scholarly journals INCIDENTAL FINDINGS IN BIO BANKS IN SOUTH AFRICA: ETHICAL AND LEGAL ISSUES

Obiter ◽  
2014 ◽  
Vol 35 (2) ◽  
Author(s):  
Maureen Mswela ◽  
Patricia Molusi
Keyword(s):  
South Africa ◽  
Incidental Findings ◽  
Genomic Research ◽  
Return Of Results ◽  
Research System ◽  
Primary Research ◽  
Potential Health ◽  
Secondary Research ◽  
Biobank Research ◽  
Legal Challenges

Biobanks have come to be essential apparatuses of genetic and genomic research as they are seen as essential tools for translational medicine in particular. Various unique ethical and legal challenges arise in the course of biobanking as biobanks generate a range of ethical and legal challenges related to privacy, informed consent, control and ownership, withdrawal of samples, commercialization, genomic sovereignty, return of results, incidental findings, and research governance. These issues have generated much policy debate within the international world, and yet in South Africa, debates on the ethical and legal challenges posed by biobanks and biobank networks still remain alienated. According to Wolf, biobanks are the dominant part of a “biobank research system,” consisting of primary research also known as collection sites, the biobank, and secondary research sites that access biobank data or samples for further research. Therefore, incidental findings could arise at several points in a biobank-research system, that is, in primary research, biobank research, and secondary research. Within the South African context literature and guidance are sparse on the handling of significant incidental findings which are identified in biobank systems. How incidental findings should be handled as well as the role of biobanks in enabling this process, are well-founded concerns. Unresolved in South Africa, is how to manage incidental findings of potential health, reproductive, environmental and medicinal risk that are of particular importance to individual contributors. With a proposal for a national biobank in South Africa, it is apparent that researchers as well as clinicians are anticipated to access data from biobanks and to this end, laws, clear public guidance and regulations on the handling of incidental findings are indispensable.

scholarly journals International Policies on Sharing Genomic Research Results with Relatives: Approaches to Balancing Privacy with Access

2015 ◽  
Vol 43 (3) ◽  
pp. 576-593
Author(s):  
Rebecca Branum ◽  
Susan M. Wolf
Keyword(s):  
Genetic Risk ◽  
Incidental Findings ◽  
Research Community ◽  
Genomic Research ◽  
Return Of Results ◽  
Research Results ◽  
International Policies

Debate over return of results and incidental findings to participants in genetic and genomic research has exploded over the last decade. At this point, there is wide agreement that investigators have a responsibility to anticipate discovery of findings that may warrant return, to incorporate in protocols a plan for evaluating such findings, and to offer at least some of these results to participants consenting to such return. However, the issue of how to handle questions from a participant’s genetic relatives about their own risk, or whether investigators should alert relatives to a genetic risk they may share, has garnered much less attention. Only recently has the genomic research community begun to debate these questions and offer recommendations.

scholarly journals ‘CTRL’: an online, Dynamic Consent and participant engagement platform working towards solving the complexities of consent in genomic research

2021 ◽  
Author(s):  
Matilda A. Haas ◽  
Harriet Teare ◽  
Megan Prictor ◽  
Gabi Ceregra ◽  
Miranda E. Vidgen ◽  
...  
Keyword(s):  
Large Scale ◽  
Genomic Medicine ◽  
International Standards ◽  
Security And Privacy ◽  
Genomic Research ◽  
Return Of Results ◽  
Future Research ◽  
Design And Development ◽  
Participant Engagement ◽  
Dynamic Consent

AbstractThe complexities of the informed consent process for participating in research in genomic medicine are well-documented. Inspired by the potential for Dynamic Consent to increase participant choice and autonomy in decision-making, as well as the opportunities for ongoing participant engagement it affords, we wanted to trial Dynamic Consent and to do so developed our own web-based application (web app) called CTRL (control). This paper documents the design and development of CTRL, for use in the Australian Genomics study: a health services research project building evidence to inform the integration of genomic medicine into mainstream healthcare. Australian Genomics brought together a multi-disciplinary team to develop CTRL. The design and development process considered user experience; security and privacy; the application of international standards in data sharing; IT, operational and ethical issues. The CTRL tool is now being offered to participants in the study, who can use CTRL to keep personal and contact details up to date; make consent choices (including indicate preferences for return of results and future research use of biological samples, genomic and health data); follow their progress through the study; complete surveys, contact the researchers and access study news and information. While there are remaining challenges to implementing Dynamic Consent in genomic research, this study demonstrates the feasibility of building such a tool, and its ongoing use will provide evidence about the value of Dynamic Consent in large-scale genomic research programs.

scholarly journals Multidrug-Resistant Listeria Species Shows Abundance in Environmental Waters of a Key District Municipality in South Africa

2021 ◽  
Vol 18 (2) ◽  
pp. 481
Author(s):  
Liyabona Mpondo ◽  
Kingsley Ehi Ebomah ◽  
Anthony Ifeanyi Okoh
Keyword(s):  
South Africa ◽  
Surface Waters ◽  
Multidrug Resistant ◽  
Eastern Cape ◽  
Environmental Waters ◽  
Potential Health ◽  
Phenotypic Resistance ◽  
Listeria Species ◽  
Polymerase Chain ◽  
Identification And Characterization

The prevalence of bacteria with multidrug-resistance (MDR) is a significant threat to public health globally. Listeria spp. are naturally ubiquitous, with L. monocytogenes particularly being ranked as important foodborne disease-causing microorganisms. This study aimed to evaluate the incidence and determine the antimicrobial resistance (AMR) profiles of multidrug-resistant Listeria spp. (MDRL) isolated from different environmental samples (river and irrigation water) in the Sarah Baartman District Municipality (SBDM), Eastern Cape Province (ECP), South Africa. Molecular identification and characterization were carried out using polymerase chain reaction (PCR) and isolates that exhibited phenotypic resistance were further screened for relevant antimicrobial-resistant genes (ARGs). Findings revealed a total of 124 presumptive Listeria isolates; 69 were molecularly confirmed Listeria species. Out of the confirmed species, 41 isolates (59%) were classified as L. monocytogenes while 9 (13%) were classified as L. welshimeri. All Listeria spp. exhibited phenotypic resistance against ampicillin, penicillin, and trimethoprim-sulphamethoxazole and further screening revealed ARGs in the following proportions: sulI (71%), blaTEM (66%), tetA (63%), and blaCIT (33%). Results confirmed the occurrence of ARGs among Listeria inhabiting surface waters of ECP. The present study indicates that the river water samples collected from SBDM are highly contaminated with MDRL, hence, constituting a potential health risk.

scholarly journals Pediatric Cancer Genetics Research and an Evolving Preventive Ethics Approach for Return of Results after Death of the Subject

2015 ◽  
Vol 43 (3) ◽  
pp. 529-537
Author(s):  
Sarah Scollon ◽  
Katie Bergstrom ◽  
Laurence B. McCullough ◽  
Amy L. McGuire ◽  
Stephanie Gutierrez ◽  
...  
Keyword(s):  
Cancer Genetics ◽  
Recurrence Risk ◽  
Genomic Research ◽  
Return Of Results ◽  
Genetics Research ◽  
Personal Significance ◽  
Pediatric Diseases ◽  
Increased Risk ◽  
Preventive Ethics ◽  
Risk Of Cancer

In the pediatric clinical setting, the parent/guardian will almost always be the authorized representative and designated recipient of clinical and research results, making the issue of to whom results should be returned in the pediatric setting less complex than in adult settings. It is also clear that, in genomic research related to pediatric diseases such as cancer, results may be of considerable clinical, ethical, and personal significance for parents in a number of ways, including a genomic explanation of the origin of their child’s cancer, implications for the genetic testing and medical care of other siblings and of the parents themselves, and reproductive planning with regard to the recurrence risk for future children to have an increased risk of cancer. However, what remains unclear is which results should be disclosed, and under what circumstances, to parents of deceased children.

scholarly journals Setting the global research agenda for community-based HIV service delivery through the faith sector

2021 ◽  
Vol 19 (1) ◽  
Author(s):  
Martha T. Ndlovu-Teijema ◽  
Maarten O. Kok ◽  
Sabine L. van Elsland ◽  
Hilleen Smeets ◽  
David Barstow ◽  
...  
Keyword(s):  
South Africa ◽  
Focus Group ◽  
Research Agenda ◽  
Primary Research ◽  
Focus Group Discussions ◽  
Online Questionnaire ◽  
Group Discussions ◽  
Community Based ◽  
Faith Leaders ◽  
Global Research

Abstract Background While leading AIDS organizations expect faith and health collaborations to play a crucial role in organizing and scaling up community-based HIV services, it is unclear how this can be realized. Little primary research has been conducted into which strategies for collaboration and service provision are most effective, efficient, scalable and sustainable. Seeking to align research with urgent needs, enhance coordination and increase the likelihood that results are used, this study aimed to set an inclusive global research agenda that reflects priority research questions from key stakeholders at the intersection of HIV healthcare and faith. Methods In order to develop this global research agenda, we drew from document analyses, focus group discussions, interviews with purposively selected key informants from all continents (policy-makers, healthcare providers, faith leaders, academics and HIV activists), an online questionnaire, and expert meetings at several global conferences. We carried out focus group discussions and interviews with faith leaders in South Africa. Other stakeholder focus groups and interviews were carried out online or in person in France, Switzerland, the Netherlands and South Africa, and virtual questionnaires were distributed to stakeholders worldwide. Respondents were purposively sampled. Results We interviewed 53 participants, and 110 stakeholders responded to the online questionnaire. The participants worked in 54 countries, with the majority having research experience (84%), experience with policy processes (73%) and/or experience as a healthcare provider (60%) and identifying as religious (79%). From interviews (N = 53) and questionnaires (N = 110), we identified 10 research themes: addressing sexuality, stigma, supporting specific populations, counselling and disclosure, agenda-setting, mobilizing and organizing funding, evaluating faith-health collaborations, advantage of faith initiatives, gender roles, and education. Respondents emphasized the need for more primary research and prioritized two themes: improving the engagement of faith communities in addressing sexuality and tackling stigma. Conclusions A wide range of respondents participated in developing the research agenda. To align research to the prioritized themes and ensure that results are used, it is essential to further engage key users, funders, researchers and other stakeholders, strengthen the capacity for locally embedded research and research uptake and contextualize priorities to diverse religious traditions, key populations and local circumstances.

scholarly journals Prevalence and Correlates of Snuff Use, and its Association With Tuberculosis, Among Women Living With HIV in South Africa

2018 ◽  
Vol 21 (8) ◽  
pp. 1087-1092 ◽  
Author(s):  
Jessica L Elf ◽  
Ebrahim Variava ◽  
Sandy Chon ◽  
Limakatso Lebina ◽  
Katlego Motlhaoleng ◽  
...  
Keyword(s):  
South Africa ◽  
Tobacco Use ◽  
Smokeless Tobacco ◽  
People Living With Hiv ◽  
Potential Health ◽  
Adjusted Analysis ◽  
Women Living With Hiv ◽  
Urine Cotinine ◽  
Smokeless Tobacco Use ◽  
Living With Hiv

Abstract Introduction A higher proportion of people living with HIV (PLWH) smoke compared to the general population, but little information exists about the prevalence and correlates of smokeless tobacco use among PLWH. In South Africa, dry powdered tobacco is inhaled nasally as snuff. Methods A cross-sectional survey among PLWH attending three HIV clinics was conducted. Snuff use was assessed via self-report and urine cotinine. Results Given the low (3%) prevalence of snuff use among men, analysis was restricted to n = 606 nonsmoking women living with HIV. Half (n = 298, 49%) were snuff users, the majority of whom (n = 244, 84%) had a positive urine cotinine test. In adjusted analysis, snuff use was negatively associated with higher education (relative risk [RR] 0.55; 95% confidence interval [CI]: 0.39, 0.77) and mobile phone ownership (RR 0.83; 95% CI: 0.71, 0.98), and positively associated with ever having tuberculosis (TB) (RR 1.22; 95% CI: 1.03, 1.45). In adjusted analysis, with current TB as the outcome, snuff use was marginally statistically significantly associated with a twofold increase in odds of a current TB diagnosis (odds ratio [OR] 1.99; 95% CI: 0.98, 4.15). Discussion A high proportion of nonsmoking South African women living with HIV use snuff, which was a risk factor for TB. Additional research is needed to understand the relationship between snuff, TB, and other potential health risks. Implications PLWH have a higher prevalence of smoking than their seronegative peers, but there is a paucity of research on smokeless tobacco use in this population, especially in low-resource settings. TB is the leading cause of death among PLWH, and with improvements to HIV treatment and care, PLWH are at greater risk of tobacco-related diseases. We report an extremely high prevalence of snuff use among women living with HIV in South Africa. Further, in this population snuff use is positively associated with ever having a TB diagnosis, as well as currently having TB.

scholarly journals Shining a Light also Casts a Shadow: Neuroimaging Incidental Findings in Neuromarketing Research

Neuroethics ◽  
2021 ◽  
Author(s):  
Owen M. Bradfield
Keyword(s):  
Public Health ◽  
Rapid Growth ◽  
Incidental Findings ◽  
Brain Research ◽  
Social Value ◽  
Financial Resources ◽  
Potential Health ◽  
Functional Brain ◽  
Public Health Systems ◽  
The Social

AbstractRapid growth in structural and functional brain research has led to increasing ethical discussion of what to do about incidental findings within the brains of healthy neuroimaging research participants that have potential health importance, but which are beyond the original aims of the study. This dilemma has been widely debated with respect to general neuroimaging research but has attracted little attention in the context of neuromarketing studies. In this paper, I argue that neuromarketing researchers owe participants the same ethical obligations as other neuroimaging researchers. The financial resources available to neuromarketing firms and the social value of neuromarketing studies should command greater attention to the elucidation and management of incidental findings. However, this needs to be balanced against finite resources available within most public health systems.

Ethical challenges of whole genome sequencing in translational research and answers by the EURAT-project

2015 ◽  
Vol 38 (4) ◽  
Author(s):  
Eva C. Winkler ◽  
Christoph Schickhardt
Keyword(s):  
Translational Research ◽  
Whole Genome Sequencing ◽  
Genome Sequencing ◽  
Incidental Findings ◽  
Whole Genome ◽  
Ethical Challenges ◽  
Research Subjects ◽  
Translation Research ◽  
Legal Questions ◽  
Legal Challenges

Abstract:The use of whole genome sequencing in translational research not only holds promise for finding new targeted therapies but also raises several ethical and legal questions. The four main ethical and legal challenges are as follows: (1) the handling of additional or incidental findings stemming from whole genome sequencing in research contexts; (2) the compatibility and balancing of data protection and research that is based on broad data sharing; (3) the responsibility of researchers, particularly of non-physician researchers, working in the field of genome sequencing; and (4) the process of informing and asking patients or research subjects for informed consent to the sequencing of their genome. In this paper, first, these four challenges are illustrated and, second, concrete solutions are proposed, as elaborated by the interdisciplinary Heidelberg EURAT project group, as guidelines for the use of genome sequencing in translation research and therapy in Heidelberg.

scholarly journals Ethical Considerations for the Return of Incidental Findings in Ophthalmic Genomic Research

2016 ◽  
Vol 5 (1) ◽  
pp. 3 ◽  
Author(s):  
Emmanuelle Souzeau ◽  
Kathryn P. Burdon ◽  
David A. Mackey ◽  
Alex W. Hewitt ◽  
Ravi Savarirayan ◽  
...  
Keyword(s):  
Incidental Findings ◽  
Genomic Research ◽  
Ethical Considerations

scholarly journals The Binding Effect of the Constitutive Documents of Companies: The 1973 and 2008 Companies Acts of South Africa

2017 ◽  
Vol 13 (1) ◽  
pp. 170
Author(s):  
Tebogo Morajane
Keyword(s):  
South Africa ◽  
The Other ◽  
Fiduciary Duties ◽  
Binding Effect ◽  
Other Hand ◽  
Legal Challenges ◽  
A Company

This contribution examines the provisions of the constitutive documents of companies under two specific provisions, namely s 65(2) of the Companies Act 61 of 1973 and s 15(6) of the Companies Act 71 of 2008.  The aim is to determine who is bound by these provisions, the circumstances which give rise to being bound by them, and the possible effect thereof on various parties. The provisions of the constitutive documents under section 65(2) of the 1973 Companies Act are interpreted by courts and academic writers to amount to a statutory contract between a company and its members and between members inter se. The members are said to be bound by the provisions of these documents only in their capacity as members. It is submitted, however, that the rights and obligations are granted to members in their capacity as such if they are membership rights which are granted by virtue on one’s membership. So far the courts have failed to provide a logical explanation of the concept “capacity of a member as such”. This failure and the “qua membership test” resulted in limitations in the interpretation of section 65(2): for example, the exclusion of persons who are regarded as outsiders. The directors, despite the fact that numerous provisions of the applicable article provides for their rights, have rights that are unenforceable via the articles, for being regarded as outsiders. The company on the other hand can enforce the obligations against the directors on the basis of breach of their fiduciary duties. These limitations called for a redraft of section 65(2).  This contribution raises the legal challenges raised by the above. It arrives inter alia at the conclusion that the “qua membership test” may find application under the 2008 Companies Act, since members/shareholders may be allowed to exercise rights that are membership rights granted to them by virtue of their membership, and directors may be allowed to exercise rights that are granted to them in their official capacities as such.

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