Stakeholder perspectives on the ethico-legal dimensions of biobanking in South Africa

Shenuka Singh,Keymanthri Moodley

doi:10.1186/s12910-021-00645-z

Abstract

BackgroundBiobanking 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.MethodsAn 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.ResultsThe 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.ConclusionThe 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.

Highlights

Biobanking provides exciting opportunities for research on stored biospecimens
The themes arising from this study included inconsistency in understanding consent models, disconnect between biobank researchers and biosample donors, inadequate support for the re-consenting process for minors involved in providing samples for biobanking; inconsistency in governance processes for biobanking research; challenges with sample and data sharing, and suboptimal strategies for benefit sharing and return of results
In response to the question: What is the state of biobanking practice in the country?, more than two thirds of the study sample believed that the climate of biobanking in South Africa was punctuated by a general lack of understanding among researchers, clinicians, research participants and communities on the exact nature and purpose of biobanks, biobanking and biorepositing of samples

Summary

Introduction

Biobanking provides exciting opportunities for research on stored biospecimens. these opportunities to advance medical science are fraught with challenges including ethical and legal dilemmas. Despite South Africa’s transition to democracy (post 1994), social and economic inequalities persist creating a fertile ground for health inequities that could open a gateway for continuing exploitation. One such case is the recent publicized dispute between an academic institution in South Africa and the Wellcome Sanger Institute in the UK over the alleged commercialization of transferred biological material and data, intended and consented for research purposes only [7,8,9]. A South African research site initially shared samples with a university in the United States (US) through a research collaborative initiative.

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