BackgroundLimited research has been conducted on explanations and understandings of biobanking for future genomic research in African contexts with low literacy and limited healthcare access. We report on the findings of a sub-study on participant understanding embedded in a multi-disease community health screening and biobank platform study known as ‘Vukuzazi’ in rural KwaZulu-Natal, South Africa.MethodsSemi-structured interviews were conducted with research participants who had been invited to take part in the Vukuzazi study, including both participants and non-participants, and research staff that (...) worked on the study. The interviews were transcribed, and themes were identified from the interview transcripts, manually coded, and thematically analysed.ResultsThirty-nine individuals were interviewed. We found that the research team explained biobanking and future genomic research by describing how hereditary characteristics create similarities among individuals. However, recollection and understanding of this explanation seven months after participation was variable. The large volume of information about the Vukuzazi study objectives and procedures presented a challenge to participant recall. By the time of interviews, some participants recalled rudimentary facts about the genetic aspects of the study, but many expressed little to no interest in genetics and biobanking.ConclusionParticipant’s understanding of information related to genetics and biobanking provided during the consent process is affected by the volume of information as well as participant’s interest in the subject matter being discussed. We recommend that future studies undertaking biobanking and genomic research treat explanations of this kind of research to participants as an on-going process of communication between researchers, participants and the community and that explanatory imagery and video graphic storytelling should be incorporated into theses explanations as these have previously been found to facilitate understanding among those with low literacy levels. Studies should also avoid having broader research objectives as this can divert participant’s interest and therefore understanding of why their samples are being collected. (shrink)

Glucocorticoids are understood to represent useful biomarkers of stress and can be measured in saliva, hair, and breastmilk. The collection of such biosamples is increasingly included in biobank and cohort studies. While collection is considered “non-invasive” by biomedical researchers (compared to sampling blood), community perspectives may differ. This cross-sectional, qualitative study utilising eight focus groups aimed to determine the feasibility and acceptability of collecting ostensibly “non-invasive” biological samples in Malawi. Breastfeeding women, couples, field workers, and healthcare providers were purposively sampled. (...) Data about prior understandings of, barriers to, and feasibility of “non-invasive” biosampling were analysed. Participants described biomaterials intended for “non-invasive” collection as sometimes highly sensitive, with sampling procedures raising community concerns. Sampling methods framed as physically “non-invasive” within biomedicine can consequently be considered socially “invasive” by prospective sample donors. Biomedical and community framings of “invasiveness’ can therefore diverge, and the former must respond to and be informed by the perspectives of the latter. Further, considerations of collection procedures are shaped by therapeutic misconceptions about the immediate health-related utility of biomedical and public health research. When researchers engage with communities about biosampling, they must ensure they are not furthering therapeutic misconceptions and actively seek to dispel these. (shrink)

Genetic results are usually not returned to research participants in Uganda despite their increased demand. We report on researchers’ perceptions and experiences of return of individual genetic research results. The study involved 15 in-depth interviews of investigators involved in genetics and/or genomic research. A thematic approach was used to interpret the results. The four themes that emerged from the data were the need for return of individual results including incidental findings, community engagement and the consenting process, implications and challenges to (...) return of individual results. While researchers are willing to return clinically significant genetic results to research participants, they remain unsure of how this should be implemented. Suggestions to aid implementation of return of results included reconsenting of participants before receiving individual genetic results and increasing access to genetic counseling services. Community engagement to determine community perceptions and individual preferences for the return of results, and also prepare participants to safely receive results emerged as another way to support return of results. Researchers have a positive attitude toward the return of clinically significant genetic results to research participants. There is need to develop national guidance on genetic research and also build capacity for clinical genetics and genetic counseling. (shrink)

Members of research ethics committees (RECs) face a number of ethical challenges when reviewing genomic research. These include issues regarding the content and type of consent, the return of individual research results, mechanisms of sharing specimens and health data, and appropriate community engagement efforts. This article presents the findings from a survey that sought to investigate the opinions and attitudes of REC members from four Arab countries in the Middle East and North Africa (Egypt, Morocco, Sudan, and Jordan) toward these (...) ethical issues. Our findings suggest that efforts are required to better familiarize REC members with the requirements for ethical biobank research. Additionally, we recommend that further research is undertaken with REC members regarding the main items that should be present in the Material Transfer Agreements /Data Transfer Agreements in their corresponding countries and the type of consent that should be used in genomic research. (shrink)

Broad consent is permitted by the South African National Department of Health Ethics Guidelines but appears to be prohibited by section 13(1) of the Protection of Personal Information Act 4 of 2013. Additionally, the Act mandates that all personal data (including biobank sample data) be collected for lawful, explicit, and clearly defined purposes. There is possibility for ambiguity in interpretation because of this discrepancy between the two instruments. Given the association between the transfer of samples and data, the long-term nature (...) of biobanking, which makes it impractical to provide too much or enough information because it is simply not available at the time of sample collection, and the various ways that the Protection of Personal Information Act 4 of 2013 have been interpreted, we aim to demonstrate that South Africa’s current regulatory framework should appropriately permit broad consent use for biobank research where the transfer of samples and their associated data are contemplated. In summary, the proposed amendments include removing regulatory ambiguity regarding broad consent use, ensuring adequate safeguards for research participants by specifying rules for data access and personal information processing, and incorporating consent form information requirements into the national Consent Template. (shrink)