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- Volume 8, Issue sup-1, 2015
South African Journal of Bioethics and Law - Supplement 1, August 2015
Supplement 1, August 2015
Author Michael S. PepperSource: South African Journal of Bioethics and Law 8, pp 2 –3 (2015)More Less
From the perspective of medical and scientific research, South Africa is well placed through its many resources to make an important positive contribution to the global knowledge base and also to the improvement of the quality of life of its patients. Our focus is on stem cells and the potential impact their clinical translation will have on the lives of many South Africans.
Author Ames DhaiSource: South African Journal of Bioethics and Law 8 (2015)More Less
Ethical, legal and social issues associated with health research in general are multiple and complex. The complexity increases when research involves human tissues, and in particular stem cells as the trajectory of the latter will include scientific and technological advances not previously explored.
Source: South African Journal of Bioethics and Law 8, pp 4 –11 (2015) http://dx.doi.org/http://dx.doi.org/10.7196/SAJBL.8008More Less
The South African (SA) legislative framework follows a hierarchical structure aligned with the relevant level of government (national, provincial or local) responsible for applying and monitoring the legislation, with the overarching and progressive Constitution as the supreme law. Delegated legislation (also known as secondary or subordinate legislation, e.g. regulations) 'adds flesh' to Acts of Parliament, or other forms of original legislation. The control and use of human tissue in South Africa is primarily governed by the National Health Act and relevant regulations, although other national acts, in differing degrees, are also relevant to this complex field. These include, among others, the Medicines and Related Substances Act, the Consumer Protection Act, the Children's Act and the Inquest Act. Regulations generally only require ministerial and not parliamentary approval and are therefore (theoretically) easier to amend. In principle, the drafting of Acts should be preceded by policy documents, which contain broad foundational guidelines or a statement of intent in the area in question. Another useful source in the interpretation of legislation, albeit not officially recognised as legislation, is guidelines (sometimes referred to as standards), that may provide greater granularity than the regulations. Although neither policy documents nor guidelines are directly legally binding, a lack of compliance with the latter may have legal significance. In this article, the components of the hierarchical structure relevant to the legal regulation of human tissue in SA will be examined, with a specific focus on stem cell research and therapy. A critical analysis of the accuracy, relevance, redundancy and completeness (or lack thereof) of these components will be provided. Furthermore, recommendations outlining the procedures that should be undertaken to remedy the inadequacies of the current legislative framework will be suggested. Given the well-defined structure of this framework and the relative youth of human tissue legislation in SA, the legislator has an opportunity to mirror the values and principles embodied in the Constitution by addressing these inconsistencies, and in the process develop a globally-applicable and appropriate legislative model in the fields of stem cell research and therapy.
A global comparative overview of the legal regulation of stem cell research and therapy : lessons for South Africa : legislationSource: South African Journal of Bioethics and Law 8, pp 12 –22 (2015) http://dx.doi.org/http://dx.doi.org/10.7196/SAJBL.8004More Less
Stem cell research and its potential translation to regenerative medicine, tissue engineering and cell and gene therapy, have led to controversy and debates similar to the calls nearly 25 years ago for a ban involving recombinant DNA. Global legislative efforts in this field have been characterised by many legal, ethical and practical challenges, stemming from conflicting views regarding human embryonic research and cloning. National policy and regulatory developments have primarily been shaped by different understandings of relevant scientific objectives, as well as those relating to the moral and legal status of the human embryo, which have been used to justify or limit a range of permissible activities. Legal obscurity in this field, a consequence of inconsistent or vague legislative responses at a national and international level, leads to negative results, which include, among others, ethical violations; lack of collaboration and co-operation among researchers across national borders; stunted scientific progress; lack of public trust in stem cell research; proliferation of untested 'stem cell therapies'; and safety issues. The purpose of this article is to explore the legal regulation of stem cell research and therapy globally, by comparing the permissibility of specific stem cell research activities in 35 selected jurisdictions, followed by a comparison of the regulatory approaches with regard to stem cell-based products in the European Union and the USA. A clearer understanding of the global regulatory framework will assist in formulating more effective legal responses at a national level and in navigating the uncertainties and risks associated with this complex and evolving scientific field.
Source: South African Journal of Bioethics and Law 8, pp 23 –31 (2015) http://dx.doi.org/http://dx.doi.org/10.7196/SAJBL.8402More Less
One of the most exciting areas of medical research involves the use of stem cells for the treatment of patients with a variety of diseases and for tissue repair. Although stem cell research is accelerating rapidly in many countries, it has in the past been limited in South Africa (SA); very little has been done in this country to explore the great potential offered by stem cells to address the high disease burden. Stem cell therapy has however been practised for many years, in SA and worldwide, in the form of haematopoietic stem cell transplantation, mainly for haematological malignancies.From a therapeutic perspective, two types of stem cells can be defined: pluripotent stem cells and adult stem cells. Pluripotent cells derived from the inner cell mass of blastocysts (either from in vitro fertilisation or following somatic cell nuclear transfer) are called embryonic stem (ES) cells, while those derived by reprogramming adult cells are called induced pluripotent stem (iPS) cells. Adult stem cells include haematopoietic, mesenchymal and neural stem cells. The purpose of this article is to critically examine the SA legislation with regard to elements that impact on pluripotent stem cell research and the use of pluripotent stem cells for therapeutic purposes. This includes (but is not limited to) legislation from the National Health Act (Chapter 8 in particular) and its regulations, and deals with matters related to research on embryos in the stem cell context, somatic cell nuclear transfer, reproductive and therapeutic cloning and the generation and therapeutic use of iPS and ES cells.
Mitochondrial transfer : ethical, legal and social implications in assisted reproduction : pluripotent stem cellsSource: South African Journal of Bioethics and Law 8, pp 32 –35 (2015) http://dx.doi.org/http://dx.doi.org/10.7196/sajbl.8002More Less
Diseases resulting from mutations in mitochondrial DNA (mtDNA) are inherited by all offspring through the maternal lineage. Multiple organs are severely affected, no preventative treatments are available and most patients experience a poor quality of life or early death. With developments in mitochondrial transfer techniques, hope for preventing transmission of mutated mtDNA onto offspring is emerging. Many ethical issues have been raised regarding such treatments, which involve transfer of nuclear material into donated oocytes with healthy mitochondria, or the introduction of healthy donor mitochondria into affected oocytes. Blastomere, ooplasmic, pronuclear and spindle transfer have been explored. Ethical concerns relate to (a) the alteration of germ line genetics and (b) the dilemma of children inheriting DNA material from three instead of two parents. In contrast to gene therapy, where only the DNA of the treated individual is altered, these techniques involve the introduction of foreign mtDNA into the germ line that will be inherited by all children in downstream generations. Mitochondrial transfer has also been closely associated with reproductive cloning, which is regulated differently worldwide. Children born from these techniques might experience an identity crisis. Although three gametes are needed to produce a healthy embryo in this scenario, the child will inherit all nuclear DNA from the intending parents, while only inheriting mtDNA from the donor. Social and scientific values must be considered when introducing new healthcare technology. Many believe that some assisted reproductive technology techniques go beyond the limits of acceptable medical intervention. But who ultimately decides what is acceptable? We address the ethical and social issues surrounding this emerging new technology, legal developments regarding its clinical introduction in the UK and the USA, the future impact on technique and patient management, and relevant legislation in South Africa.
Source: South African Journal of Bioethics and Law 8, pp 36 –40 (2015) http://dx.doi.org/http://dx.doi.org/10.7196/SAJBL.8005More Less
The promise stem cell therapy holds for curing diseases for which no therapy currently exists is often translated as fact. Unfortunately, enforced misconceptions between fact and promise often also translate into exploitation and harming of patients. This article aims to clear up misconceptions about the biological promise and legal consequences of insisting on promises not based on scientific facts.
Source: South African Journal of Bioethics and Law 8, pp 41 –45 (2015) http://dx.doi.org/http://dx.doi.org/10.7196/SAJBL.8006More Less
The past few years have seen a sharp rise in the propagation of unproven stem cell 'treatments', also known as 'stem cell tourism'. Patients suffering from a variety of diseases unresponsive to conventional medical therapy often travel to certain destinations to receive these therapies, mostly from bogus operators advertising various 'stem cell treatment cures' for a wide range of conditions, and in the process mislead vulnerable patients with unfounded promises of recovery. Stem cell tourism, made possible by legal lacunae or weak national regulatory frameworks, raises grave legal and ethical concerns, as patients not only receive treatments which are unproven, but often also unregulated, potentially dangerous and fraudulent. Existing proven therapeutic applications using stem cells are limited to those for blood and immunological disorders and are based on clinical trials that have demonstrated the efficacy and safety of these applications. As a result of weak legislative enforcement in this area, South Africa has unfortunately become an attractive destination for fraudulent stem cell operators. The purpose of this article is provide an update on the South African legal position relating to stem cell therapy by evaluating the effectiveness of the Medicines and Related Substances Act and other relevant legislative provisions in regulating cell-based therapies, drawing strongly on recent international developments and case law in this field. The article will make specific recommendations aimed at improving the existing position.
Source: South African Journal of Bioethics and Law 8, pp 46 –48 (2015) http://dx.doi.org/http://dx.doi.org/10.7196.sajbl.8408More Less
Stem cell science is advancing at an unprecedented rate, with thousands of research papers being published every year and many clinical trials for a wide range of conditions underway as registered on ClinicalTrials.gov. This rapidly expanding and alluring field has brought with it ever more complex and multifaceted ethical issues, many of which require new guidelines, consent protocols and even change in legislation, since they do not fit comfortably in the existing bioethical regulations and protocols. Keeping up with the ethical implications of stem cell research is daunting to the expert and non-expert. We review the various types of stem cells and then focus on multipotent and pluripotent cell types, since it is these cell types that bring with them the greatest research and therapeutic potential, while concurrently delivering novel ethical conundrums. Certain key considerations are currently lacking and what is needed is how to obtain permission from individuals who donate their biological material for both scientific inquiry and eventually, for their potential therapeutic utility.
Informed consent in clinical trials using stem cells : suggestions and points of attention from informed consent training workshops in Japan : informed consentSource: South African Journal of Bioethics and Law 8, pp 49 –54 (2015) http://dx.doi.org/http://dx.doi.org/10.7196/SAJBL.8016More Less
Informed consent (IC) is an essential requirement of ethical research involving human participants, and is usually achieved by providing prospective research participants (PRPs) with a document that explains the study and its procedures. However, results of a series of IC workshops held in Tokyo during 2014 indicate that consent forms alone are not enough to achieve full IC in regenerative medicine research, due to the necessity of long-term patient-safety observations to meet the ethical challenges of such research. Adequate training of the people who are responsible for obtaining IC (elucidators) is also necessary to ensure full IC. Elucidators must be able to provide PRPs with sufficient information to ensure adequate comprehension of the study and its potential after-effects; judge PRPs' voluntariness and eligibility; and establish and/or maintain partnerships with PRPs. The workshops used role-playing simulations, to demonstrate how to effectively obtain fuller IC, to members of several Japanese research groups preparing for clinical stem cell trials. Workshop results were correlated with the results of a 2013 workshop on what information patients want when considering participation in induced pluripotent stem cell (iPSC) research. The correlated results showed the need for continuous training and education of elucidators in order to make sure that they acquire and maintain IC competency.
Source: South African Journal of Bioethics and Law 8, pp 55 –59 (2015) http://dx.doi.org/http://dx.doi.org/10.7196/SAJBL.8060More Less
Biobanks are repositories that store human biological materials and their associated data. They are rapidly becoming part of national and international networks and give rise to unique ethico-regulatory issues. Whether consent is informed and whether this term should be used when specimens are collected for biobank research is questionable. Where risks occur, they are usually social and relate to identifiability. Public trust and confidence are important for the success of this type of research. Consensus is growing that governance of biobanks should be harmonised. Controlled specimen and data access agreements are essential. The South African National Health Act (NHA) and its Regulations, that provide the foundation for the legal framework with regard to human tissue and research in South Africa, are silent on the issue of biobanks and the law lags behind while science and technology advance rapidly. The use of biobank assets will lead to significant benefits in human health and should be encouraged while taking account of the associated ethical, legal and social issues and working towards a balance between these two positions.
Source: South African Journal of Bioethics and Law 8, pp 60 –64 (2015) http://dx.doi.org/http://dx.doi.org/10.7196/SAJBL.8012More Less
The necessity of benefit sharing may be questioned when research activities are funded by international sources within a developing country. Benefit sharing is a topic which remains uncertain in the context of genetic research, particularly with regard to how and with whom benefits should be shared. A Material Transfer Agreement (MTA) is one way (and in some instances the only way) in which the transfer of human biological materials is regulated. With biobank research increasing and the historical exploitation of research participants in Africa a reality, it is essential that the transfer of human tissues across national boundaries is regulated with specific regard to the sharing of benefits and the respect and protection of traditional values. This paper will debate the requirement of benefit sharing when research is undertaken; discuss its meaning in the context of genetic research; and outline some South African and international perspectives on the sharing of benefits. While this paper emphasises benefit sharing in the context of genetic research, the principles apply to all human participant research.