Understanding and retention of the informed consent process among parents in rural northern Ghana
Identifieur interne : 000B25 ( Main/Exploration ); précédent : 000B24; suivant : 000B26Understanding and retention of the informed consent process among parents in rural northern Ghana
Auteurs : Abraham R. Oduro [Ghana] ; Raymond A. Aborigo [Ghana] ; Dickson Amugsi [Ghana] ; Francis Anto [Ghana] ; Thomas Anyorigiya [Ghana] ; Frank Atuguba [Ghana] ; Abraham Hodgson [Ghana] ; Kwadwo A. Koram [Ghana]Source :
- BMC Medical Ethics [ 1472-6939 ] ; 2008.
Abstract
The individual informed consent model remains critical to the ethical conduct and regulation of research involving human beings. Parental informed consent process in a rural setting of northern Ghana was studied to describe comprehension and retention among parents as part of the evaluation of the existing informed consent process.
The study involved 270 female parents who gave consent for their children to participate in a prospective cohort study that evaluated immune correlates of protection against childhood malaria in northern Ghana. A semi-structured interview with questions based on the informed consent themes was administered. Parents were interviewed on their comprehension and retention of the process and also on ways to improve upon the existing process.
The average parental age was 33.3 years (range 18–62), married women constituted a majority (91.9%), Christians (71.9%), farmers (62.2%) and those with no formal education (53.7%). Only 3% had ever taken part in a research and 54% had at least one relation ever participate in a research. About 90% of parents knew their children were involved in a research study that was not related to medical care, and 66% said the study procedures were thoroughly explained to them. Approximately, 70% recalled the study involved direct benefits compared with 20% for direct risks. The majority (95%) understood study participation was completely voluntary but only 21% recalled they could withdraw from the study without giving reasons. Younger parents had more consistent comprehension than older ones. Maternal reasons for allowing their children to take part in the research were free medical care (36.5%), better medical care (18.8%), general benefits (29.4%), contribution to research in the area (8.8%) and benefit to the community (1.8%). Parental suggestions for improving the consent process included devoting more time for explanations (46.9%), use of the local languages (15.9%) and obtaining consent at home (10.3%).
Significant but varied comprehension of the informed consent process exists among parents who participate in research activities in northern Ghana and it appears the existing practices are fairly effective in informing research participants in the study area.
Url:
DOI: 10.1186/1472-6939-9-12
PubMed: 18565230
PubMed Central: 2443367
Affiliations:
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Oduro</name><affiliation wicri:level="1"><nlm:aff id="I1">Navrongo health research centre, Ghana health service, Box 114, Navrongo, Ghana</nlm:aff><country xml:lang="fr">Ghana</country><wicri:regionArea>Navrongo health research centre, Ghana health service, Box 114, Navrongo</wicri:regionArea><wicri:noRegion>Navrongo</wicri:noRegion></affiliation></author><author><name sortKey="Aborigo, Raymond A" sort="Aborigo, Raymond A" uniqKey="Aborigo R" first="Raymond A" last="Aborigo">Raymond A. Aborigo</name><affiliation wicri:level="1"><nlm:aff id="I1">Navrongo health research centre, Ghana health service, Box 114, Navrongo, Ghana</nlm:aff><country xml:lang="fr">Ghana</country><wicri:regionArea>Navrongo health research centre, Ghana health service, Box 114, Navrongo</wicri:regionArea><wicri:noRegion>Navrongo</wicri:noRegion></affiliation></author><author><name sortKey="Amugsi, Dickson" sort="Amugsi, Dickson" uniqKey="Amugsi D" first="Dickson" last="Amugsi">Dickson Amugsi</name><affiliation wicri:level="1"><nlm:aff id="I1">Navrongo health research centre, Ghana health service, Box 114, Navrongo, Ghana</nlm:aff><country xml:lang="fr">Ghana</country><wicri:regionArea>Navrongo health research centre, Ghana health service, Box 114, Navrongo</wicri:regionArea><wicri:noRegion>Navrongo</wicri:noRegion></affiliation></author><author><name sortKey="Anto, Francis" sort="Anto, Francis" uniqKey="Anto F" first="Francis" last="Anto">Francis Anto</name><affiliation wicri:level="1"><nlm:aff id="I1">Navrongo health research centre, Ghana health service, Box 114, Navrongo, Ghana</nlm:aff><country xml:lang="fr">Ghana</country><wicri:regionArea>Navrongo health research centre, Ghana health service, Box 114, Navrongo</wicri:regionArea><wicri:noRegion>Navrongo</wicri:noRegion></affiliation></author><author><name sortKey="Anyorigiya, Thomas" sort="Anyorigiya, Thomas" uniqKey="Anyorigiya T" first="Thomas" last="Anyorigiya">Thomas Anyorigiya</name><affiliation wicri:level="1"><nlm:aff id="I1">Navrongo health research centre, Ghana health service, Box 114, Navrongo, Ghana</nlm:aff><country xml:lang="fr">Ghana</country><wicri:regionArea>Navrongo health research centre, Ghana health service, Box 114, Navrongo</wicri:regionArea><wicri:noRegion>Navrongo</wicri:noRegion></affiliation></author><author><name sortKey="Atuguba, Frank" sort="Atuguba, Frank" uniqKey="Atuguba F" first="Frank" last="Atuguba">Frank Atuguba</name><affiliation wicri:level="1"><nlm:aff id="I1">Navrongo health research centre, Ghana health service, Box 114, Navrongo, Ghana</nlm:aff><country xml:lang="fr">Ghana</country><wicri:regionArea>Navrongo health research centre, Ghana health service, Box 114, Navrongo</wicri:regionArea><wicri:noRegion>Navrongo</wicri:noRegion></affiliation></author><author><name sortKey="Hodgson, Abraham" sort="Hodgson, Abraham" uniqKey="Hodgson A" first="Abraham" last="Hodgson">Abraham Hodgson</name><affiliation wicri:level="1"><nlm:aff id="I1">Navrongo health research centre, Ghana health service, Box 114, Navrongo, Ghana</nlm:aff><country xml:lang="fr">Ghana</country><wicri:regionArea>Navrongo health research centre, Ghana health service, Box 114, Navrongo</wicri:regionArea><wicri:noRegion>Navrongo</wicri:noRegion></affiliation></author><author><name sortKey="Koram, Kwadwo A" sort="Koram, Kwadwo A" uniqKey="Koram K" first="Kwadwo A" last="Koram">Kwadwo A. Koram</name><affiliation wicri:level="4"><nlm:aff id="I2">Noguchi memorial institute for medical research, University of Ghana, Box LG 581, Accra, Ghana</nlm:aff><country xml:lang="fr">Ghana</country><wicri:regionArea>Noguchi memorial institute for medical research, University of Ghana, Box LG 581, Accra</wicri:regionArea><placeName><settlement type="city">Accra</settlement><region nuts="2">Région du Grand Accra</region></placeName><orgName type="university">Université du Ghana</orgName></affiliation></author></analytic><series><title level="j">BMC Medical Ethics</title><idno type="eISSN">1472-6939</idno><imprint><date when="2008">2008</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en"><sec><title>Background</title><p>The individual informed consent model remains critical to the ethical conduct and regulation of research involving human beings. Parental informed consent process in a rural setting of northern Ghana was studied to describe comprehension and retention among parents as part of the evaluation of the existing informed consent process.</p></sec><sec sec-type="methods"><title>Methods</title><p>The study involved 270 female parents who gave consent for their children to participate in a prospective cohort study that evaluated immune correlates of protection against childhood malaria in northern Ghana. A semi-structured interview with questions based on the informed consent themes was administered. Parents were interviewed on their comprehension and retention of the process and also on ways to improve upon the existing process.</p></sec><sec><title>Results</title><p>The average parental age was 33.3 years (range 18–62), married women constituted a majority (91.9%), Christians (71.9%), farmers (62.2%) and those with no formal education (53.7%). Only 3% had ever taken part in a research and 54% had at least one relation ever participate in a research. About 90% of parents knew their children were involved in a research study that was not related to medical care, and 66% said the study procedures were thoroughly explained to them. Approximately, 70% recalled the study involved direct benefits compared with 20% for direct risks. The majority (95%) understood study participation was completely voluntary but only 21% recalled they could withdraw from the study without giving reasons. Younger parents had more consistent comprehension than older ones. Maternal reasons for allowing their children to take part in the research were free medical care (36.5%), better medical care (18.8%), general benefits (29.4%), contribution to research in the area (8.8%) and benefit to the community (1.8%). Parental suggestions for improving the consent process included devoting more time for explanations (46.9%), use of the local languages (15.9%) and obtaining consent at home (10.3%).</p></sec><sec><title>Conclusion</title><p>Significant but varied comprehension of the informed consent process exists among parents who participate in research activities in northern Ghana and it appears the existing practices are fairly effective in informing research participants in the study area.</p></sec></div></front><back><div1 type="bibliography"><listBibl><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct></listBibl></div1></back></TEI><affiliations><list><country><li>Ghana</li></country><region><li>Région du Grand Accra</li></region><settlement><li>Accra</li></settlement><orgName><li>Université du Ghana</li></orgName></list><tree><country name="Ghana"><noRegion><name sortKey="Oduro, Abraham R" sort="Oduro, Abraham R" uniqKey="Oduro A" first="Abraham R" last="Oduro">Abraham R. Oduro</name></noRegion><name sortKey="Aborigo, Raymond A" sort="Aborigo, Raymond A" uniqKey="Aborigo R" first="Raymond A" last="Aborigo">Raymond A. Aborigo</name><name sortKey="Amugsi, Dickson" sort="Amugsi, Dickson" uniqKey="Amugsi D" first="Dickson" last="Amugsi">Dickson Amugsi</name><name sortKey="Anto, Francis" sort="Anto, Francis" uniqKey="Anto F" first="Francis" last="Anto">Francis Anto</name><name sortKey="Anyorigiya, Thomas" sort="Anyorigiya, Thomas" uniqKey="Anyorigiya T" first="Thomas" last="Anyorigiya">Thomas Anyorigiya</name><name sortKey="Atuguba, Frank" sort="Atuguba, Frank" uniqKey="Atuguba F" first="Frank" last="Atuguba">Frank Atuguba</name><name sortKey="Hodgson, Abraham" sort="Hodgson, Abraham" uniqKey="Hodgson A" first="Abraham" last="Hodgson">Abraham Hodgson</name><name sortKey="Koram, Kwadwo A" sort="Koram, Kwadwo A" uniqKey="Koram K" first="Kwadwo A" last="Koram">Kwadwo A. 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