Regulation of donor participation in research studies: is there another way?
Regulation of donor participation in research studies: is there another way?
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监管捐助者参与研究：还有其他方法吗？
DOI：
10.1038/bmt.2010.268
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发表时间：
2011
影响因子：
4.8
通讯作者：
Apperley JF
中科院分区：
文献类型：
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作者：
Apperley JF
移植界，包括病人和护理人员、医生、科学家和卫生保健工作者，长期以来一直受益于兄弟姐妹或无关志愿者提供的利他捐赠。因此，令我们感到羞耻的是，花了40多年的时间才仔细考虑捐赠者的权利，充分了解移植中心正在进行的研究的性质，并出现在移植文献中。King和他的同事们对这个问题进行了深入的思考，并得出结论，当捐赠者被要求做的不仅仅是简单地为简单的移植程序提供细胞，或者提供将以可识别的方式使用的数据和/或材料时，研究方案应该在捐赠者和患者的原籍国获得批准，捐助者应充分知情，并有权拒绝参加。这似乎是完全合理的，而且正如作者所说，符合赫尔辛基协定的精神。然而，这一建议的实用性、解释和影响并不那么简单。作者特别引用了一个例子，要求捐赠者提供超过通常数量的细胞，因为例如，技术程序需要比通常收集更多的细胞。但这是司空见惯的。众所周知，通过离体阳性或阴性选择进行的T细胞耗竭会导致潜在再增殖细胞的损失，非清髓性制备方案部分基于输注大量CD 34+细胞的能力，这两种策略无疑会增加移植失败和疾病复发的风险，增加要求提供第二次收获和/或淋巴细胞捐献的机会。非清髓性移植已成为几种移植适应症的标准治疗，包括骨髓增生异常、骨髓纤维化和低度淋巴组织增生性疾病，然而，供体中心极不可能知道预处理方案的性质。这会被认为是关于捐赠者的研究协议还是仅仅是一种不便？如果患者参与了清髓性与非清髓性预处理的研究方案，供体是否也会参与？不一致的风险似乎相当大。我们定期收集供体选择所需的供体数据，并且我们长期以来一直将这些数据提交给当地、国家和国际登记中心，用于研究目的的回顾性分析。此外，HLA分型技术的发展和对细胞因子多态性的研究也使供者选择的逐步改进
The transplant community, including patients and carers, physicians, scientists and health-care workers, has long benefited from the altruistic donations provided by sibling or unrelated volunteer individuals. It is, therefore, to our shame that it has taken over 40 years for a careful consideration of the rights of the donor to be fully informed of the nature of the research being undertaken in the transplant centre, to appear in the transplant literature. King and colleagues have given great thought to this matter and have concluded that when the donor is required to do more than simply provide cells for a straightforward transplant procedure or to provide data and/or material that will be used in an identifiable manner, the research protocol should be approved in the country of origin of both donor and patient, the donor should be fully informed and should have the right to refuse to participate. This seems entirely reasonable and, as the authors argue, in keeping with the spirit of the Helsinki agreement. The practicalities, interpretation and implications of such a recommendation, however, are not so simple. The authors particularly cite the example of a donor being asked to provide more than the usual number of cells because, for instance, a technical procedure necessitates a larger than the usual collection. But this is commonplace. T-cell depletion by ex vivo positive or negative selection is well known to result in the loss of potential repopulating cells, non-myeloablative preparative regimens are based in part on the ability to infuse large numbers of CD34+ cells and both strategies undoubtedly increase the risks of both graft failure and disease relapse, increasing the chance of a request for the provision of a second harvest and/or lymphocyte donations. Nonmyeloablative transplants have become the standard of care for several transplant indications, including myelodysplasia, myelofibrosis and low-grade lymphoproliferative disorders, yet, the donor centre is highly unlikely to know the nature of the conditioning regimen. Would this be considered a research protocol with respect to the donor or simply an inconvenience? If the patient was participating in a research protocol of myeloablative vs non-myeloablative conditioning, will the donor also be involved? The risk of inconsistency seems considerable.We routinely collect data about the donor that are required for donor selection and we have long submitted these data to local, national and international registries where they are used for retrospective analyses with research intent. Furthermore, gradual improvements in donor selection have resulted from technical developments in HLA typing, and research into cytokine polymorphisms