Shickle Darren
Institute of Health Sciences and Public Health Research, University of Leeds, 71-75 Clarendon Road, Leeds LS2 9PL, UK.
Stud Hist Philos Biol Biomed Sci. 2006 Sep;37(3):503-19. doi: 10.1016/j.shpsc.2006.06.007. Epub 2006 Aug 22.
Large prospective biobanks are being established containing DNA, lifestyle and health information in order to study the relationship between diseases, genes and environment. Informed consent is a central component of research ethics protection. Disclosure of information about the research is an essential element of seeking informed consent. Within biobanks, it is not possible at recruitment to describe in detail the information that will subsequently be collected because people will not know which disease they will develop. It will also be difficult to describe the specific research that will be performed using the biobank, other than to stipulate categories of research or diseases that are not included. Potential subjects can only be given information about the sorts of research that will be performed and by whom. Organisations responsible for biobanks usually argue that this disclosure of information is adequate when seeking informed consent, especially if coupled with a right to withdraw, as it would not be feasible or it would be too expensive to seek consent renewal on a regular basis. However, there are concerns about this 'blanket consent' approach'. Consent waivers have also been proposed in which research subjects entrust their consent with an independent third party to decide whether subsequent research using the biobank is consistent with the original consent provided by the subject.
大型前瞻性生物样本库正在建立，其中包含DNA、生活方式和健康信息，以便研究疾病、基因和环境之间的关系。知情同意是研究伦理保护的核心组成部分。研究信息的披露是寻求知情同意的一个基本要素。在生物样本库中，招募时不可能详细描述随后将收集的信息，因为人们不知道自己会患哪种疾病。除了规定不包括的研究类别或疾病外，也很难描述将使用生物样本库进行的具体研究。只能向潜在受试者提供有关将进行的研究类型以及由谁进行研究的信息。负责生物样本库的组织通常认为，在寻求知情同意时，这种信息披露是足够的，特别是如果再加上撤回权，因为定期寻求同意更新是不可行的，或者成本太高。然而，人们对这种“全面同意”的方法存在担忧。还提出了同意豁免的建议，即研究对象将其同意委托给独立第三方，以决定随后使用生物样本库的研究是否符合研究对象最初提供的同意。
