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- Volume 5, Issue 2, 2012
South African Journal of Bioethics and Law - Volume 5, Issue 2, 2012
Volume 5, Issue 2, 2012
Author Ames DhaiSource: South African Journal of Bioethics and Law 5, pp 62 –63 (2012)More Less
The Bill of Rights of the Constitution of South Africa, a cornerstone of democracy in the country enshrines the rights of all people and affirms the democratic values of human dignity, equality and freedom. The state is assigned the responsibility of respecting, protecting, promoting and fulfilling these rights. Several Acts of Parliament that have followed the Constitution make reference in their preambles to socio-economic injustices, imbalances and inequities of the past. Some articulate the importance of social justice, fundamental human rights and the need to improve the quality of life for all and to free the potential of each person in the country.
Hospital exclusion clauses limiting liability for medical malpractice resulting in death or physical or psychological injury : what is the effect of the Consumer Protection Act?Author D. McQuoid-MasonSource: South African Journal of Bioethics and Law 5, pp 65 –68 (2012)More Less
In 2002 the Supreme Court of Appeal ruling in Afrox Healthcare Beperk v. Strydom held that the common law allows hospitals to exclude liability for medical malpractice resulting in death or physical or psychological injury - except in the case of gross negligence. The effect of this judgment has now been superseded by the provisions of the Consumer Protection Act of 2008, which came into effect in March 2011. The Act states that unfair, unreasonable or unjust contract terms are prohibited and that certain terms and conditions have to be drawn to consumers' attention and cannot be buried in the small print.
It is argued that as a result of the Act, exclusion clauses that unfairly, unreasonably or unjustly protect hospitals from liability for death or bodily or psychological injury caused by the fault of their staff, may be declared by the courts to be invalid and not binding on consumers. They may also be regarded as unconstitutional.
Source: South African Journal of Bioethics and Law 5, pp 69 –73 (2012)More Less
Stem cell tourism has become a common phenomenon worldwide and is increasingly affecting South Africa, as is evident from recent media reports. We examine the South African legal framework regulating stem cell therapy, focusing first on the effects of unproven stem cell treatments, and provide recommendations that may assist in strengthening the legal position.
Source: South African Journal of Bioethics and Law 5, pp 74 –77 (2012)More Less
Biobanking policy needs to take into account the concept of human dignity, because this concept is enshrined in both international and South African law. The accepted understanding of informed consent, which is also required by law, is inadequate for biobanking because it is often not possible to inform people of possible uses of their stored tissue.
If human dignity is understood as a multidimensional concept that corresponds to the multidimensionality of the human person, then human dignity can be said to be both (i) something that all people already have, as an inviolable worth that inheres in their potential to live meaningful lives; and (ii) something that people seek to realise through morally good behaviour in historically-situated relationships.
This understanding of human dignity can be used as both an interpretive lens and a normative vision. It is interpretive because it reveals how various attitudes to biobanking and the various proposed consent regimes - presumed, broad, and specific - might all be underpinned by appeals to human dignity. It is a normative vision because, given that all of these positions can be underpinned as morally meaningful with respect to human dignity, provision should be made for all of the possible consent regimes in law and in biobanking practice.
Nonetheless, where compromise cannot be avoided, then, at the very least, human dignity understood as the human potential to live a meaningful moral life must be protected.
The 'war on drugs' has failed : is decriminalisation of drug use a solution to the problem in South Africa?Source: South African Journal of Bioethics and Law 5, pp 78 –82 (2012)More Less
This article engages in the debate surrounding decriminalisation of drug use and whether this is a possible solution to the problem of drug use in South Africa - a question becoming more prevalent in global discussions about drug policy and its efficacy.
We argue that two aspects must be addressed when evaluating a policy: its philosophical justification and its efficacy. We find that criminalising drugs may be justified by the public harm principle, but it does not effectively achieve the purpose of preventing and decreasing drug use and associated burdens. Thus, we argue that prohibition is a constitutional limitation, but does not necessarily achieve its purpose in the least repressive or most effective way.
Finally, we suggest that a solution to the drug problem will have to address the health needs of the drug user and the context, particularly socio-economic, of drug use. Decriminalisation could theoretically do this by changing society's perception of drug users, thus helping to promote a human rights-based, public health-orientated approach to the drug problem in South Africa.
Author A. PlomerSource: South African Journal of Bioethics and Law 5, pp 83 –86 (2012)More Less
The Declaration of Helsinki (DoH) is widely recognised as the leading authoritative source on ethical standards of medical research worldwide. Yet, in the past decade, different sources have questioned the authority of the DoH and its compliance with human rights, and argued for its replacement with UNESCO's Universal Declaration on Bioethics and Human Rights.
This paper argues that the tensions and alleged conflicts between Helsinki and human rights instruments are overstated, and that the latest version of the DoH is an important complement to human rights instruments in protecting the rights of disadvantaged populations and participants in biomedical research.
FDA abandons the Declaration of Helsinki : the effect on the ethics of clinical trial conduct in South Africa and other developing countriesSource: South African Journal of Bioethics and Law 5, pp 87 –90 (2012)More Less
Four years ago, the US Food and Drug Administration (FDA) ceased compliance with the Declaration of Helsinki (DoH) (2000 revision and all subsequent revisions) for conduct of clinical trials outside its borders. It instead ruled that compliance with the Good Clinical Practices (GCP) of the International Conference of Harmonization (ICH) is sufficient. However, the ICH-GCP guidelines do not address certain ethical requirements stipulated in the DoH, such as the use of placebos v. standard therapy, post-trial access to treatment and other benefits for participants; public disclosure of trial design; publication of trial results; and disclosure of conflicts of interest.
The FDA's adoption of less morally stringent guidelines could encourage pharmaceutical companies to take ethical short cuts. It could also have practical consequences for trial ethics in developing countries, especially where research ethics committees may not be promoting high standards of protection for participants in clinical trials, due to lack of financial and human resources.
Pharmaceutical companies may also pressurise research ethics committees to relax guidelines and legislation, in order to facilitate future clinical trials in developing and emerging countries that lack the resources to conduct their own clinical research on epidemics such as HIV/AIDS, which have devastating effects on their populations.
Compensation for research-related injury in South Africa : a critique of the good clinical practice (GCP) guidelinesSource: South African Journal of Bioethics and Law 5, pp 91 –94 (2012)More Less
This article examines the current South African Department of Health Good Clinical Practice (2006) guideline recommendations regarding compensation for harm incurred in clinical trials. It applies the case of a phase IIb HIV vaccine trial in South Africa, for which enrolments and vaccinations were suspended early, based on data from an international companion study that indicated no evidence of efficacy and greater susceptibility to HIV infection in a subgroup of vaccinees. The case application indicates certain substantive and procedural limitations within the South African Department of Health Good Clinical Practice (2006) guideline recommendations on compensation for harm, which should be re-considered in order to improve protections for trial participants.
Are students being coerced into HIV testing? Ethical considerations related to offering incentives for HIV counselling and testing at tertiary institutions in South AfricaSource: South African Journal of Bioethics and Law 5, pp 95 –97 (2012)More Less
A social marketing strategy, including substantial prizes, was used to promote HIV testing at 17 institutions of higher learning in South Africa. Over 20 000 students with a mean age of 19 years were counselled and tested for HIV. The majority were being tested for the first time. Afterwards they signed a public pledge: 'We, the class of 2010, pledge to know our status, to stop HIV/AIDS stigma and to contribute to the struggle against HIV/AIDS.' The students' opinion of the campaign was surveyed and they were found to be overwhelmingly in favour of it. The issue of whether the prizes unduly influenced the students' participation is investigated and an approach to resolving ethical dilemmas is presented. The potential of incentives to undermine 'moral sentiments' is reviewed.
Source: South African Journal of Bioethics and Law 5, pp 98 –101 (2012)More Less
Background. Discharge against medical advice (DAMA) is a problematic issue for physicians worldwide, which can disrupt the physician-patient relationship, have adverse medical outcomes and increase healthcare costs. This review aims to highlight the ethical and legal aspects of the issue from the perspective of developing countries in Africa, and make suggestions for resolving them.
Methods. A comprehensive literature review of articles relating to DAMA was performed using databases such as PubMed, Medline and Google Scholar. The search criteria used were 'discharge against medical advice AND ethics*', 'discharge against medical advice AND Africa', 'leaving against medical advice', 'discharge against medical advice AND legal issues' and 'self-discharge'. Relevant articles published from 1980 till 31 December 2011 were included.
Results. The conflict between the professional values (beneficence) of the physician and the autonomy (self-determination) of the patient is the most prominent ethical dilemma in cases of DAMA. The issue of DAMA is more complicated in developing countries, especially because of communal models of decision making. One important ethical dilemma is the rationing of hospital admissions, especially for chronic conditions with poor prognosis. We have suggested a communal model for dealing with the issues. The main legal issue found in this review is the possibility of medical doctors being sued for medical malpractice.
Conclusion. DAMA is associated with numerous ethical and legal issues of which physicians need to take cognizance.
Conflict of interest : a tenacious ethical dilemma in public health policy, not only in clinical practice/researchSource: South African Journal of Bioethics and Law 5, pp 102 –108 (2012)More Less
In addition to the ethical practice of individual health professionals, bioethical debate about conflict of interest (CoI) must include the institutional ethics of public policy-making, as failure to establish independence from powerful stakeholder influence may pervert public health goals. All involved in public policy processes are accountable for CoI, including experts, scientists, professionals, industry and government officials. The liquor industry in South Africa is presented as a case study. Generic principles of how to identify, manage and address CoI are discussed. We propose that health professionals and policy makers should avoid partnering with industries that are harmful to health. Regarding institutional CoI, we recommend that there should be effective policies, procedures and processes for governing public-private joint ventures with such industries. These include arms-length funding, maintaining the balance between contesting vested interests, and full disclosure of the identity and affiliations of all participants in structures and reports pertaining to public policy-making.
Bridging the gap : focused, in-depth and practical short courses in bioethics and health law : education and trainingSource: South African Journal of Bioethics and Law 5 (2012)More Less