Ethics and Public Attitudes Concerning the Use of Archived Biological Samples

描述(由申请人提供)：大多数关于研究生物库增长带来的伦理挑战的讨论都依赖于这样一个假设，即唯一与伦理相关的利益是那些涉及受试者福利或福祉风险的利益。一旦收集了材料，并且通过去鉴定将任何进一步的风险降低到几乎为零，那么就不需要进一步保护研究对象的利益。出于这个原因，人类研究保护办公室已经确定，对生物库中未识别的材料的研究不受美国联邦研究法规的管辖。从伦理上讲，这是一个非常有问题的假设，因为人们对可能使用他们的材料的研究类型有各种各样的其他兴趣或担忧。这些“非福利”利益一直是很少有实证研究或伦理分析的主题。这项拟议的研究将通过开发、实施和评估方法来解决这些问题：1.公众对非福利利益的态度的性质、频率、分布和强度可能会受到非福利利益的影响？2.在为未来的研究设计收集和使用生物样本的政策时，这些利益的伦理权重是多少？3.保护或容纳这些利益的各种模式的适当性是什么？方法将包括一项因素调查，旨在评估选定的非福利利益对受试者是否愿意全面同意未来使用生物材料的影响；使用各种伦理框架，如共谋和集体伤害理论，评估这种利益的伦理权重；以及系统地评估保护或适应研究对象的非福利利益的各种方法的适宜性，这将远远超出对知情同意作为伦理保护的主要形式的依赖。 与公共健康相关：使用在“生物库”中收集的存档生物样本进行研究，特别是当这些样本是匿名或未识别的时候，可能通常不会对捐献样本的人的福利构成风险--但福利利益并不是个人使用其样本可能具有的唯一类型的利害关系。关于贡献者可能拥有的“非福利利益”，以及他们应该如何制定适用于使用生物样本进行研究的伦理保护，人们知之甚少。这项研究将确定这些类型的利益对人们有多重要，以及生物库政策应该如何适应这些利益。

DESCRIPTION (provided by applicant): Most discussion of the ethical challenges raised by the growth of research biobanks relies on the assumption that the only ethically relevant interests are those that concern risks to subjects' welfare or well-being. Once materials have been collected, and any further risks have been reduced to near-zero by de-identification, it follows that no further protection of the interests of research subjects is required. For this reason, the Office of Human Research Protections has determined that research on de-identified material in biobanks is exempt from the authority of US Federal research regulations. Ethically, this is a highly questionable assumption, since people have a variety of other interests or concerns about the kinds of research that might use their material. These "non-welfare" interests have been the subject of very little empirical research or ethical analysis. The proposed study will remedy this by developing, implementing, and evaluating methods to answer these questions: 1. What is the nature, frequency, distribution, and strength of public attitudes toward non-welfare interests that might be affected by uses of de-identified archived biological samples? 2. What is the ethical weight of those interests in designing policies for the collection and use of biological samples for future research? 3. What is the appropriateness of various models for protecting or accommodating such interests? Methods will include a factorial survey designed to evaluate the effect of selected non-welfare interests on subjects' willingness to give a blanket consent to future uses of biological materials; evaluation of the ethical weight of such interests using various ethical frameworks, such as theories of complicity and group harm; and a systematic evaluation of the suitability of various methods for protecting or accommodating the non-welfare interests of research subjects, which will extend well beyond reliance on informed consent as the primary form of ethical protection. PUBLIC HEALTH RELEVANCE: Research using archived biological samples collected in "biobanks," especially when these are anonymized or de-identified, may often pose no risks to the welfare of those who contributed their samples -- but welfare interests are not the only kind of stake that individuals may have in the uses of their samples. Too little is known about the "non-welfare interests" contributors might have, and how they should shape the ethical protections appropriate to research using biological samples. This study will determine how much these sorts of interests matter to people, and how such interests should be accommodated by biobank policies.