Ethics and Public Attitudes Concerning the Use of Archived Biological Samples

关于使用存档生物样本的道德和公众态度

• 批准号: 7871580
• 负责人: Tom Tomlinson
• 金额: $ 22.16万
• 依托单位: MICHIGAN STATE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2010
• 资助国家: 美国
• 起止时间: 2010-04-08 至 2012-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7871580
• 关键词: Address; Affect; Archives; Attitude; Biocompatible Materials; Biological; Collection; Complicity; Consent; Empirical Research; Ethical Analysis; Ethics; Evaluation; Frequencies; Future; Growth; Individual; Informed Consent; Literature; Methods; Modeling; Nature; Office for Human Research Protections; Personal Satisfaction; Policies; Regulation; Reliance; Research; Research Subjects; Risk; Sampling; Shapes; Social Welfare; Sorting - Cell Movement; Surveys; Weight; authority; biobank; design; interest; public health relevance; theories; willingness

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.

描述（由申请人提供）：大多数关于研究生物库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，并且任何进一步的风险都通过去识别化降低到接近零，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，对生物库中去识别材料的研究不受美国联邦研究法规的管辖。 从伦理上讲，这是一个非常值得怀疑的假设，因为人们对可能使用他们材料的研究类型有各种各样的其他兴趣或关注。这些“非福利”利益很少受到实证研究或伦理分析的关注。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使用去识别存档生物样本的影响？2.在制定收集和使用生物样本用于未来研究的政策时，这些利益的道德分量如何？3.保护或照顾这些利益的各种模式是否适当？ 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是否愿意全盘同意未来使用生物材料的影响;使用各种伦理框架，如共谋和群体伤害理论，评估这些利益的伦理分量;以及对各种保护或照顾研究对象非福利利益的方法的适宜性进行系统评价，这将远远超出依赖知情同意作为道德保护的主要形式。 公共卫生相关性：使用“生物库”中收集的存档生物样本进行研究，特别是当这些样本被匿名或去识别时，通常可能不会对贡献样本的人的福利造成风险-但福利利益并不是个人在使用其样本时可能拥有的唯一一种利益。对于贡献者可能拥有的“非福利利益”，以及他们应该如何塑造适合使用生物样本进行研究的道德保护，人们知之甚少。这项研究将确定这些利益对人们的影响有多大，以及生物库政策应该如何适应这些利益。