Institute of Mental Health, Mental Health and Clinical Neurosciences, School of Medicine, University of Nottingham, Nottingham, United Kingdom.
National Institute for Health and Care Research (NIHR) Nottingham Biomedical Research Centre, Institute of Mental Health, University of Nottingham, Nottingham, United Kingdom.
J Med Internet Res. 2024 Sep 9;26:e58939. doi: 10.2196/58939.
Digital mental health interventions are routinely integrated into mental health services internationally and can contribute to reducing the global mental health treatment gap identified by the World Health Organization. Research teams designing and delivering evaluations frequently invest substantial effort in deliberating on ethical and legal challenges around digital mental health interventions. In this article, we reflect on our own research experience with digital mental health intervention design and evaluation to identify 8 of the most critical challenges that we or others have faced, and that have ethical or legal consequences. These include: (1) harm caused by online recruitment work; (2) monitoring of intervention safety; (3) exclusion of specific demographic or clinical groups; (4) inadequate robustness of effectiveness and cost-effectiveness findings; (5) adequately conceptualizing and supporting engagement and adherence; (6) structural barriers to implementation; (7) data protection and intellectual property; and (8) regulatory ambiguity relating to digital mental health interventions that are medical devices. As we describe these challenges, we have highlighted serious consequences that can or have occurred, such as substantial delays to studies if regulations around Software as a Medical Device (SaMD) are not fully understood, or if regulations change substantially during the study lifecycle. Collectively, the challenges we have identified highlight a substantial body of required knowledge and expertise, either within the team or through access to external experts. Ensuring access to knowledge requires careful planning and adequate financial resources (for example, paying public contributors to engage in debate on critical ethical issues or paying for legal opinions on regulatory issues). Access to such resources can be planned for on a per-study basis and enabled through funding proposals. However, organizations regularly engaged in the development and evaluation of digital mental health interventions should consider creating or supporting structures such as advisory groups that can retain necessary competencies, such as in medical device regulation.
数字心理健康干预措施在国际上已常规纳入精神卫生服务，有助于缩小世界卫生组织所确定的全球精神卫生治疗缺口。设计和提供评估的研究团队经常投入大量精力来审议数字心理健康干预措施所涉及的伦理和法律挑战。在本文中，我们反思了我们自己在数字心理健康干预措施设计和评估方面的研究经验，以确定我们或其他人所面临的 8 个最关键的挑战，这些挑战具有伦理或法律后果。这些挑战包括：（1）在线招募工作造成的伤害；（2）干预安全性监测；（3）排除特定的人口统计学或临床群体；（4）有效性和成本效益研究结果不够稳健；（5）充分概念化和支持参与和依从性；（6）实施的结构性障碍；（7）数据保护和知识产权；（8）与作为医疗器械的数字心理健康干预措施相关的监管模糊性。在描述这些挑战时，我们强调了可能已经或已经发生的严重后果，例如，如果对软件即医疗器械（SaMD）的监管不完全了解，或者在研究生命周期中监管发生重大变化，研究可能会出现重大延迟。我们所确定的这些挑战共同突显了团队内部或通过外部专家获取所需知识和专业技能的大量工作。确保获取知识需要精心规划和充足的财务资源（例如，支付公众参与者就关键伦理问题进行辩论，或支付法律意见以解决监管问题）。可以在每项研究的基础上进行此类资源的规划，并通过资助提案来实现。然而，经常参与数字心理健康干预措施的开发和评估的组织应考虑创建或支持顾问小组等结构，以保留必要的能力，例如在医疗器械监管方面。
