Catherine Slack

Ethical Dilemmas of South African Clinical Psychologists

This study asked a sample of 487 South African clinical psychologists to describe situations that they identified as ethically troubling. Forty-nine psychologists described 51 incidents that were categorized according to Pope and Vetters (1992) system. Psychologists most often described dilemmas involving confidentiality, followed by dual relationship dilemmas. These ethical concerns are presented and discussed in the light of current South African ethical codes and relevant professional literature. The results are compared with six similar international studies. Results suggest that the concerns voiced by South African psychologists resemble those raised by their international colleagues. Similarities with findings from the United States and Finland may be the most marked. These results are discussed in the light of current professional trends. Implications for the development of specific ethical guidelines and professional education are also discussed.

The South African Medical Research Council's Guidelines on Ethics for Medical Research - implications for HIV preventive vaccine trials with children

Children are at risk of HIV infection, stand to benefit from the development of HIV preventive vaccines, and therefore should be enrolled in trials of HIV vaccines in order to generate relevant safety, immunogenicity and efficacy data. In South Africa, the national vaccine initiative is considering the future conduct of trials involving children; this requires an analysis of the current ethical framework, including elements that facilitate or constrain the conduct of such trials. In this article, we examine the Medical Research Council (MRC)s Guidelines on Ethics for Medical Research: General Principles (Book 1), and their provisions on research involving children. We argue that this set of influential guidelines includes provisions on research with children that are conceptually problematic and may prohibit critical research with healthy (but at-risk) child participants, including trials of HIV-preventive vaccines. We recommend that Book 1 provisions should be redrafted to reflect a balance between protecting children from research-related risks and testing interventions critical to their health.

Using the concept of ‘parental responsibilities and rights’ to identify adults able to provide proxy consent to child research in South Africa

There are circumstances where independent consent to research by children is appropriate (for example, where the participants are older adolescents and the research approximates minimal risk). However, in many instances an important safeguard will be a dual consenting process involving an appropriate adult alongside the potential child participant (according to their evolving capacities). But what adults are appropriate in what instances? We attempt to use principles set out in the Children’s Act (2010) to address this question. This article differentiates between those adults who according to the Children’s Act (2010) have full parental responsibilities and rights (i.e. parents/guardians) and those who have no parental responsibilities and rights (i.e. caregivers). We argue that some responsibilities accorded to caregivers are substantially similar to the authority to provide proxy consent to research in which the research risks approximate those risks present in the child’s everyday life. In these instances, we argue that where parents and guardians are not available, caregivers should be considered by research ethics committees as a possible source of proxy consent for younger children. This approach might not be logically extended to caregiver consent for clinical trial enrolment, for which alternative arguments may need to be debated.

Implications of the ethical-legal framework for adolescent HIV vaccine trials--report of a consultative forum.

The ethical-legal framework in South Africa is in a period of transition, with a number of new developments changing the substantive principles and procedures for health research in the country. Some of the changing dynamics include both law reform and the review of ethical guidelines. This changing environment poses many complexities for researchers, research ethics committees and participating communities involved in planning, implementing and reviewing research with child participants, including HIV vaccine trials. This paper presents the major themes and outcomes of a consultative meeting convened by the HIV AIDS Vaccines Ethics Group in July 2004 for key stakeholder groups. At this forum participants discussed the complexities posed by a transitional and sometimes contradictory ethical-legal framework and how the framework could be improved to simultaneously promote critical research and the welfare of child participants.

One step forward, two steps back - requiring ministerial approval for all 'non-therapeutic' health research involving minors

The new National Health Act has clarified that children may take part in non-therapeutic research (NTR) and the age at which they may provide independent consent to such research, viz. at legal majority. However, the Act will require consent from the Minister of Health for all research classed as NTR and involving minors regardless of the level of risk. This requirement is overly broad. It will require that low-risk research without direct benefits, which might be adequately reviewed by an accredited research ethics committee (REC), must also be reviewed by the Minister. As it currently stands this requirement serves no plausible ethical purpose, will cause delays and discourage essential research on the needs of children, and may inspire researchers and RECs alike to foil the system. We argue that in the long term there should be comprehensive law reform for child research. However, in the short term, amendments should be made to the Act to narrow the scope of this provision. The amendment should require ministerial consent for research that is currently not approvable by an REC in terms of national ethical guidelines, namely, research that does not hold out direct benefit but presents more than a minor increase over minimal risk. If our law reform recommendations are rejected, we favour the delegation of this task to RECs because, if they receive appropriate training, they should be competent to conduct it. We accept the disadvantages, namely that the same body will review protocols twice from slightly different perspectives and that certain categories of research will remain unapprovable.