Showing papers in "South African Journal of Bioethics and Law in 2016"

Contextualising the role of the gatekeeper in social science research

Abstract: Accessing research participants within some social institutions for research purposes may involve a simple single administrative event. However, accessing some institutions to conduct research on their data, personnel, clients or service users can be quite complex. Research ethics committee chairpersons frequently field questions from researchers wanting to know when and why gatekeeper permission should be sought. This article examines the role and influence of gatekeepers in formal and organisational settings and explores pragmatic methods to improve understanding and facilitation of this process. Conscientious and well-informed negotiations with gatekeepers are required in order to honour the ethical obligations to conduct appropriate stakeholder engagement before and during research, along with respect for the autonomy of institutions and their employees/clients/service recipients. Provision must be made to identify explicit and implicit gatekeepers to initiate and build collaborative networks that could best support the research process. Careful mutually respectful access agreements which consider the needs and vulnerabilities of both the gatekeeper and the researcher can improve the quality of the scientific data collected. Strategic planning in the research process must take these sometimes complex processes of gatekeeper permission into careful account.

Social media in the healthcare context: Ethical challenges and recommendations

Abstract: The popularity of social media has grown rapidly and healthcare practitioners and students commonly use sites such as Facebook. The ethical and professional implications and their benefits and hazards must be considered. Concerns include blurring of boundaries between an individual’s public and professional lives, maintaining privacy and confidentiality of patient information, damaging the public image of the profession and inter-professional relationships. The same laws that apply to conduct in the real world also apply in cyberspace. Harmful or derogatory posts may result in a defamation lawsuit. The internet may also provide opportunities for patient education through peerreviewed websites and to build professional networks. Institutions should have policies on the uses of social media. Emerging technology will continue to change the landscape of social media and social networking and the way patients and practitioners use websites will continue to evolve. Practitioners should proactively manage digital identity by reviewing publicly available material and maintaining strict privacy settings about their information.

A critical review of health research ethical guidelines regarding caregiver consent for HIV research involving minors in South Africa: Ethical and legal issues

Abstract: 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.

HIV, trauma and the emergency departments: The CDC opt-out approach should be adopted in South Africa

Abstract: 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.

Mediation as an alternative solution to medical malpractice court claims

Abstract: Is there a crisis in the healthcare industry? Most certainly there is Dr Motsoaledi, Minister of Health, publicly acknowledged the existence of such a crisis at a Medico-Legal Summit held at his initiative in Pretoria on 9 and 10 March 2015 at St Georges Hotel[1] Currently, as recently confirmed by the MEC for Health, Ms Mahlangu, there are about 2 000 pending court cases against the Gauteng Provincial Health Department, the total quantum being claimed amounting to approximately ZAR 35 billion During 2013/2014 this department spent about ZAR 256 million on legal costs payable to claimants’ attorneys No budget for these expenses exists, resulting in payment being made from funds designated for the acquisition of medical equipment and other purposes[1] This undermines the department’s ability to renew old equipment and upgrade to more modern equipment, resulting in even further claims More claims are therefore to be expected The Medical Protection Society also confirmed an increase in medical malpractice claims against their members of nearly 550% compared to 10 years ago The quantum of claims that exceeded ZAR 5 million per claim, also increased by 900%[2,3] The ripple effect of these increases in medico-legal claims causes insurance premiums for healthcare professionals to become exorbitantly expensive, resulting in some practitioners leaving the medical profession Practitioners also act more defensively in applying their trade, resulting in additional and sometimes unnecessary tests that increase the costs of medical care and often cause further grounds for the institution of claims

Climate change in Africa and the Middle East in light of health ubuntu and Islam

Abstract: 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.

Respect for vulnerability is a human right: Article 8 of the UNESCO Declaration on Bioethics and Human Rights, and senior citizens in South Africa

Abstract: It is untrue that the elderly in South Africa (SA) are probably discriminated against in healthcare as the result of inadequate legislation that does not conform to international standards. The National Health Act recognises vulnerability and gives expression to it. Respect for vulnerability has not yet been introduced to fundamental political and bioethical frames of reference in SA and that is probably the reason why the concept and right have not become part of the ethical awareness in healthcare. The appeal of this article is that respect for vulnerability must be brought to conform to the Universal Declaration on Bioethics and Human Rights by declaring the ethical principle as an independent human right.

Constitutional, legal and regulatory imperatives for the renewed care and prevention of congenital disorders in South Africa

Abstract: Medical genetic services for the care and prevention of congenital disorders have declined significantly in recent years due to competing health priorities, with previously developed services becoming compromised With an infant mortality rate of 28/1 000 live births, South Africa (SA) has passed the threshold of 40/1 000 when such services should be implemented This article outlines the international background and SA legislative framework for medical genetic services and their implementation International, regional and national conventions, legislation, and policy were studied for relevance to genetic services and their implementation was evaluated, including a comparison of sector capacity between 2001 and 2015 A comprehensive legislative and regulatory framework exists in SA for the provision of medical genetic services, but implementation has been fragmented and unsustained Congenital disorders and genetic services are not prominent in national strategies and excluded from interventions aimed at combating child mortality and non-communicable diseases Capacity today is at a lower level than in 2001 The failure to recognise the burden of disease represented by congenital disorders is the underlying reason for the implementation and service shortfall Child mortality rates have stagnated since 2011 and can be significantly further reduced by prioritising healthcare issues other than HIV/AIDS, including congenital disorders It is now an imperative that SA responds to World Health Assembly Resolution 6317 and prioritises congenital disorders as a healthcare issue, providing services to uphold the dignity and human rights of the most vulnerable members of society

The right to physical integrity and informed refusal : just how far does a patient’s right to refuse medical treatment go?

Abstract: 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.

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

Abstract: 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 was set at p <0.05. 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 WMA Declaration of Taipei: Human databases and biobanks for the common good

Abstract: 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.[1] The guidelines, named The Declaration of Taipei,[2] were approved by delegates at the WMA’s annual assembly in Taiwan.

But is this really the 'parent' or 'guardian'? Practical strategies for consent to child research in South Africa

Abstract: Research ethics committees (RECs) in South Africa may require consent from a parent or legal guardian for child research. In instances where an REC determines that parental or guardianship consent is required, how far should researchers go to establish if the accompanying adult is in fact the parent or guardian? Should researchers accept disclosures at face value, probe assertions that are made, or even call for supporting documentation? In this article we set out the facts research staff should possess, propose key questions they could ask, and recommend practical steps for uncertain cases. We recognise that a parental/guardianship consent strategy may not be appropriate in all instances, but do not debate that issue in this article. This article is confined to practical advice for researchers wishing to implement a parental or guardianship consent approach.

Enhanced REC collaborative review through video-conferencing

Abstract: 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.

Medical negligence: Alternative claims resolution an answer to the epidemic?

Abstract: The price paid by society because of unreasonable medical neg­ ligence claims cannot be ignored While medical malpractice systems in the country are exorbitantly costly, they are also inefficient This impacts directly on access to healthcare, a basic human right in the country as enshrined in section 27 of the Bill of Rights of the Constitution of South Africa (SA) [1] Practising defensive medicine, irrespective of the sector in which healthcare is delivered, has now become the norm, with the focus being not just patient health and best interests, but also that of safeguarding against possible medical malpractice liability, thereby increasing unnecessary clinical and diagnostic procedures The unequivocal situation is that currently the fear of lawsuits holds hostage practitioners’ options and preferences for delivery of ethically exercised care to their patients, leading to frustration and dissatisfaction both to practitioners and patients [2]

Reproductive autonomy : a case study

Abstract: 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.

Knowledge and attitude of postgraduate students in Kenya on ethics in mental health research

Abstract: 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 practice 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.

Should drinking during pregnancy be criminalised to prevent fetal alcohol spectrum disorder

Abstract: The harmful effects of alcohol use during pregnancy have been well documented. Fetal alcohol spectrum disorder (FASD) is the collective term encompassing the various clinical diagnoses that can occur in a child who was exposed to alcohol prenatally. The affected child suffers a range of lifelong primary and secondary disabilities. There is no cure for FASD, but it is preventable if women do not drink during pregnancy. Should women be banned from, and/or punished for drinking during pregnancy for the sake of preventing fetal harm? This article considers the appropriateness of criminalising drinking during pregnancy as a means of preventing fetal harm and consequently FASD in children, and concludes that criminal approaches are unjustified, potentially discriminatory and likely to be ineffective.

Medical Ethics Today. The BMA's Handbook of Ethics and Law, British Medical Association, Ethics Department : book review

Abstract: With rapid advances in science and technology modern healthcare gives rise to complex multidimensional dilemmas that the physician is not fully equipped to handle. Furthermore, in many countries, physician autonomy has been restrained by governments and other authorities enforcing controls on medical practitioners, adding to the many issues they are confronted with. Physicians are challenged with questions on behavior and decision-making as frequently as scientific and technical ones on an almost daily basis in current medical practice. It is therefore not surprising that the BMA's Handbook of Ethics and Law goes beyond a simple guidebook or manual and is a voluminous comprehensive sourcebook of around 1 000 pages covering almost every eventuality that physicians could face in the practice of healthcare.

May doctors refuse to treat rape survivors in order to avoid having to give evidence in court

Abstract: It has been reported recently that private doctors often refuse to treat rape survivors because they do not want to give evidence in court. Private doctors and hospitals must treat patients in emergency situations, but may otherwise refuse to treat patients provided such refusal is not unconstitutional. Rape survivors require emergency medical treatment and should not be refused treatment by private doctors and hospitals because practitioners do not wish to give evidence in court. Such refusal is unconstitutional. Sexual assault evidence kits may be used by both private doctors and hospitals. Given the high rate of sexual violence in South Africa it is recommended that both private and state doctors should have stocks of sexual assault kits, and the National Police Commissioner’s national instruction for providing assistance to survivors of sexual offences. District surgeons ‘on call’ must treat rape survivors as requiring emergency medical treatment. They may not defer seeing them until the next day as this violates their constitutional right to dignity and exposes them to secondary victimisation.

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?

Abstract: 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.

Ethical considerations in implementing a biometric co-enrolment prevention system in clinical trials in South Africa

Abstract: Preventing co-enrolment in clinical trials ensures participant safety and data integrity To facilitate co-enrolment checks, a novel biometric coenrolment prevention system (BCEPS) was developed and implemented in 2010 by the HIV Prevention Research Unit (HPRU) in collaboration with the South African Medical Research Council’s (SAMRC) Information Technology Services Division The use of this web-based system to capture participant’s identification details in real time was approved by the SAMRC Ethics Committee BCEPS was implemented at 13 other research organisations conducting clinical trials in South Africa (SA) Participants who screened at the clinical research sites (CRSs) had their names, SA identity or passport number and fingerprints captured onto BCEPS after comprehensive education and discussion This information was verified at all study visits If a participant attempted to screen or co-enrol at multiple CRSs, the system flagged this as a potential coenrolment By addressing the ethical concerns around participant consent and rights, participant confidentiality and privacy, data security and access, and data management and storage, we were able to successfully implement BCEPS within the clinical trials conducted at HPRU, while adhering to the principles of good clinical practice (GCP), including respect for persons, beneficence and justice

Client confidentiality: Perspectives of students in a healthcare training programme

Abstract: Background . Confidentiality is an important ethical principle for all health professionals and also has a legal bearing on duty. One of the most difficult issues health professionals face in their daily fieldwork practice is a conflict between their professional duties, as illustrated in keeping a patient’s medical information confidential, and having empathy with a family member’s need to know. This moral dilemma is difficult for students to circumvent and therefore this paper presents healthcare students’ perspectives of confidentiality. Methods . We aimed to explore healthcare students’ views and experiences of confidentiality as an ethical principle by adopting a qualitative explorative approach. Purposeful sampling was undertaken where specific individuals with specific experiences were identified. Data were collected by means of written responses from two open-ended questions and analysed thematically. Two themes emerged. Conclusion . Confidentiality, as with other ethical principles, is an important obligation of a good client-therapist relationship as identified by students. However, the students’ responses illustrate that it cannot be absolute, and cognisance must be taken as to when it is acceptable, and even desirable, to override confidentiality because of conflicting, greater duties.

Bioethical Insights into Values and Policy: Climate Change and Health

Abstract: 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.