A proposal for a model of informed consent for the collection, storage and use of biological materials for research purposes
A proposal for a model of informed consent for the collection, storage and use of biological materials for research purposes
复制标题
DOI：
10.1016/j.pec.2007.12.003
复制
发表时间：
2008-04-01
影响因子：
3.5
通讯作者：
Borry, Pascal
中科院分区：
文献类型：
--
作者：
Porteri, Corinna;Borry, Pascal
目的：为健康研究目的，在当地生物库中收集、储存和使用生物材料，提出一个知情同意的模型。方法：回顾与收集、储存和使用人类生物材料有关的主要伦理问题。结果：在特定研究项目中收集和使用生物材料的知情同意书，以及收集的知情同意书，生物材料库中生物材料的储存和使用是单独开发的。拟议的模式有两个主要规则，即：使用生物材料的知情同意应（i）向捐赠者提供足够的信息，以便就其生物材料目前和未来的可能用途作出知情决定;（ii）考虑正在进行的研究的具体生物和遗传目的。即使知情同意的收集，储存和使用的生物材料是一个艰难的过程中，捐助者实际上可以提供足够的信息和选择，给一个“真正知情的consents. Practice影响：建议的模型可以是一个有用的指导方针，用于开发特定的知情同意书的形式，供研究人员使用。它也可以是一个很好的工具，让捐助者知道他们可以要求研究人员提供哪些信息和保证。(C)2007爱思唯尔爱尔兰有限公司保留所有权利。
Objective: To suggest a model of informed consent for the collection, storage and use of biological materials in local biobanks for health research purposes.Methods: Review of the major ethical issues related to collection, storage and use of human biological materials for research purposes.Results: An informed consent form for the collection and use of biological materials in a specific research project, and an informed consent form for the collection, storage and use of biological materials in a biobank were separately developed.Two main rules govern the proposed model, as follows: the informed consent for the use of biological materials shall (i) give donors sufficient information to take informed decisions about possible present and future uses of their biological materials and (ii) consider the specific biological and genetic aims of the research being performed.Conclusion: Even if informed consent for the collection, storage and use of biological materials is a hard process, donors can actually be provided with sufficient information and choices to give a 'really informed consent'.Practice implications: The proposed model can be a useful guideline for the development of specific informed consent forms to be used by researchers. It can also be a good tool to let the donors know which information and guarantees they can request from researchers. (C) 2007 Elsevier Ireland Ltd. All rights reserved.