An analysis of consent with specific regard to stem cell therapy and research

Abstract

This thesis argues that stem cells cannot be properly regulated when understood in terms of medical treatment only. This is due to the uncertain scope and untested efficacy of stem cell therapy which renders treatment applications tantamount to research involving human subjects. This thesis therefore examines consent as regulatory instrument in context of stem cell related interventions and endeavours to introduce a sufficient consent model for such interventions. To this end, a clinical overview and explanation of stem cells is provided in order to establish an understanding of the field of science in need of regulatory control. This is followed by a background and introduction to consent, a discussion of specific aspects of consent and the National Health Act of 2003 and the Regulations made in terms of the Act to provide insight into consent as understood in South Africa. Consent in international instruments and international law is then examined. The law of the United Kingdom is also analysed by providing an examination of the legal systems in the United Kingdom which is then followed by a discussion of the Human Tissue Act of 2004 and the Human Tissue (Scotland) Act of 2006. Finally, dynamic informed consent is explained and introduced as the recommended consent format for the proper and valid regulation of stem cell therapy-research interventions. At the close of this thesis, the conclusions drawn throughout are compounded and pertinent recommendations are made regarding consent procedures and specifications.