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

Abstract

BackgroundThe 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.MethodsIn 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.ResultsSurprisingly 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.ConclusionsThere 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.

Ethical considerations in global HIV phylogenetic research

“…In addition, a large and diverse academic and policy literature exists addressing the ethical, legal and social implications (ELSI) of the research and clinical uses of human genomics in high-income countries (HIC) (8). In recent years, this has been accompanied by a growing bioethics and social science literature on the implications of genomic research in low-and middle-income countries (LMIC) (9)(10), and by stakeholder engagement initiatives in these settings (11)(12)(13). The key documents, position statements and initiatives are summarized in Supplementary Table 1. HIV phylogenetic research presents complex ethical issues, including two specific challenges.…”

The Emergence of Genomic Research in Africa and New Frameworks for Equity in Biomedical Research

“…Out of concern over historic exploitation and a perpetuation of inequalities by sending African samples to non-African laboratories, some African nations have strict guidelines regulating the export of samples. 31 However, retaining genomic samples in Africa for analysis depends on: 1) having researchers with sufficient genomic expertise to run analyses; 2) storage facilities with reliable power to store the samples;…”

“…27 Additionally, without ethical guidelines, there is greater risk that researchers and ethics committees may make decisions based on fear or misunderstandings. 31 In many African regions, IRBs have relatively little experience with reviewing protocols for genomic research, 38 and standard operating procedures for research ethics committees are still being developed in most countries. 31 As a result, unanticipated delays in the implementation of research projects could occur.…”

“…31 In many African regions, IRBs have relatively little experience with reviewing protocols for genomic research, 38 and standard operating procedures for research ethics committees are still being developed in most countries. 31 As a result, unanticipated delays in the implementation of research projects could occur. 38 Guidelines regarding broad consent and data and sample sharing are important for ethics review committees as they receive increasing applications with a focus on genomic research.…”

Legal implications of data sharing in biobanking research in low-income settings: The Nigerian experience

“…[14] Despite the existence of a substantial and developing literature on the ethical and legal issues arising from sharing data in biobank research, this literature has as yet not adequately addressed the specific legal challenges presented by genomics research to the legal systems of lower-middle income countries (LMICs) such as Nigeria. De Vries et al [15] conclude that there is a need for guidelines in African countries to be adapted to the changing landscape.…”