empirical examination.

Ethical issues associated with HIV phylogenetics in HIV transmission dynamics research: A review of the literature using the Emanuel Framework.

The reduced costs of DNA sequencing and the use of such data for HIV-1 clinical management and phylogenetic analysis have led to a massive increase of HIV-1 sequences in the last few years. Phylogenetic analysis has shed light on the origin, spread and characteristics of HIV-1 epidemics and outbreaks. Phylogenetic analysis is now also being used to advance our knowledge of the drivers of HIV-1 transmission in order to design effective interventions. However, HIV phylogenetic analysis presents unique ethical challenges, which have not been fully explored. This review presents an analysis of what appear to be key ethical issues in HIV phylogenetics in the hope of stimulating further conceptual and empirical work in this rapidly emerging area. We structure the review using the Emanuel Framework, a systematic, holistic framework, which has been adapted for use in developing countries, which bear the brunt of the HIV-1 pandemic.

Undue inducement: a case study in CAPRISA 008.

: Participant safety and data integrity, critical in trials of new investigational drugs, are achieved through honest participant report and precision in the conduct of procedures. HIV prevention post-trial access studies in middle-income countries potentially offer participants many benefits including access to proven efficacious but unlicensed technologies, ancillary care that often exceeds local standards-of-care, financial reimbursement for participation and possibly unintended benefits if participants choose to share or sell investigational drugs. This case study examines the possibility that this combination of benefits may constitute an undue inducement for some participants in middle-income countries, where economic challenges are prevalent. A case study is presented of a single participant in a cohort of 382 participants who used concealment, fabrication and deception to ensure eligibility for a post-trial access study of an unlicensed HIV prevention technology at potential risk to her health and that of her fetus. A root cause analysis revealed her desire to access HIV prevention during an unplanned pregnancy with a partner whose faithfulness was in question. Researchers should consider implementation of systems to efficiently identify similar cases without inconveniencing the majority of participants TRIAL REGISTRATION NUMBER: NCT01691768.

Defining and Negotiating the Social Value of Research in Public Health Facilities: Perceptions of Stakeholders in a Research-Active Province of South Africa.

This article reports on qualitative research conducted in KwaZulu-Natal, South Africa, among researchers and gate-keepers of health facilities in the province. Results suggest disparate but not irreconcilable perceptions of the social value of research in provincial health facilities. This study found that researchers tended to emphasize the contribution of research to the generation of knowledge and to the health of future patients while gate-keepers of health facilities tended to emphasize its contribution to the healthcare system and to current patients. Furthermore, relations between research stakeholders were perceived to be somewhat fragile, making it difficult for stakeholders to achieve consensus about the social value of research, as well as on ways to maximize value. Interventions to negotiate a shared perspective on the social value of research would appear to be warranted, and the findings of this study suggest some focus areas for such intervention.

Promoting research integrity in Africa: an African voice of concern on research misconduct and the way forward.

African researchers and their collaborators have been making significant contributions to useful research findings and discoveries in Africa. Despite evidence of scientific misconduct even in heavily regulated research environments, there is little documented information that supports prevalence of research misconduct in Africa. Available literature on research misconduct has focused on the developed world, where credible research integrity systems are already in place. Public attention to research misconduct has lately increased, calling for attention to weaknesses in current research policies and regulatory frameworks. Africa needs policies, structural and governance systems that promote responsible conduct of research. To begin to offset this relative lack of documented evidence of research misconduct, contributors working in various research institutions from nine African countries agreed to share their experiences to highlight problems and explore the need to identify strategies to promote research integrity in the African continent. The experiences shared include anecdotal but reliable accounts of previously undocumented research misconduct, including some 'normal misbehavior' of frontline staff in those countries. Two broad approaches to foster greater research integrity are proposed including promotion of institutional and individual capacity building to instil a culture of responsible research conduct in existing and upcoming research scientist and developing deterrent and corrective policies to minimize research misconduct and other questionable research practices. By sharing these experiences and through the strategies proposed, the authors hope to limit the level of research misconduct and promote research integrity in Africa.

Factors associated with COVID-19 vaccine uptake among south African health care workers.

BACKGROUND: Identifying factors associated with vaccine uptake among health care workers (HCWs) remains crucial to generating evidence aimed at guiding national COVID-19 vaccination and future infectious disease outbreak strategies. This study aimed to elucidate these factors, focusing on the interplay between socio-demographic, health, knowledge, beliefs and attitudinal indicators. METHODS: This was a cross-sectional online survey administered to HCWs across South Africa between August and October 2022. Bivariate and Multivariate logistic regressions identified associations between COVID-19 vaccine uptake and demographics, occupational characteristics, general knowledge of and attitudes towards vaccination, perceived COVID-19 risk and perceived importance of COVID-19 vaccine attributes. RESULTS: Analysis revealed high vaccine uptake rates among the sample of 5564 HCWs, with 87.6% of the sample vaccinated at the time of the study. Demographic measures significantly associated with vaccine uptake were age (P-value = 0.001), race (P-value = 0.021), religion (P-value = 0.004), and having a chronic illness (P-value <0.001). Belief and attitude measures significantly associated with vaccine uptake included: need for vaccines (P-value <0.001), perceived risk of infection (P-value = 0.001), perceived patient risk (P-value <0.001), and perceived vaccine knowledge (P-value <0.001). Multivariate analysis revealed that HCWs who listed their religion as African Spirituality (OR = 0.4; 95% CI = 0.2-0.7; P-value = 0.002) and had any occupation other than nurse or doctor (OR = 0.6; 95% CI = 0.4-0.8; P-value <0.001), were less likely to vaccinate, while HCWs who had a chronic condition (OR = 1.5; 95% CI = 1.2-2.0; P-value <0.001) were more likely to have been vaccinated. CONCLUSION: This study provides useful insights into the factors associated with and possibly driving COVID-19 vaccine uptake among HCWs in South Africa. These results add to a limited body of knowledge on contextual dynamics associated with vaccination programmes in Africa.

The role of 'micro-decisions' in involuntary admissions decision-making for inpatient psychiatric care in general hospitals in South Africa.

While the ethics of involuntary admission for psychiatric inpatient care is widely contested, the practice is legally permissible across most jurisdictions. In many countries, laws governing the use of involuntary admission set out core criteria under which involuntary admission is permitted; these parameters broadly related to either risk of harm to self or others, need for treatment, or both. In South Africa, the use of involuntary admission is governed by the Mental Health Care Act no. 17 of 2002 (MHCA 2002), which sets out clear criteria to direct mental healthcare practitioners' decision-making and delineates a process by which decision-making should occur. However, recent research suggests that, in practice, the process of decision-making differs from the procedure prescribed in the MHCA 2002. To further explore how decision-making for involuntary admission occurs in practice, we interviewed 20 mental healthcare practitioners, all with extensive experience of making involuntary admission decisions, working in district, regional, and tertiary hospitals across five provinces. We also interviewed four mental health advocates to explore patient-centered insights. Our analysis suggests that the final decision to involuntarily admit individuals for a 72-h assessment period under the MHCA 2002 was preceded by a series of 'micro-decisions' made by a range of stakeholders: 1) the family's or police's decision to bring the individual into hospital, 2) a triage nurse's decision to prioritise the individual along a mental healthcare pathway in the emergency centre, and 3) a medical officer's decision to sedate the individual. Practitioners reported that the outcomes of each of these 'micro-decisions' informed aspects of their final decision to admit an individual involuntarily. Our analysis therefore suggests that the final decision to admit involuntarily cannot be understood in isolation because practitioners draw on a range of additional information, gleaned from these prior 'micro-decisions', to inform the final decision to admit.

Understanding COVID-19 Vaccine Hesitancy among Healthcare Workers in South Africa.

Healthcare workers (HCWs) were the first population group offered coronavirus disease 2019 (COVID-19) vaccines in South Africa because they were considered to be at higher risk of infection and required protecting as they were a critical resource to the health system. In some contexts, vaccine uptake among HCWs has been slow, with several studies citing persistent concerns about vaccine safety and effectiveness. This study aimed to determine vaccine uptake among HCWs in South Africa whilst identifying what drives vaccine hesitancy among HCWs. We adopted a multimethod approach, utilising both a survey and in-depth interviews amongst a sample of HCWs in South Africa. In a sample of 7763 HCWS, 89% were vaccinated, with hesitancy highest among younger HCWs, males, and those working in the private sector. Among those who were hesitant, consistent with the literature, HCWs raised concerns about the safety and effectiveness of the vaccine. Examining this further, our data revealed that safety and effectiveness concerns were formed due to first-hand witnessing of patients presenting with side-effects, concern over perceived lack of scientific rigor in developing the vaccine, confidence in the body's immune system to stave off serious illness, and both a general lack of information and distrust in the available sources of information. This study, through discursive narratives, provides evidence elucidating what drives safety and effectiveness concerns raised by HCWs. These concerns will need to be addressed if HCWs are to effectively communicate and influence public behaviour. HCWs are key role players in the national COVID-19 vaccination programme, making it critical for this workforce to be well trained, knowledgeable, and confident if they are going to improve the uptake of vaccines among the general population in South Africa, which currently remains suboptimal.

Examining the uptake of COVID-19 vaccine booster doses among healthcare workers in South Africa: A mixed-methods study.

This study aimed examin the factors associated with the uptake and non-acceptance of COVID-19 vaccine booster doses among healthcare workers (HCWs) in South Africa. We used a mixed-methods design with data from a web-based self-administered survey followed by semi-structured in-depth interviews (IDIs) with selected participants. Of the 6235 HCWs included in our analysis who had fully vaccinated, 3470 (56%) had taken their booster dose with a further 17% intending to get the booster. HCWs aged 35 to 49 years (OR = 1.30 [95% CI: 1.15-1.46]), and those aged 50 years or older (OR = 2.66 [95% CI: 2.32-3.05]) were more likely to get the booster dose. Females were less likely to have received the booster dose (OR = 0.88 [95% CI: 0.79-0.98]) with doctors more likely (OR = 1.58 [95% CI: 1.35-1.84]) than Nurses to have received the booster dose. HCWs in direct contact with patients (OR = 1.17 [95% CI: 1.00-1.38]) and who had previously received a flu vaccine (OR = 1.99 [95% CI: 1.56-2.55]) were more likely to have received the booster dose. Four themes emerged from the qualitative data analysis: (1) Vaccination as routine practice among HCWs; (2) Emergence of new COVID-19 variants necessitating vaccine boosters; (3) Fear of potential side-effects; and (4) Limited value of COVID-19 vaccine boosters. Some HCWs broadly accepted the value of vaccination, and believed that boosters were necessary to effectively combat emergent new virus strains, which contrasted with peers who believed that boosters offered little defence against virus mutations. Fear prohibited some HCWs from getting the booster, with some having experienced adverse side effects from their initial vaccination, whilst others were concerned about future complications. Waning booster uptake rates could be arrested through invigorated communication strategies, while effective evidence-based training can potentially create positive normative vaccination practices amongst HCWs.

The use of students as participants in a study of eating disorders in a developing country: case study in the ethics of mental health research.

This article describes the ethical analysis of an eating disorder study in which a university-based researcher in South Africa set out to establish the cross-cultural validity of the Eating Disorders Inventory. The following ethical issues are considered in the analysis: study design, social value, study population, risks and benefits, oversight, informed consent, and posttrial obligations. The ethics analysis is based on an adaptation of the structured framework proposed by Emanuel et al. (The Oxford textbook of clinical research ethics; pp. 123-133, 2008) for ethical research in developing countries. The analysis reveals that research that, on superficial analysis, seems to be low risk and noninterventional can result in adverse psychosocial effects and complexities for research participants and researchers alike. The study underlines the need for special ethics scrutiny of mental health-related research proposals involving students as research participants, especially when conducted by their own teachers.

Improving understanding of clinical trial procedures among low literacy populations: an intervention within a microbicide trial in Malawi.

BACKGROUND: The intervention reported in this paper was a follow up to an empirical study conducted in Malawi with the aim of assessing trial participants' understanding of randomisation, double-blinding and placebo use. In the empirical study, the majority of respondents (61.1%; n=124) obtained low scores (lower than 75%) on understanding of all three concepts under study. Based on these findings, an intervention based on a narrative which included all three concepts and their personal implications was designed. The narrative used daily examples from the field of Agriculture because Malawi has an agro-based economy. METHODS: The intervention was tested using a sample of 36 women who had been identified as low scorers during the empirical study. The 36 low scorers were randomly assigned to control (n=18) and intervention arms (n=18). The control arm went through a session in which they were provided with standard informed consent information for the microbicide trial. The intervention arm went through a session in which they were provided with a narrative in ChiChewa, the local language, with the assistance of a power point presentation which included pictures as well as discussions on justification and personal implications of the concepts under study. RESULTS: The findings on the efficacy of the intervention suggest that the 3 scientific concepts and their personal implications can be understood by low literacy populations using simple language and everyday local examples. The findings also suggest that the intervention positively impacted on understanding of trial procedures under study, as 13 of the 18 women in the intervention arm, obtained high scores (above 75%) during the post intervention assessment and none of the 18 in the control arm obtained a high score. Using Fischer's exact test, it was confirmed that the effect of the intervention on understanding of the three procedures was statistically significant (p=0.0001). CONCLUSIONS: Potential trial participants can be assisted to understand key clinical trial procedures, their justification and personal implications by using innovative tailored local narratives.

Mapping African ethical review committee activity onto capacity needs: the MARC initiative and HRWeb's interactive database of RECs in Africa.

Health research initiatives worldwide are growing in scope and complexity, particularly as they move into the developing world. Expanding health research activity in low- and middle-income countries has resulted in a commensurate rise in the need for sound ethical review structures and functions in the form of Research Ethics Committees (RECs). Yet these seem to be lagging behind as a result of the enormous challenges facing these countries, including poor resource availability and lack of capacity. There is thus an urgent need for ongoing capacity and resource development in these regions in general, and in Africa in particular. Similarly, there is a need for research and initiatives that can identify existing capacity and funding and indicate the areas where this needs to be developed. This discussion paper argues that the Mapping African Research Ethics Capacity (MARC) project is a timely initiative aimed at identifying existing capacity. MARC provides a platform and tool on the Council on Health Research for Development's (COHRED) Health Research website (HRWeb), which can be used by RECs and key stakeholders in health research in Africa to identify capacity, constraints and development needs. MARC intends to provide the first comprehensive interactive database of RECs in Africa, which will allow for the identification of key relationships and analyses of capacity. The potential of MARC lies in the mapping of current ethical review activity onto capacity needs. This paper serves as a starting point by providing a descriptive illustration of the current state of RECs in Africa.

Health care users' acceptance of broad consent for storage of biological materials and associated data for research purposes in Uganda.

Background: Implementation of appropriate informed consent has become a cornerstone for the use of biological materials and data from clinical care to use in research. During 2017-2018, the Ugandan National Biorepository has since sought prior informed consent for long-term storage and use of remnant clinical human biological materials, where a shortened informed consent form (ICF) was incorporated on the laboratory investigation form. This project aimed at determining the acceptability rate of broad consent from health care users (HCUs) for storage of biological materials and data for research purposes in Uganda. Methods: A cross-sectional study was conducted at three Primary Health Care Facilities. 500 HCUs above 18 years of age seeking health care at outpatient departments between March to December 2020 were invited to enrol. A shortened experimental ICF for this study was developed and attached to the Laboratory investigation form. Results: Overall the acceptability of broad consent for storage of biological materials and data was 86.2% [95% CI: 82.9%-88.9%]. Compared to participants who perceived that the informed consent information is understandable (OR=0.10, CI [0.03-0.32], participants who either partly or totally disagreed were significantly less likely to perceive information as understandable (OR=0.27, CI [0.15-0.46]. 226 out of 431 respondents that accepted storage of biological materials and data, majority (61.7%) preferred to receive feedback on results of relevance to their health. Conclusion: Acceptance of broad consent for storage of biological materials and data for future research purposes was high among HCUs. A shortened and simplified ICF may trigger discussions between participants and health care workers hence increase research participant understanding of study related materials in biobanking. This in turn could enrich ethically collected biobank resources for future research of public health relevance.

Convergent ethical issues in HIV/AIDS, tuberculosis and malaria vaccine trials in Africa: Report from the WHO/UNAIDS African AIDS Vaccine Programme's Ethics, Law and Human Rights Collaborating Centre consultation, 10-11 February 2009, Durban, South Africa.

BACKGROUND: Africa continues to bear a disproportionate share of the global HIV/AIDS, tuberculosis (TB) and malaria burden. The development and distribution of safe, effective and affordable vaccines is critical to reduce these epidemics. However, conducting HIV/AIDS, TB, and/or malaria vaccine trials simultaneously in developing countries, or in populations affected by all three diseases, is likely to result in numerous ethical challenges. METHODS: In order to explore convergent ethical issues in HIV/AIDS, TB and malaria vaccine trials in Africa, the Ethics, Law and Human Rights Collaborating Centre of the WHO/UNAIDS African AIDS Vaccine Programme hosted a consultation on the Convergent Ethical Issues in HIV/AIDS, TB and Malaria Vaccine Trials in Africa in Durban, South Africa on the 10-11 February 2009. RESULTS: Key cross cutting ethical issues were prioritized during the consultation as community engagement; ancillary care obligations; care and treatment; informed consent; and resource sharing. CONCLUSION: The consultation revealed that while there have been few attempts to find convergence on ethical issues between HIV/AIDS, TB and malaria vaccine trial fields to date, there is much common ground and scope for convergence work between stakeholders in the three fields.

A developing country response to Lavery et al. "In global health research, is it legitimate to stop clinical trials early on account of their opportunity costs?".

BACKGROUND: A recent paper presents an argument and mechanism for the possible stopping of clinical trials early based on opportunity costs. DISCUSSION: Although we agree that the costs and opportunity costs of clinical trials need to be reduced wherever possible, we raise concerns about the motivation and mechanism for stopping clinical trials early raised by Lavery et al. SUMMARY: We argue that there are already enough acceptable criteria and actors in the clinical trials arena to justify early stoppage of clinical trials, and argue that factors other than efficacy need to be carefully considered, especially in developing country contexts.

Ethical issues in medical research in the developing world: a report on a meeting organised by Fondation Mérieux.

This paper reports on a multidisciplinary meeting held to discuss ethical issues in medical research in the developing world. Many studies, including clinical trials, are conducted in developing countries with a high burden of disease. Conditions under which this research is conducted vary because of differences in culture, public health, political, legal and social contexts specific to these countries. Research practices, including standards of care for participants, may vary as a result. It is therefore not surprising that ethical issues emerge. This meeting sought to identify and discuss these issues from the perspectives of the many actors in such research, including community representatives, with a view to finding ethical and pragmatic solutions to these issues. Dialogue between these actors was also promoted, with a view to identifying the need to develop such dialogue in future. Drawing from the experiences of the speakers, the colloquium attempted to outline some answers to several key questions characterising the field today. Experiences related to epidemiologic research, vaccine trials, drug trials, diagnostic tests and to some fundamental ethical issues in health research. Speakers were from different countries, disciplines and professions. The meeting provided a forum for consultation and debate between different ethics actors. Both encouraging findings and challenges emerged.