Background:The SA DTA was updated to better serve the South African research community by providing clarity on exactly when - at what stage during research - institutions hold rights to the data they generate in collaborative research contexts where raw data are received and integrated with other data. SA DTA 1.1 introduces significant enhancements in data governance, focusing on the explicit definition and management of 'inferential data'. Objectives:To introduce SA DTA 1.1 and demonstrate its practical application in real-world research contexts. Methods:Using a descriptive design, the study presents two practical case studies: one involving two universities and another a university and a pharmaceutical company. The first case focuses on identifying genetic markers for neurodegenerative diseases, while the second addresses genetic markers for chronic diseases. Results:In the first case study, the entity conducting the analysis generated inferential data independently, thereby gaining sole rights in such data. In the second case study, both collaborating entities contributed to the data analysis, leading to joint rights in the inferential data. These findings demonstrate the flexibility and clarity provided by SA DTA 1.1 in managing data ownership and intellectual property rights. Conclusion:SA DTA 1.1 significantly advances data governance by providing clear and adaptable guidelines for data rights in collaborative research. It supports ethical and efficient data sharing, protecting researchers' interests and fostering global scientific innovation.

Many people who have reached the age of majority still qualify as financial dependents of their parents, and may be registered as dependents on their parents’ medical schemes. This poses a practical conundrum, because major persons enjoy complete autonomy over their bodies to choose healthcare services as they please, including informational determination. However, their sensitive health information may end up being disclosed in the accounts rendered to their parents, as main members of medical schemes, thereby breaching their informational privacy, medical confidentiality and possibly also damaging personal relationships. On the other hand, medical schemes must ensure that they strictly manage the business of their hospitalisation to ensure that they can adhere to their contractual and legal medical insurance obligations. Both major but financially dependent patients and medical schemes have good legal grounds to defend their respective positions. In this article, we will analyse and clarify the applicable legal and ethical grounds by considering medical confidentiality, the Protection of Personal Information Act, the Consumer Protection Act and the Medical Schemes Act and rules. We shall conclude with recommendations to accommodate the interests of both parties.

The idea of a data transfer agreement (DTA) template for the South African (SA) research community is receiving increasing attention. While developing such a DTA template is certainly a worthwhile project, questions regarding the project's practical execution should be addressed, including how to best operationalise the envisioned DTA template, and the content of the envisioned DTA template. It is proposed that an empowerment approach be followed in operationalising the envisioned DTA template, which is contrasted with the regulatory approach followed with the material transfer agreement that the Minister of Health promulgated in 2018. While the regulatory approach would entail government making the use of the envisioned DTA template compulsory regardless of the quality of such a template, the empowerment approach, by contrast, entails a focus on developing a high-quality, professionally drafted DTA template for the SA research community and making the use thereof a matter of own choice. Regarding the content of the envisioned DTA template, four hot-button content provisions are analysed, and it is argued that SA research institutions and researchers should be empowered to: (i) have clarity and legal certainty regarding their ownership of data, where relevant; (ii) be able to commercialise their research findings without unnecessary contractual constraints; (iii) avoid falling into the trap of unlawful benefit sharing with research participants; and (iv) be aware that their legal role as responsible parties, where relevant, cannot be contracted out via a DTA.

The prevalence of technology-embedded products, services, and cities, described colloquially as ‘smart’ technologies and ‘smart’ cities, has seen a spate of unprecedented growth in recent years. South Africa (SA) has not been left behind, with smartphones, smart watches, and smart voice-controlled virtual personal assistants such as Amazon’s Alexa now frequently used. But while these technologies hold great promise to revolutionise homes, offices and cities, their adoption poses challenges to individual and collective interests and wellbeing. After demonstrating the legal and ethical difficulties brought about by the introduction of these technologies, this article explores whether SA legislation is sufficiently robust to address these challenges. While the current legislative landscape addresses certain crucial difficulties – such as the safeguarding of personal data by the Protection of Personal Information Act No. 4 of 2013 (‘POPIA’) – it is suggested that the position regulating other aspects of smart technology adoption is, in large part, fragmented and ill-equipped to deal with some of the more pressing legal and ethical questions. Our contention is that, not dissimilar to the issues arising from artificial intelligence-based technological adoption, the extant legislative and regulatory frameworks do not go far enough in addressing the many concerns emerging from recent novel technological design, development, and deployment. Not only do smart technologies give rise to unique challenges, so does their deployment within the Global South and in South Africa, in particular. We suggest that appropriate and effective regulatory reform measures be undertaken in SA to provide better ethical guidance and policy prescriptions buttressed by rigorous regulatory oversight.

The transmission of cholera, a highly infectious disease, is closely linked to inadequate access to clean water and sanitation facilities, with resource-poor communities, including refugees, rural communities and temporary displacement camps particularly vulnerable to outbreaks. Any disruption in water and sanitation systems or a sudden surge in community size owing to displacement can spark a humanitarian and health crisis, elevating the risk of cholera transmission and possibly triggering a regional epidemic. Recently, Hammanskraal in Gauteng, South Africa, experienced such an epidemic. A multifaceted approach is essential to minimise fatalities and effectively manage healthcare services in such health emergencies. This approach includes early detection, rapid response to contain outbreaks, and the effective deployment of technical support, advocacy, resource mobilisation and partnerships at local, national, and international levels. This paper explores the responsibilities of individuals, healthcare workers, communities and governments in addressing epidemics. It also delves into the concept of collective responsibility with regard to climate change and cholera, as part of the multifaceted approach for cholera prevention and control. While economic development, equal access to safe drinking water, and adequate sanitation are necessary for cholera control, major challenges persist in achieving the fundamental right to a healthy environment in the long term. We also discuss these obstacles and conclude with practical suggestions and recommendations for future cholera prevention.

Globally, there has been a move toward ‘open science’ that includes the sharing of health data for research. The importance of data sharing for research is generally acknowledged, but this must only be done with legal and ethical procedures and protections in place. The use and sharing of health data for research in South Africa has changed with the coming into force of the Protection of Personal Information Act (POPIA). POPIA should ensure greater transparency and accountability in the use of personal information. POPIA, however, adopts a principle-based approach to the regulation of personal information, and there is a lack of clarity and uncertainty in the application of some of these principles to the use of health data for research. POPIA provides for sector-specific responses through the development of codes of conduct. In this article, we discuss the need for a code of conduct for health research, and an approach that could be adopted in its development.

No known cure exists for COVID-19, and medical practitioners are exhausted and at their wits' end trying to find treatments that prevent patients from ending up in hospital or intensive care, or even dying. A variety of treatments tried by medical practitioners include standard registered medicine, investigational or so-called experimental, unapproved or preapproved medicines, emergency or compassionate-use authorised medicine and pre-market approved medicine. However, the medicines that can be accessed via each of these categories are at different stages of efficacy testing and knowledge about adverse effects, dosages and risks. To obtain ethical and legal informed consent, medical practitioners must deal with a lot of medical uncertainty, and care must be taken to ensure that the patient understands the difference in risks they may be willing to take depending on the medicine's stage of development. Often additional information is required to obtain ethical consent as opposed to legal consent. A purely legal approach to informed consent, especially when dealing with the medical uncertainties of health emergencies and pandemics, may lead to patients' consent lacking in enough substance to be truly considered legal and ethical. Informed consent as respect for autonomy in this sense requires more than the patient's explicit agreement or compliance with a certain treatment proposal. This article explains the difference in consent content attached to each different stage of a medicine's development, especially considering the additional difficulties posed by obtaining truly informed consent during a pandemic with uncertain characteristics, treatment and solutions.

Open Access Exploring management perceptions of competitive versus transient advantage M. Botes M. Pretorius M. Botes M. Pretorius http://orcid.org/0000-0001-9729-3716 Affiliations 1University of Pretoria Published Online:1 Jul 2020https://hdl.handle.net/10520/EJC-1c35911b98SectionsPDF ToolsAdd to favouritesDownload CitationsTrack Citations ShareShare onFacebookTwitterLinked InRedditGMailOutlookYammermore AboutAbstractCreating a Sustainable Competitive Advantage (SCA) is regarded as the central principle of strategy. Yet, scholarly and practical debates require the ability to pursue a SCA as an organisational purpose. With contemporary environmental pressures, it is uncertain whether organisations practically have the ability to succeed in creating and sustaining a Competitive Advantage (CA). On the contrary, the concept of transient advantage (TA) shows an increasing prevalence and synergy towards dynamic environments. Despite this, several organisations indicate the retention of CA as focus. This research confirms that many decision-makers fail to understand the concepts and their applicability in business. The authors of this study address the limited academic attention to the understanding, relevance and differentiation of competitive and TA at practical level. The findings of exploratory research with senior-level managers point to business executives misapprehending other terms for CA, one being TA. Transient advantage appears to be deemed more prevalent, due to contemporary environmental pressures as well as volatile regulatory requirements. The pursuance of sustainability appears problematic. The study contributes practically in that TA can be intentionally pursued through the business model flexibility to improve organisational performance. Previous article Next article FiguresReferencesRelatedDetails None Volume 17, Issue 1 | Jul 2020 Downloaded 158 times AccreditationDepartment of Higher Education and Training (DHET)LanguagesEnglish InformationCopyright © 2020, JCMANLicensesThis work is licensed under a Creative Commons Attribution 4.0 International License.KeywordsCARelevanceTransient advantageQualitative studyNew competitive landscapePDF download Disclosure The authors confirm that the manuscript has been read and approved by all named authors and that there are no other persons who satisfied the criteria for authorship but are not listed. The authors confirm that they have given due consideration to the protection of intellectual property associated with this work and that there are no impediments to publication, including the timing of publication, with respect to intellectual property. Ethical conduct of research The authors state that they have obtained appropriate institutional review board outlined in the Declaration of Helsinki for all human or animal experimental investigations. A signed informed consent document has been obtained from all participants included in the study.

Containing the COVID-19 pandemic necessitates the use of personal information without the consent of the person. The protection of personal information is fundamental to the rights that ensure an open and democratic society. When regulations that limit the right to privacy are issued outside of the democratic process, every effort must be made to protect personal information and privacy. The limitation of human rights must be treated as an exception to the norm, and any regulations should be drafted to ensure minimum limitation of rights, rather than to the minimum acceptable standard. The contact tracing regulations included in the COVID-19 disaster regulations include some basic principles to ensure privacy; however, other important principles are not addressed. These include principles of transparency and data security. The envisaged future use of human data for research purposes, albeit de-identified, needs to be addressed by the COVID-19 designated judge appointed under the regulations.

Genomic research has been identified in South Africa (SA) as important in developing a strong bio-economy that has the potential to improve human health, drive job creation and offer potential solutions to the disease burden harboured by low- and middle-income countries. Central to the success of genomic research is the wide sharing of biological samples and data, but the true value of data can only be unlocked if there are laws and policies in place that foster the legal and ethical sharing of genomic data. The introduction and entry into force of SA's Protection of Personal Information Act (POPIA) No. 4 of 2013 is to be welcomed, but the wording of POPIA as it pertains to consent for the processing of personal information for research purposes has sparked a debate about the legal status of broad consent. We argue that a purposive interpretation of the legislation would permit broad consent for the processing of personal information for research. Although there are ongoing debates surrounding the ethical use of broad consent in Africa, the objective of this article is not to engage with the ethics of broad consent itself, but rather to focus on the legal status of broad consent for genomic data sharing under POPIA.

Background: Many people take wellness drinks on a daily basis to enhance physical and emotional well-being. The safety and/ or efficacy of these are not always known or even established in the populations likely to consume these. The safety, tolerability and clinical impact of CHD-FA in a formulated wellness drink (F0210) (a pure and novel fulvic acid) were researched in a pre-ART HIV-1 positive population in India an area where patients are known to use organic acids such as fulvic acids (Shilajit) for health enhancement. Methods: This double-blind, placebo-controlled, parallel study recruited 332 patients (n = 166 on active; n = 166 on placebo). The study outcomes recorded safety and tolerability data, as well as the time to ART and/or the time to a decrease in CD4 count of 100 cells/mm3 for subjects in each treatment group. Change in immune status is an important clinical endpoint. The secondary outcomes were CD4 count, HIV-1 viral load changes and quality of life (the latter as a further proxy for tolerability). Results: The only notable side effect of the active medication was gastrointestinal intolerance such as diarrhoea, nausea and vomiting, which were more frequently experienced compared with placebo. The study was terminated before full recruitment due to regulatory changes in India and at the time of study termination there were too few clinical study endpoints reached to demonstrate any clinical difference between active and placebo treatments (no difference in hazard of experiencing an event (reaching indication for ART) between groups; p = 0.5724). An interesting trend was that patients’ CD4 counts in the study demonstrated a slower than anticipated decline compared with trends recorded in the literature for natural progression of disease. Conclusion: The CHD FA wellness drink is well tolerated in an ART-naive study population and does not negatively affect the disease-specific parameters and hence does not adversely affect the natural progression of the HIV-1 disease or patients’ general health. Further exploration of fulvic acids is therefore warranted.

HIV drug resistance has been described in all antiretroviral drug classes and threatens the long-term success of HIV treatment. Here, we describe the first reported case of acquired resistance to the integrase strand transfer inhibitors in South Africa. This case illustrates the dilemma of treatment in the context of inadequate adherence and poor psychosocial support and highlights the potential risk of transmission of multidrug-resistant virus.

One of the biggest medical accomplishments of the beginning of this century has been the expanded access to life-saving antiretroviral treatment for HIV-infected people living in sub-Saharan Africa. A potential downside of the large-scale exposure to antiretroviral drugs is the emergence of HIV drug resistance. This risk is increased by the weak health systems in many African countries, characterized by poor infrastructure, intermittent drug supply, and shortage of skilled staff. In order to evaluate the extent of HIV drug resistance in Africa, the PharmAccess African Studies to Evaluate Resistance (PASER) network was established in 2006. In six countries - Kenya, Nigeria, South Africa, Uganda, Zambia and Zimbabwe - over fifteen clinics participated in observational studies among HIV-infected adults. In Uganda, a pediatric study was initiated to investigate the development of HIV drug resistance among children. The studies included in this thesis were conducted as part of the PASER adult and pediatric programs.

BACKGROUNDAs antiretroviral therapy (ART) programs in sub-Saharan Africa mature, increasing numbers of persons with human immunodeficiency virus (HIV) infection will experience treatment failure, and require second- or third-line ART. Data on second-line failure and development of protease inhibitor (PI) resistance in sub-Saharan Africa are scarce.METHODSHIV-1-infected adults were included if they received >180 days of PI-based second-line ART. We assessed risk factors for having a detectable viral load (VL, ≥400 cps/mL) using Cox models. If VL was ≥1000 cps/mL, genotyping was performed.RESULTSOf 227 included participants, 14.6%, 15.2% and 11.1% had VLs ≥400 cps/mL at 12, 24, and 36 months, respectively. Risk factors for a detectable VL were as follows: exposure to nonstandard nonnucleoside reverse-transcriptase inhibitor (NNRTI)-based (hazard ratio, 7.10; 95% confidence interval, 3.40-14.83; P < .001) or PI-based (7.59; 3.02-19.07; P = .001) first-line regimen compared with zidovudine/lamivudine/NNRTI, PI resistance at switch (6.69; 2.49-17.98; P < .001), and suboptimal adherence (3.05; 1.71-5.42; P = .025). Among participants with VLs ≥1000 cps/mL, 22 of 32 (69%) harbored drug resistance mutation(s), and 7 of 32 (22%) harbored PI resistance.CONCLUSIONSAlthough VL suppression rates were high, PI resistance was detected in 22% of participants with VLs ≥1000 cps/mL. To ensure long-term ART success, intensified support for adherence, VL and drug resistance testing, and third-line drugs will be necessary.

BACKGROUND:After the scale-up of antiretroviral therapy (ART) for human immunodeficiency virus (HIV) infection in Africa, increasing numbers of patients have pretreatment drug resistance.METHODS:In a large multicountry cohort of patients starting standard first-line ART in six African countries, pol genotyping was retrospectively performed if viral load (VL) ≥1000 cps/mL. Pretreatment drug resistance was defined as a decreased susceptibility to ≥1 prescribed drug. We assessed the effect of pretreatment drug resistance on all-cause mortality, new AIDS events and switch to second-line ART due to presumed treatment failure, using Cox models.RESULTS:Among 2579 participants for whom a pretreatment genotype was available, 5.5% had pretreatment drug resistance. Pretreatment drug resistance was associated with an increased risk of regimen switch (adjusted hazard ratio [aHR] 3.80; 95% confidence interval [CI], 1.49-9.68; P = .005) but was not associated with mortality (aHR 0.75, 95% CI, .24-2.35; P = .617) or new AIDS events (aHR 1.06, 95% CI, .68-1.64; P = .807). During three years of follow up, 106 (4.1%) participants switched to second-line, of whom 18 (17.0%) switched with VL < 1000 cps/mL, 7 (6.6%) with VL ≥ 1000 cps/mL and no drug resistance mutations (DRMs), 46 (43.4%) with VL ≥ 1000 cps/mL and ≥1 DRMs; no HIV RNA data was available for 32 (30.2%) participants.CONCLUSIONS:Given rising pretreatment HIV drug resistance levels in sub-Saharan Africa, these findings underscore the need for expanded access to second-line ART. VL monitoring can improve the accuracy of failure detection and efficiency of switching practices.

Objective:Maraviroc, a chemokine co-receptor type 5 (CCR5) antagonist, has demonstrated comparable efficacy and safety to efavirenz, each in combination with zidovudine/lamivudine, over 96 weeks in the Maraviroc vs. Efavirenz Regimens as Initial Therapy (MERIT) study. Here we report 5-year findings.Design:A randomized, double-blind, multicenter phase IIb/III study with an open-label extension phase.Methods:Treatment-naive patients with CCR5-tropic HIV-1 infection (Trofile) received maraviroc 300 mg twice daily or efavirenz 600 mg once daily, and zidovudine/lamivudine 300 mg/150 mg twice daily. After the last patient's week 96 visit, the study was unblinded and patients could enter a nominal 3-year open-label phase. Endpoints at the 5-year nominal visit (week 240) included proportion of patients (CCR5 tropism re-confirmed by enhanced sensitivity Trofile) with viral load (plasma HIV-1 RNA) below 50 and 400 copies/ml, and change from baseline in CD4(+) cell count, as well as safety.Results:The proportion of patients maintaining viral load below 50 copies/ml was similar between treatment arms throughout the study and at week 240 (maraviroc 50.8% vs. efavirenz 45.9%). Maraviroc-treated patients had a greater increase from baseline in mean CD4(+) cell count than efavirenz-treated patients at week 240 (293 vs. 271 cells/mu l, respectively). Fewer patients on maraviroc vs. efavirenz experienced treatment-related adverse events (68.9 vs. 81.7%) and discontinued as a result of any adverse event (10.6 vs. 21.3%).Conclusion:Maraviroc maintained similar long-term antiviral efficacy to efavirenz over 5 years in treatment-naive patients with CCR5-tropic HIV-1. Maraviroc was generally well tolerated with no unexpected safety findings or evidence of long-term safety concerns.

A theoretical concern exists that atazanavir (ATV) use during pregnancy may exacerbate physiologic neonatal hyperbilirubinemia. The aim of this substudy was to evaluate patterns of neonatal bilirubin following ATV/ritonavir (RTV) treatment of pregnant mothers and clinical and pharmacogenetic factors that may correlate. The design involved a subanalysis of study AI424182, a multicenter, open-label, prospective, single-arm Phase I study. The study had two treatment arms: (1) ATV/RTV 300/100 mg once daily or (2) ATV/RTV 400/100 mg once daily, both in combination with zidovudine/lamivudine 300/150 mg twice daily. Total bilirubin was assessed at baseline, each visit, and delivery day for mothers and on days 1 (delivery day), 3, 5, and 7 and weeks 2 and 6 for neonates. Blood samples were obtained for UGT1A1 genotyping and ATV cord blood concentration. Bilirubin elevation of any grade occurred in 14/40 neonates (35%). All Grade 3 to 4 bilirubin abnormalities (n=7) occurred after day 14. The pattern of neonatal bilirubin levels reported was consistent with neonatal physiologic elevations of bilirubin. Little correlation was observed between either maternal bilirubin levels over the last 4 weeks of pregnancy (including delivery) or ATV cord concentration and neonatal bilirubin. There was a significant association between UGT1A1 genotype and bilirubin grade in the maternal population (p=0.0006) but not neonates (p=0.49). Neither neonatal UGT1A1 genotype nor cord blood ATV concentration is a good predictor of neonatal hyperbilirubinemia. ATV/RTV treatment of mothers does not appear to exacerbate neonatal physiologic hyperbilirubinemia.

BACKGROUND:This study assessed HIV-hepatitis B virus (HBV) coinfection in southern Africa in terms of prevalence, viral characteristics, occult HBV, and the effect of lamivudine- versus tenofovir-containing first-line combination antiretroviral treatment (cART) on HBV-related outcomes.METHODS:A multicenter prospective cohort of HIV-infected adults in Zambia and South Africa who initiated cART. Outcomes by month 12 on cART were immunological recovery, hepatitis B surface antigen (HBsAg) loss, viral suppression, and drug resistance. We used descriptive statistics, logistic regression, and linear mixed models.RESULTS:Of the 1087 participants, 92 were HBsAg seropositive, yielding a sample-weighted prevalence of 7.4% (95% confidence interval: 5.6 to 9.2), with 76% genotype HBV-A1. The estimated CD4 recovery on cART was similar between HIV monoinfection and HIV-HBV coinfection groups and between lamivudine- and tenofovir-treated participants. HBsAg loss was documented in 20% (4/20) of lamivudine-treated and 18% (3/17) of tenofovir-treated participants (P = 0.305). Viral suppression (HBV-DNA < 20 IU/mL) was achieved in 61.5% (16/26) of lamivudine-treated and 71.4% (15/21) of tenofovir-treated participants (P = 0.477). HBV pol sequencing demonstrated M204I (n = 3) and N236T (n = 1) resistance-associated mutations in 4 of 8 (50%) lamivudine-treated participants and none in tenofovir-treated participants. Occult HBV infection was present in 13.3% before cART, but by month 12, HBV-DNA was below the limit of detection (<15 IU/mL) in 90.5% (19/21) of lamivudine-treated and 100% (18/18) of tenofovir-treated participants (P = 0.179).CONCLUSIONS:Tenofovir-containing first-line cART is preferred for HIV-HBV coinfection in Africa because of a superior resistance profile relative to lamivudine monotherapy. Extended follow-up will be needed to determine long-term complications of occult HBV coinfection. Improved access to HBsAg screening and tenofovir is needed.

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Little is known about the effect of human immunodeficiency virus type 1 (HIV-1) resistance mutations present at time of regimen switch on the response to second-line antiretroviral therapy in Africa. In adults who switched to boosted protease inhibitor-based regimens after first-line failure, HIV-RNA and genotypic resistance testing was performed at switch and after 12 months. Factors associated with treatment failure were assessed using logistic regression. Of 243 participants, 53% were predicted to receive partially active second-line regimens due to drug resistance. The risk of treatment failure was, however, not increased in these participants. In this African cohort, boosted protease inhibitors successfully resuppressed drug-resistant HIV after first-line failure.