Consensus Statement on Ethical & Safety Practices for Conducting Digital Monitoring Studies with People at Risk of Suicide and Related Behaviors.
Consensus Statement on Ethical & Safety Practices for Conducting Digital Monitoring Studies with People at Risk of Suicide and Related Behaviors.
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DOI：
10.1176/appi.prcp.20200029
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发表时间：
2021
影响因子：
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通讯作者：
Pearson JL
中科院分区：
文献类型：
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作者：
Nock MK;Kleiman EM;Abraham M;Bentley KH;Brent DA;Buonopane RJ;Castro-Ramirez F;Cha CB;Dempsey W;Draper J;Glenn CR;Harkavy-Friedman J;Hollander MR;Huffman JC;Lee HIS;Millner AJ;Mou D;Onnela JP;Picard RW;Quay HM;Rankin O;Sewards S;Torous J;Wheelis J;Whiteside U;Siegel G;Ordóñez AE;Pearson JL
数字监控技术（例如，智能手机和可穿戴设备）提供了前所未有的机会来研究潜在的有害行为，如自杀、暴力和酒精/物质使用的真实的时间。这些新技术的使用有可能大大促进对这些行为的理解、预测和预防。然而，这些技术也引入了无数的伦理和安全问题，例如，如果参与者的反应表明研究期间风险升高，则决定何时以及如何进行干预？我们使用了一个修改后的德尔菲过程，在不同的专家小组中就对有自杀和相关行为风险的人进行数字监测研究的伦理和安全实践达成共识。包括科学家、临床医生、伦理学家、法律的专家和具有实际经验的专家在内的24位专家为迭代、多阶段调查和讨论过程提供了意见。就此类研究的多个方面达成了共识，包括：入选标准、知情同意要素、技术和安全性程序、研究期间的数据审查实践、真实的实时应对不同水平的参与者风险以及数据和安全性监测。该共识声明为研究人员，资助机构和机构审查委员会提供了关于对有自杀风险的人进行数字监测研究的当前最佳实践的专家意见的指导-与一系列其他潜在有害行为的研究相关（例如，酒精/药物使用和暴力）。该声明还强调了在就数字监测研究的最佳伦理和安全实践达成共识之前需要更多数据的领域。数字监控技术提供了前所未有的机会，可以真实的研究潜在的有害行为，如自杀，暴力和酒精/物质使用，但也引入了无数的伦理和安全问题。我们召集了一个专家科学家，临床医生，伦理学家，法律的专家小组，以及那些有生活经验的人，为迭代，多阶段的调查和讨论过程提供了投入。这项研究为研究人员提供了指导，供资机构和机构审查委员会就对高危人群进行数字监测研究的当前最佳做法提出专家意见
Digital monitoring technologies (e.g., smartphones and wearable devices) provide unprecedented opportunities to study potentially harmful behaviors such as suicide, violence, and alcohol/substance use in real‐time. The use of these new technologies has the potential to significantly advance the understanding, prediction, and prevention of these behaviors. However, such technologies also introduce myriad ethical and safety concerns, such as deciding when and how to intervene if a participant's responses indicate elevated risk during the study? We used a modified Delphi process to develop a consensus among a diverse panel of experts on the ethical and safety practices for conducting digital monitoring studies with those at risk for suicide and related behaviors. Twenty‐four experts including scientists, clinicians, ethicists, legal experts, and those with lived experience provided input into an iterative, multi‐stage survey, and discussion process. Consensus was reached on multiple aspects of such studies, including: inclusion criteria, informed consent elements, technical and safety procedures, data review practices during the study, responding to various levels of participant risk in real‐time, and data and safety monitoring. This consensus statement provides guidance for researchers, funding agencies, and institutional review boards regarding expert views on current best practices for conducting digital monitoring studies with those at risk for suicide—with relevance to the study of a range of other potentially harmful behaviors (e.g., alcohol/substance use and violence). This statement also highlights areas in which more data are needed before consensus can be reached regarding best ethical and safety practices for digital monitoring studies. Digital monitoring technologies provide unprecedented opportunities to study potentially harmful behaviors such as suicide, violence, and alcohol/substance use in real‐time, but also introduce myriad ethical and safety concerns We convened a panel of expert scientists, clinicians, ethicists, legal experts, and those with lived experience provided input into an iterative, multi‐stage survey and discussion process This study provides guidance for researchers, funding agencies, and institutional review boards regarding expert views on current best practices for conducting digital monitoring studies with those at risk