TY - JOUR
T1 - Obtaining informed consent for genomics research in Africa
T2 - Analysis of H3Africa consent documents
AU - Munung, Nchangwi Syntia
AU - Marshall, Patricia
AU - Campbell, Megan
AU - Littler, Katherine
AU - Masiye, Francis
AU - Ouwe-Missi-Oukem-Boyer, Odile
AU - Seeley, Janet
AU - Stein, D. J.
AU - Tindana, Paulina
AU - De Vries, Jantina
PY - 2016
Y1 - 2016
N2 - 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. 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. 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. Conclusion 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.
AB - 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. 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. 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. Conclusion 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.
UR - http://www.scopus.com/inward/record.url?scp=84958118284&partnerID=8YFLogxK
U2 - 10.1136/medethics-2015-102796
DO - 10.1136/medethics-2015-102796
M3 - Article
C2 - 26644426
AN - SCOPUS:84958118284
SN - 0306-6800
VL - 42
SP - 132
EP - 137
JO - Journal of Medical Ethics
JF - Journal of Medical Ethics
IS - 2
ER -