Submitted in partial fulfilment of the degree of MSc (Med) in Bioethics and Health Law, Steve Biko Centre for Bioethics, University of the Witwatersrand. Johannesburg, 25 January 2015 / Since his death at the hands of the South African security police on 12 September 1977, much has been written in medical, legal and other literature about Steve Biko. This dissertation explores the medical literature and finds that the vast majority of authors, when writing about Biko, refer primarily to his death, the role of the medical profession in the events leading up to his death, and the ethical issues regarding dual loyalties that arise from studying those issues. In my research question I ask: Does Steve Biko have more to offer medical ethics than his death? In exploring Steve Biko’s writings as collected together in I Write What I Like, I find an underlying thinking which guided Biko’s philosophy. I show that this underlying philosophy is nothing other than the philosophy which underlies ubuntu and I explore how ubuntu should influence our medical ethical thinking and suggest that this could be Biko’s real contribution to medical ethics, namely an ethic that takes seriously the contribution that African moral thinking has to make in the field of medical ethics, a contribution that does nothing less than give to medical ethics a more human face, a contribution which Biko himself believed was what Africa was still to give to the world, a more human face. I critically review the writings and philosophy of Steve Biko and identify key notions or conceptions that are of relevance to medical ethics and then explore the impact and relevance of these key notions and conceptions to the fundamental bioethical issues of autonomy, dignity and confidentiality. I defend the normative claim that integrating Biko’s and other salient African ethical conceptions into our predominantly Western bioethical thinking is a moral requirement.

This research report tells the story of a doctor and a journalist who, at the height of Apartheid’s State of Emergency, placed themselves at risk for the sake of practicing their professions ethically. They chose to defy the law, and bring to the attention of the public, the plight of many detainees who suffered at the hands of the State. In the report, I set out to give an account of the events and to ethically reflect on the actions of the two professionals involved. In particular, I consider the role played by professional codes of conduct in the actions of the two professionals and I reflect on the notion of trust as a centrally important ethical conception with respect to the events described.

A research report submitted to the Faculty of Health Sciences, Steve Biko Centre for Bioethics, University of the Witwatersrand, in partial fulfillment of the requirements for the degree of Master of Science in Medicine In the field of Bioethics and Health Law Johannesburg, 2011 / Although Human Biological Materials (HBMs) are invaluable resources in biomedical research, they have not been without controversy in collaborative research between developed and developing countries. The normative arm of the study compared the key ethical issues in the laws, regulations and guideline documents of developed and developing countries with regard to the use, collection, storage, export and benefit-sharing of HBMs in collaborative research with developed countries. The empirical arm of the study examined how investigators and a Research Ethics Committee (REC) at a South African institution addressed these ethical issues, implemented national and international frameworks with regard to the use of HBMs. The majority of sponsors (59.6%, 90/151) in the study were from the USA compared to other developed countries (p=0.0001) with the bulk (65.84%) of the funds (R517.19 million) allocated for HIV research. HBMs for storage was obtained largely from adults (80.8%, 122/151) compared to children (12.6%, 19/151) [p <0.0001]. Whilst the principle investigators (PIs) of all 151 protocols informed the REC of their intent to store HBMs, only 87.4% (132/151) of PIs informed research participants (P <0.0001). In 47.7% (72/151) and 71.5 % (57/151) of protocols research participants were informed of the location and duration of storage, respectively, compared to 86% (130/151) and 19.25% (29/151) informing the REC (p < 0.0001), respectively. In 98% (149/151) of protocols informed consent (IC) was obtained from research participants with 76.8% (116/151) of protocols soliciting broad consent compared to specific consent (21.2%, 32/151) [p < 0.0001]. In the remaining 2% (3/151) of protocols IC for storage was not obtained. In 69.5% (105/151) of protocols confidentiality was maintained by a code and in 9.35% (14/151) of protocols HBMs was anonymised [p < 0.0001]. Significantly more protocols informed the REC (90/151, 59.6%) than the research participants (67/151, 44.4%) that HBMs will be exported (p= 0.011). Separate consent forms were not available for 60.9% (92/151) of protocols as per the requirement REC’s standard operating procedures (SOP). In 74% (51/69) of protocols the rationale for export was to access specialised laboratories (74%, 51/69) that were not available locally. Export permits were not available for 73.2% (109/151) of protocols. Where export permits were available, there were more exports to the USA (31/42, 73.8%) than to Europe (26.2%, 11/42) [p < 0.0001]. In the majority of protocols research participants were not informed of benefit sharing from any discoveries (129/151, 85.4%) or commercialisation (123/151, 81.5%) of products derived from their HBMs. Material Transfer Agreements (MTAs) were not available for 94.7% (143/151) protocols. Whilst 122/151(80.8%) protocols disclosed the amount of funds available from the sponsors for the research to the REC, not a single PI made such disclosures to the research participants (p < 0.0001). The varied definitions of what constitutes HBMs, the different terminologies used to describe identifiability, confidentiality, the different models of informed consent and different standards of ownership in the various national and international frameworks are characterised by a maze of definitions, laws, regulations and guidelines that are confusing, conflicting and defy generalisation. International and national laws, regulations and guidelines are fragmented and lack harmonisation. Most developing countries are in favour of severe restrictions on the use of their HBMs in collaborative research with developed countries. The protocols in the empirical study did not adequately address the inter-related ethical issues of export, storage, IC, commercialisation and benefit sharing derived from HBMs that are currently the subject of intense debate and controversy and central to the access to HBMs in collaborative research with developed countries. Because the empirical study is limited by the use of a convenient sample, the results cannot be generalised to other RECs in South Africa. Nevertheless, the data gives some credibility to the anecdotal evidence that HBMs are leaving the country unaccounted for without export permits and MTAs in place. Given the long delays in harmonizing and publishing new regulations and changes, outdated regulations and regulatory frameworks create opportunities for the proliferation of undesirable and unethical practices. Omissions in the RSA regulatory and ethical frameworks with regard to HBMs and Tissue Biobanking are concerning and require urgent action.

In partial fulfilment of the degree of MSc Med (Bioethics & Health Law) Steve Biko Centre for Bioethics, Faculty of Health Sciences, University of the Witwatersrand. Johannesburg, December 2011 / ‘Whistle blowing’ means to blow a whistle calling attention to practices which an individual considers as immoral or illegal and harmful to the public. Some people think whistle blowing is a good or right act; others consider it wrong. There are numerous reports concerning blowing the whistle in scientific research. I place whistle blowing in the context of institutions, focusing on good clinical practice and Research Ethics Committees. Many research activities take place resulting in monetary and personal gain which may influence research conduct. I explore some issues in the development and organization of Research Ethics Committees, discuss the nature of whistle blowing and whistle blowers, and examine some whistle blowing incidents in scientific research. I conclude that although the function of Research Ethics Committees does not necessarily include mechanisms for whistle blowing, that this idea has merit and should be considered.

No description available.

The great power of the medical profession over the lives of men entails a wealth of moral problems in medical practice and lends particular importance to questions of the responsibility of the physician. We investigate the solutions offered by Galen, the most prolific medical author of classical Antiquity, in his medical and philosophical writings. Issues of ethics and moral psychology are discussed in numerous passages of Galen's works, and he even devoted a number of treatises exclusively to ethics. The main results of our analysis of these treatises and passages can be summarized as follows. Starting with his interpretation of a prominent Hippocratic maxim, we discuss possible motivations for Galen's re-definition of the relationship between physician and patient. For Galen, it was the physician, not the patient, who led the fight against the disease. This prominent position of the Galenic physician entailed particular obligations and responsibilities. But Galen also took the view that certain responsibilities resided with the patient, particularly that of selecting the right physician and keeping the prescribed diets. Moreover Galen thought that everybody ought to pursue the systematic liberation of the soul from passions and errors, guided by his ethical methodology. Galen gave disciplined care for one's health and acquisition of medical knowledge the status of moral duties for every educated person. For physicians, he provided a wealth of additional principles and rules of conduct, covering areas as diverse as experimentation with drugs, surgical risks, promulgation of knowledge on poisons, remuneration and other social impacts of medicine, and medical education, all of them inspired by respect for the health of man, the animal who topped the teleological hierarchy of creation, and medicine, the art whose task it was to preserve and restore man's health. Galen held medicine in exceptionally high esteem, even by the standards of physicians. His view of medicine as the divine art kat 'exochen is considered in the context of his high valuation of human life and health. Health assumed a high rank in the hierarchy of goods, for it provided the basis for all the other goods and virtues. For Galen, preservation and restoration of health could be attained only on the basis of a sound scientific methodology. He was reluctant to apply criteria external to medicine proper to its practice, and mostly judged the morality of medical activities by the adherence to the principles of a well-founded therapy and avoidance of undue harm.

Thesis (Ph. D.)--University of Virginia, 1991. / Includes bibliographical references. Also available online through Digital Dissertations.

Thesis (Ph. D.)--University of Hong Kong, 1999. / Includes bibliographical references.

Thesis (M.A.)--Trinity International University, Deerfield, Ill., 1998. / Abstract. Includes bibliographical references (leaves 134-139).

A new opportunity to reduce cervical cancer deaths as well as other HPV associated diseases arises from recently developed prophylactic vaccines. A large body of scientific literature concludes that the vaccines provide 100% protection against the oncogenic (high-risk) HPV types 16 and 18, which are responsible for about 70% of all cervical cancers in women. The vaccines also protect against infections with HPV 6 and 11, the cause of about 90% of genital warts (condylomataacuminata) in both males and females. South Africa is faced with uncertainties about how to implement a HPV vaccine immunisation programme aimed at the improvement of health in relation to the burden of disease caused by cervical cancer and related HPV-implicated diseases whilst struggling to provide the most basic of healthcare services in the midst of a HIV pandemic and a diminished base of key healthcare professionals. In such a context and relative to other priorities and the comparative benefits of different interventions, should, and if so why should South Africa invest in a HPV vaccine immunisation programme; likewise, if not, why not? In this research, report I will provide the main ethical and legal issues related to the implementation of a National HPV vaccine immunisation intervention programme. The research method used is a literature review of some ethical & legal issues in HPV vaccine immunisation analysing findings by way of critical thinking and moral reasoning. The outcomes of my research report suggest that South Africa is bound ethically and legally to provide HPV vaccine immunisation as an intervention to reduce the scourge of HPV infections, especially cervical cancer-based on the outcomes, I make recommendations concerning policy changes at the National level. These changes include interventions targeting the youth with an HPV vaccine immunisation programme included as one type of intervention.