Obtaining informed consent for genomics research in Africa: analysis of H3Africa consent documents

Abstract

BackgroundThe 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.MethodsA 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.ResultsInformed 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.ConclusionH3Africa 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.

Return of individual genomic research results: what do consent forms tell participants?

“…This is not surprising, as many of these ICDs were developed prior to the current guidelines, 19 and other studies have found similar results. 28 Yet, our research with GWAS investigators suggests that, although they believe results should be returned in some circumstances, the decision about whether to communicate them to participants is heavily influenced by what was written in the original ICD, and that investigators may view the ICD similar to a contract and feel bound to its terms. 29 RECs, likewise, are expected to ensure that return of results is consistent with the original ICD (https://gds.nih.gov/ 13faqs_gds.html).…”

Genomic and environmental risk factors for cardiometabolic diseases in Africa: methods used for Phase 1 of the AWI-Gen population cross-sectional study

“…Our protocols were included in an analysis of H3Africa Consortium consent documents [66] and we contributed to discussions on promoting fairness for genomic research in an African context [30]. …”

Genomic Research Data Generation, Analysis and Sharing – Challenges in the African Setting

“…Empirical evidence from across the continent shows that the majority of research participants do not grasp these concepts of genomics or are unable to explain what they mean , although there is notable variation with regards to the location (urban/rural) and demographics of research participants (Marshall et al 2014). There is often difficulty in finding local equivalent words for genomics terms and explaining these novel, unfamiliar and highly technical subjects in local languages (Munung et al 2016;Traore et al 2015;Tindana et al 2012). The process of working out comprehensible language is crucial, whether in writing or verbally.…”

“…Unsurprisingly, there is no uniform informed consent template across different countries for genomic studies because there are wide cultural and ethnic disparities that make broad consent for data sharing difficult to apply across multinational studies (Wright et al 2014). There are legal and ethical challenges to the transition from narrow consent, which is the usual practice, to broad consent, which is necessary in emerging fields, such as genomics research (Munung et al 2016;Tindana et al 2014;De Vries et al 2015c). There are additional layers of bureaucratic obstacles in some countries, due to the strict requirements for Materials Transfer Agreements (MTAs).…”

“…DACs and IRB/RECs) deciding on reuse of samples, (ii) restrictions on secondary use (e.g. when providing conditions for broad consent) (iii) reasons for storage and sharing of data and samples and (iv) the role of biobanks, which may include timeline for sample storage (Munung et al 2016).…”