Stakeholder perspectives on the ethico-legal dimensions of biobanking in South Africa
Date
2021
Authors
Journal Title
Journal ISSN
Volume Title
Publisher
BioMed Central
Abstract
Background: Biobanking provides exciting opportunities for research on stored biospecimens. However, these
opportunities to advance medical science are fraught with challenges including ethical and legal dilemmas. This
study was undertaken to establish perspectives of South African stakeholders on the ethico-legal dimensions of
biobanking.
Methods: An in-depth exploratory study was conducted with 25 purposively selected biobankers, clinicians,
researchers, postgraduate students in biobanking research, and research ethics committee (REC) members in South
Africa. Potential study participants were recruited through known hubs for biobanking in the country, online searches
and the snowball sampling technique. A semi-structured face-to-face or Skype interview was arranged. Data was
analysed using thematic analysis.
Results: The emergent themes included: inconsistency in understanding consent models, disconnect between
biobank researchers and biosample donors, inadequate processes to support re-consenting minors, inconsistent
governance processes for biobanking research; challenges with sample and data sharing, and suboptimal strategies
for benefit sharing and return of results. Biobanking practice in general appeared to be inconsistent and fragmented.
While the need for consent in research is explicitly outlined in legislative documents, some respondents were unclear
on the type of consent model to apply in biosample collection. They also reported inconsistencies in research participants’
understanding of consent. Furthermore, these respondents’ own understanding of consent and consent
models were dependent on where they were positioned in biobanking practice (roles occupied). Respondents were
unsure about the process to follow to re-consent child participants once the age of majority (≥ 18 years) was reached.
It was not surprising that consent was identified as one of the major ethical challenges in biobanking practice. In
certain settings, some respondents reported suboptimal governance processes for sample collection. Participants
were generally unsure about how to operationalise benefit sharing and how to approach the idea of returning results
to research participants and biobank donors.
Conclusion: The study findings indicated inconsistencies in stakeholder understanding of ethico-legal considerations
related to biobanking in South Africa. A need for ongoing ethics capacity development among stakeholders was
identified. Improving understanding of the ethics of biobanking could be facilitated by acknowledging the disconnect
created by biosamples in the relationship between biobank researchers and donors.
Description
CITATION: Singh, S. & Moodley, K. 2021. Stakeholder perspectives on the ethico-legal dimensions of biobanking in South Africa. BMC Medical Ethics, 22:84, doi:10.1186/s12910-021-00645-z.
The original publication is available at https://bmcmedethics.biomedcentral.com
Publication of this article was funded by the Stellenbosch University Open Access Fund.
The original publication is available at https://bmcmedethics.biomedcentral.com
Publication of this article was funded by the Stellenbosch University Open Access Fund.
Keywords
Biobanks -- Moral and ethical aspects -- South Africa, Biological specimens -- Law and legislation -- South Africa, Informed consent (Medical law) -- South Africa, Donation of organs, tissues etc. -- Law and Legislation -- South Africa, Biobanks -- Law and legislation -- South Africa
Citation
Singh, S. & Moodley, K. 2021. Stakeholder perspectives on the ethico-legal dimensions of biobanking in South Africa. BMC Medical Ethics, 22:84, doi:10.1186/s12910-021-00645-z