South African Journal of Bioethics and Law - latest Issue
Volume 9, Issue 2, 2016
Source: South African Journal of Bioethics and Law 9, pp 50 –51 (2016) http://dx.doi.org/10.7196/SAJBL.2016.v9i2.270More Less
On 22 October 2016, the World Medical Association (WMA) announced that it had approved new ethical guidelines for physicians involved in the collection and use of identifiable health data and biological material in health databases and biobanks, and that these guidelines would help people control the use of their health data. The WMA believed this would be achieved by respecting the rights to autonomy, privacy and confidentiality which individuals should be entitled to and as set out in the guidelines. In this way they would be able to exercise control over the secondary use of their personal data and biological material, both in and beyond research. The guidelines, named The Declaration of Taipei, were approved by delegates at the WMA’s annual assembly in Taiwan.
Harm to patients and others caused by impaired junior doctors compelled to work 30-hour shifts or longer : can the minister of health, provincial MECs for health and public health officials be held liable?Author D. McQuoid-MasonSource: South African Journal of Bioethics and Law 9, pp 52 –56 (2016) http://dx.doi.org/10.7196/SAJBL.495More Less
Junior doctors in most provinces in South Africa are compelled to work 30-hour shifts without a break. Shifts in excess of 24 hours can result in serious bodily harm to patients, third parties and the doctors themselves. These risks have been drawn to the attention of the health authorities but the 30-hour policy continues to be implemented in all provinces, except recently in the Western Cape. Public health officials may be held directly liable for the harm caused to patients, third parties or the junior doctors themselves, if it can be shown that they are at fault and are acting unlawfully in violation of the Constitution. Where officials carry out the unlawful orders of senior officials, including the minister of health and provincial members of the executive council (MECs) for health, they may not raise the defence of ‘obedience to orders’ and may be held directly liable for harm caused. Superior officials issuing such orders will also be held directly liable for harm caused.
HIV, trauma and the emergency departments : the CDC opt-out approach should be adopted in South AfricaSource: South African Journal of Bioethics and Law 9, pp 57 –60 (2016) http://dx.doi.org/10.7196/SAJBL.2016.v9i2.486More Less
Background. Trauma is the fourth burden of disease in South Africa (SA). The risk group is the same as that for HIV/AIDS. The Centers for Disease Control and the World Health Organization promulgated the opt-out testing system 10 years ago and several high- and lower-middleincome countries have adopted this approach.
Objective. To review the feasibility of implementing the opt-out system in SA emergency departments.
Methods. We examined the clinical, economic, practical and patient/provider perceptions concerning the scientific and ethical aspects of the opt-out concept.
Results. Patients were generally positive about the opt-out system and the overall test rate and disease identification rates were better than with other systems. Although initial costs may increase, the long-term cost benefit and prevention of transmission, due to linking to care, make this option attractive.
Conclusion. The opt-out option for patients presenting to emergency departments with an acute life-threatening illness or trauma, and for those in critically ill states in an intensive care unit, is justifiable based on international and regional practices. This also has the potential to advance early highly active antiretroviral therapy and reduce treatment costs and the disease-adjusted life years for HIV management and trauma critical care. SA should adopt an opt-out testing system instead of the current tedious opt-in system.
Source: South African Journal of Bioethics and Law 9, pp 61 –64 (2016) http://dx.doi.org/10.7196/SAJBL.2016.v9i2.496More Less
Reproductive autonomy (RA) has been challenged by the availability of genetic information, disability and the ethics of selective reproduction. Utilitarian and rights-based approaches, as well as procreative beneficence (PB) fail to provide compelling reasons for infringing RA, and may even be likened to dangerous eugenics. Parents are not morally obliged to prevent the birth of a disabled child. Society should rather adopt inclusivity, recognising and providing persons with disabilities opportunities for capability and worthwhile lives.
Source: South African Journal of Bioethics and Law 9, pp 65 –68 (2016) http://dx.doi.org/10.7196/SAJBL.2016.v9i2.470More Less
Background. Most people with mental illness live in developing countries, where a large proportion of these illnesses are undiagnosed and untreated. As effort is made to encourage mental health (MH) research as an avenue to optimise the management of mental illness, this should be accompanied by adequate knowledge, correct attitude and practic on ethical conduct of research. This study reports the knowledge and attitude among postgraduate students in Kenya on ethics in MH research.
Methods. Consenting students undertaking master’s degree courses (n=40) with interest in carrying out MH research were assessed using adapted standard tools for assessing knowledge and attitude. Primary comparison is made on the level of knowledge and attitude between the different cohorts.
Results. Participants undertaking postgraduate degrees in medicine, clinical psychology, pharmacy and nursing were individually scored and collectively found to have a medium (n=32, 79.5%) or high (n=8, 20.5%) level of knowledge. The general attitude towards most aspects of the consent process and confidentiality was observed to be appropriate. Low knowledge of international ethics guidelines was observed.
Conclusion. Gaps in knowledge and attitude on ethics among the participants have been identified, and this may initiate the process of appropriate interventions necessary in maintenance of ethical practices in the management of mental illness.
What changes are there in decisions by the Wits Human Research Ethics Committee (Medical) and in process errors by research applicants between 2003 and 2015?Author P. Cleaton-JonesSource: South African Journal of Bioethics and Law 9, pp 69 –72 (2016) http://dx.doi.org/10.7196/SAJBL.2016.v9i2.494More Less
Objective. A retrospective examination of numbers of applications, decision rates, and process errors in 2015 was done for comparison with earlier studies to understand current ethics secretariat workload.
Methods. In December 2015 information from committee minutes of all the meetings (N=11) in 2015 (January - November) was collected to quantify change in application numbers and process errors. Statistical analysis used SAS for Windows (version 9.4). Statistical significance
Results. There were 809 new general research applications considered in 2015. Monthly approvals at first evaluation ranged from 4 to 30% with an overall approval rate of 16%. Minor revision was required in 72%, major revision in 11% and 1% of applications were not approved. The χ2 test for trend for initial approval showed a statistically significant decrease across the study periods (p<0.0001). However, the χ2 test for trend for pending responses from applicants was also statistically significant (χ2=29.64). Informed consent and missing information process errors were the most frequent. There were statistically significant increases in lapses of confidentiality methods (p<0.0001) and discrepancies on application forms (p<0.005).
Conclusion. Applications to the Wits Human Research Ethics Committee (Medical) (HREC (M)) for ethics clearance almost doubled between 2003 and 2015 while approvals at first evaluation approximately halved. This has increased the workload on the HREC (M) secretariat. Process error rates are similar to those in an earlier study except that confidentiality and discrepancies have shown a statistically significant increase. Given limitation on the number of secretariat staff in the current stringent financial circumstances of South African universities, applicants need to improve the quality of their applications to increase approval at first review and reduce secretariat workload.
The right to physical integrity and informed refusal : just how far does a patient’s right to refuse medical treatment go?Source: South African Journal of Bioethics and Law 9, pp 73 –77 (2016) http://dx.doi.org/10.7196/SAJBL.2016.v9i2.472More Less
The article presents a legal analysis of the right to physical integrity as guaranteed by the South African Constitution, 1996, and the subsequent right of a competent adult person to refuse medical treatment under South African law. We consider whether the right to refuse treatment is an absolute right and very briefly reflect on the application of the constitutional limitations clause to this right. Instances in which patients’ right to physical integrity is limited by factors, which detract from (patient) autonomy, are considered: these represent a limitation of their right to refuse medical treatment. We conclude that forced medical interventions, for the most part, are not desirable but, indeed, necessary in some narrowly defined circumstances. When a person makes a decision to refuse a medical intervention, which may seem unusual or may be perceived as irrational, it does not mean that person does not warrant the protection of the constitution and the courts. Provided that the patient makes an informed refusal while of sound mind, generally there is no reason to discredit his/her decision, difficult as it may be for others to accept. At all times the right to bodily integrity is pivotal in any health-related context and should not be lightly disregarded.
A critical review of health research ethical guidelines regarding caregiver consent for HIV research involving minors in South Africa : ethical and legal issuesSource: South African Journal of Bioethics and Law 9, pp 78 –83 (2016) http://dx.doi.org/10.7196/SAJBL.2016.v9i2.458More Less
Background. Over the past decades there have been tremendous efforts to improve the ethical conduct of research involving humans throughout the world. As a one-size-fits-all philosophy can no longer work, most countries have developed specific legal and ethical guidelines for research, tailored to their own context. We reviewed South African (SA) ethical guidelines and Health Research Acts as they pertain to the role of caregivers in consent practices for minors’ participation in HIV/AIDS-related research.
Methods. An argument-driven review was conducted on two SA Acts and Guidelines respectively: the SA National Health Act of 2003; the Children’s Act No. 38 of 2005 and the Department of Health Ethics in Health Research Guidelines 2nd edition of 2015 and the Good Clinical Practice Guidelines of 2006, with a particular focus on minors as research participants. We also examined the relevant ethical and legal guidance using an exemplar of paediatric HIV testing within research conducted in SA.
Results. Available ethical guidelines for caregivers’ consent in research involving minors are still not comprehensive or aligned with SA regulations governing research with minors. The recent revision and development of the National Health Research Ethics Guidelines (2015), regarding the role of caregivers in consent practice for minors’ participation in health research, may be a positive move in clarifying the proper role for caregivers when enrolling minors in research..
Conclusion. Caregivers are deemed to have a role to play in research involving minors. Therefore, the inconsistencies in existing ethical guidelines and governing regulations regarding the role of caregivers in paediatric HIV research, need to be addressed following the recent ethical paradigm change.
Source: South African Journal of Bioethics and Law 9, pp 84 –87 (2016) http://dx.doi.org/10.7196/SAJBL.2016.v9i2.483More Less
As international collaborative health research activities increase, building research ethics committees (REC) infrastructure and capacity in lowand middle-income countries for efficient and thorough review of research protocols becomes more critical, especially in sub-Saharan Africa. International investigators may face multiple challenges when conducting research in these settings, an important one being the length of time involved in securing REC review and approval. We discuss an approach to the problem that involved organisation of ‘rapid review’ REC sub-committees who met via video-conference for collaborative review of research protocols.
Author T. MetzSource: South African Journal of Bioethics and Law 9, pp 88 –92 (2016) http://dx.doi.org/10.7196/SAJBL.2016.v9i2.489More Less
This article principally addresses the likely effects of global warming on health in developing countries in sub-Saharan Africa, northern Africa and the Middle East as well as how medical professionals, such as doctors, nurses, bioethicists and public health researchers, should respond to them in light of ubuntu and Islam, values characteristically held in those regions.
Source: South African Journal of Bioethics and Law 9, pp 93 –93 (2016)More Less
The aim of this pocketbook-size manual is to assist Institutional Review Board (IRB) members and chairs to conduct ethics reviews by balancing the two major morally relevant considerations in health research: that of protecting research participants and that of the benefits of health research, namely, societal well-being and progress. The recurring refrain throughout the book is that many IRBs today have misplaced both balance and focus, and while the primary function of IRBs is to protect participants, many today protect scientists, try to forestall controversies, attempt to prevent lawsuits and aspire to improve the methodology of the science they review. These activities as claimed by the author are ‘all manifestations of the curse of power’ and IRBs should avoid these distractions and focus on protecting participants. As someone who has been engaged in ethics review for many years, involving collaborative studies with researchers from the USA, and having been on the receiving end of the IRBs’ attempts to interfere with our local review processes, I can understand all too well the author’s disquiet with regard to the all-too-powerful IRB.
Source: South African Journal of Bioethics and Law 9, pp 94 –94 (2016)More Less
This book, a valuable addition to the slowly increasing bioethical literature on climate change, provides an excellent overview of the ethical dimensions pertinent to climate change. Bioethics, in the main, focuses on individual autonomy and the use of emerging technologies in medical practice and research. Even though climate change has resulted in serious health burdens globally, it receives relatively little attention in scholarly bioethics publications and at conferences. The importance of bioethics as an interdisciplinary field, with dilemmas being framed in light of the well-being of humans, ecosystems and other living things and the centrality of natural environments and resources to health and well-being, is underscored in the book. The unfortunate predicament raised by the fact that climate change harms health by inter alia reducing the availability of safe food, water, air and shelter (and there is abundant evidence of this), coupled with global population growth and socioeconomic development raising demand for these resources, is discussed, together with the harms of deforestation, energy consumption, pollution and other greenhouse gas-emitting activities. The latter includes direct and indirect health impacts, such as extreme weather, warmer air and seas, rising sea levels, and changing seasonal patterns decreasing agricultural productivity, altering distributions of disease vectors and threatening health and well-being in wealthy and poor nations with most harm resulting in the poor and marginalised, namely those who are least able to protect against or recover from these impacts.