BMC Medical Ethics
(Accessed 4 February 2017)
Regulation of genomic and biobanking research in Africa: a content analysis of ethics guidelines, policies and procedures from 22 African countries
Jantina de Vries, Syntia Nchangwi Munung, Alice Matimba, Sheryl McCurdy, Odile Ouwe Missi Oukem-Boyer, Ciara Staunton, Aminu Yakubu and Paulina Tindana
Published on: 2 February 2017
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.
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.
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.
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.
Overall, in the rapidly changing landscape of science—epitomised in the fields of genomic research and biobanking—ethics guidelines need to be broad and flexible enough to accommodate changes, whilst also offering guidance on the principles that should be applied to foster ethically sound health research. Key principles that ought to be incorporated into African guidance for genomic research and biobanking relate to promoting African leadership and ownership of genomics and biobanking science and capacity strengthening as an essential feature of international collaboration. In terms of specific guidance supporting ethics committee decision-making, we think that what is required are guidelines that address issues relating to sample and data sharing and the requirements of governance frameworks supporting these. What is also required is a clear statement, by African governments, national health ethics councils or other authorities charged with developing the ethical frameworks for research, about the appropriateness of using broad consent in the context of African genomics and biobanking research.