Research Article: Understanding Ethical, Legal and Societal Issues (ELSIs) in Human Biobanking and Genomics for Research and Healthcare in Zimbabwe: The Genomics Inheritance Law Ethics and Society (GILES) initiative

Date Published: June 12, 2019

Publisher: F1000 Research Limited

Author(s): Alice Matimba, Andrew Chimatira, Oppah Kuguyo, James January, Zivayi Mupambireyi, Bazondlile Marimbe-Dube, Vasco Chikwasha, Zibusiso Nyati-Jokomo, Shamiso Muteti, Pedzisayi Mangezvo, Abigail Kangwende, Alfred Chingono, Midion Chidzonga, Jonathan Gandari, James Hakim, Kusum Nathoo, Christopher Samkange, Walter Mangezi, Sandra Lee, Lovemore Gwanzura, Mildred Cho, Paul Ndebele.

http://doi.org/10.12688/aasopenres.12917.2

Abstract

Biobanks and human genomics applications are key for understanding health, disease and heredity in Africa and globally. Growing interest in these technologies calls for strengthening relevant legal, ethical and policy systems to address knowledge disparities and ensure protection of society, while supporting advancement of science. In Zimbabwe there is limited understanding of ethical, legal, and societal issues (ELSI) for biobanking and genomics. The Genomics Inheritance Law Ethics and Society (GILES) initiative was established in 2015 to explore the current status and gaps in the ethical and legal frameworks, knowledge among various stakeholders, and to establish capacity for addressing ELSI of biobanking and genomics as applied in biomedical and population research, and healthcare. The project was conducted over a countrywide geographical region and established one of the most comprehensive studies for ELSI of human biobanking and genomics in Africa. This paper outlines the strategy undertaken during the implementation of the GILES initiative and discusses the importance of such an initiative for characterisation of ELSI of human biobanking and genomics in Zimbabwe and Africa.

Partial Text

Biobanks of human biospecimen collections are key resources for understanding individual and population diversity, and are integral to healthcare research, medical care, and drug discovery
1,
2. Linked to biobanking, advances in technology are enabling large-scale biochemical and genomic analysis, generating substantial amounts of data of personal and health relevance with ethical implications for communities and populations
3–
6. Although the benefits of human biobanking and genomics applications are well recognised, ethical, legal and social challenges arise alongside unclear regulations and policies, and limited understanding among research scientists, healthcare professionals and the wider public
7. In particular, African countries are faced with a growing need for the application of genomics in medicine and research. African genomics and population data are drawing regional and global interests as they add rich genomic background diversity to existing efforts to fully understand human genomic variation. This plays an important role in biomarker identification, improving disease diagnostics, and development of targeted therapies, which take into account interplay of environmental and demographic factors
8. However, the nature of biobanking and genomics gives rise to ethical and social issues at personal and population level. Therefore, there is urgent need to understand the current status, gaps and needs to build capacity for appropriately applying these technologies at the national, regional and international level. The main objective of this article is to describe the strategy and experiences of the Genomics Inheritance Law Ethics and Society (GILES) initiative aimed at understanding ethical, legal and societal issues (ELSIs) in human biobanking and genomics. In this article we build upon the rationale for addressing ELSIs in Africa using Zimbabwe as an example of a country with less advanced structures for human biobanking and genomics and where ELSIs are poorly understood among professional and community groups. We highlight challenges and opportunities observed during the implementation of the project and outline potential locally tailored approaches for comprehensive characterization and capacity building for ELSIs of human biobanking and genomics in Africa.

Recently, several consortia have embarked on projects to characterize African population genomics. The largest consortium is the Human Heredity and Health in Africa (H3Africa) program, which is focused on supporting biobanking and collaborative genomics research for understanding population genomic diversity in relation to disease susceptibility, diagnosis and association with environmental factors
9–
11. This and other ongoing initiatives create the need for anticipating and addressing emerging issues in human genomics notably: increased biobanking activities, whole genome sequencing, genome wide association studies, large scale databases and bioinformatics. Researchers in Zimbabwe are actively contributing to this initiative, and other related continent-wide consortia whereby associated ethical, legal, and societal issues (ELSI) remain under-explored. For example, despite the expectations of the international collaborative projects in the cross-border storage of human biospecimens and depositing of research results in consortia databases for access by scientists locally and abroad, differing terms and norms which are likely to present barriers to access and use are not well addressed. In addition, the uni-directional flow of samples and data out of Africa has created a sense of exploitation and distrust and the African genomics research community are playing a leading role in addressing such concerns and limitations as they become more likely to occur
12,
13.

In Zimbabwe, human biospecimen collections or biobanks have largely focused on infectious diseases research, national surveillance programs, disease outbreaks and molecular diagnostic applications. In this work, we acknowledge the existence of biobanks both in their rudimentary and advanced form, and the potential for their samples to be used for a wider variety of human genomics applications than for which they were originally collected. To date, the Biobank and Pharmacogenetics Database of African Populations is the only openly reported resource, which marked a significant step in multi-national collaborative biobanking efforts, and was designed for the study of variations associated with drug response in Africa
14. Such activities were established with limited knowledge and expertise about ELSIs and create a basis for strengthening the current structures for human biobanking and genomics sciences oversight.

Driven by the need to understand the current status and to determine needs for building capacity and harmonised guidelines for addressing ELSI of biobanking and human genomics in Zimbabwe, the Genomics Inheritance Law Ethics and Society (GILES) initiative was launched in 2015. The strategy involving steps to establish empirical evidence for ELSI regulations and knowledge-based participation in biobanking and human genomics for research and healthcare is shown in
Figure 1 and the methods are outlined below. The rationale behind the methods, site selection and emerging findings are also summarized. Full accounts of the methods and results will be reported in separate manuscripts.

Lessons learnt during during implementation:

The GILES initiative established a platform for the study of ELSI related to bio- and data resources for human genomics activities, which involve biospecimen collection, storage, analysis, data sharing and use (biobanking, databases and bioinformatics) in Zimbabwe. This was achieved through a multi-disciplinary approach involving research scientists, health and academic professionals and community members. The GILES initiative is innovative in being the first to address ELSI regarding the human genomics resources for health research and application in Zimbabwe. This was enriched by using a comprehensive methodology encompassing desk reviews and interviews and by involving a diverse research team of biomedical scientists, clinicians, public health and ethics experts and social scientists. Further comprehensive descriptions of findings will be reported separately.

The views expressed in this article are those of the author(s). Publication in AAS Open Research does not imply endorsement by the AAS.

The GILES study was approved by the Joint Research Ethics Committee (JREC) at Parirenyatwa Central Hospital, and College of Health Sciences at University of Zimbabwe Reference: number 06/15. Additionally, the study was reviewed and approved by the national research ethics Committee at the Medical Research Council of Zimbabwe Reference number: MRCZ/A/2051). Prior to the focus group discussions and in-depth interviews, written informed consent was obtained from all participants. All participants were given pseudonyms to use instead of their names for confidentiality purposes. Permissions to conduct interviews and document reviews were obtained from the heads of the relevant institutes and organisations. Permission to engage with community members and health care staff was obtained from the Ministry of Health and Child Care as we used health centres to recruit community participants. Further permission was obtained from the community leaders from the respective communities.

No data is associated with this article.

 

Source:

http://doi.org/10.12688/aasopenres.12917.2

 

Leave a Reply

Your email address will not be published.