Human guinea pigs? The ethics of undergraduate and postgraduate student involvement in medical training in South Africa

Irrespective of theoretical and skills laboratories training, clinical competencies need to be honed through real patient contacts. South African (SA) medical training takes place mainly in tertiary hospitals. Most patients come from disadvantaged backgrounds, are scientifically naïve, have difficulty communicating with medical staff and may be intimidated by their surroundings. These patients may be particularly vulnerable and resigned to insidious paternalism. The question is whether authentic informed consent is actually provided by these patients for their involvement in medical training. Implied consent for this purpose is invalid. I justify the demand for explicit consent on the grounds of ethical and regulative frameworks. The human rights of patients and the dictums of the SA National Health Act and the Health Professions Council of SA should actively be promoted and upheld. I conclude with practical suggestions intended to stimulate debate and action at institutional and clinical departmental levels

Successful resuscitation in severe accidental hypothermia : a case report

ArticleThe original publication is available at http://www.samj.org.zaAccidental hypothermia has a mortality rate of 30-80% and should always be borne in mind with comatose, hypotensive patients. It is a preventable condition when adequate safety measures are ensured. One should act in the case of early symptoms, because collapse may soon follow and evacuation of a patient on a stretcher is time-consuming, dangerous and a major undertaking. In severe cases absence of respiration and circulation should not preclude resuscitation. Resuscitation should be continued until the patient is warm and all biochemical abnormalities have been corrected and intoxication has been ruled out. Resuscitation may be successful in primitive, adverse conditions, as illustrated by this case of a 13-year-old boy with cardiopulmonary arrest and a core temperature of only 25°C, who was successfully reanimated.Publishers' versio

Ethical challenges in developing an educational video to empower potential participants during consent processes in future HIV cure research in South Africa

Obtaining consent for HIV research is complex, particularly in low- and middle-income countries. Low levels of education, complexity of science and research processes, confusion about basic elements of research, and socio-economic conditions that make access to medical care difficult have collectively led to concerns about the adequacy of the consent process. Given the exponential growth of HIV prevention and treatment research in South Africa, HIV researchers are increasingly facing challenges obtaining authentic informed consent from potential participants. It is anticipated that HIV cure research, despite being in its infancy in South Africa, will introduce a new discourse into a population that is often struggling to understand the differences between ‘cure’, ‘preventive and therapeutic vaccines’ and other elements of the research process. Coupled with this, South Africa has a complex history of ‘illegitimate’ or ‘false cures’ for HIV. It is therefore logical to anticipate that HIV cure research may face significant challenges during consent processes. HIV prevention research in South Africa has demonstrated the importance of early community engagement in educating potential research participants and promoting community acceptance of research. Consequently, in an attempt to extrapolate from this experience of engaging with communities early regarding cure research, a 15-minute educational video entitled ‘I have a dream: a world without HIV’ was developed to educate and ultimately empower potential research participants to make informed choices during consent processes in future HIV cure clinical trials. To aid others in the development of educational interventions, this paper discusses the challenges faced in developing this educational video

Marketing novel devices in medicine with reference to gynaecological innovations : ethical dimensions

New scientific and technological discoveries in all spheres of Medicine continuously challenge the boundaries of healthcare. To this end, the discipline is considered progressive and accomplished. The birth of this heavily professionalized discipline has leveraged the potential for the healthcare industry to innovate, regulate and disseminate proprietary products with relative ease. The rise and fall of four novel gynaecological devices represent excellent examples of ethical dilemmas in clinical medicine. This paper aims to deconstruct the power versus knowledge conflict, and suggest that reappraisal and recourse to Aristotelian virtue ethics will assist in shifting the decisional power balance primarily towards the physician.https://journals.co.za/journal/medogam2022Obstetrics and Gynaecolog

The psychology of “cure” - unique challenges to consent processes in HIV cure research in South Africa

BACKGROUND : Consent processes for clinical trials involving HIV prevention research have generated considerable debate globally over the past three decades. HIV cure/eradication research is scientifically more complex and consequently, consent processes for clinical trials in this field are likely to pose a significant challenge. Given that research efforts are now moving toward HIV eradication, stakeholder engagement to inform appropriate ethics oversight of such research is timely. This study sought to establish the perspectives of a wide range of stakeholders in HIV treatment and research to inform consent processes for cure research. METHODS : In total, 68 South African stakeholders participated in two qualitative research modalities. In-depth interviews (IDIs) were conducted with a purposive sample of 42 individuals - audiotaped with consent. Twenty-six stakeholders participated in three focus group discussions (FGDs). Thematic analysis of transcribed IDIs and FGDs was conducted. RESULTS : The majority of respondents indicated that there could be unique challenges in HIV cure research requiring special attention. In particular, given the complexity of cure science, translation of concepts into lay language would be critical for potential participants to adequately appreciate risks and benefits in early phase research with experimental interventions. Furthermore, to aid understanding of risks and benefits against a background of desperation for a cure, specially trained facilitators would be required to assist with a psychological assessment prior to consent to avoid curative misconceptions. Long-term participant engagement to assess durability of a cure would mean that the consent process would be prolonged, necessitating annual re-consent. Building trust to maintain such long-term relationships would be critical to retain study participants. CONCLUSION : Unique consent requirements for cure research in South Africa would include significant efforts to maximise understanding of trial procedures, risks and the need for long-term follow-up. However, the psychological dimension of cure must not be underestimated. Beyond an understanding of cure science, the emotional impact of HIV cure advances the discourse from cure to healing. Consequently, the consent process for cure research would need to be enhanced to include psychological support and counselling. This has several important implications for research ethics review requirements for consent in HIV cure research.Fogarty International Center and Office of AIDS Research, OD and National Institute of Allergy and Infectious Diseases and the National Institute of Mental Health of the National Institutes of Health.http://www.biomedcentral.com/bmcmedethicsam2020Immunolog

Genetic and Epigenetic Factors at COL2A1 and ABCA4 Influence Clinical Outcome in Congenital Toxoplasmosis

Background: Primary Toxoplasma gondii infection during pregnancy can be transmitted to the fetus. At birth, infected infants may have intracranial calcification, hydrocephalus, and retinochoroiditis, and new ocular lesions can occur at any age after birth. Not all children who acquire infection in utero develop these clinical signs of disease. Whilst severity of disease is influenced by trimester in which infection is acquired by the mother, other factors including genetic predisposition may contribute.Methods and Findings: In 457 mother-child pairs from Europe, and 149 child/parent trios from North America, we show that ocular and brain disease in congenital toxoplasmosis associate with polymorphisms in ABCA4 encoding ATP-binding cassette transporter, subfamily A, member 4. Polymorphisms at COL2A1 encoding type II collagen associate only with ocular disease. Both loci showed unusual inheritance patterns for the disease allele when comparing outcomes in heterozygous affected children with outcomes in affected children of heterozygous mothers. Modeling suggested either an effect of mother's genotype, or parent-of-origin effects. Experimental studies showed that both ABCA4 and COL2A1 show isoform-specific epigenetic modifications consistent with imprinting.Conclusions: These associations between clinical outcomes of congenital toxoplasmosis and polymorphisms at ABCA4 and COL2A1 provide novel insight into the molecular pathways that can be affected by congenital infection with this parasite

Qualitative analysis of how patients decide that they want risk-reducing mastectomy, and the implications for surgeons in responding to emotionally-motivated patient requests

Objective Contemporary approaches to medical decision-making advise that clinicians should respect patients’ decisions. However, patients’ decisions are often shaped by heuristics, such as being guided by emotion, rather than by objective risk and benefit. Risk-reducing mastectomy (RRM) decisions focus this dilemma sharply. RRM reduces breast cancer (BC) risk, but is invasive and can have iatrogenic consequences. Previous evidence suggests that emotion guides patients’ decision-making about RRM. We interviewed patients to better understand how they made decisions about RRM, using findings to consider how clinicians could ethically respond to their decisions. Methods Qualitative face-to-face interviews with 34 patients listed for RRM surgery and two who had decided against RRM. Results Patients generally did not use objective risk estimates or, indeed, consider risks and benefits of RRM. Instead emotions guided their decisions: they chose RRM because they feared BC and wanted to do ‘all they could’ to prevent it. Most therefore perceived RRM to be the ‘obvious’ option and made the decision easily. However, many recounted extensive post-decisional deliberation, generally directed towards justifying the original decision. A few patients deliberated before the decision because fears of surgery counterbalanced those of BC. Conclusion Patients seeking RRM were motivated by fear of BC, and the need to avoid potential regret for not doing all they could to prevent it. We suggest that choices such as that for RRM, which are made emotionally, can be respected as autonomous decisions, provided patients have considered risks and benefits. Drawing on psychological theory about how people do make decisions, as well as normative views of how they should, we propose that practitioners can guide consideration of risks and benefits even, where necessary, after patients have opted for surgery. This model of practice could be extended to other medical decisions that are influenced by patients’ emotions

The anaesthetic management of distal (thoracic) tracheal resection in a quadriplegic patient

CITATION: De Roubaix, J.A.M. 1980. The anaesthetic management of distal (thoracic) tracheal resection in a quadriplegic patient. S Afr Med J, 57(6):1078-1080.The original publication is available at http://www.samj.org.zaENGLISH ABSTRACT: The anaesthetic management of distal tracheal resection in a quadriplegic patient is described. Ketamine, halothane, fentanyl and Entonox (50% N2O, 50% O2) were successfully employed. The major problems discussed include airway maintenance, cardiovascular instability and autonomic hyperreflexia, the dangers of depolarizers, and the need for monitoring temperature, blood pressure and fluid balance. The importance of team work is mentioned.Publisher’s versio

A modified latex armoured endotracheal tube for distal tracheal resection

LetterThe original publication is available at http://www.samj.org.za[No abstract available]Publishers' versio