Institutional Review Board approaches to the incidental findings problem
Institutional Review Board approaches to the incidental findings problem
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DOI：
10.1111/j.1748-720x.2008.00279.x
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发表时间：
2008-06-01
影响因子：
2.1
通讯作者：
Keane, Moira A.
中科院分区：
文献类型：
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作者：
Keane, Moira A.
机构审查委员会(IRBs)在履行现有监管任务的同时，面对不断扩大的技术面临新的挑战，以确保制定保护受试者的计划，并向他们通报参与研究的风险和好处。现有的条例和指导意见没有处理附带调查结果的问题，因此，人们对这一问题的认识和伦理原则在IRB判决中的应用是唯一的。为了确保研究人员意识到综合免疫系统的潜力，研究所必须确定哪些研究可能确定综合免疫系统，并在研究开始之前确定应该实施什么计划，以确保适当地告知受试者综合系统的可能性，如何将综合系统告知受试者，以及后续行动的负担是落在研究人员身上还是受试者的责任。
Institutional Review Boards (IRBs) are confronted with new challenges in the face of expanding technologies while fulfilling their existing regulatory mandate to ensure that plans are in place to protect subjects and to inform them of risks and benefits of research participation. Existing regulations and guidance do not address the issue of incidental findings (IFs), thus leaving awareness of the issue and the application of ethical principles to IRB judgment alone. In order to assure that researchers are aware of the potential for IFs, IRBs must identify which studies are likely to identify IFs and establish what plans should be put into place prior to study initiation to assure the subjects are appropriately informed of the likelihood of IFs, how IFs will be communicated to subjects, and whether the burden of follow-up falls on the researchers or is the subject's responsibility.