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

BMC Medical Ethics

Research Article

Odile Ouwe Missi Oukem-Boyer¹  Sheryl McCurdy²  Alice Matimba³  Jantina de Vries⁴  Syntia Nchangwi Munung⁴  Aminu Yakubu⁵  Paulina Tindana⁶  Ciara Staunton⁷ 

[1] Cameroon Bioethics Initiative (CAMBIN), Yaounde, Cameroon;Center for Health Promotion and Prevention Research, School of Public Health, University of Texas Health Science Center at Houston, Houston, USA;Department of Clinical Pharmacology, College of Health Sciences, University of Zimbabwe, Harare, Zimbabwe;Department of Medicine, Faculty of Health Sciences, University of Cape Town, Cape Town, South Africa;National Health Research Ethics Committee, Federal Ministry of Health, Abuja, Nigeria;Navrongo Health Research Centre, Ghana Health Service, Navrongo, Ghana;University of Stellenbosch, Stellenbosch, South Africa;

关键词: Health Research;    African Country;    International Collaboration;    Genomic Research;    Genetic Test Result;   

DOI  :  10.1186/s12910-016-0165-6

 received in 2016-09-06, accepted in 2016-12-29,  发布年份 2017

来源: Springer

【 摘 要 】

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.

【 授权许可】

CC BY   
© The Author(s). 2017