Considering Actionability at the Participant's Research Setting Level for Anticipatable Incidental Findings from Clinical Research
Considering Actionability at the Participant's Research Setting Level for Anticipatable Incidental Findings from Clinical Research
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DOI：
10.1111/jlme.12304
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发表时间：
2015-09-01
影响因子：
2.1
通讯作者：
Brooks, Judith
中科院分区：
文献类型：
--
作者：
Ortiz-Osorno, Alberto (Betto);Ehler, Linda A.;Brooks, Judith
确定什么是临床研究中的可预期偶然发现（IF），并确定是否以及何时应将该IF返还给参与者，这是过去10年来人类受试者保护领域的讨论主题。人们一直在争论，实施一种全面的综合框架方法，既解决研究人员归还综合框架的责任，又解决参与者收到综合框架的期望，在后勤上可能具有挑战性。在不同层面上对综合框架进行了辩论，例如考虑披露这些框架的伦理理由，或在开展研究期间规划这些框架的必要性。一些作者讨论了重新联系参与者以披露IF的方法，以及考虑IF临床重要性的相关性。同样，其他作者也讨论了何时应向参与者披露国际单项体育联合会。然而，没有一个作者讨论了在参与者的研究设置水平上，应如何考虑、评估或描述国际单项体育联合会的可行动性。本文定义了参与者的研究设置水平（APRSL）的概念，可预见的IF从临床研究，讨论了一些相关的伦理概念，以证明APRSL的概念，提出了一种策略，将APRSL纳入规划和管理的IF，并建议在每个本地研究设置的APRSL整合的策略。
Determining what constitutes an anticipatable incidental finding (IF) from clinical research and defining whether, and when, this IF should be returned to the participant have been topics of discussion in the field of human subject protections for the last 10 years. It has been debated that implementing a comprehensive IF-approach that addresses both the responsibility of researchers to return IFs and the expectation of participants to receive them can be logistically challenging. IFs have been debated at different levels, such as the ethical reasoning for considering their disclosure or the need for planning for them during the development of the research study. Some authors have discussed the methods for re-contacting participants for disclosing IFs, as well as the relevance of considering the clinical importance of the IFs. Similarly, other authors have debated about when IFs should be disclosed to participants. However, no author has addressed how the actionability of the IFs should be considered, evaluated, or characterized at the participant's research setting level. This paper defines the concept of Actionability at the Participant's Research Setting Level (APRSL) for anticipatable IFs from clinical research, discusses some related ethical concepts to justify the APRSL concept, proposes a strategy to incorporate APRSL into the planning and management of IFs, and suggests a strategy for integrating APRSL at each local research setting.