Obtaining informed consent for genomics research in Africa: analysis of H3Africa consent documents.
Identifieur interne : 000944 ( PubMed/Curation ); précédent : 000943; suivant : 000945Obtaining informed consent for genomics research in Africa: analysis of H3Africa consent documents.
Auteurs : Nchangwi Syntia Munung [Afrique du Sud] ; Patricia Marshall [États-Unis] ; Megan Campbell [Afrique du Sud] ; Katherine Littler [Royaume-Uni] ; Francis Masiye [Afrique du Sud] ; Odile Ouwe-Missi-Oukem-Boyer [Cameroun] ; Janet Seeley [Ouganda] ; D J Stein [Afrique du Sud] ; Paulina Tindana [Ghana] ; Jantina De Vries [Afrique du Sud]Source :
- Journal of medical ethics [ 1473-4257 ] ; 2016.
Descripteurs français
- KwdFr :
- Afrique, Biobanques (éthique), Consentement libre et éclairé (législation et jurisprudence), Consentement libre et éclairé (éthique), Diffusion de l'information (législation et jurisprudence), Diffusion de l'information (éthique), Formulaires de consentement (éthique), Humains, Population d'origine africaine (génétique), Recherche génétique (législation et jurisprudence), Recherche génétique (éthique), Recherche participative basée sur la communauté (éthique).
- MESH :
- génétique : Population d'origine africaine.
- législation et jurisprudence : Consentement libre et éclairé, Diffusion de l'information, Recherche génétique.
- éthique : Biobanques, Consentement libre et éclairé, Diffusion de l'information, Formulaires de consentement, Recherche génétique, Recherche participative basée sur la communauté.
- Afrique, Humains.
English descriptors
- KwdEn :
- Africa, African Continental Ancestry Group (genetics), Biological Specimen Banks (ethics), Community-Based Participatory Research (ethics), Consent Forms (ethics), Genetic Research (ethics), Genetic Research (legislation & jurisprudence), Humans, Information Dissemination (ethics), Information Dissemination (legislation & jurisprudence), Informed Consent (ethics), Informed Consent (legislation & jurisprudence).
- MESH :
- geographic : Africa.
- ethics : Biological Specimen Banks, Community-Based Participatory Research, Consent Forms, Genetic Research, Information Dissemination, Informed Consent.
- genetics : African Continental Ancestry Group.
- legislation & jurisprudence : Genetic Research, Information Dissemination, Informed Consent.
- Humans.
Abstract
The rise in genomic and biobanking research worldwide has led to the development of different informed consent models for use in such research. This study analyses consent documents used by investigators in the H3Africa (Human Heredity and Health in Africa) Consortium.
DOI: 10.1136/medethics-2015-102796
PubMed: 26644426
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Town, Cape Town, South Africa.</nlm:affiliation><country xml:lang="fr">Afrique du Sud</country><wicri:regionArea>Department of Medicine, University of Cape Town, Cape Town</wicri:regionArea></affiliation></author><author><name sortKey="Marshall, Patricia" sort="Marshall, Patricia" uniqKey="Marshall P" first="Patricia" last="Marshall">Patricia Marshall</name><affiliation wicri:level="1"><nlm:affiliation>Center for Genetic Research Ethics and Law Department of Bioethics, School of Medicine, Case Western Reserve University, Cleaveland, Ohio, USA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Center for Genetic Research Ethics and Law Department of Bioethics, School of Medicine, Case Western Reserve University, Cleaveland, Ohio</wicri:regionArea></affiliation></author><author><name sortKey="Campbell, Megan" sort="Campbell, Megan" uniqKey="Campbell M" first="Megan" last="Campbell">Megan Campbell</name><affiliation wicri:level="1"><nlm:affiliation>Department 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Medicine, University of Cape Town, Cape Town</wicri:regionArea></affiliation></author><author><name sortKey="Ouwe Missi Oukem Boyer, Odile" sort="Ouwe Missi Oukem Boyer, Odile" uniqKey="Ouwe Missi Oukem Boyer O" first="Odile" last="Ouwe-Missi-Oukem-Boyer">Odile Ouwe-Missi-Oukem-Boyer</name><affiliation wicri:level="1"><nlm:affiliation>Centre de Recherche Médicale et Sanitaire (CERMES), Niamey, Niger Cameroon Bioethics Initiative (CAMBIN), Yaounde, Cameroon.</nlm:affiliation><country xml:lang="fr">Cameroun</country><wicri:regionArea>Centre de Recherche Médicale et Sanitaire (CERMES), Niamey, Niger Cameroon Bioethics Initiative (CAMBIN), Yaounde</wicri:regionArea></affiliation></author><author><name sortKey="Seeley, Janet" sort="Seeley, Janet" uniqKey="Seeley J" first="Janet" last="Seeley">Janet Seeley</name><affiliation wicri:level="1"><nlm:affiliation>MRC/UVRI Uganda Research Unit on AIDS, Entebbe, Uganda.</nlm:affiliation><country 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xml:lang="fr">Ghana</country><wicri:regionArea>Navrongo Health Research Centre, Ghana Health Service, Navrongo</wicri:regionArea></affiliation></author><author><name sortKey="De Vries, Jantina" sort="De Vries, Jantina" uniqKey="De Vries J" first="Jantina" last="De Vries">Jantina De Vries</name><affiliation wicri:level="1"><nlm:affiliation>Department of Medicine, University of Cape Town, Cape Town, South Africa.</nlm:affiliation><country xml:lang="fr">Afrique du Sud</country><wicri:regionArea>Department of Medicine, University of Cape Town, Cape Town</wicri:regionArea></affiliation></author></analytic><series><title level="j">Journal of medical ethics</title><idno type="eISSN">1473-4257</idno><imprint><date when="2016" type="published">2016</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Africa</term><term>African Continental Ancestry Group (genetics)</term><term>Biological Specimen Banks (ethics)</term><term>Community-Based Participatory Research (ethics)</term><term>Consent Forms (ethics)</term><term>Genetic Research (ethics)</term><term>Genetic Research (legislation & jurisprudence)</term><term>Humans</term><term>Information Dissemination (ethics)</term><term>Information Dissemination (legislation & jurisprudence)</term><term>Informed Consent (ethics)</term><term>Informed Consent (legislation & jurisprudence)</term></keywords><keywords scheme="KwdFr" xml:lang="fr"><term>Afrique</term><term>Biobanques (éthique)</term><term>Consentement libre et éclairé (législation et jurisprudence)</term><term>Consentement libre et éclairé (éthique)</term><term>Diffusion de l'information (législation et jurisprudence)</term><term>Diffusion de l'information (éthique)</term><term>Formulaires de consentement (éthique)</term><term>Humains</term><term>Population d'origine africaine (génétique)</term><term>Recherche génétique (législation et jurisprudence)</term><term>Recherche génétique (éthique)</term><term>Recherche participative basée sur la communauté (éthique)</term></keywords><keywords scheme="MESH" type="geographic" xml:lang="en"><term>Africa</term></keywords><keywords scheme="MESH" qualifier="ethics" xml:lang="en"><term>Biological Specimen Banks</term><term>Community-Based Participatory Research</term><term>Consent Forms</term><term>Genetic Research</term><term>Information Dissemination</term><term>Informed Consent</term></keywords><keywords scheme="MESH" qualifier="genetics" xml:lang="en"><term>African Continental Ancestry Group</term></keywords><keywords scheme="MESH" qualifier="génétique" xml:lang="fr"><term>Population d'origine africaine</term></keywords><keywords scheme="MESH" qualifier="legislation & jurisprudence" xml:lang="en"><term>Genetic Research</term><term>Information Dissemination</term><term>Informed Consent</term></keywords><keywords scheme="MESH" qualifier="législation et jurisprudence" xml:lang="fr"><term>Consentement libre et éclairé</term><term>Diffusion de l'information</term><term>Recherche génétique</term></keywords><keywords scheme="MESH" qualifier="éthique" xml:lang="fr"><term>Biobanques</term><term>Consentement libre et éclairé</term><term>Diffusion de l'information</term><term>Formulaires de consentement</term><term>Recherche génétique</term><term>Recherche participative basée sur la communauté</term></keywords><keywords scheme="MESH" xml:lang="en"><term>Humans</term></keywords><keywords scheme="MESH" xml:lang="fr"><term>Afrique</term><term>Humains</term></keywords></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en">The rise in genomic and biobanking research worldwide has led to the development of different informed consent models for use in such research. This study analyses consent documents used by investigators in the H3Africa (Human Heredity and Health in Africa) Consortium.</div></front></TEI><pubmed><MedlineCitation Status="MEDLINE" Owner="NLM"><PMID Version="1">26644426</PMID><DateCreated><Year>2016</Year><Month>01</Month><Day>26</Day></DateCreated><DateCompleted><Year>2016</Year><Month>09</Month><Day>26</Day></DateCompleted><DateRevised><Year>2017</Year><Month>09</Month><Day>02</Day></DateRevised><Article PubModel="Print-Electronic"><Journal><ISSN IssnType="Electronic">1473-4257</ISSN><JournalIssue CitedMedium="Internet"><Volume>42</Volume><Issue>2</Issue><PubDate><Year>2016</Year><Month>Feb</Month></PubDate></JournalIssue><Title>Journal of medical ethics</Title><ISOAbbreviation>J Med Ethics</ISOAbbreviation></Journal><ArticleTitle>Obtaining informed consent for genomics research in Africa: analysis of H3Africa consent documents.</ArticleTitle><Pagination><MedlinePgn>132-7</MedlinePgn></Pagination><ELocationID EIdType="doi" ValidYN="Y">10.1136/medethics-2015-102796</ELocationID><Abstract><AbstractText Label="BACKGROUND" NlmCategory="BACKGROUND">The rise in genomic and biobanking research worldwide has led to the development of different informed consent models for use in such research. This study analyses consent documents used by investigators in the H3Africa (Human Heredity and Health in Africa) Consortium.</AbstractText><AbstractText Label="METHODS" NlmCategory="METHODS">A qualitative method for text analysis was used to analyse consent documents used in the collection of samples and data in H3Africa projects. Thematic domains included type of consent model, explanations of genetics/genomics, data sharing and feedback of test results.</AbstractText><AbstractText Label="RESULTS" NlmCategory="RESULTS">Informed consent documents for 13 of the 19 H3Africa projects were analysed. Seven projects used broad consent, five projects used tiered consent and one used specific consent. Genetics was mostly explained in terms of inherited characteristics, heredity and health, genes and disease causation, or disease susceptibility. Only one project made provisions for the feedback of individual genetic results.</AbstractText><AbstractText Label="CONCLUSION" NlmCategory="CONCLUSIONS">H3Africa research makes use of three consent models-specific, tiered and broad consent. We outlined different strategies used by H3Africa investigators to explain concepts in genomics to potential research participants. To further ensure that the decision to participate in genomic research is informed and meaningful, we recommend that innovative approaches to the informed consent process be developed, preferably in consultation with research participants, research ethics committees and researchers in Africa.</AbstractText><CopyrightInformation>Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/</CopyrightInformation></Abstract><AuthorList CompleteYN="Y"><Author ValidYN="Y"><LastName>Munung</LastName><ForeName>Nchangwi Syntia</ForeName><Initials>NS</Initials><AffiliationInfo><Affiliation>Department of Medicine, University of Cape Town, Cape Town, South Africa.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Marshall</LastName><ForeName>Patricia</ForeName><Initials>P</Initials><AffiliationInfo><Affiliation>Center for Genetic Research Ethics and Law Department of Bioethics, School of Medicine, Case Western Reserve University, Cleaveland, Ohio, USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Campbell</LastName><ForeName>Megan</ForeName><Initials>M</Initials><AffiliationInfo><Affiliation>Department of Psychiatry and Mental Health, University of Cape Town, Cape Town, South Africa.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Littler</LastName><ForeName>Katherine</ForeName><Initials>K</Initials><AffiliationInfo><Affiliation>Wellcome Trust, London, UK.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Masiye</LastName><ForeName>Francis</ForeName><Initials>F</Initials><AffiliationInfo><Affiliation>Department of Medicine, University of Cape Town, Cape Town, South Africa.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Ouwe-Missi-Oukem-Boyer</LastName><ForeName>Odile</ForeName><Initials>O</Initials><AffiliationInfo><Affiliation>Centre de Recherche Médicale et Sanitaire (CERMES), Niamey, Niger Cameroon Bioethics Initiative (CAMBIN), Yaounde, Cameroon.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Seeley</LastName><ForeName>Janet</ForeName><Initials>J</Initials><AffiliationInfo><Affiliation>MRC/UVRI Uganda Research Unit on AIDS, Entebbe, Uganda.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Stein</LastName><ForeName>D J</ForeName><Initials>DJ</Initials><AffiliationInfo><Affiliation>MRC Unit on Anxiety & Stress Disorders Department of Psychiatry and Mental Health, University of Cape Town, Cape Town, South Africa.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Tindana</LastName><ForeName>Paulina</ForeName><Initials>P</Initials><AffiliationInfo><Affiliation>Navrongo Health Research Centre, Ghana Health Service, Navrongo, Ghana.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>de Vries</LastName><ForeName>Jantina</ForeName><Initials>J</Initials><AffiliationInfo><Affiliation>Department of Medicine, University of Cape Town, Cape Town, South Africa.</Affiliation></AffiliationInfo></Author></AuthorList><Language>eng</Language><GrantList CompleteYN="Y"><Grant><GrantID>U01 MH096754</GrantID><Acronym>MH</Acronym><Agency>NIMH NIH HHS</Agency><Country>United States</Country></Grant><Grant><GrantID>WT099313</GrantID><Agency>Wellcome Trust</Agency><Country>United Kingdom</Country></Grant><Grant><GrantID>5U01MH096754</GrantID><Acronym>MH</Acronym><Agency>NIMH NIH HHS</Agency><Country>United States</Country></Grant></GrantList><PublicationTypeList><PublicationType UI="D016428">Journal Article</PublicationType><PublicationType UI="D052061">Research Support, N.I.H., Extramural</PublicationType><PublicationType UI="D013485">Research Support, Non-U.S. Gov't</PublicationType></PublicationTypeList><ArticleDate DateType="Electronic"><Year>2015</Year><Month>12</Month><Day>07</Day></ArticleDate></Article><MedlineJournalInfo><Country>England</Country><MedlineTA>J Med Ethics</MedlineTA><NlmUniqueID>7513619</NlmUniqueID><ISSNLinking>0306-6800</ISSNLinking></MedlineJournalInfo><CitationSubset>E</CitationSubset><CitationSubset>IM</CitationSubset><CommentsCorrectionsList><CommentsCorrections RefType="Cites"><RefSource>EMBO Rep. 2008 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Version="1">19308065</PMID></CommentsCorrections><CommentsCorrections RefType="Cites"><RefSource>PLoS One. 2015;10(9):e0135545</RefSource><PMID Version="1">26331716</PMID></CommentsCorrections><CommentsCorrections RefType="Cites"><RefSource>Eur J Hum Genet. 2010 Jul;18(7):741-5</RefSource><PMID Version="1">20332813</PMID></CommentsCorrections><CommentsCorrections RefType="Cites"><RefSource>PLoS Negl Trop Dis. 2009;3(7):e482</RefSource><PMID Version="1">19621067</PMID></CommentsCorrections><CommentsCorrections RefType="Cites"><RefSource>Genome Med. 2010 Mar 24;2(3):20</RefSource><PMID Version="1">20346094</PMID></CommentsCorrections><CommentsCorrections RefType="Cites"><RefSource>Glob Public Health. 2010;5(2):154-63</RefSource><PMID Version="1">20213565</PMID></CommentsCorrections></CommentsCorrectionsList><MeshHeadingList><MeshHeading><DescriptorName UI="D000349" MajorTopicYN="N" Type="Geographic">Africa</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D044383" 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