Telehealth in south africa: a guide for healthcare practitioners in primary care

The use of telehealth is becoming a prevalent feature in clinical practice worldwide, partly because of advances in medical and telecommunications technology. The coronavirus disease 2019 (COVID-19) pandemic has been a key driver in justifying the accelerated use of telehealth, leading to healthcare practitioners (HCPs) utilising virtual consultations more avidly. Although challenges remain, recent data have shown that remote consultations are feasible, safe and effective in South Africa (SA) and that HCPs should become proficient in conducting telehealth, virtual or remote consultations. These guidelines are based on the revised Health Professions Council of South Africa (HPCSA) General Ethical Guidelines for Good Practice in Telehealth (Booklet 10) and guidelines on remote or video consultations from the University of Oxford, the Royal Australian College of General Practitioners and the Royal College of Psychiatrists. These guidelines aim to equip HCPs with the basic knowledge and skills pertaining to medicolegal, communication and practical aspects of telehealth and how to practise telehealth safely and effectively in primary care settings in SA during the COVID-19 pandemic and beyond.Keywords: telehealth; virtual consultations; remote consultations; primary care; guidelines; ethics; medicolegal; communication.

Challenges to ethical integration of reproductive health education in schools of Tshwane District, South Africa

The Integrated School Health Policy was set to ensure the incorporation of a multi-disciplinary approach to health care in South African schools. However, the implementation of sexuality and reproductive health teaching and learning has not been without problems. Central to sexuality and reproductive health education is the common ethical application of the subject in teaching. School sexuality and reproductive health education have proved to be a sensitive issue across a socio-cultural environment. Compliance with ISHP programs in sexuality and gender orientation is related to the inclusion of a more comprehensive education for learners to cover human rights and sexual diversity. This paper aims to reflect on the ethical challenges related to the integration of reproductive health education and teaching in schools in the City of Tshwane. This study applied a descriptive exploratoryquantitative research design. Data was collected using a survey questionnaire and a checklist, and applied stratified random sampling to select schools that participated in the study. Data were analysed using descriptive statistics which included frequencies and percentages (%). The results show that the absence of health care values in organisational strategies will challenge the ethical dimension relating to sexuality and reproductive health education. The ethical dilemma of teaching sexual and reproductive health in schools can prove to be a challenging exercise since its a sensitive issue in most societies. Sexuality and reproductive health education is compounded by a lack of clear guidelines in the ISHP programs and the diversity of stakeholders that do not hold a common or standardised ethical framework. Furthermore, lack of sufficient teacher preparation adds to the ethical dilemma in managing school ethical issues in general. (Afr J Reprod Health 2022; 26[4]: 75-81).

Etat des lieux de la règlementation des essais cliniques au Mali / State of play of the regulation of clinical trials in Mali

Objectif: L'objectif était de réaliser l'état des lieux de la réglementation des essais cliniques au Mali. Matériel et Méthodes: Il s'agissait d'une étude transversale descriptive réalisée du 1er septembre au 15 décembre 2019. Elle a consisté en une recherche documentaire et une enquête de terrain dans les centres de recherche, les comités d'éthique et les structures règlementaires du Mali. Résultats: En 2019, il y a eu 15 essais cliniques autorisés et réalisés par trois centres de recherche, dont 12 vaccinaux et 3 médicamenteux tous approuvés par un comité d'éthique. Le cadre juridique des essais cliniques est régi au Mali par deux textes dont l'un législatif et l'autre réglementaire. Ils prévoient l'autorisation, la suspension ou l'interdiction de la recherche biomédicale par le ministre en charge de la santé. Les insuffisances recensées sont relatives à la faible remontée et au manque d'évaluation des données de pharmacovigilance, la rareté des inspections des sites et surtout l'absence de comité technique d'évaluation règlementaire des dossiers à la Direction de la Pharmacie et du Médicament (DPM). Conclusion: Le renforcement du cadre juridique est, plus que jamais, nécessaire pour assurer la protection des droits, la sécurité et le bien-être des sujets de recherche dans un contexte de délocalisation croissante des essais cliniques vers nos pays

Objective: The objective was to take stockof the regulation of clinical trials in Mali. Material and Methods: This was a descriptive cross-sectional study carried out of the September 1 to December 15, 2019. It consisted of a literature search and a survey in research centers, ethics committees and regulatory structures in Mali. Results: In 2019, there were 15 clinical trials authorized and conducted by three research centers, including 12 vaccines and 3 drugs trials all approved by an ethics committee. The legal framework for clinical trials is governed in Mali by two texts, one legislative and the other regulatory. They provide for the authorization, suspension or prohibition of biomedical research by the minister in charge of Health. The shortcomings identified relate to the low recovery and lack of evaluation of pharmacovigilance data, the scarcity of site inspections and especially the absence of a technical committee for regulatory evaluation of files at the Pharmacy and Medicines Department (DPM). Conclusion: The strengthening of the legal framework is, more than ever, necessary to ensure the protection of the rights, safety and well-being of research subjects in a context of increasing relocation of clinical trials to our countries

Sufficient informed consent to medical treatment of adults legal and ethical perspectives from Malawi

This special communication discusses the current legal and ethical requirements for informed consent to medical treatment of adults in Malawi. It analyzes the scope of the laws and code of ethics on professional discipline, including criminal privilege for surgeries and clarifies when insufficient disclosures entitle patients to compensation under civil law. Inconsistencies and uncertainties in the law are made apparent. It evaluates to which degree disclosure standards of other Commonwealth jurisdictions (e.g. the case of Montgomery) would be suitable for the health care setting of a country like Malawi that is characterized by shortages of resources, high illiteracy rates and a communitarian cultural context. Doctor-patient communication is not alien to African culture and part of sufficient informed consent. In order to balance the need for efficiency in health care delivery, accountability for quality care, fairness and effective patient-doctor communication the authors suggest to adopt the reasonable patient test only, if a defence of heavy workload on case-to-case basis is introduced at the same time. This does not dispense the need for organisational diligence on part of the institutional health care provider within its capacity

Perspectives of healthcare workers in South Africa on COVID-19 vaccination passports

Background: Following the rollout of several effective vaccines against coronavirus disease 2019 (COVID-19), many countries have introduced vaccination passports or certificates as a means of certifying that an individual has been vaccinated against, is immune to, or is presently uninfected with COVID-19. An extensive ethical debate has ensued. Aim: To determine the perspectives of South African healthcare workers (HCWs) on the implementation of COVID-19 vaccination passports (C19VPs) in South Africa (SA). Setting: Healthcare workers working in various fields and practice settings throughout SA were invited to complete an online questionnaire. Methods: An online questionnaire was distributed using convenience sampling via social media platforms to HCWs over a 1-month period, collecting demographic details and responses to 8 Likert-type items regarding agreement with C19VPs, ethical issues and feasibility. Each item was graded from 1 (strongly disagree) to 5 (strongly agree), with grouping of 4 of the 8 items exploring a common theme of C19VPs being a good idea, constituting a score out of 20. Non-parametric tests were performed to determine differences in responses between groups. Results: One thousand HCWs responded to the survey and fulfilled inclusion criteria. The majority (83.2%) of respondents were medical practitioners (MPs). Overall, most (73.5%) respondents agreed that C19VPs are a good idea. Older respondents agreed more strongly than younger respondents (medians 18 and 17, respectively, p = 0.001), and respondents in private practice agreed more strongly than those in state practice (medians 18 and 16, respectively, p = 0.042). The median response was neutral (3) in response to the ethics of C19VPs considering variations in vaccine access and tending towards disagreement (2.5) in disadvantaging poorer people. Most respondents disagreed that vaccine hesitancy would make C19VPs unethical, and responses from provinces with the highest vaccination proportions disagreed more than others with lower vaccination proportion (median 2 compared with 3, p < 0.001). There was uncertainty about the feasibility of C19VPs in SA, with older HCWs, non-students, senior MPs and those who thought C19VPs are a good idea being more likely to consider them feasible. Conclusion: The perspectives of HCWs, mainly MPs, about C19VPs in SA were obtained. Further research should focus on vaccine hesitancy and its factors in HCWs and the effect of C19VPs on restrictions, reduction in transmission and benefits on economies and mental health.

Direito versus bioética em tempos de pandemia. Que desafios? / Law versus bioethics in pandemic times. What challenges?

NA