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

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

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

Ethical challenges in developing an educational video to empower potential participants during consent processes in future HIV cure research in South Africa

Obtaining consent for HIV research is complex, particularly in low- and middle-income countries. Low levels of education, complexity of science and research processes, confusion about basic elements of research, and socio-economic conditions that make access to medical care difficult have collectively led to concerns about the adequacy of the consent process. Given the exponential growth of HIV prevention and treatment research in South Africa, HIV researchers are increasingly facing challenges obtaining authentic informed consent from potential participants. It is anticipated that HIV cure research, despite being in its infancy in South Africa, will introduce a new discourse into a population that is often struggling to understand the differences between ‘cure’, ‘preventive and therapeutic vaccines’ and other elements of the research process. Coupled with this, South Africa has a complex history of ‘illegitimate’ or ‘false cures’ for HIV. It is therefore logical to anticipate that HIV cure research may face significant challenges during consent processes. HIV prevention research in South Africa has demonstrated the importance of early community engagement in educating potential research participants and promoting community acceptance of research. Consequently, in an attempt to extrapolate from this experience of engaging with communities early regarding cure research, a 15-minute educational video entitled ‘I have a dream: a world without HIV’ was developed to educate and ultimately empower potential research participants to make informed choices during consent processes in future HIV cure clinical trials. To aid others in the development of educational interventions, this paper discusses the challenges faced in developing this educational video

Engaging research ethics committees to develop an ethics and governance framework for best practices in genomic research and biobanking in Africa: the H3Africa model [Commentary]

In the past decade, there has been an increase in genomic research and biobanking activities in Africa. Research initiatives such as the Human Heredity and Health in Africa (H3Africa) Consortium are contributing to the development of scientific capacity and infrastructure to support these studies on the continent. Despite this growth, genomic research and biobanking have raised important ethical challenges for key research stakeholders, including members of research ethics committees. One of these is the limited ethical and regulatory frameworks to guide the review and conduct of genomic studies, particularly in Africa. This paper is a reflection on a series of consultative activities with research ethics committees in Africa which informed the development of an ethics and governance framework for best practices in genomic research and biobanking in Africa. The paper highlights the engagement process and the lessoned learned

A global assessment of surveillance methods for dominant malaria vectors

The epidemiology of human malaria differs considerably between and within geographic regions due, in part, to variability in mosquito species behaviours. Recently, the WHO emphasised stratifying interventions using local surveillance data to reduce malaria. The usefulness of vector surveillance is entirely dependent on the biases inherent in the sampling methods deployed to monitor mosquito populations. To understand and interpret mosquito surveillance data, the frequency of use of malaria vector collection methods was analysed from a georeferenced vector dataset (> 10,000 data records), extracted from 875 manuscripts across Africa, the Americas and the Asia-Pacific region. Commonly deployed mosquito collection methods tend to target anticipated vector behaviours in a region to maximise sample size (and by default, ignoring other behaviours). Mosquito collection methods targeting both host-seeking and resting behaviours were seldomly deployed concurrently at the same site. A balanced sampling design using multiple methods would improve the understanding of the range of vector behaviours, leading to improved surveillance and more effective vector control

Regulation of genomic and biobanking research in Africa: a content analysis of ethics guidelines, policies and procedures from 22 African countries

Background: The introduction of genomics and biobanking methodologies to the African research context has also introduced novel ways of doing science, based on values of sharing and reuse of data and samples. This shift raises ethical challenges that need to be considered when research is reviewed by ethics committees, relating for instance to broad consent, the feedback of individual genetic findings, and regulation of secondary sample access and use. Yet existing ethics guidelines and regulations in Africa do not successfully regulate research based on sharing, causing confusion about what is allowed, where and when. Methods: In order to understand better the ethics regulatory landscape around genomic research and biobanking, we conducted a comprehensive analysis of existing ethics guidelines, policies and other similar sources. We sourced 30 ethics regulatory documents from 22 African countries. We used software that assists with qualitative data analysis to conduct a thematic analysis of these documents. Results: Surprisingly considering how contentious broad consent is in Africa, we found that most countries allow the use of this consent model, with its use banned in only three of the countries we investigated. In a likely response to fears about exploitation, the export of samples outside of the continent is strictly regulated, sometimes in conjunction with regulations around international collaboration. We also found that whilst an essential and critical component of ensuring ethical best practice in genomics research relates to the governance framework that accompanies sample and data sharing, this was most sparingly covered in the guidelines. Conclusions: There is a need for ethics guidelines in African countries to be adapted to the changing science policy landscape, which increasingly supports principles of openness, storage, sharing and secondary use. Current guidelines are not pertinent to the ethical challenges that such a new orientation raises, and therefore fail to provide accurate guidance to ethics committees and researchers

Engaging research ethics committees to develop an ethics and governance framework for best practices in genomic research and biobanking in Africa: the H3Africa model [Commentary]

In the past decade, there has been an increase in genomic research and biobanking activities in Africa. Research initiatives such as the Human Heredity and Health in Africa (H3Africa) Consortium are contributing to the development of scientific capacity and infrastructure to support these studies on the continent. Despite this growth, genomic research and biobanking have raised important ethical challenges for key research stakeholders, including members of research ethics committees. One of these is the limited ethical and regulatory frameworks to guide the review and conduct of genomic studies, particularly in Africa. This paper is a reflection on a series of consultative activities with research ethics committees in Africa which informed the development of an ethics and governance framework for best practices in genomic research and biobanking in Africa. The paper highlights the engagement process and the lessoned learned

Zoonotic malaria transmission and land use change in Southeast Asia: what is known about the vectors

Zoonotic Plasmodium infections in humans in many Southeast Asian countries have been increasing, including in countries approaching elimination of human-only malaria transmission. Most simian malarias in humans are caused by Plasmodium knowlesi, but recent research shows that humans are at risk of many different simian Plasmodium species. In Southeast Asia, simian Plasmodium species are mainly transmitted by mosquitoes in the Anopheles leucosphyrus and Anopheles dirus complexes. Although there is some evidence of species outside the Leucosphyrus Group transmitting simian Plasmodium species, these await confirmation of transmission to humans. The vectors of monkey malarias are mostly found in forests and forest fringes, where they readily bite long-tailed and pig-tailed macaques (the natural reservoir hosts) and humans. How changing land-uses influence zoonotic malaria vectors is still poorly understood. Fragmentation of forests from logging, agriculture and other human activities is associated with increased zoonotic Plasmodium vector exposure. This is thought to occur through altered macaque and mosquito distributions and behaviours, and importantly, increased proximity of humans, macaques, and mosquito vectors. Underlying the increase in vector densities is the issue that the land-use change and human activities create more oviposition sites and, in correlation, increases availably of human blood hosts. The current understanding of zoonotic malaria vector species is largely based on a small number of studies in geographically restricted areas. What is known about the vectors is limited: the data is strongest for distribution and density with only weak evidence for a limited number of species in the Leucosphyrus Group for resting habits, insecticide resistance, blood feeding habits and larval habitats. More data are needed on vector diversity and bionomics in additional geographic areas to understand both the impacts on transmission of anthropogenic land-use change and how this significant disease in humans might be controlled