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

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dc.contributor.authorde Vries, Jantina
dc.contributor.authorMunung, Syntia N
dc.contributor.authorMatimba, Alice
dc.contributor.authorMcCurdy, Sheryl
dc.contributor.authorOuwe Missi Oukem-Boyer, Odile
dc.contributor.authorStaunton, Ciara
dc.contributor.authorYakubu, Aminu
dc.contributor.authorTindana, Paulina
dc.contributor.authorH3Africa Consortium
dc.date.accessioned2017-03-30T09:43:12Z
dc.date.available2017-03-30T09:43:12Z
dc.date.issued2017-02-02
dc.date.updated2017-02-02T19:06:09Z
dc.description.abstractBackground: 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. Methods: 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. Results: 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. Conclusions: 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.
dc.identifier.apacitationde Vries, J., Munung, S. N., Matimba, A., McCurdy, S., Ouwe Missi Oukem-Boyer, O., Staunton, C., ... (2017). Regulation of genomic and biobanking research in Africa: a content analysis of ethics guidelines, policies and procedures from 22 African countries. <i>BMC Medical Ethics</i>, http://hdl.handle.net/11427/24112en_ZA
dc.identifier.chicagocitationde Vries, Jantina, Syntia N Munung, Alice Matimba, Sheryl McCurdy, Odile Ouwe Missi Oukem-Boyer, Ciara Staunton, Aminu Yakubu, Paulina Tindana, and "Regulation of genomic and biobanking research in Africa: a content analysis of ethics guidelines, policies and procedures from 22 African countries." <i>BMC Medical Ethics</i> (2017) http://hdl.handle.net/11427/24112en_ZA
dc.identifier.citationde Vries, J., Munung, S. N., Matimba, A., McCurdy, S., Oukem-Boyer, O. O. M., Staunton, C., ... & Tindana, P. (2017). Regulation of genomic and biobanking research in Africa: a content analysis of ethics guidelines, policies and procedures from 22 African countries. BMC Medical Ethics, 18(1), 8.
dc.identifier.ris TY - Journal Article AU - de Vries, Jantina AU - Munung, Syntia N AU - Matimba, Alice AU - McCurdy, Sheryl AU - Ouwe Missi Oukem-Boyer, Odile AU - Staunton, Ciara AU - Yakubu, Aminu AU - Tindana, Paulina AU - H3Africa Consortium AB - Background: 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. Methods: 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. Results: 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. Conclusions: 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. DA - 2017-02-02 DB - OpenUCT DO - 10.1186/s12910-016-0165-6 DP - University of Cape Town J1 - BMC Medical Ethics LK - https://open.uct.ac.za PB - University of Cape Town PY - 2017 T1 - Regulation of genomic and biobanking research in Africa: a content analysis of ethics guidelines, policies and procedures from 22 African countries TI - Regulation of genomic and biobanking research in Africa: a content analysis of ethics guidelines, policies and procedures from 22 African countries UR - http://hdl.handle.net/11427/24112 ER - en_ZA
dc.identifier.urihttp://dx.doi.org/10.1186/s12910-016-0165-6
dc.identifier.urihttp://hdl.handle.net/11427/24112
dc.identifier.vancouvercitationde Vries J, Munung SN, Matimba A, McCurdy S, Ouwe Missi Oukem-Boyer O, Staunton C, et al. Regulation of genomic and biobanking research in Africa: a content analysis of ethics guidelines, policies and procedures from 22 African countries. BMC Medical Ethics. 2017; http://hdl.handle.net/11427/24112.en_ZA
dc.language.isoen
dc.publisherBioMed Central
dc.publisher.departmentDepartment of Medicineen_ZA
dc.publisher.facultyFaculty of Health Sciencesen_ZA
dc.publisher.institutionUniversity of Cape Town
dc.rightsThis article is distributed under the terms of the Creative Commons Attribution 4.0 International License
dc.rights.holderThe Author(s).
dc.rights.urihttps://creativecommons.org/licenses/by/4.0/
dc.sourceBMC Medical Ethics
dc.source.urihttps://link.springer.com/journal/12910
dc.titleRegulation of genomic and biobanking research in Africa: a content analysis of ethics guidelines, policies and procedures from 22 African countries
dc.typeJournal Article
uct.type.filetypeText
uct.type.filetypeImage
uct.type.publicationResearchen_ZA
uct.type.resourceArticleen_ZA
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