"The keeping is the problem": A qualitative study of IRB-member perspectives in Botswana on the collection, use, and storage of human biological samples for research
"The keeping is the problem": A qualitative study of IRB-member perspectives in Botswana on the collection, use, and storage of human biological samples for research
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DOI：
10.1186/s12910-015-0047-3
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发表时间：
2015-08-19
影响因子：
2.7
通讯作者：
Merz, Jon F.
中科院分区：
文献类型：
--
作者：
Barchi, Francis;Matlhagela, Keikantse;Merz, Jon F.
背景资料：在非洲努力建立国家和区域生物储存库的同时，人们普遍认可伦理委员会是个人捐助者及其社区利益的管理者。迄今为止，博茨瓦纳IRB成员的伦理培训计划重点关注伦理原则和国际指南，而不是特定医疗技术和研究方法的伦理层面。知之甚少的知识和关注的当前和未来的IRB成员在博茨瓦纳的出口，再利用，存储和利益共享biostecums.Methods：本定性研究探讨的观点IRB成员在博茨瓦纳的收集和使用的生物标本的研究。2013年3月，代表博茨瓦纳五个委员会的41名审查和评价委员会成员参加了小组讨论。对录音带和现场记录的传输进行了分析，以确定可能通过教育和能力建设缓解的关注问题，以及需要持续讨论或额外监管guiding.Results的领域：关注的领域包括患者和提供者对生物标本在临床护理和研究中的使用缺乏了解;生物标本的重复使用，特别是同意、所有权和决策问题;出口标本和失去对再利用和潜在利益的控制;认为需要监管指导和IRB成员培训。当地人对身体完整性和强烈的民族认同感的信念体系在利益的构建中可能与涉及外国生物储存库或将此类收集视为全球公共产品的举措不一致。需要开展教育，以加强IRB成员审查和监测要求收集和使用生物标本的协议的能力，并以明确的国家政策为指导，确定优先事项，建立伙伴关系，审查，和监督。需要与当地利益攸关方合作，以协调对人体和社区身份的根本不同的理解方式与当代生物医学的目标。
Background: Concurrent with efforts to establish national and regional biorepositories in Africa is widespread endorsement of ethics committees as stewards of the interests of individual donors and their communities. To date, ethics training programs for IRB members in Botswana have focused on ethical principles and international guidelines rather than on the ethical dimensions of specific medical technologies and research methodologies. Little is known about the knowledge and concerns of current and prospective IRB members in Botswana with respect to export, reuse, storage, and benefit-sharing of biospecimens.Methods: This qualitative study examined perspectives of IRB members in Botswana about the collection and use of biospecimens in research. Forty-one IRB members representing five committees in Botswana participated in discussions groups in March 2013. Transcriptions of audiotapes and field notes were analyzed to identify issues of concern that might be alleviated through education and capacity-building, and areas that required ongoing discussion or additional regulatory guidance.Results: Areas of concern included lack of understanding among patients and providers about the use of biospecimens in clinical care and research; reuse of biospecimens, particularly issues of consent, ownership and decision-making; export of specimens and loss of control over reuse and potential benefits; and felt need for regulatory guidance and IRB-member training. Local belief systems about bodily integrity and strong national identity in the construct of benefits may be at odds with initiatives that involve foreign biorepositories or consider such collections to be global public goods.Conclusion: Education is needed to strengthen IRB-member capacity to review and monitor protocols calling for the collection and use of biospecimens, guided by clear national policy on priority-setting, partnerships, review, and oversight. Engagement with local stakeholders is needed to harmonize fundamentally different ways of understanding the human body and community identity with the aims of contemporary biomedicine.