Tindana Paulina, Molyneux Catherine S, Bull Susan, Parker Michael
Navrongo Health Research Centre, Ghana Health Service, P,O, Box 114, Navrongo, Ghana.
BMC Med Ethics. 2014 Oct 18;15:76. doi: 10.1186/1472-6939-15-76.
For many decades, access to human biological samples, such as cells, tissues, organs, blood, and sub-cellular materials such as DNA, for use in biomedical research, has been central in understanding the nature and transmission of diseases across the globe. However, the limitations of current ethical and regulatory frameworks in sub-Saharan Africa to govern the collection, export, storage and reuse of these samples have resulted in inconsistencies in practice and a number of ethical concerns for sample donors, researchers and research ethics committees. This paper examines stakeholders' perspectives of and responses to the ethical issues arising from these research practices.
We employed a qualitative strategy of inquiry for this research including in-depth interviews and focus group discussions with key research stakeholders in Kenya (Nairobi and Kilifi), and Ghana (Accra and Navrongo).
The stakeholders interviewed emphasised the compelling scientific importance of sample export, storage and reuse, and acknowledged the existence of some structures governing these research practices, but they also highlighted the pressing need for a number of practical ethical concerns to be addressed in order to ensure high standards of practice and to maintain public confidence in international research collaborations. These concerns relate to obtaining culturally appropriate consent for sample export and reuse, understanding cultural sensitivities around the use of blood samples, facilitating a degree of local control of samples and sustainable scientific capacity building.
Drawing on these findings and existing literature, we argue that the ethical issues arising in practice need to be understood in the context of the interactions between host research institutions and local communities and between collaborating institutions. We propose a set of 'key points-to-consider' for research institutions, ethics committees and funding agencies to address these issues.
几十年来，获取人类生物样本，如细胞、组织、器官、血液以及诸如DNA等亚细胞物质，用于生物医学研究，一直是全球了解疾病本质和传播的核心。然而，撒哈拉以南非洲地区当前的伦理和监管框架在管理这些样本的采集、出口、储存和再利用方面存在局限性，导致实践中出现不一致情况，并引发了样本捐赠者、研究人员和研究伦理委员会的一些伦理问题。本文探讨了利益相关者对这些研究实践中产生的伦理问题的看法和应对措施。
我们采用了定性研究策略，包括对肯尼亚（内罗毕和基利菲）以及加纳（阿克拉和纳瓦龙戈）的主要研究利益相关者进行深入访谈和焦点小组讨论。
接受访谈的利益相关者强调了样本出口、储存和再利用在科学上的重要性，并承认存在一些管理这些研究实践的结构，但他们也强调迫切需要解决一些实际的伦理问题，以确保高标准的实践，并维持公众对国际研究合作的信心。这些问题涉及获得关于样本出口和再利用的文化上适当的同意、理解围绕血液样本使用的文化敏感性、促进一定程度的样本本地控制以及可持续的科学能力建设。
基于这些发现和现有文献，我们认为实践中出现的伦理问题需要在宿主研究机构与当地社区之间以及合作机构之间的互动背景下加以理解。我们为研究机构、伦理委员会和资助机构提出了一套“要点考量”，以解决这些问题。
