Responding to signals of mental and behavioral health risk in pragmatic clinical trials: Ethical obligations in a healthcare ecosystem.
Responding to signals of mental and behavioral health risk in pragmatic clinical trials: Ethical obligations in a healthcare ecosystem.
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DOI：
10.1016/j.cct.2021.106651
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发表时间：
2022-03
影响因子：
2.2
通讯作者：
Sugarman J
中科院分区：
文献类型：
--
作者：
Ali J;Morain SR;O'Rourke PP;Wilfond B;O'Brien EC;Zigler CK;Staman KL;Weinfurt KP;Sugarman J
描述了在一般临床研究中监测和应对行为和精神健康风险信号（如自杀意念、阿片类药物使用障碍或抑郁症）的伦理责任；然而，实用临床试验（pct）提出了新的背景挑战。我们利用我们在PRISM（减少阿片类药物处方的疼痛管理的务实和实施研究）项目中的经验，该项目是帮助结束长期成瘾（HEAL）倡议的一个组成部分，提供研究收集敏感数据的非药物干预疼痛的研究实例。PRISM伦理与监管核心和以患者为中心的结果核心工作组的成员讨论并完善了考虑和建议。PCT研究人员可以通过理解和协调利益攸关方的期望，帮助确定其监测和应对潜在行为和心理健康风险信号的道德义务的程度；考虑试验和研究人群的特点；定义行动的触发点、阈值和责任；确定适当的反应机制和能力；将应对措施与卫生系统结合起来；解决隐私问题。基于这样的评估，研究人员应该主动确定是否、何时以及如何触发反应。这样做需要利益相关者了解他们在管理此类风险中的角色。最后，同意表格和其他研究披露应该清楚地说明如果有任何反应可能会采取什么措施。在管理和应对可能表明个人风险增加的行为和心理健康数据时，与相关利益攸关方进行早期和持续的双向沟通对于确定和应对pct面临的伦理挑战至关重要。
Ethical responsibilities for monitoring and responding to signals of behavioral and mental health risk (such as suicidal ideation, opioid use disorder, or depression) in general clinical research have been described; however, pragmatic clinical trials (PCTs) raise new contextual challenges. We use our experience with the PRISM (Pragmatic and Implementation Studies for the Management of Pain to Reduce Opioid Prescribing) program, which is a component of the Helping End Addiction Long-Term (HEAL) Initiative, to provide examples of research studying nonpharmacologic interventions for pain that collect sensitive data. Members of the PRISM Ethics and Regulatory Core and Patient-Centered Outcome Core Working Group discussed and refined considerations and recommendations. PCT researchers can help identify the extent of their ethical obligations to monitor and respond to signals of potential behavioral and mental health risks by understanding and aligning stakeholder expectations; considering characteristics of the trial and study population; defining triggers, thresholds, and responsibilities for action; identifying appropriate response mechanisms and capabilities; integrating responses with health systems; and addressing privacy. Based on such an assessment, researchers should proactively identify if, when, and how a response will be triggered. Doing so necessitates that stakeholders understand their roles in managing such risks. Finally, consent forms and other study disclosures should clearly state what if any responses might be taken. Early and ongoing bi-directional communication with relevant stakeholders is critical to identifying and meeting the ethical challenges for PCTs when managing and responding to behavioral and mental health data that potentially signal elevated risk to individuals.
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影响因子：
2.1
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