Background Whenever South African (SA) research institutions share human biological material and associated data for health research or clinical trials they are legally compelled to have a material transfer agreement (MTA) in place that uses as framework the standard MTA newly gazetted by the South African Minister of Health (SA MTA). Main body The article offers a legal analysis of the SA MTA and focuses on its substantive fit with the broader legal environment in South Africa, and the clarity and practicality of its terms. The following problematic aspects of the SA MTA are highlighted: (a) Where only data and no human biological material are transferred, the SA MTA does not apply, leaving a lacuna; (b) Health Research Ethics Committees are required to be parties to a MTA despite it being outside their legal mandate and undermining their oversight function; (c) the SA MTA’s consent provisions are not aligned with extant law; and, similarly, (d) its provision on donor ownership is misaligned with extant law; (e) its creation of fictitious performance can only cause frustration on the part of an injured party; (f) its benefit-sharing provision is vague and will have little practical effect; (g) its dispute-resolution provisions fail to adequately protect South African research institutions and research participants; (h) it fails to provide substantive guidance regarding intellectual property as its provisions relating to intellectual property may cause practical problems; and, finally, (i) its data privacy provision is insufficiently specific, is overbroad, and fails to provide terms that in general would facilitate the international sharing of human biological material and associated data in terms of existing privacy law. Conclusions While some of the problematic aspects of the SA MTA are intricate and require consultative processes with stakeholders and others, to develop comprehensive solutions, most of the problematic aspects can be resolved immediately through amendments by the South African Minister of Health. The formulation of such amendments is proposed and, where possible, interim measures are suggested that may ameliorate the problems presented by the SA MTA.

Why a need for MTAs?Research using HBMs should have societal benefits and contribute to public health objectives. [1] It was common practice for researchers to share research materials freely, as scientific research relies, inter alia, on the ability of researchers to replicate and test published research results. In the context of health research, such an exercise would require access to the relevant biological material and/or This open-access article is distributed under Creative Commons licence CC-BY-NC 4.0.

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Summary Governments have committed themselves at international human rights

The article examines the legal requirements relating to the informed consent of mentally ill persons to participation in clinical research in South Africa. First, the juridical basis of informed consent in South African law is outlined; and second, the requirements for lawful consent developed in South African common law and case law are presented. Finally, the article deliberates upon the requirements for the participation of mentally ill persons in research as laid down by the Mental Health Care Act and its regulations, the National Health Act and its (draft) regulations, and the South African Constitution.

Chapter 9 of the National Health Act came into effect in March 2012. This article examines the Act’s statutory requirements relating to the informed consent to participation in clinical research by mentally ill children and adolescents in South Africa. The necessity of doing clinical research in mentally ill children and adolescents is canvassed briefly and the requirements that chapter 9 sets out for lawful child and adolescent consent to research participation are presented. The article deliberates upon the limitations of the newly enacted legislation and proposes selective improvements. Because of the likely erosion of the minor’s privacy, the article finds that the requirement that a parent or legal guardian must consent to children’s and adolescents’ participation in research has the potential to obstruct much-needed mental health research. This requirement is likely to be found unconstitutional. In certain circumstances, ethics committees tasked with the review of research should be allowed to dispense with parental consent, and adolescents recognised as having the necessary capacity to consent independently to research participation. Furthermore, the Act’s classification of research into therapeutic and non-therapeutic categories is considered problematic. The article recommends that research permissible in minors be stated in terms of well-defined risk standards. Finally, the article finds the requirement set in subsection 71(3) for ministerial consent in the case of non-therapeutic research in children and adolescents to be overly protectionist, as it precludes the capacity of ethics committees to judge the ethics of the proposed research.

Debates on many university campuses call for a refocused or "decolonised" university curriculum. These demands reject curricula that are considered narrow and unreformed and cultures that position many in the university as unwelcome outsiders. In response to these calls there have been attempts at a renewal of the South African higher education system and several universities currently are revising their curricula in an endeavour to be responsive to students' concerns. Drawing on Michel Foucault's idea of the "episteme", the article narrates a university professor's quest to reconceptualise the undergraduate and post-graduate international law curricula at the university where she lectures, and highlights the lessons she has learnt in the process about the boundaries of her and other international law scholars' knowledge and ways of knowing.

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