"I didn't have anything to decide, I wanted to help my kids"-An interview-based study of consent procedures for sampling human biological material for genetic research in rural Pakistan.
"I didn't have anything to decide, I wanted to help my kids"-An interview-based study of consent procedures for sampling human biological material for genetic research in rural Pakistan.
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DOI：
10.1080/23294515.2018.1472148
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发表时间：
2018-07-01
影响因子：
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通讯作者：
Sandoe, Peter
中科院分区：
文献类型：
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作者：
Kongsholm, Nana Cecilie Halmsted;Lassen, Jesper;Sandoe, Peter
背景技术：在涉及人体材料采样的研究中，个人、全面和书面的知情同意书被广泛认为是一项道德义务。然而，在发展中国家，当地的情况，如普遍的文盲、低教育水平和等级社会结构，使遵守这些标准变得复杂。因此，研究人员可能会修改同意过程以确保参与。为了评估这种修改后的同意策略的伦理状况，有必要评估当地的做法在多大程度上符合雅阁的价值观的基础知情consent.METHODS：在2014年4月，我们进行了半结构化的采访，研究人员从遗传研究所在巴基斯坦农村和家庭谁给了他们的研究血液样本。对研究人员的采访集中在该研究所的同意要求，以及研究人员在该领域获得同意的策略和经验。与捐助者的采访集中在他们的动机捐赠样本，他们的经验，同意和捐赠，什么因素是中央在他们的决定给予consent.RESULTS：研究人员经常报告修改同意程序适合当地情况下，standardising采用口头和老年人的同意，并定制信息的社会教育水平的捐助者家庭。捐赠者关于他们同意的决定的中心主题是希望从他们的参与中得到一些东西，以及他们对研究人员的高度信任。一些捐赠者的报告表明，参与和诊断存在一定程度的混淆，导致对治疗益处的错误预期。我们认为，虽然在研究中建立和保持信任关系很重要，尤其是在发展中国家，但为这一奋进服务的战略应该辅之以确保适当提供和理解相关信息的努力，特别是关于研究的性质以及个人同意和选择退出的措施。
BACKGROUND: Individual, comprehensive, and written informed consent is broadly considered an ethical obligation in research involving the sampling of human material. In developing countries, however, local conditions, such as widespread illiteracy, low levels of education, and hierarchical social structures, complicate compliance with these standards. As a result, researchers may modify the consent process to secure participation. To evaluate the ethical status of such modified consent strategies it is necessary to assess the extent to which local practices accord with the values underlying informed consent.METHODS: Over a 2-week period in April 2014 we conducted semistructured interviews with researchers from a genetic research institute in rural Pakistan and families who had given blood samples for their research. Interviews with researchers focused on the institute's requirements for consent, and the researchers' strategies for and experiences with obtaining consent in the field. Interviews with donors focused on their motivation for donating samples, their experience of consent and donation, and what factors were central in their decisions to give consent.RESULTS: Researchers often reported modifications to consent procedures suited to the local context, standardly employing oral and elder consent, and tailoring information to the social education level of donor families. Central themes in donors' accounts of their decision to consent were the hope of getting something out of their participation and their remarkably high levels of trust in the researchers. Several donor accounts indicated a degree of confusion about participation and diagnosis, resulting in misconceived expectations of therapeutic benefits.CONCLUSIONS: We argue that while building and maintaining trusting relationships in research is important-not least in developing countries-strategies that serve this endeavor should be supplemented with efforts to ensure proper provision and understanding of relevant information, specifically about the nature of research and measures for individual consent and opt-out.