Orygen, Locked Bag 10, 35 Poplar Road, Parkville, VIC, 3052, Australia.
Centre for Youth Mental Health, University of Melbourne, 35 Poplar Road, Parkville, VIC, 3052, Australia.
BMC Med Ethics. 2020 May 13;21(1):37. doi: 10.1186/s12910-020-00479-1.
People who are at elevated risk of suicide stand to benefit from internet-based interventions; however, research in this area is likely impacted by a range of ethical and practical challenges. The aim of this study was to examine the ethical issues and practical barriers associated with clinical studies of internet-based interventions for suicide prevention.
This was a mixed-methods study involving two phases. First, a systematic search was conducted to identify studies evaluating internet-based interventions for people at risk of suicide, and information pertaining to safety protocols and exclusion criteria was extracted. Second, investigators on the included studies were invited to complete an online survey comprising open-ended and forced-choice responses. Quantitative and qualitative methods were used to analyse the data.
The literature search identified 18 eligible studies, of which three excluded participants based on severity of suicide risk. Half of the 15 suicide researchers who participated in the survey had experienced problems obtaining ethics approval, and none had encountered adverse events attributed to their intervention. Survey respondents noted the difficulty of managing risk in online environments and the limitations associated with implementing safety protocols, although some also reported increased confidence resulting from the ethical review process. Respondents recommended researchers pursue a collaborative relationship with their research ethics committees.
There is a balance to be achieved between the need to minimise the risk of adverse events whilst also ensuring interventions are being validated on populations who may be most likely to use and benefit from them (i.e., those who prefer anonymity). Further research is required to obtain the views of research ethics committees and research participants on these issues. Dialogue between researchers and ethics committees is necessary to address the need to ensure safety while also advancing the timely development of effective interventions in this critical area.
有自杀风险的人可以从基于互联网的干预措施中受益；然而，该领域的研究可能受到一系列伦理和实际挑战的影响。本研究旨在探讨与预防自杀的基于互联网的干预措施的临床研究相关的伦理问题和实际障碍。
这是一项混合方法研究，包括两个阶段。首先，进行了系统搜索，以确定评估有自杀风险的人群的基于互联网的干预措施的研究，并提取了有关安全协议和排除标准的信息。其次，邀请纳入研究的研究人员完成一项在线调查，其中包括开放式和强制性选择的回答。使用定量和定性方法对数据进行分析。
文献搜索确定了 18 项符合条件的研究，其中 3 项研究根据自杀风险的严重程度排除了参与者。参与调查的 15 名自杀研究人员中有一半人在获得伦理批准方面遇到了问题，而且没有人遇到归因于其干预措施的不良事件。调查受访者指出在在线环境中管理风险的困难，以及实施安全协议的相关限制，尽管一些人也报告说，由于伦理审查过程，他们的信心有所增强。受访者建议研究人员与他们的研究伦理委员会建立合作关系。
需要在尽量减少不良事件风险与确保干预措施在最有可能使用和受益于干预措施的人群（即那些更喜欢匿名的人群）上进行验证之间取得平衡。需要进一步研究以获取研究伦理委员会和研究参与者对这些问题的意见。研究人员和伦理委员会之间需要进行对话，以解决确保安全的必要性，同时在这一关键领域及时开发有效的干预措施。
