A critical evaluation of the consent requirement for child participation in health research
__________________________________________________________________ In the context of medical research, children are especially vulnerable to exploitation. As a result several codes of research ethics emphasise the need for special protection. Prior to the implementation of the National Health Act children participating in medical research enjoyed limited legal protection. Instead, research and ethical committees relied on non-research law and ethical guidelines to identify protective measures for children. The National Health Act establishes a platform for developing a wide range of legal norms for research on human subjects and supplements and strengthens the already existing principles related to informed consent. The Act deals specifically with consent for child participation in research. Section 71 requires written consent from a parent or legal guardian for a child to participate in all research conducted with minors, irrespective of age. In addition, minors with sufficient understanding must consent alongside their parents or legal guardians. While the purpose of the Act is to provide legal protection to participants, it fails to take into account the emerging autonomy of the adolescent sufficiently and ignores the fact that many children do not have parents or legal guardians and are cared for by alternative caregivers. These stricter controls are in contravention with other legislation such as the Children’s Act and Choice on Termination of Pregnancy Act, and may also undermine the constitutional rights of children. The study critically evaluates the consent requirements of the National Health Act with reference to the evolving capabilities of children and the exercise of their parents’ or caregivers’ parental or similar responsibilities and rights, and relevant suggestions are made.
Voluntary informed consent and good clinical practice for clinical research in South Africa: ethical and legal perspectives.
Most differences, shortcomings and contradictions regarding voluntary informed consent for participation in clinical research relate to the South African-specific guidance documents, i.e. South African Guidelines for Good Practice in the Conduct of Clinical Trials with Human Participants in South Africa (2006) and Ethics in Health Research: Principles, Structures and Processes (2004). These documents do not fulfil all the ethical and legal requirements for voluntary informed consent for clinical research participation in South Africa. International guidance documents reflect the minimum of the ethical requirements for the conduct of clinical research. Country-specific documents should be updated and aligned with relevant legislative and legal principles of that jurisdiction to ensure that research participants are adequately protected. The South African-specific guidance documents therefore require revision to address these deficiencies.
The Three Faces of Defeasibility in the Law
In this paper we will analyse the issue of defeasibility in the law, taking into account research carried out in philosophy, artificial intelligence and legal theory. We will adopt a very general idea of legal defeasibility, in which we will include all different ways in which certain legal conclusions may need to be abandoned, though no mistake was made in deriving them. We will argue that defeasibility in the law involves three different aspects, which we will call inference-based defeasibility, process-based defeasibility, and theory-based defeasibility. Only the integration of these three perspectives allows us to provide a satisfactory account of the role of defeasibility in legal reasoning.