人类材料的使用和采购的伦理需求和关注,特别是血清,经合组织在2019年举行的专门国际研讨会上探讨了体外测试指南。捐赠程序中与健康相关的方面,包括组织筛查,捐献者的健康,实验室工作健康保护,捐赠者的商业用途许可,捐助者的付款以及利用低收入人口的潜力和捐助者的数据保护;可用性,以及与临床需求的竞争;测试指南计划的血清和可审计性/GLP需求的可追溯性,进行了检查。在这里,我们提供了研讨会关于使用人血清的建议,以及可能的其他人类试剂,特别是关于经合组织测试指南效用的测试方法开发,作为所有经合组织成员国相互接受数据要求的一部分。其中包括知情捐助者同意术语,将包括在良好实验室实践报告中的人类血清信息要求清单,以及合适的人体血清来源,以确保废物供应得到使用,不能再用于医疗目的,确保基本医疗用途的供应没有竞争。
The ethical needs and concerns with use and sourcing of human materials, particularly serum, in OECD in vitro test
guidelines were explored in a dedicated international workshop held in 2019. The health-related aspects of the donation procedure, including tissue screening, donor health, laboratory work health protection, permission from the donor for commercial use, payment of the donors and the potential for exploitation of low-income populations and data protection of the donors; supply, availability, and competition with clinical needs; traceability of the serum and auditability/GLP needs for the Test
Guideline Programme, were examined. Here we provide the recommendations of the workshop with respect to the use of human serum, and potentially other human reagents, specifically with regard to test method development for OECD Test
Guideline utility as part of the Mutual Acceptance of Data requirement across all OECD member countries. These include informed donor consent terminology, a checklist of human serum information requirements to be included with the Good Laboratory Practise report, and suitable sources for human serum to ensure waste supplies are used, that can no longer be used for medical purposes, ensuring no competition of supply for essential medical use.