Human rights and the COVID-19 pandemic: a retrospective and prospective analysis.

When the history of the COVID-19 pandemic is written, the failure of many states to live up to their human rights obligations should be a central narrative. The pandemic began with Wuhan officials in China suppressing information, silencing whistleblowers, and violating the freedom of expression and the right to health. Since then, COVID-19's effects have been profoundly unequal, both nationally and globally. These inequalities have emphatically highlighted how far countries are from meeting the supreme human rights command of non-discrimination, from achieving the highest attainable standard of health that is equally the right of all people everywhere, and from taking the human rights obligation of international assistance and cooperation seriously. We propose embedding human rights and equity within a transformed global health architecture as the necessary response to COVID-19's rights violations. This means vastly more funding from high-income countries to support low-income and middle-income countries in rights-based recoveries, plus implementing measures to ensure equitable distribution of COVID-19 medical technologies. We also emphasise structured approaches to funding and equitable distribution going forward, which includes embedding human rights into a new pandemic treaty. Above all, new legal instruments and mechanisms, from a right to health treaty to a fund for civil society right to health advocacy, are required so that the narratives of future health emergencies-and people's daily lives-are ones of equality and human rights.

Evolving capacity of children and their best interests in the context of health research in South Africa: An ethico-legal position.

The existing ethico-legal regulation of adolescent children's participation in health research in South Africa is currently unclear. The article interrogates the existing framework governing children's consent to research participation, with specific emphasis on discrepancies in consent norms in law and ethical guidelines. Against the backdrop of the constitutional directive that requires that a child's best interests are of paramount importance in every matter concerning the child, the article assesses whether sufficient consideration is given to children's evolving maturity and capacities when consent to their participation in health research is sought. The article provides specific recommendations and proposes a legislative change to consent provisions in the National Health Act 61 of 2003 in order to address the existing lacunae and to align the framework with constitutional imperatives and international fundamental rights considerations.

Increasing medical student numbers in resource constrained settings: Ethical and legal complexities intersecting patients' rights and responsibilities.

There is a need to increase the number of practicing medical doctors in South Africa. We examine the ethical implications of patients' rights being affected in medical education in a South African context. The South African legal framework advocates public healthcare access. Yet, the State's ethical obligations when it comes to guaranteeing public healthcare access, conflict with its utilitarian policy, that allows for medical education to help achieve the State's public healthcare commitments, at the cost of eroding patients' rights, and accepts that certain actions are imperative, in line with Ubuntu, which is tenable yet nuanced. A patient treated by a licenced doctor today, benefits because other patients have allowed themselves to be used as hands-on learning material for medical students yesterday. Healthcare institutions need to take cognisance of the numbers of medical students that patients can reasonably be expected to endure. There is a need for the Health Professions Council of South Africa and medical schools to adopt guidelines on reasonable levels of medical student-patient interaction, and medical student-to-patient ratios in healthcare delivery.

Public engagement in the development of the National Health Insurance: a study involving patients from a central hospital in South Africa.

BACKGROUND: The National Health Insurance (NHI) is a proposed health policy in South Africa that aims to change the structure of the current health system. Public involvement in policy making is important and it is a constitutional requirement in the legislation development process in South Africa. Patients are key stakeholders and should be engaged in NHI policy process. Before patients can be engaged, they need to be provided with sufficient information about the NHI. Therefore, the aim of this exploratory study was to examine the levels of patient awareness of the NHI, which is a requisite for meaningful engagement. METHODS: This was a cross sectional study of 244 patients from the follow-up clinics at the Department of Internal Medicine, Charlotte Maxeke Johannesburg Academic Hospital in the Gauteng Province, South Africa. The patients were interviewed using a structured interview process and a questionnaire. Descriptive statistics and logistic regression analyses were conducted. RESULTS: The majority (79.51%) of the participants were not aware of the proposed National Health Insurance (NHI) in South Africa even though the NHI policy process commenced in 2011. Of the participants who were aware of the NHI, 86% responded that they had not been provided with an opportunity to be involved in the policy making process of the NHI. The odds of awareness were higher for male (OR: 2.08, 95% CI: 1.11-3.9, p value: 0.02) than female participants; White (OR: 2.36, 95% CI: 1.06-5.26, p value: 0.04) and Indian (OR: 2.76, 95% CI: 0.10-7.60, p value: 0.05) participants when compared to Black participants; and retired (OR: 3.13, 95% CI: 1.35-7.25, p value: 0.008) than unemployed participants. CONCLUSION: The levels of awareness of the NHI were low among the participants from Department of Internal Medicine, CMJAH. Without the awareness and information about the NHI, patients are not equipped to be involved in the NHI policy process in a meaningful way. Public patients are the intended beneficiaries of universal health coverage, therefore they should be prioritized in the NHI community engagement process to ensure that the NHI is community and patient centred.

Engaging diverse social and cultural worlds: perspectives on benefits in international clinical research from South african communities.

The issue of benefits in international clinical research is highly controversial. Against the background of wide recognition of the need to share benefits of research, the nature of benefits remains strongly contested. Little is known about the perspectives of research populations on this issue and the extent to which research ethics discourses and guidelines are salient to the expectations and aspirations existing on the ground. This exploratory study contributes to filling this void by examining perspectives of people in low-income South African communities on benefits in international clinical research. Twenty-four individuals with and without experience of being involved in clinical research participated in in-depth interviews. Respondents felt that ancillary care should be provided to clinical research participants, while a clinical study conducted in particular community should bring better health to its members through post-trial benefits. Respondents' perspectives were grounded in the perception that the ultimate goal of international clinical research is to improve local health. We argue that perspectives and understandings of the respondents are shaped by local moral traditions rather than clinical research specificities and require attention as valid moral claims. It is necessary to acknowledge such claims and cultural worlds from which they emerge, thus building the foundation for equal and embracing dialogue to bridge different perspectives and handle contradicting expectations.

Improving the Quality of Host Country Ethical Oversight of International Research: The Use of a Collaborative 'Pre-Review' Mechanism for a Study of Fexinidazole for Human African Trypanosomiasis.

Developing countries face numerous barriers to conducting effective and efficient ethics reviews of international collaborative research. In addition to potentially overlooking important scientific and ethical considerations, inadequate or insufficiently trained ethics committees may insist on unwarranted changes to protocols that can impair a study's scientific or ethical validity. Moreover, poorly functioning review systems can impose substantial delays on the commencement of research, which needlessly undermine the development of new interventions for urgent medical needs. In response to these concerns, the Drugs for Neglected Diseases Initiative (DNDi), an independent nonprofit organization founded by a coalition of public sector and international organizations, developed a mechanism to facilitate more effective and efficient host country ethics review for a study of the use of fexinidazole for the treatment of late stage African Trypanosomiasis (HAT). The project involved the implementation of a novel 'pre-review' process of ethical oversight, conducted by an ad hoc committee of ethics committee representatives from African and European countries, in collaboration with internationally recognized scientific experts. This article examines the process and outcomes of this collaborative process.

Developing personal attributes of professionalism during clinical rotations: views of final year bachelor of clinical medical practice students.

BACKGROUND: Medical professionalism as a set of behaviours that transcends personal values, beliefs and attitudes to incorporate ethical and moral principles is considered a covenant between society and the practice of medicine. The Bachelor of Clinical Medical Practice (BCMP) a three year professional degree was launched at the University of the Witwatersrand in January 2009 in response to a documented shortage of doctors especially in the rural areas of South Africa. The BCMP programme is unique in its offering as it requires a teaching approach that meets the needs of an integrated curriculum, providing for an accelerated transition from the classroom to the patient's bedside. METHODS: Following five week attachments in designated District Education Campuses, 25 final year BCMP students were required to reflect individually on the covenant that exists between society and the practice of medicine based on their daily interactions with health care workers and patients for three of the five rotations in a one page document. A retrospective, descriptive case study employed qualitative methods to group emerging themes from 71 portfolios. Ethical clearance was obtained from the Human Research Ethics Committee at the University of the Witwatersrand. RESULTS: As an outcome of an ethical analysis, the majority of BCMP students reflected on the determinants of accountable and responsible practice (N=54). The commitment to the Oath became significant with a personalised reference to patients 'as my patients'. Students acknowledged professional health care workers (HCWs) who demonstrated commitment to core values of good practice as they recognised the value of constantly reflecting as a skill (n=51). As the students reflected on feeling like 'guinea pigs' (n=25) migrating through periods of uncertainity to become 'teachable learners', they made ethical judgements that demonstrated the development of their moral integrity. A few students felt vulnerable in instances where they were pressured into 'pushing the line'. CONCLUSIONS: Through their portfolio narratives, BCMP students showed a willingness to shape their evolving journeys of moral growth and personal development. This study has highlighted as an ongoing challenge the need to identify a process by which professionalism is sustained by HCWs to benefit health sciences students.

Ethically acceptable consent approaches to adolescent research in South Africa.

Background: Adolescents are a unique population with significant unmet health needs. They are often excluded from research that may benefit them as they are perceived as vulnerable and needing protection from research participation. For Research Ethics Committees, conflicting positions in statutes, regulations and ethical guidelines about who provides informed consent for adolescent involvement in health research can be a significant barrier to approving adolescent research. For researchers, the requirement for parental/guardian proxy consent or prolonged approval processes may potentially result in the exclusion of those adolescents most vulnerable and at risk, particularly if issues such as gender-based violence, gender identity, sexuality and sexual practices are in question. Objectives: To describe the challenges to adolescent research and suggest strategies to address these. Method: We consider the legal and ethical framework in South Africa regarding the consenting age for adolescents in research, outline the challenges and, using examples of best practices, suggest strategies to address the current conundrum. Results: We suggest three principles to guide Research Ethics Committees on their approach to reviewing health research involving adolescents. Strategies to develop ethically acceptable approaches to adolescent research and consent processes are described, which include community involvement. We elaborate on examples of nuanced approaches to adolescent research. Conclusion: The inclusion of adolescents in research is critical in informing appropriate and effective health services for this vulnerable population, whilst providing an opportunity to link them into care and services where relevant.

A pilot study evaluating an intervention designed to raise awareness of clinical trials among potential participants in the developing world.

BACKGROUND: This pilot study evaluated the speaking book 'What it means to be part of a clinical trial'. The book aims at empowering populations with information on their rights and responsibilities when enrolled in clinical research. Wide publication of the book-at significant cost-is anticipated. It is important that the book is evaluated within the communities for whom it is intended, and the necessary changes (if any) are made, before translation and large-scale publication takes place. OBJECTIVE: The objective of the study was to measure the efficacy and ease of use of the book. METHODS: Participants were recruited from a catering company. Participants were questioned on their knowledge of clinical trials and were then given the book. Instructions for use of the book were given to one group ('experimental' group). The other group ('control' group) was not given any instructions. A week later, the investigators returned, repeated the knowledge questions and asked 'ease of use' questions. RESULTS: A two-way repeated measure of covariants showed a statistically significant positive increase in knowledge of clinical trials among the intervention group (p=0.02). Results for the control group displayed trends that were not statistically significant. Percentage analysis of 'ease of use' questions proved that the book is easy to use, although some changes would be beneficial. CONCLUSION: This study revealed that the speaking book is easy to use. It significantly increased knowledge of clinical trials among the study sample if instructions on use of the book were provided.

Perceptions of patients and medical students towards each other in the setting of patient care-a South African perspective.

INTRODUCTION: South Africa urgently needs more doctors. We examined perceptions of patients and students to provide evidence for optimum student-patient ratios and substantiate solutions for this dilemma. METHODS: We interviewed 118 patients and invited 120 students to complete a self-administered questionnaire from four specialities in an academic hospital in Johannesburg. RESULTS: The total sample size was 238 participants. A total of 91/118 (77%) patients and 78/120 (65%) students were female. Almost all the patients had some level of education, with most patients having received at least a secondary education (71/120). More than half of the students (69/120) were final year students. A third (41/118) of the patients were unaware they were admitted to a teaching hospital. Half of the patients (60/118) thought they had the right to refuse interaction with students. Patients and students preferred smaller groups of between 1-3 and 4-8 students at a bedside tutorial (p < 0.001), although patients preferred smaller groups (1-3) compared with the students (4-8). Majority of patients said they never refused consent to students, while a third of students reported at least up to three patients refusing consent to be examined. The most frequent reason cited by students for refusal of consent by patients was the exposure to excessive numbers of students and healthcare professionals. CONCLUSION: Medical schools should consider patient safeguards while responding to the country's need for more doctors. The Medical Council and medical schools need to draw up professional guidelines on patient-student interactions, including the role of patients in this setting.

Placebo use in vaccine trials: recommendations of a WHO expert panel.

Vaccines are among the most cost-effective interventions against infectious diseases. Many candidate vaccines targeting neglected diseases in low- and middle-income countries are now progressing to large-scale clinical testing. However, controversy surrounds the appropriate design of vaccine trials and, in particular, the use of unvaccinated controls (with or without placebo) when an efficacious vaccine already exists. This paper specifies four situations in which placebo use may be acceptable, provided that the study question cannot be answered in an active-controlled trial design; the risks of delaying or foregoing an efficacious vaccine are mitigated; the risks of using a placebo control are justified by the social and public health value of the research; and the research is responsive to local health needs. The four situations are: (1) developing a locally affordable vaccine, (2) evaluating the local safety and efficacy of an existing vaccine, (3) testing a new vaccine when an existing vaccine is considered inappropriate for local use (e.g. based on epidemiologic or demographic factors), and (4) determining the local burden of disease.

Parents' perceptions of HIV counselling and testing in schools: ethical, legal and social implications.

In view of the high prevalence of HIV and AIDS in South Africa, particularly among adolescents, the Departments of Health and Education have proposed a school-based HIV counselling and testing (HCT) campaign to reduce HIV infections and sexual risk behaviour. Through the use of semi-structured interviews, our qualitative study explored perceptions of parents regarding the ethico-legal and social implications of the proposed campaign. Despite some concerns, parents were generally in favour of the HCT campaign. However, they were not aware of their parental limitations in terms of the Children's Act. Their views suggest that the HCT campaign has the potential to make a positive contribution to the fight against HIV and AIDS, but needs to be well planned. To ensure the campaign's success, there is a need to enhance awareness of the programme. All stakeholders, including parents, need to engage in the programme as equal partners. 

Pilot social feasibility study for the establishment of a public human umbilical cord blood stem cell bank in South Africa.

There is a large unmet need in South Africa for bone marrow transplantation. Umbilical cord blood (UCB) is an important source of stem cells for the treatment of haematological and non-haematological diseases. Access to the two existing private umbilical cord blood stem cell banks (UCB SCBs) in South Africa is limited to individuals that can afford it, which further aggravates the ever increasing divide between families from different socio-economic classes. The problem is compounded by a severe global shortage of genetically compatible samples, representative of the South African demographics. Establishing a public human UCB SCB in South Africa would provide more South Africans with access to previously unavailable treatment in the form of affordable, genetically compatible stem cells for bone marrow transplantation. A public UCB SCB has many facets to consider, one of which is public preparedness and support for the bank. This was assessed in a social feasibility pilot study which is reported here. In addition to the findings of this social feasibility study, other important considerations for establishing a public human UCB SCB in SA include; (a) testing the samples for HIV and other infectious diseases (required for compliance with international regulatory standards); (b) flow cytometric analysis for enumeration of CD34+ UCB stem cells; (c) mapping of HLA genotypes/alleles; and (d) a study of the economic feasibility of this endeavour.The social feasibility study was conducted to gauge public preparedness and support for a public SCB through patient interviews and questionnaires. The process was dynamic due to its novel nature for interviewers and interviewees alike. Many obstacles were met and dealt with which lead to the compilation of results discussed here in the form of a pilot social feasibility study.In the South African context, we are faced with unique and rich challenges relating to cultural and religious differences that are further augmented by linguistic constraints, educational insufficiencies and logistical and administrative limitations. Complicating factors encountered during the informed consent process included cultural differences, religious practices, traditions and superstitions together with language constraints and an educational disparity.Despite many initial obstacles, preliminary results from the informed consent questionnaire were favourable with regard to the establishment of a public UCB SCB. These initial results prompted the revision of the questionnaire and interview process and the compilation of a more succinct and coherent definitive social feasibility study which will form a separate study and which we hope will ultimately assist in the decision of whether or not to establish a public UCB SCB in South Africa. Nevertheless, results from this pilot study appear to be favourable and highlight particular areas which could influence community support for a public SCB. Educating the general public with regard to the workings and benefits of public stem cell banking is the first step in determining the viability of such an undertaking-a unique and rich challenge in the South African context.

Professionalism and the intimate examination - are chaperones the answer?

Complaints of sexual impropriety against healthcare practitioners are escalating. Professionalism in the practitioner-patient relationship and the role-based trust in health care do not allow crossing of sexual boundaries. Communication with patients is key to prevent erroneous allegations of sexual misconduct. The intimate examination is difficult to define. A chaperone present during an intimate examination protects the patient and practitioner and should be considered a risk reduction strategy in practice.

Module five: implementation of ethics review.

The objective of this module is to inform you on issues of concern for Research Ethics Committee members and investigators during the review process. The many guidelines on research ethics, including those from the South African Department of Health and the World Health Organisation, will be referred to extensively to educate you on the requirements of Research Ethics Committees. The evolution of the review process in South Africa will be detailed.