Informed consent for HIV cure research in South Africa: issues to consider

Background: South Africa has made great progress in the development of HIV/AIDS testing, treatment and prevention campaigns. Yet, it is clear that prevention and treatment campaigns alone are not enough to bring this epidemic under control. Discussion: News that the “Berlin patient” and the “Mississippi baby” have both been “cured” of HIV brought hope to people living with HIV/AIDS in South Africa that a cure for HIV/AIDS is within reach. Despite the recent setbacks announced in the “Mississippi Baby” case, protocols aimed at curing HIV/AIDS are being developed in South Africa. However with evidence to suggest that participants in clinical trials do not understand the basic concepts in the informed consent process, there is concern that future participants in HIV/AIDS cure research will lack comprehension of the basic elements of future clinical trials that aims to cure HIV/AIDS and confuse research with clinical care. Summary: Research ethics committees have an important role to play in ensuring that participants understand the basic concepts discussed in the informed consent process, that they understand that research is not clinical care and they are unlikely to benefit from any early phase trials seeking to cure HIV/AIDS

Harmonisation of Biobank Regulations in Africa: lessons to be learned from Europe

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The regulation of stem cell research in Ireland: from the Commission on Assisted Human Reproduction to the Assisted Human Reproduction Bill 2017

In 2005 Ireland’s Commission on Assisted Reproduction (CAHR) published a comprehensive report on the regulation of assisted reproduction and associated technologies. Yet since that that Report, successive Irish governments have failed to bring forth any legislation on this matter. This legislative inaction has resulted in a situation whereby the embryo in vivo has the right to life under the Irish Constitution, but embryos in vitro have no protection in law. Irish policy makers have also endorsed and funded embryonic stem cell research (ESCR) at a European level, but continues to prevent researchers in Ireland from accessing any public funds for this research. The publication in October 2017 of the General Scheme of the Assisted Human Reproduction Bill 2017 is thus a welcomed development. However further reading of the Bill reveals that it is restrictive in nature and likely to stifle research in Ireland. This paper will discuss the legal, ethical and scientific developments that have occurred since the CAHR report and the impact, if any, they have had on the development of this Bill. It will critically reflect on provisions of the Bill as they relate to ESCR and make a number of suggestions for reform

"It’s about actually having a proactive regulatory framework versus a reactive one" - stakeholder perspectives on the governance of embryonic stem cell research in Ireland

Over the past 20 years, the ethical concerns associated with embryonic stem cell research (ESCR) have been the source of great debate. Due to the promise of ESCR, many jurisdictions have introduced regulations to govern it. Despite this, Irish policymakers have failed to introduce legislation to regulate ESCR and embryo research. Successive calls for legislation were ignored until the publication of the General Scheme of the Assisted Human Reproduction Bill 2017 in October 2017. Although the publication of the Heads of this Bill is welcomed, there have been no attempts to assess the current regulatory framework and its impact on the development of stem cell research in Ireland. To address this vacuum, empirical research was conducted with scientists, regulators and funders to explore the current regulatory framework in Ireland. This paper reports on and discusses the findings of these interviews and critically reviews the 2017 Bill

Analysis of the contour structural irregularity of skin lesions using wavelet decomposition

The boundary irregularity of skin lesions is of clinical significance for the early detection of malignant melanomas and to distinguish them from other lesions such as benign moles. The structural components of the contour are of particular importance. To extract the structure from the contour, wavelet decomposition was used as these components tend to locate in the lower frequency sub-bands. Lesion contours were modeled as signatures with scale normalization to give position and frequency resolution invariance. Energy distributions among different wavelet sub-bands were then analyzed to extract those with significant levels and differences to enable maximum discrimination. Based on the coefficients in the significant sub-bands, structural components from the original contours were modeled, and a set of statistical and geometric irregularity descriptors researched that were applied at each of the significant sub-bands. The effectiveness of the descriptors was measured using the Hausdorff distance between sets of data from melanoma and mole contours. The best descriptor outputs were input to a back projection neural network to construct a combined classifier system. Experimental results showed that thirteen features from four sub-bands produced the best discrimination between sets of melanomas and moles, and that a small training set of nine melanomas and nine moles was optimum

Features: Community engagement for biobanking research: perspectives from Africa

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Data mining and biological sample exportation from South Africa: a new wave of bioexploitation under the guise of clinical care?

Discovery Health, one of the leading healthcare funders in South Africa (SA), will offer genetic testing to its members for USD250 (approximately ZAR3 400) per test from 2016. On the surface, this appears to be innovative and futuristic. However, a deeper look at this announcement reveals considerable problems in the exportation of biological samples and data out of SA, and brings into sharp focus the lack of protection in place for potential donors. In return for a reduced-cost genetic test, which will nevertheless be billed to a member’s savings plan, data from the patient’s results and probably the sample itself Author: OK? will be sent to the USA for storage, research purposes and possible commercialisation, Author ‘commercial use’? with no further benefit for the patient. This development has demonstrated the need for more stringent protection of the movement of biological samples and data out of SA, particularly with reference to consenting procedures, material transfer agreements, and the export of biological data themselves

The governance of genomic biobank research in Africa: reframing the regulatory tilt

Genomic biobank research has experienced exponential growth in recent years. It represents a real opportunity to remedy global health inequity that has seen limited investment in diseases affecting populations from low and middle income countries (LMICs). Previous research in Africa continent was limited to so-called parachute research whereby samples were taken from local populations for use in high income countries (HICs) with no local oversight or use of the sample. These exploitative practices must be guarded against, but the current regulation of genomic research in Africa adopts a risk-based precautionary approach, that at times is restrictive in nature. We argue that the regulation and oversight of genomic biobank research should guard against exploitative research, but in a manner that promotes reciprocal benefit and not restrictive research practices. To achieve this there must be a rebalancing of the regulatory tilt

The implications of Methylphenidate use by healthy medical students and doctors in South Africa

Background: The use of medical stimulants to sustain attention, augment memory and enhance intellectual capacity is increasing in society. The use of Methylphenidate for cognitive enhancement is a subject that has received much attention in the literature and academic circles in recent times globally. Medical doctors and medical students appear to be equally involved in the off-label use of Methylphenidate. This presents a potential harm to society and the individual as the long-term side effect profile of this medication is unknown. Discussion: The implication of the use of Methylphenidate by medical students and doctors has not been fully explored. This article considers the impact of this use on the traditional role of medicine, society, the patient and suggests a way forward. We discuss the salient philosophy surrounding the use of cognitive enhancement. We query whether there are cognitive benefits to the use of Methylphenidate in healthy students and doctors and whether these benefits would outweigh the risks in taking the medication. Could these benefits lead to tangible outcomes for society and could the off label-use of Methylphenidate potentially undermine the medical profession and the treatment of patients? If cognitive benefits are proven then doctors may be coerced explicitly or implicitly to use the drug which may undermine their autonomy. The increased appeal of cognitive enhancement challenges the traditional role of medicine in society, and calls into question the role of a virtuous life as a contributing factor for achievement. In countries with vast economic disparity such as South Africa an enhancement of personal utility that can be bought may lead to greater inequities. Summary: Under the status quo the distribution of methylphenidate is unjust. Regulatory governmental policy must seek to remedy this while minimising the potential for competitive advantage for the enhanced. Public debate on the use of cognitive enhancement is long overdue and must be stimulated. The use of Methylphenidate for cognitive enhancement is philosophically defendable if long-term research can prove that the risks are negligible and the outcomes tangible

Protection of personal information Act No. 4 of 2013: Implications for biobanks

The Protection of Personal Information Act (POPIA) No. 4 of 2013 is the first comprehensive data-protection regulation to be passed in South Africa (SA). Its objectives include giving effect to the constitutional right to privacy by regulating the way in which personal information must be processed, balancing the right to privacy against other rights, and establishing an Information Regulator to ensure that the rights protected by POPIA are respected. POPIA will have an impact on health research, including biobanks. As sharing of samples and data is a central feature of biobanks, POPIA could change the way in which data are obtained, shared and exported. In particular, the provisions regarding data minimisation, requirements pertaining to the transfer of data abroad, consent provisions and identification of the 'responsible person' will impact the operation of biobanks in SA. With POPIA soon to come into force, it is now time to consider its implications for biobanks in SA