COVID-19 and its impact on informed consent: What should health professionals tell their patients or their proxies?

Given the increasing number of ethical and legal issues arising from the impact of the COVID-19 epidemic on informed consent by patients, it is necessary for health professionals to explain to patients how the measures taken to combat the spread of the virus impact on their right to give informed consent. Patients need to be reassured that wherever possible, health professionals are ethically bound to obtain informed consent from patients before they subject them to diagnostic testing and treatment, but at the same time, have to comply with the demands of the law. While the South African Constitution, statutory law and the common law all recognise a person's right to consent before being subjected to treatment or surgical operations, it is necessary to take remedial steps, because of the dangers of spreading the potentially fatal COVID-19 virus, to prevent this. Such steps may involve compelling patients to be screened, tested and treated ­ sometimes without their consent. Guidance is given to healthcare professionals on how they should counsel their patients, and what they should tell patients about the impact of the COVID-19 regulations on healthcare professionals' ethical and legal duties regarding the obtaining of informed consent, as well as on whether, if asked, employers can compel their employees to undergo testing without consent, and what to tell patients about this

Research on COVID-19 in South Africa: Guiding principles for informed consent

Research is imperative in addressing the COVID-19 epidemic, both in the short and long term. Informed consent is a key pillar of research and should be central to the conduct of COVID-19 research. Yet a range of factors, including physical distancing requirements, risk of exposure and infection to research staff, and multiple pressures on the healthcare environment, have added layers of challenges to the consent process in COVID-19 patients. Internationally, the recognition that consent for COVID-19 research may be imperfect has led to a range of suggestions to ensure that research remains ethical. Drawing on these guidelines, we propose a consent process for COVID-19 research in the South African context that combines individual consent with delayed and proxy consent for individuals who may be temporarily incapacitated, combined with key principles that should be considered in the design of a consent process for COVID-19 research

National age-of-consent laws and adolescent HIV testing in subSaharan Africa: a propensity-score matched study

Objective To estimate the association between legal age of consent and coverage of human immunodeficiency virus (HIV) testing among adolescents in countries with high HIV-burden. Methods We analysed data from adolescents aged 15­18 years, who participated in Demographic and Health Surveys or AIDS Indicator Surveys between 2011 and 2016, in 15 sub-Saharan African countries. To improve balance in the distribution of measured individual- and country-level haracteristics, we used propensity score matching between adolescents in countries with more versus less restrictive ageof-consent laws (≤15 years versus ≥16 years). We estimated the percentage of individuals who self-reported that they have done an HIV test in the past 12 months and compared the differences in such testing rates among adolescents exposed to lower versus higher age-ofconsent laws. We also investigated effect modifications by sex and age. Findings Legal age of consent below 16 years was associated with an 11.0 percentage points higher coverage of HIV testing (95% confidence interval, CI: 7.2 to 14.8), corresponding to a rate ratio of 1.74 (95% CI: 1.35 to 2.13). HIV testing rate had a stronger association with lower age of consent among females than males. The testing rates differences were 14.0 percentage points (95% CI: 8.6 to 19.4) for females and 6.9 percentage points (95% CI: 1.6 to 12.2) for males (P-value for homogeneity=0.07). Conclusion This study provides evidence to support the recent World Health Organization's recommendations that countries should examine current laws and address age-related barriers to uptake of sexual and reproductive health services

Statut de travailleur tuberculeux et environnement professionnel, Cotonou, Bénin / NA

Le partage du statut de tuberculose (TB) peut être pour le patient une source de conflit en milieu professionnel en raison de la stigmatisation liée à la maladie. L'objectif de la présente étude était d'évaluer les raisons et les réactions de partage ou non du statut de patient TB en milieu professionnel.Il s'agissait d'une étude transversale descriptive ayant inclus lestravailleurs TB du Centre National Hospitalier de Pneumo-Phtisiologie de Cotonou. Sur les 107 travailleurs inclus, 50% provenaient des petites entreprises privées et 30% du secteur informel. Parmi ceux qui avaient des supérieurs (43/107) ou des collègues (68/107) de service, respectivement 65,1% et 41,2% n'ont pas informé leur supérieur hiérarchique ou au moins un collègue. Les raisons évoquées étaient : crainte d'une perte de l'emploi (40%), peur du rejet (68%).La majorité de ceux qui avait partagé leur statut avaiteu en retour une réaction d'acceptation de la part de leur employeur (86,7 %) et collègues (85%).

Sharing tuberculosis status can be a source of conflict for the patient in the workplace due to the stigma associated with the disease. The objective of this study was to assess the reasons and reactions for and against sharing TB patient status in the workplace. This was a descriptive cross-sectional study that included tuberculosis workers at the National Tuberculosis Center at Cotonou. Of the 107 workers included, 50% came from small private companies and 30% from the informal sector. Of those who had supervisors (43/107) or colleagues (68/107) on duty, 65.1% and 41.2% respectively did not inform their supervisor or at least one colleague. The reasons given were: fear of job loss (40%), fear of rejection (68%). The majority of those who had shared their status had in turn received an acceptance reaction from their employer (86.7%) and colleagues (85%).

An audit of the informed consent process at the surgical department of Korle Bu teaching hospital, Accra

Background: Surgeons carry out procedures on patients daily, many of which are invasive and may be associated with some risks and complications. The concept of informed consent in surgical practice was introduced after certain legal issues arose. Today patients are entitled to know and be accorded the right to determine what happens to their bodies. This study set out to determine if there had been any improvement in the informed consent process over the years, taking a closer look at the various aspects of the information given :This was a cross-sectional study carried out at the Department of Surgery, Korle Bu Teaching Hospital. One hundred consecutive post-operative patients were recruited and interviewed on information discussed at various stages during the preoperative period and on the administration of the consent form. Results: Thirty seven (66.0%) out of 56 elective cases felt they had been given enough information to their understanding to enable them give informed consent. Thirty (68.1%) out of 44 emergencies also felt they had been given enough information. Forty (71.4%) of elective cases were able tell what their diagnosis was but only 23 (41.0%) knew what procedure had been done. Similarly 32 (72.2%) emergency cases were able to tell what their diagnosis was but only 16 (36.3%) knew what procedure had been done. Conclusion: Informed consent in the Department of Surgery of the Korle Bu Teaching Hospital is unsatisfactory and needs to be improved

But is this Really the 'Parent' or 'Guardian'? Practical Strategies for Consent to Child Research in South Africa

Research ethics committees (RECs) in South Africa may require consent from a parent or legal guardian for child research. In instances where an REC determines that parental or guardianship consent is required; how far should researchers go to establish if the accompanying adult is in fact the parent or guardian? Should researchers accept disclosures at face value; probe assertions that are made; or even call for supporting documentation? In this article we set out the facts research staff should possess; propose key questions they could ask; and recommend practical steps for uncertain cases. We recognise that a parental/guardianship consent strategy may not be appropriate in all instances; but do not debate that issue in this article. This article is confined to practical advice for researchers wishing to implement a parental or guardianship consent approach

Ethical Considerations in Implementing a Biometric Co-Enrolment Prevention System in Clinical Trials in South Africa

Preventing co-enrolment in clinical trials ensures participant safety and data integrity. To facilitate co-enrolment checks; a novel biometric coenrolment prevention system (BCEPS) was developed and implemented in 2010 by the HIV Prevention Research Unit (HPRU) in collaboration with the South African Medical Research Council's (SAMRC) Information Technology Services Division. The use of this web-based system to capture participant's identification details in real time was approved by the SAMRC Ethics Committee. BCEPS was implemented at 13 other research organisations conducting clinical trials in South Africa (SA). Participants who screened at the clinical research sites (CRSs) had their names; SA identity or passport number and fingerprints captured onto BCEPS after comprehensive education and discussion. This information was verified at all study visits. If a participant attempted to screen or co-enrol at multiple CRSs; the system flagged this as a potential coenrolment By addressing the ethical concerns around participant consent and rights; participant confidentiality and privacy; data security and access; and data management and storage; we were able to successfully implement BCEPS within the clinical trials conducted at HPRU; while adhering to the principles of good clinical practice (GCP); including respect for persons; beneficence and justice

An audit of consent practices and perceptions of lumbar puncture, Botswana inpatient setting experience

Introduction:The epidemic of HIV/AIDS in sub-Saharan Africa has led to significant increases in the burden of meningitis; especially cryptococcal meningitis. Morbidity and mortality resulting from meningitis occur partly due to delays in performing lumbar punctures both for diagnostic and therapeutic purposes. This study was conducted with the primary objective of exploring the attitudes and concerns that patients have with regard to lumbar puncture; and also to assess current consenting practices of doctors with regard to lumbar puncture. Methods : A descriptive cross-sectional study was conducted in medical wards of Princess Marina Hospital; a tertiary hospital in Gaborone; Botswana. Data were collected by means of a questionnaire-based survey involving patients or their next of kin; and doctors. Other relevant information was obtained from patient charts. Data collection involved 12 patients and 23 doctors. Results :Of the 12 patients interviewed; four stated that the reasons for doing lumbar puncture (LP) were explained to them. One respondent stated that LP risks were mentioned; while two stated that they were given the option to refuse LP. Most patients' possible reasons for refusal of LP was attributed to fear of pain. Five (42.7) patients/next of kin had never heard of LP before; and most of the interviewed patients associated the procedure with death and paralysis; while none associated with meningitis or HIV. Twenty-two (95.7) of 23 doctors stated that they routinely consent patients for LP; 11 (47.8) mentioned risks; and nine (39.1) stated that the patient has the option to decline the procedure. Only 26 of doctors routinely used local anaesthesia while 22 routinely asked for written consent. Conclusion: Contrasting responses between doctors and patients indicates a need for standard consenting practices among doctors. Also; patients' attitudes and receptiveness to lumbar punctures can be improved through education on lumbar puncture indications; benefits; and risks

Boni Mores and Consent for Child Research in South Africa

Consent is required for almost all health research. In order for consent to be valid a number of requirements must be met including that the consent cannot be contra bonos mores or contrary to public policy. This principle has its roots in the common law and it is used to ensure that the consent to harm; or the risk of harm; is permitted or ought to be permitted by the legal order. Recently; it has also become a statutory requirement embedded in the consent obligations relating to non-therapeutic health research with minors. Section 71 of the National Health Act provides that the Minister of Health (or potentially his or her delegated authority) must provide consent to non-therapeutic research with minors. However; such consent may not be granted if 'the reasons for the consent to the research or experimentation are contrary to public policy'. Limited work has been done on how to determine when consent to health research with children would be contrary to public policy. This article attempts to begin the debate by describing the boni mores principle; setting out some of the general factors that could be used to assess whether consent is consistent with it and suggesting how they could be applied to health research.The article concludes by stating that simply requiring proxy consent for non-therapeutic health research with children is insufficient as it cannot always be assumed that proxy consenters will act in the best interests of the child. Thus the boni mores principle acts as a limit on autonomy in order to protect the child participant. It is further submitted that establishing when consent to health research is consistent with public policy requires an assessment of whether the research is consistent with constitutional values; prevailing legal norms regarding children; and an assessment of the legal convictions of the community

Protection of Children by Substitute Consent: A Universal Principle and Right

In 2005; the world community and the United Nations Educational; Scientific and Cultural Organization (UNESCO); comprising 191 member nations; unanimously accepted the Universal Declaration on Bioethics and Human Rights (UDBHR). This declaration is the first and only bioethical text to which the entire world has committed itself and helps put bioethics on the agenda of states. However; it appears to have had little or no impact in South Africa (SA). This article aims to join UNESCO's mission and to form part of the social responsibility initiative of teaching the universal right and the ethical principle of proxy consent in the context of medical intervention to promote the UDBHR in SA. We compare the UDBHR and SA Children's Act No. 38 of 2005. It is clear that the world community sees surrogate consent as the right and duty of all communities

Dilemmas of Telling Bad News: Paediatric Palliative Care Providers' Experiences in Rural KwaZulu-Natal; South Africa

Background. In general; the principles of palliative care suggest that; at some stage; patients should be given 'bad news' about poor illness prognosis. The information is often important for care planning; especially when it involves disclosure to children. Although there are ongoing debates about whether to tell or not to tell children bad news; these debates have largely been informed by patients who live in a developed-world context. In contrast; this paper focuses on telling bad news to children and their families from a rural; developing-world context.Objective. The objective was to analyse the experiences of providers of palliative care to children when they attempted to fulfil one of their roles as palliative caregivers; i.e. to prepare patients and families for a child's poor illness prognosis. Method. This was an exploratory study that was approached qualitatively. Five nurses and eight home-based care workers who provided palliative care for children in rural areas of South Africa formed a purposive; information-rich; self-selected sample. Data were produced through discussions with participants; using photographs taken by the caregivers to stimulate and contextualise the discussions.Results. Participants experienced four dilemmas with regard to telling bad news: when families did not want to be told any bad news; when participants felt uncomfortable about telling bad news; when participants and patients shared dissimilar values about telling bad news; and when participants were unsure about when to tell bad news.Conclusion. In the rural areas where the study was conducted; children are not usually given bad news about their illness. Disclosing poor prognosis led to the dilemmas faced by caregivers. The result was that the emotionally charged work of caring for children reaching the end of their lives became more challenging for the caregivers because they were not prepared for cultural complexities. In view of the findings of this study; there is a need for ongoing research into paediatric palliative caregiving in context

Value and Importance of Informed Consent to Researchers at Makerere University

Background: Respect for persons requires that research participants be given the opportunity to make choices about what should be done to them. Many times; the process of informed consent is abused to the benefit of researchers while exploitation and harm to the research participants may occur. In Uganda; issues of questionable research ethics have been highlighted in the past. Objective: To determine the Value and importance of the informed consent process among researchers at Makerere University. Materials and Methods: This was a qualitative descriptive study design involving faculty and graduate students in the faculties of Medicine and Social Sciences. Results: Of the 37 respondents 68were faculty while 32were graduate students in the fields of social sciences; clinical and basic sciences. Mean research experience was 8.5 years. More than 70of the respondents have had no formal training in research ethics. Only 22of the respondents appreciated the need for research participants to comprehend the informed consent; 38thought it is not always the case and in many cases their subjects do not have to comprehend; while the remaining 40believe that research subjects' understanding of the informed consent process may not be necessary. All respondents appreciated the importance of confidentiality although data management procedures were lacking by many. Conclusion: Most researchers appreciate the importance of confidentiality; but have limited understanding of the process of informed consent; information handling and the importance of feedback

Safety; Efficacy and Acceptability of Implanon a Single Rod Implantable Contraceptive (Etonogestrel) in University of Benin Teaching Hospital

Objective: The study evaluated the safety, efficacy and acceptability of Implanon (etonogestrel) subdermal implant contraceptive amongst its acceptors. Study Design: This was part of an on going prospective longitudinal study that involved 32 women out of 46sexually active healthy informed volunteers recruited from our family planning clinic between February and March 2007. All the subjects received the single rod subdermal implant Implanon which contains 68mg etonogestrel. Data on socio-demographic characteristics, menstrual pattern, haematological indices, weight,blood pressure, side effects and user's satisfaction were collected and analysed. The subjects served as theirown control.Results: The mean age and parity were 33.9 ± 5.2 years and 3.1 ± 1.7 respectively. The mean weight was 71.4 ± 12.0kg at pre-insertion. At 6 months the weight reduced to a non significant (p < 0.13) mean value of 70.0 ± 10.5kg and increased to a non significant (p < 0.88) mean value of 71.5 ± 11.6kg at 12 months. The mean systolic and diastolic blood pressures did not show statistical significant changes at 6 months follow up(p<0.17/0.64). However at 12 months there were significant but within normal reductions (p < 0.003/0.05) in the systolic and diastolic blood pressures. The side effects were menstrual abnormalities. Eighteen (56.3%), 1 (3.1%) and 13 (40.6%) reported reduced, increased and combinations of bleeding patterns respectively. No participant had normal cycle. Other experiences were headache, 4 (12.5%) and reduced libido 3 (9.4%). The mean packed and white blood cell concentrations did not show statistical significant changes at 6 and 12 months follow up. At 12 months there was statistical significant increase (p<0.04) in the mean ± SD platelet count (205312.5 ± 75694.8per ul) when compared with the pre-insertion mean value (176343.8 ±52945.3perul). One acceptor had thrombocytopenia without any untoward effect.Two subjects discontinued method on account of menorrhagia and headache. The efficacy and continuation rate were 100% and 93.8% respectively. All the clients received adequate information about the method and most of them were satisfied with it at follow up.Conclusion: Implanon was an effective, safe and acceptable method of contraception amongst its acceptors.Menstrual abnormalities were the major side effects which most of the subjects found tolerable with adequate counseling. The reduced platelet concentration of the one acceptor would require follow up to ascertain the trend

Differences in Tunisian adolescents' knowledge; misconceptions and attitudes towards HIV/AIDS from 1997 to 2002

Surveys were conducted to estimate the extent to which knowledge; misconceptions and attitudes of adolescents in Tunisia towards HIV/AIDS had changed after a period of five years. A population of school-going adolescents of both sexes; age 16 to 20; was sampled in 1997 and again in 2002. We found that HIV/AIDS and sexually transmitted diseases became better known; there was more tolerance expressed for people living with AIDS; and the use of condoms was more positively judged. Fewer misconceptions surrounding the condition were also noted. However; many results recorded during the 1997 survey remained unchanged (e.g.; scepticism about awareness campaigns; TV as a primary source of information). We discuss the socio-economic and medical/social context in Tunisia during the period 1997-2002 that seemed to allow adolescents to improve their knowledge of HIV/AIDS and to acquire positive attitudes towards persons living with the condition

Informed consent: the radiologist administering radiological contrast media

This study represents the understanding and practice of radiologists in Nigeria in obtaining informed consent from patients before administering radiological contrast media. 120 questionnaires were sent to radiologists practicing in Nigeria. 78(65%) responded, 60(76.9%) of the respondents understood informed consent to mean informing a patient about a procedure and obtaining consent to carry out the procedure. Whereas for consent to be informed it must include the nature of the procedure, purpose, risks and benefits. 52(66.7%) obtained either written or verbal consent while 26(33.3%) neither informed patient nor obtained consent. However, all respondents understood that failure to obtain consent may result in possible litigation by patient or relative while 69(88.5%) requested for a specific policy regarding informed consent. It is concluded that the radiologist in Nigeria does not fully understand the concept of informed consent. A specific policy should be made by the appropriate professional body in Nigeria as to what constitutes the requirements of a truly informed consent since there are simply no guidelines for now. Also informed consent forms, simple enough for patients to understand should be designed. These will assist the individual specialist in the conduct of their practice

The value of a clinical definition for epidemic KS in predicting HIV seropositivity in Africa

Kaposi's sarcoma (KS) in African adults can present in endemic (non-HIV-related) and epidemic (HIV-related) forms. We evaluated the usefulness of a clinical case definition for epidemic KS in predicting HIV seropositivity. A total of 235 patients with KS presenting to the Uganda Cancer Institute from January 1; 1988 to March 31; 1990 were evaluated with history and physical examination. Symptomatic patients underwent chest radiography and upper gastrointestinal endoscopy. One hundred seventy-four patients (80pc) underwent HIV ELISA testing with Western blot confirmation. The clinical case definition had a 91pc sensitivity and a 95pc specificity in predicting HIV seropositivity. Oral KS was the most sensitive specific site of involvement in predicting HIV seropositivity. The clinical case definition is useful in assessing patients to determine prognosis and likelihood of responding to aggressive therapy