IRB CHAIRS' PERSPECTIVES ON GENOMICS RESEARCH INVOLVING STORED BIOLOGICAL MATERIALS: ETHICAL CONCERNS AND PROPOSED SOLUTIONS
IRB CHAIRS' PERSPECTIVES ON GENOMICS RESEARCH INVOLVING STORED BIOLOGICAL MATERIALS: ETHICAL CONCERNS AND PROPOSED SOLUTIONS
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DOI：
10.1525/jer.2008.3.4.99
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发表时间：
2008-12-01
影响因子：
1.3
通讯作者：
Lo, Bernard
中科院分区：
文献类型：
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作者：
Wolf, Leslie E.;Catania, Joseph A.;Lo, Bernard
我们在一项涉及心理健康相关基因组学研究的假设研究中评估了 55 位 IRB 主席对伦理问题的观点，该研究使用存储的样本来识别此类研究的潜在障碍和解决方案。大多数主席认为同意和保密的道德问题很重要。大多数主席对在新研究中使用材料表示担忧，特别是有关心理健康状况的材料，这在最初的同意中没有讨论。很少有主席考虑允许的策略，例如去身份识别和放弃同意，这些策略可能允许拟议的研究在未经同意的情况下继续进行。审查了更多协议并参加过人类受试者保护会议的主席们发现了该场景中更多突出的道德问题。我们的研究无法确定主席是否不熟悉去识别化和放弃同意的策略，或者认为他们没有充分保护提供研究样本的参与者。因此，我们的研究结果表明，研究者和 IRB 应考虑样本的未来使用，并在采集样本之前获得适当的同意。此外，我们的研究结果表明，IRB 可以通过重新设计表格来促使 IRB 成员考虑一些推荐用于此类研究的策略，例如去身份化和保密证书，并派成员参加有关人类受试者保护和研究伦理的会议，从而改进对涉及存储标本的基因组学研究的审查。
WE EVALUATED 55 IRB CHAIRS' perspectives on ethical issues in a hypothetical study involving mental health-related genomics research using stored specimens to identify potential barriers and solutions to such research. Most chairs identified the ethical issues of consent and confidentially as important. The majority of Chairs expressed concern about using materials in new research, especially concerning a mental health condition, that was not discussed in the original consent. Few Chairs considered permissible strategies, such as de-identification and waiver of consent, which could allow the proposed research to go forward without consent. Chairs who reviewed more protocols and had attended conferences on human subjects protection identified more of the salient ethical issues in the scenario. Our study could not determine whether Chairs were not familiar with the strategies of de-identification and waiver of consent, or believed that they did not adequately protect participants who had provided specimens for research. Thus, our findings suggest that investigators and IRBs should consider future use of specimens and obtain appropriate consent before collection of specimens. Furthermore, our findings suggest that IRBs can improve review of genomics research involving stored specimens by redesigning forms to prompt IRB members to consider some strategies, such as de-identification and Certificates of Confidentiality, that are recommended for this type of research and by sending members to conferences on human subjects protections and research ethics.