Research ethics committees in a tight spot: Approving consent strategies for child research that are prima facie illegal but are ethical in terms of national guidelines.

It is an internationally accepted principle that ethics norms should be applied and enforced in research with humans through ethics review by research ethics committees (RECs). This places RECs at the very heart of the system for protecting participants and enforcing their rights. In the South African ethical-legal framework for child research, there are divergent approaches to consent. That is, section 71 of the National Health Act (No. 61 of 2003) (NHA) requires mandatory parental consent for child research, and limits the authority for proxy consent to parents and legal guardians. However, national ethics guidelines authorised by section 72 of the NHA and issued by the National Health Research Ethics Council (NHREC) acting in terms of its mandate (National Department of Health, 2015) allow a more nuanced approach - i.e. self-consent by older adolescents, provided certain conditions are met, and consent by a range of parental substitutes where there are no available parents or legal guardians. We have argued elsewhere that the consent approach in section 71 is inappropriately restrictive and are of the view that the consent approach endorsed in national ethics guidelines is more defensible. An REC that elects to approve a consent strategy allowable in ethics guidelines is effectively electing to not follow section 71, which raises the question of what the consequences might be for that REC. This article examines the legal liability of RECs through three 'threads' of accountability: the NHREC, the institutions hosting RECs, and the courts. We conclude that: (i) if an REC approves a child protocol with consent strategies allowable in terms of national ethics guidelinesbut not in terms of section 71, it is unlikely that the NHREC would discipline the REC in the face of a complaint - provided the REC acted within national ethics guidelines issued by the NHREC in terms of the latter's section 72 mandate to set national norms and standards; (ii) if an REC approves a consent approach allowed for in ethics guidance, it is also unlikely that the host institution would discipline the REC in the face of a complaint - especially if the institution is aware of the REC's explicit decision to follow national ethics guidelines that are authorised by section 72 of the NHA; and (iii) an REC could only be sued by a participant in terms of the law of delict (and be liable for damages) if several demanding components are proven, such as that the harm suffered by the participant resulted directly from the REC's actions in approving a particular consent strategy for that research. Furthermore, the court may well look to national ethics guidelines in making determinations about whether an REC's conduct was wrongful for the purposes of liability in civil law. RECs are protected from being collectively liable by insurance taken out by their host institutions. We make a series of recommendations to address this issue.

'Even if they ask you to stand by a tree all day, you will have to do it (laughter)...!': community voices on the notion and practice of informed consent for biomedical research in developing countries.

Ethical dilemmas in biomedical research, especially in vulnerable populations, often spark heated debate. Despite recommendations and guidelines, many issues remain controversial, including the relevance, prioritisation and application of individual voluntary informed consent in non-Western settings. The voices of the people likely to be the subjects of research have been notably absent from the debate. We held discussions with groups of community members living in the rural study area of a large research unit in Kenya. Discussions were facilitated by three research study vignettes outlining one field-based and two hospital-based studies being planned or taking place at the time. In addition to gathering general views about the aims and activities of the research unit, questions focused on whether consent should be sought for studies, and if so from whom (chiefs, elders, men/women, children), and on ascertaining whether there are any special concerns about the physical act of signing consent forms. The findings revealed the community's difficulty in distinguishing research from clinical investigations conducted in clinical settings. There was a spectrum of views regarding perceived appropriateness of consent procedures, in part because of difficulty in disentangling clinical from research aims, and because of other challenges to applying consent in practice. Debates between community members highlight the inadequacy of simplistic assumptions about community members' views on informed consent, and the complexity of incorporating lay opinions into biomedical research. Failure to appreciate these issues risks exaggerating differences between settings, and underestimating the time and resources required to ensure meaningful community involvement in research processes. Ultimately, it risks inadequately responding to the needs and values of those on whom the success of most biomedical research depends. Although compliance with community views does not necessarily make the research more ethical, it is argued that community opinions on local issues and practices should inform ethical decision-making in health research.

Acculturation and eating disorder symptomatology in Black men and women.

OBJECTIVE: We assessed the prevalence of eating disorder symptoms in Black South African men and also explored their possible links with acculturation. METHOD: The Eating Disorders Inventory (EDI) and the South African Acculturation Scale (SAAS) were administered to a sample of undergraduate students consisting of 50 Black women, 50 Black men and 50 White men. RESULTS: The Black men had significantly higher scores than the White men on the psychological subscales of the EDI and higher than cut-off scores on perfectionism, interpersonal distrust and maturity fears subscales. There were marginal racial differences in the average acculturation scores, whereas gender appeared to have a variable effect on acculturation attitudes. Specific acculturation strategies were found to be differentially associated with the EDI subscales. The association between acculturation and eating disorder symptoms in Black men was significantly higher than that in White men. DISCUSSION: Our results indicate that there is a higher prevalence of eating disorder pathology in Black men than in White men. This lends support to the possible association between acculturation and eating disorders, and challenges the assumption that non-Western individuals--and Black men in particular--are protected from body image disturbances and disordered eating patterns.

Non-fatal suicidal behaviour in women--the role of spousal substance abuse and marital violence.

OBJECTIVE: To investigate the precipitants of non-fatal suicidal behaviour in women using a gender-based comparison. DESIGN: A retrospective analysis of case records. Data were analysed using chi-square tests of significance. SUBJECTS: One hundred men and 100 women admitted for non-fatal suicidal behaviour at a general hospital. OUTCOME MEASURES: Subjects' biographical details and self reports of precipitating factors such as marital conflict, spousal extramarital affairs, alcohol abuse and marital violence. RESULTS: Significantly more married women than men cited spousal extramarital affairs, spousal alcohol abuse and marital violence as precipitants of their self-destructive behaviours. CONCLUSION: The findings emphasise the role of spousal behaviour and resultant stress in precipitating non-fatal suicidal behaviour in women. Preventive efforts must focus on the psychological, social and economic empowerment of women.

Women in cultural transition: suicidal behavior in South African Indian women.

Young South African Indian women are a population with relatively high rates of suicidal behavior. This article presents three illustrative case studies of nonfatal suicidal behavior by South African Indian women. The cases are discussed in relation to a review of epidemiological, historical, and sociocultural perspectives on South African Indian women. It is argued that suicidal behaviors in this group can be understood in the context of sociocultural transition. Transitional tensions between traditional Indian culture and Westernization have an impact on traditional gendered power relations and generate conflicts that have intrapsychic and interpersonal consequences for women and for men. These in turn may have adverse effects on marital functioning, quality of life, and specific aspects of emotional functioning, which have been identified as precursors of suicidal behavior. The case studies are discussed with reference to gender narratives. Implications for prevention, intervention, and future research are discussed.

Recent stressors and family satisfaction in suicidal adolescents in South Africa.

A study of 40 adolescents who had engaged in suicidal behaviours showed that 77.5% of them reported conflict with their parents in the few hours before the event. Significantly more suicidal subjects than controls experienced family conflict, problems at school and problems with boy/girlfriends during the preceding 6 months. The suicidal subjects also expressed significantly lower levels of family satisfaction than the controls. The results support the view that suicidal adolescents are dissatisfied with their family functioning and use suicidal behaviour as a means of communicating their distress.

Family dynamics, hopelessness and psychiatric disturbance in parasuicidal adolescents.

OBJECTIVE: Adolescent parasuicide has often has been associated with family disturbance, hopelessness and psychiatric disturbance, but little empirical work has been done to verify these clinical impressions. METHOD: The present study compares matched groups of hospitalised parasuicidal adolescents, non-psychiatric medically hospitalised adolescents and a control group on measures of family disturbance, hopelessness and psychopathology. RESULTS: The findings reveal significantly higher levels of family disturbance, hopelessness and depressive symptoms in the parasuicidal group. CONCLUSIONS: The results suggest that prevention and treatment of adolescent parasuicide should focus on both individual and family dynamics.

Psychological intervention, spontaneous remission, hopelessness, and psychiatric disturbance in adolescent parasuicides.

A study of 40 Indian adolescent parasuicides in South Africa showed that these subjects have significantly higher levels of hopelessness and psychiatric disturbance than nonsuicidal controls. Approximately half the parasuicides received psychological intervention. Posttesting at 6 months revealed that the treated subjects improved significantly on measures of hopelessness and psychiatric disturbance. The untreated subjects showed no significant reduction in hopelessness although they improved significantly on ratings of psychiatric disturbance. The results are discussed with possible explanations and recommendations.

Rescue expectations and hopelessness in adolescent parasuicides.

The study examined 40 adolescent parasuicides' reports of whether they expected to be rescued following parasuicide gestures. Measures of hopelessness were also assessed. 45% of these Indian South Africans reported that they expected to be rescued while the rest did not. There was no significant sex difference in expectation of rescue. There was also no significant difference between hopelessness scores of those expecting rescue and those not expecting rescue; however, the latter had a mean hopelessness score above the cut-off score suggested as predictive of subsequent suicide.