Center for Identification and Study of Individuals with Atypical Diabetes Mellitus

非典型糖尿病个体识别和研究中心

• 批准号: 10364884
• 负责人: JOSE CARLOS FLOREZ
• 金额: $ 16.39万
• 依托单位: UNIVERSITY OF CHICAGO
• 依托单位国家: 美国
• 财政年份: 2018
• 资助国家: 美国
• 起止时间: 2018-09-10 至 2024-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10364884
• 关键词: Area; Attitude; Back; Case Study; Clinical; Clinical Research; Cognitive; Communities; Consultations; Data; Demographic Factors; Diabetes Mellitus; Disclosure; Distress; Endocrinology; Enrollment; Genetic Predisposition to Disease; Genetic Research; Genotype; Goals; Health Personnel; Healthcare Systems; Image; Individual; Informed Consent; Interview; Laboratories; Laboratory Finding; Measurement; Morals; Motivation; Nature; Outcome; Parents; Participant; Patients; Pattern; Peer Review; Perception; Phenotype; Physicians; Policies; Process; Provider; Publications; Readiness; Records; Reporting; Research; Research Design; Research Ethics; Research Personnel; Role; Standardization; Structure; Testing; Time; Uncertainty; Work; base; clinical care; clinically actionable; demographics; diabetes mellitus genetics; expectation; experience; genetic testing; health data; health literacy; insight; knowledge base; non-genetic; novel; preference; primary endpoint; psychologic; research clinical testing; screening; symposium; virtual

PROJECT SUMMARY/ABSTRACT RADIANT [Rare and Atypical DIAbetes NeTwork] is a nationwide network of researchers seeking to identify new rare, atypical forms of diabetes. To discover novel forms of atypical diabetes, the RADIANT investigators will perform genetic testing and deep phenotyping which may include some or all of the following: a physical exam, psychological and cognitive screening tests, laboratory data, and a variety of other clinical tests. This deep phenotyping will enable the investigators to look for patterns amongst patient-participants presenting with atypical diabetes. It will generate a significant amount of participant-specific health data, some of which will have unknown significance. RADIANT investigators are developing policies about which results to return and how to return them. In this supplement we focus on the return of non-genetic clinical results. Returning all results may not be beneficial (information overload); and yet deciding which results to return is not inherently value neutral. Returning results is further complicated by the fact that not all of the results are fully interpretable; leaving participants with information of unknown significance and investigators unsure of how to explain the uncertainty. We aim to explore what participants think they are signing up for when they agree to the return of results and whether investigators are prepared to return these results. The controversies being faced by the RADIANT consortium are five-fold: 1) which results to share; 2) how to disclose abnormal results; 3) whether and to what extent investigators have an obligation to provide an interpretation of research findings to participants; 4) whether participants can refuse to get research results that may be clinically actionable; and 5) what are the obligations of RADIANT investigators if participants elect not to receive results and/or elect not to allow the results to be shared with their HCPs. Given that these types of findings may become more common as discovery research continues to expand, it is important to understand how best to serve the needs and goals of both participants and investigators in an era where reporting back results is also becoming more commonplace. We aim to explore these questions with individuals who have atypical diabetes and the RADIANT investigators who study them. The timing of this project is ideal given that the 21st Century Cures Act goes into effect on April 5, 2021. The Cures Act gives patients fast and free virtual access to their clinical laboratory records, imaging data, and physician notes. We will explore the challenges raised by blurring practices in clinical care and research from the perspective of RADIANT participants and investigators, and the ability of physician-investigators and patient-participants to distinguish between the two. The outcome of the proposed study is highly generalizable to many other studies outside of diabetes genetics research given broad support for (patient and) participant access to their individual (clinical and) research results.

项目总结/摘要 RADIANT [Rare and Atypical Diabetes Network]是一个全国性的研究人员网络， 新型罕见非典型糖尿病为了发现非典型糖尿病的新形式， 将进行基因检测和深度表型分析，其中可能包括以下部分或全部： 检查，心理和认知筛查测试，实验室数据和各种其他临床测试。这 深入的表型分析将使研究人员能够在患者参与者中寻找模式， 非典型糖尿病它将产生大量特定于参与者的健康数据，其中一些将 具有未知的意义。RADIANT研究人员正在制定关于返回哪些结果的政策， 如何归还它们。在本补充中，我们重点关注非遗传临床结果的返回。返回 并非所有结果都是有益的（信息过载）;但决定返回哪些结果并不是 本质上是中立的。返回结果由于并非所有结果都完全 可解释;使参与者获得意义不明的信息，研究人员不确定如何 解释不确定性。我们的目标是探索当参与者同意时，他们认为他们正在签署什么 结果的返回以及研究者是否准备返回这些结果。争议在于 RADIANT财团面临的问题有五个方面：1）分享哪些结果; 2）如何披露异常结果; 3)研究者是否以及在何种程度上有义务对研究结果进行解释 4）参与者是否可以拒绝获得可能在临床上可采取行动的研究结果;以及 5)如果参与者选择不接收结果和/或选择不 以便与其HCP共享结果。考虑到这些类型的发现可能会变得更多， 随着发现研究的不断扩展，了解如何最好地满足需求是很重要的 参与者和研究者的目标，在一个报告结果的时代， 平凡我们的目标是探索这些问题与个人谁有非典型糖尿病和 研究他们的辐射研究人员。鉴于《21世纪世纪治愈法》 将于2021年4月5日生效。治愈法案为患者提供了快速和免费的虚拟访问他们的临床 实验室记录、成像数据和医师记录。我们将探讨模糊化带来的挑战 从RADIANT参与者和研究者的角度来看， 医生研究者和患者参与者区分两者的能力。的结果 拟议的研究是高度概括的许多其他研究以外的糖尿病遗传学研究， 广泛支持（患者和）参与者访问其个人（临床和）研究结果。