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.
Highlights
The introduction of genomics and biobanking methodologies to the African research context has introduced novel ways of doing science, based on values of sharing and reuse of data and samples
The introduction of genomics and biobanking methodologies to the African research context through platforms such as MalariaGEN [1], 1000Genomes [2] and H3Africa [3] has simultaneously introduced some of the ethical challenges associated with it [4, 5]
Most pertinently, such past experiences offered little opportunity for African scientists to intellectually engage in, or lead, African health research, and often reduced their contribution to operational tasks such as for instance those relating to sample collection [12]. These past practices inform current legislation, policies and tentative responses to unknowns involved in genomic research [13]. In response to these challenges, we set out to work with members of ethics committees and National Ethics Councils to explore ethical challenges around genomic research and biobanking [14, 15], but we put together a comprehensive analysis of the existing ethics regulatory framework for genomics and biobanking research, which we report in this paper
Summary
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
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