Clinical Ethics Committees in Africa: lost in the shadow of RECs/IRBs?

BACKGROUND: Clinical Ethics Committees (CECs) are well established at healthcare institutions in resource-rich countries. However, there is limited information on established CECs in resource poor countries, especially in Africa. This study aimed to establish baseline data regarding existing formal CECs in Africa to raise awareness of and to encourage the establishment of CECs or Clinical Ethics Consultation Services (CESs) on the continent. METHODS: A descriptive study was undertaken using an online questionnaire via SunSurveys to survey healthcare professionals and bioethicists in Africa. Data were subjected to descriptive analysis and Fischer's exact test was applied to determine associations. Texts from the open-ended questions were thematically analysed. RESULTS: In total 109 participants from 37 African countries completed the survey in December 2019. A significant association was found between participants' bioethics qualification or training and involvement in clinical ethics (p = 0.005). All participants were familiar with Research Ethics Committees (RECs), and initially conflated RECs with CECs. When CECs were explained in detail, approximately 85.3% reported that they had no formal CECs in their institutions. The constraints to developing CECs included lack of training, limited resources, and lack of awareness of CECs. However, the majority of participants (81.7%) were interested in establishing CECs. Participants listed assistance required in establishing CECs including funding, resources, capacity building and collaboration with other known CECs. The results do not reflect CECs established since the onset of COVID-19 in Africa. CONCLUSIONS: This study provides a first look into CECs in Africa and found very few formal CECs on the continent indicating an urgent need for the establishment of CECs or CESs in Africa. While the majority of healthcare professionals and bioethicists are aware of ethical dilemmas in healthcare, the concept of formal CECs is foreign. This study served to raise awareness of CECs. Research ethics and RECs overshadow CECs in Africa because international funders from the global north support capacity development in research ethics and establish RECs to approve the research they fund in Africa. Raising awareness via educational opportunities, research and conferences about CECs and their role in improving the quality of health care in Africa is sorely needed.

Lopinavir serum concentrations of critically ill infants: a pharmacokinetic investigation in South Africa.

The role of therapeutic drug monitoring in pediatric antiretroviral therapy is unclear. A little pharmacokinetic datum from clinical practice exists beyond controlled approval studies including clinically stable children. The aim of this study is to quantify LPV exposure of critically ill infants in an ICU and-by identifying risk factors for inadequate exposure-to define sensible indications for TDM in pediatric HIV care; in addition, assume total drug adherence in ICU to compare LPV exposure with a setting of unknown adherence. In this prospective investigation, 15 blood samples from critically ill infants in the pediatric ICU at Tygerberg Hospital were analyzed for LPV-serum concentrations. They were then compared to those of 22 blood samples from out-patient children. Serum-level measurements were performed with an established high-performance liquid chromatography method. All LPV-serum levels of ICU patients were higher than a recommended Ctrough (= 1.000 ng/ml), 60% of levels were higher than Cmax (8.200 ng/ml). Partly, serum levels reached were extremely high (Maximum: 28.778 ng/ml). Low bodyweight and age correlated significantly with high LPV concentrations and were risk factors for serum levels higher than Cmax. Significantly fewer serum levels from infants in ICU care (mean: 11.552 ng/ml ± SD 7760 ng/ml) than from out-patient children (mean: 6.756 ng/ml ± SD 6.003 ng/ml) were subtherapeutic (0 vs. 28%, p = 0.008). Under total adherence in the ICU group, there were no subtherapeutic serum levels, while, in out-patient, children with unknown adherence 28% of serum levels were found subtherapeutic. Low bodyweight and age are risk factors for reaching potentially toxic LPV levels in this extremely fragile population. TDM can be a reasonable tool to secure sufficient and safe drug exposure in pediatric cART.

Autonomy of the child in the South African context: is a 12 year old of sufficient maturity to consent to medical treatment?

BACKGROUND: A child is a developing person with evolving capacities that include autonomy, mental (decisional) capacity and capacity to assume responsibility. Hence, children are entitled to participatory (autonomy) rights in South Africa as observed in the Children's Act 38 of 2005. According to section 129 of the Act a child may consent to his or her own medical treatment provided that he or she is over the age of 12 years and is of sufficient maturity and decisional capacity to understand the various implications of the treatment including the risks and benefits thereof. However, the Act does not provide a definition for what qualifies as 'sufficient maturity' nor does it stipulate how health professionals ought to assess the decisional capacity of a child. In addition, South Africa is a culturally diverse country. The Western liberal notion of autonomy may not necessarily find equal prominence in the mores of people with a different worldview. Hence we demonstrate a few salient comparisons between legal liberal moral theory and African communitarianism as pertinent to the autonomy of the child. DISCUSSION: Children are rights-holders by virtue of their humanity. Their dignity as individual human persons affords them the entitlement to human rights as contemplated under the Constitution of the Republic of South Africa. However, contrary to the traditional Western notion of individual autonomous persons African societies hold a communalistic notion of person hence there is less regard for individual autonomy and rights with more emphasis on the communal good and maintaining the continuity of relationships and interdependencies shared within a community. A child considered in this view is not regarded as a full person. This implies that decisions concerning the child, including consent to medical treatment are discussed and determined by the community to which the child belongs. Lastly, in this article, we draw on the notion of capacity for responsibility to produce a pragmatic definition of sufficient maturity. CONCLUSION: It seems reasonable to suggest a move away from a general legal age of consent for medical treatment toward more individualised, context-specific approaches in determining the maturity of a child patient to consent to medical treatment. Perhaps, decision-making with respect to consent to the medical treatment of a child belonging to a traditional African community where the notion of a person is embedded in communitarianism ought to involve the child's parents/guardians/caregivers where possible provided that the best interests of the child are awarded priority.

Informed consent in paediatric critical care research--a South African perspective.

BACKGROUND: Medical care of critically ill and injured infants and children globally should be based on best research evidence to ensure safe, efficacious treatment. In South Africa and other low and middle-income countries, research is needed to optimise care and ensure rational, equitable allocation of scare paediatric critical care resources. Ethical oversight is essential for safe, appropriate research conduct. Informed consent by the parent or legal guardian is usually required for child research participation, but obtaining consent may be challenging in paediatric critical care research. Local regulations may also impede important research if overly restrictive. By narratively synthesising and contextualising the results of a comprehensive literature review, this paper describes ethical principles and regulations; potential barriers to obtaining prospective informed consent; and consent options in the context of paediatric critical care research in South Africa. DISCUSSION: Voluntary prospective informed consent from a parent or legal guardian is a statutory requirement for child research participation in South Africa. However, parents of critically ill or injured children might be incapable of or unwilling to provide the level of consent required to uphold the ethical principle of autonomy. In emergency care research it may not be practical to obtain consent when urgent action is required. Therapeutic misconceptions and sociocultural and language issues are also barriers to obtaining valid consent. Alternative consent options for paediatric critical care research include a waiver or deferred consent for minimal risk and/or emergency research, whilst prospective informed consent is appropriate for randomised trials of novel therapies or devices. We propose that parents or legal guardians of critically ill or injured children should only be approached to consent for their child's participation in clinical research when it is ethically justifiable and in the best interests of both child participant and parent. Where appropriate, alternatives to prospective informed consent should be considered to ensure that important paediatric critical care research can be undertaken in South Africa, whilst being cognisant of research risk. This document could provide a basis for debate on consent options in paediatric critical care research and contribute to efforts to advocate for South African law reform.

Decompression of enlarged mediastinal lymph nodes due to mycobacterium tuberculosis causing severe airway obstruction in children.

BACKGROUND: Large airway compression by enlarged tuberculosis (TB) lymph nodes results in life-threatening airway obstruction in a small proportion of children. The indications, safety, and efficacy of TB lymph node decompression are inadequately described. This study aims to describe the indications and efficacy of TB lymph node decompression in children with severe airway compression and investigate variables influencing outcome. METHODS: A prospective cohort of children (aged 3 months to 13 years) with life-threatening airway obstruction resulting from TB lymph node compression of the large airways were enrolled. The site and degree of airway obstruction were assessed by bronchoscopy and chest computed tomography scan. RESULTS: Of the 250 children enrolled, 34% (n = 86) required transthoracic lymph node decompression, 29% as an urgent procedure and 71% (n = 63) after failing 1 month of antituberculosis treatment that included glucosteroids. Compression (less than 75%) of the bronchus intermedius (odds ratio 2.28, 95% confidence interval: 1.29 to 4.02) and left main bronchus (odds ratio 3.34, 95% confidence interval: 1.73 to 6.83) were the best predictors for lymph node decompression. Human immunodeficiency virus status, drug resistance, and malnutrition were not associated with decompression. Few complications (self-limiting, 8%) or treatment failures (2%) resulted from the decompression. There were no deaths. CONCLUSIONS: In one third of children with TB, severe airway obstruction caused by enlarged lymph nodes requires decompression. Transthoracic decompression can be safely performed with low complication, failure, and fatality rates.

Bronchoscopic assessment of airway involvement in children presenting with clinically significant airway obstruction due to tuberculosis.

INTRODUCTION: The incidence of complicated lymph node disease in tuberculosis (TB) in children less than 15 years of age varies from 8% to 38%. There are few published studies on the bronchoscopic appearance and severity of airway obstruction caused by lymph node involvement of the airways resulting from Mycobacterium tuberculosis (MTB). The primary aim of the study was to describe the flexible bronchoscopic findings of lymph node involvement of the airways caused by MTB in children with severe airway obstruction. The secondary aim was to compare the degree of airway involvement in HIV negative to HIV positive children as well the airway involvement caused by drug susceptible and drug resistant MTB. PATIENTS AND METHODS: All children between 1 month and 13 years of age presenting with clinical and radiological signs of significant airway obstruction suspected of being the result of MTB infection were studied. In addition to routine examination for MTB disease a flexible bronchoscope and bronchoalveolar lavage (BAL) for MTB culture were performed on all the children. RESULTS: Two hundred fifty children (16% HIV positive) were studied. Median age was 14 months and the median weight 8.5 kg. MTB was cultured from 78% (n = 194) of children with the BAL positive in 44%. The BAL culture yield was significantly higher in children with radiological evidence of pneumonia when compared to children with airway involvement alone (P = 0.004). The bronchial tree was obstructed on the right in 85% (n = 212), the left in 66% (n = 164), and both sides in 53% (n = 132) of cases. The commonest sites of obstruction were bronchus intermedius (72%) and left main bronchus (62%). Drug resistance was present in 16% (n = 28). There was no difference in the site or severity of obstruction when comparing drug susceptible to drug resistant cases or HIV positive to HIV negative children. CONCLUSIONS: Bronchus intermedius and left main bronchus were the commonest sites of airway obstruction. The MTB culture yield from BAL was higher in children with pneumonia when compared to those with airway involvement alone. HIV positive or children with drug resistant TB did not have more severe airway obstruction.

Children with human immunodeficiency virus infection admitted to a paediatric intensive care unit in South Africa.

BACKGROUND: Early data regarding the outcome of human immunodeficiency virus (HIV)-infected children in paediatric intensive care units (PICU) suggested mortality as high as 100%. Recent studies report mortality of 38%. Survival depends on the indication for admission. OBJECTIVES: To describe the prevalence, duration of stay, and outcome of HIV-infected patients in a single PICU over a 1-year period. Additional objectives included describing the indications for admission as well as the clinical and laboratory characteristics of HIV-infected infants and children requiring PICU admission. METHOD: Retrospective chart review of all children with serological proof of HIV admitted to PICU at Tygerberg Children's Hospital from 1 January to 31 December 2003. RESULTS: Of the 465 patients admitted, 47 (10%) were HIV-infected. For HIV-infected children the median age on admission was 4 months. The median duration of stay was 6 days, significantly longer than for the non-HIV group (p = 0.0001). Fifty-seven percent had advanced clinical and immunological disease. Seventeen died in PICU and four shortly afterwards, poor PICU outcome was significantly associated with HIV status (p = 0.001). Lower total lymphocyte count (p = 0.004) and higher gamma globulin level (p = 0.04) were paradoxically the only findings significantly associated with survival. Acute respiratory failure (ARF) accounted for 76% of admissions, including Pneumocystis jiroveci in 38%. Fifty-one percent had evidence of cytomegalovirus infection. CONCLUSIONS: HIV-infected children requiring PICU can survive despite the lack of availability of antiretroviral therapy.