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银行增长所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，并且通过去识别将任何进一步的风险降低到接近于零，那么就不需要进一步保护研究对象的利益了。出于这个原因，人类研究保护办公室已经确定，对生物库中去识别材料的研究不受美国联邦研究法规的管辖。从道德上讲，这是一个非常值得怀疑的假设，因为人们对可能使用他们的材料的研究有各种各样的其他兴趣或担忧。这些“非福利”利益很少成为实证研究或伦理分析的主题。建议的研究将通过开发、实施和评估方法来解决这些问题：公众对非福利利益的态度的性质、频率、分布和强度是什么，这些非福利利益可能会受到使用去身份化的存档生物样本的影响？2. 在为未来研究收集和使用生物样本制定政策时，这些利益的伦理重要性是什么？3. 保护或容纳这些利益的各种模式的适当性是什么？方法将包括一项析因调查，旨在评估选定的非福利利益对受试者全面同意未来使用生物材料的意愿的影响；利用各种伦理框架，如共犯理论和群体伤害理论，评估这些利益的伦理重要性；以及对保护或容纳研究对象的非福利利益的各种方法的适用性进行系统评估，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。

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.