精神病学中数字健康研究的伦理检查表(英文)卡塔尔世界杯8强波胆分析观点%A Shen,Francis X %A Silverman,Benjamin C %A Monette,Patrick %A Kimble,Sara %A Rauch,Scott L %A Baker,Justin T %+哈佛医学院，641 Huntington Ave, Boston, MA, 02115, usa, 1 617 462 3845, fshen1@mgh.harvard.edu %K数字表型%K计算精神病学%K伦理学%K法律%K隐私%K知情同意%D 2022 %7 9.2.2022 %9观点%J J Med Internet Res %G English %X背景:精神病学长期以来一直需要一种更好、更可扩展的方法来捕捉行为的动态及其干扰，通过多个数据通道，以高时间分辨率实时定量。通过将位置、移动、电子邮件和文本通信以及社交媒体等全天候数据与脑部扫描、遗传学、基因组学、神经心理学电池和临床访谈相结合，研究人员将获得前所未有的大量客观、个人层面的数据。用不断发展的人工智能分析这些数据，有一天可能会以方便、高效、有效和及时的方式为现实世界中的患者提供干预措施。然而，通往这一创新未来的道路充满了伦理困境以及伦理、法律和社会影响(ELSI)。目的:伦理检查表的目的是促进研究的精心设计和执行。这并不意味着要强制要求特定的研究设计;事实上，在这个早期阶段，在没有共识指导的情况下，研究人员可能会做出一系列合理的选择。然而，该清单旨在明确这些伦理选择，并要求研究人员给出与ELSI问题相关的决定的理由。 The Ethics Checklist is primarily focused on procedural safeguards, such as consulting with experts outside the research group and documenting standard operating procedures for clearly actionable data (eg, expressed suicidality) within written research protocols. Methods: We explored the ELSI of digital health research in psychiatry, with a particular focus on what we label “deep phenotyping” psychiatric research, which combines the potential for virtually boundless data collection and increasingly sophisticated techniques to analyze those data. We convened an interdisciplinary expert stakeholder workshop in May 2020, and this checklist emerges out of that dialogue. Results: Consistent with recent ELSI analyses, we find that existing ethical guidance and legal regulations are not sufficient for deep phenotyping research in psychiatry. At present, there are regulatory gaps, inconsistencies across research teams in ethics protocols, and a lack of consensus among institutional review boards on when and how deep phenotyping research should proceed. We thus developed a new instrument, an Ethics Checklist for Digital Health Research in Psychiatry (“the Ethics Checklist”). The Ethics Checklist is composed of 20 key questions, subdivided into 6 interrelated domains: (1) informed consent; (2) equity, diversity, and access; (3) privacy and partnerships; (4) regulation and law; (5) return of results; and (6) duty to warn and duty to report. Conclusions: Deep phenotyping research offers a vision for vastly more effective care for people with, or at risk for, psychiatric disease. The potential perils en route to realizing this vision are significant; however, and researchers must be willing to address the questions in the Ethics Checklist before embarking on each leg of the journey. %M 35138261 %R 10.2196/31146 %U //www.mybigtv.com/2022/2/e31146 %U https://doi.org/10.2196/31146 %U http://www.ncbi.nlm.nih.gov/pubmed/35138261