Matandika Limbanazo, Ngóngóla Ruby Tionenji, Mita Khama, Manda-Taylor Lucinda, Gooding Kate, Mwale Daniel, Masiye Francis, Mfutso-Bengo Joseph
Centre for Bioethics in Eastern and Southern Africa, College of Medicine, University of Malawi, Private Bag 360, Chichiri, Blantyre 3, Malawi.
College of Medicine Research Ethics Committee, University of Malawi, Blantyre, Malawi.
BMC Med Ethics. 2020 Jul 20;21(1):61. doi: 10.1186/s12910-020-00503-4.
There is growing interest in the collection, storage and reuse of biological samples for future research. Storage and future use of biological samples raise ethical concerns and questions about approaches that safeguard the interests of participants. The situation is further complicated in Africa where there is a general lack of governing ethical frameworks that could guide the research community on appropriate approaches for sample storage and use. Furthermore, there is limited empirical data to guide development of such frameworks. A qualitative study to address this gap was conducted with key stakeholders in Malawi to understand their experiences and perspectives regarding storage and usage of samples for future research.
This study conducted 13 in-depth interviews with ethics committee members, regulators and researchers, and five focus group discussions with community representatives and clinical trial participants in Malawi. Interviews and focus group discussions were audio-recorded, transcribed verbatim, and thematically analysed.
On the current regulatory guidelines that governs the collection, storage and reuse of samples in Malawi, participants highlighted their different understanding of it, with some indicating that it prohibited the reuse and sharing of samples, while others believed it permitted. Views on the informed consent model used in Malawi, some stakeholders expressed that the current model limited options for sample contributors regarding future use. Researchers supported storing samples for future use in order to maximize their value and reduce research costs. However, they expressed concern over the exportation of samples highlighting that it could lead to misuse and would not support the development of research capacity within Malawi. They recommended use of broad consent or tiered consent and establishment of biobanks to address these concerns.
Study findings highlighted the need for a review of the current regulatory guideline and the development of infrastructure to support the use of stored biological samples for future use among the research community in Malawi. At the moment, there are ethical and practical concerns arising from the collection, storage and secondary use of biological samples make it hard to reconcile scientific progress and the protection of participants.
人们对收集、存储和再利用生物样本以供未来研究的兴趣日益浓厚。生物样本的存储和未来使用引发了伦理问题以及关于保障参与者利益的方法的疑问。在非洲，情况更为复杂，因为普遍缺乏能够指导研究界采用合适的样本存储和使用方法的伦理框架。此外，用于指导此类框架制定的实证数据有限。针对这一差距，在马拉维与关键利益相关者开展了一项定性研究，以了解他们在样本存储和用于未来研究方面的经验和观点。
本研究对伦理委员会成员、监管人员和研究人员进行了13次深入访谈，并与马拉维的社区代表和临床试验参与者进行了5次焦点小组讨论。访谈和焦点小组讨论进行了录音，逐字转录，并进行了主题分析。
关于马拉维目前管理样本收集、存储和再利用的监管指南，参与者强调了他们对此的不同理解，一些人表示该指南禁止样本的再利用和共享，而另一些人则认为是允许的。对于马拉维使用的知情同意模式，一些利益相关者表示，当前模式限制了样本提供者对未来使用的选择。研究人员支持存储样本以供未来使用，以便使其价值最大化并降低研究成本。然而，他们对样本出口表示担忧，强调这可能导致滥用，并且不会支持马拉维国内研究能力的发展。他们建议采用广泛同意或分层同意，并建立生物样本库来解决这些问题。
研究结果强调需要对当前的监管指南进行审查，并发展基础设施以支持马拉维研究界将存储的生物样本用于未来研究。目前，生物样本的收集、存储和二次使用引发了伦理和实际问题，使得难以协调科学进步与参与者保护之间的关系。
