Centre for Medical Ethics and Law, Department of Medicine, Faculty of Health Sciences, Stellenbosch University, Tygerberg, South Africa.
BMC Med Ethics. 2021 Jul 1;22(1):84. doi: 10.1186/s12910-021-00645-z.
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.
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.
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.
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.
生物库为存储生物标本的研究提供了令人兴奋的机会。然而，这些推进医学科学的机会充满了挑战，包括伦理和法律困境。本研究旨在确定南非利益相关者对生物库伦理法律维度的看法。
在南非，我们对 25 名生物银行家、临床医生、研究人员、生物库研究的研究生和研究伦理委员会（REC）成员进行了深入的探索性研究。通过该国生物库的已知中心、在线搜索和滚雪球抽样技术招募潜在的研究参与者。安排了半结构化的面对面或 Skype 访谈。使用主题分析对数据进行分析。
出现的主题包括：对同意模式的理解不一致、生物库研究人员与生物样本捐赠者之间的脱节、支持未成年人重新同意的程序不足、生物库研究的治理过程不一致；样本和数据共享的挑战以及利益共享和结果回报的策略不佳。生物库实践总体上似乎不一致且分散。虽然立法文件明确规定了研究中的同意要求，但一些受访者对在生物样本采集时应用哪种同意模式不清楚。他们还报告说，研究参与者对同意的理解存在不一致。此外，这些受访者对同意和同意模式的理解取决于他们在生物库实践中的位置（所担任的角色）。受访者不确定一旦达到成年年龄（≥18 岁）如何重新同意儿童参与者。因此，同意被确定为生物库实践中的主要伦理挑战之一，这并不奇怪。在某些情况下，一些受访者报告说，样本采集的治理过程不理想。参与者通常不清楚如何实施利益共享，以及如何向研究参与者和生物库捐赠者提出回报结果的想法。
研究结果表明，南非利益相关者对与生物库相关的伦理法律问题的理解存在不一致。确定需要对利益相关者进行持续的伦理能力建设。通过承认生物样本在生物库研究人员和捐赠者之间的关系中造成的脱节，可以促进对生物库伦理的理解。
