Golder Su, Scantlebury Arabella, Christmas Helen
Department of Health Sciences, University of York, York, United Kingdom.
Leeds Teaching Hospitals NHS Trust, Leeds, United Kingdom.
J Med Internet Res. 2019 Aug 29;21(8):e7081. doi: 10.2196/jmir.7081.
Adverse events are underreported in research studies, particularly randomized controlled trials and pharmacovigilance studies. A method that researchers could use to identify more complete safety profiles for medications is to use social media analytics. However, patient's perspectives on the ethical issues associated with using patient reports of adverse drug events on social media are unclear.
The objective of this study was to explore the ethics of using social media for detecting and monitoring adverse events for research purposes using a multi methods approach.
A multi methods design comprising qualitative semistructured interviews (n=24), a focus group (n=3), and 3 Web-based discussions (n=20) with members of the public was adopted. Findings from a recent systematic review on the use of social media for monitoring adverse events provided a theoretical framework to interpret the study's findings.
Views were ascertained regarding the potential benefits and harms of the research, privacy expectations, informed consent, and social media platform. Although the majority of participants were supportive of social media content being used for research on adverse events, a small number of participants strongly opposed the idea. The potential benefit of the research was cited as the most influential factor to whether participants would give their consent to their data being used for research. There were also some caveats to people's support for the use of their social media data for research purposes: the type of social media platform and consideration of the vulnerability of the social media user. Informed consent was regarded as difficult to obtain and this divided the opinion on whether it should be sought.
Social media users were generally positive about their social media data being used for research purposes; particularly for research on adverse events. However, approval was dependent on the potential benefit of the research and that individuals are protected from harm. Further study is required to establish when consent is required for an individual's social media data to be used.
在研究中，尤其是随机对照试验和药物警戒研究中，不良事件的报告不足。研究人员可用于识别药物更完整安全性概况的一种方法是使用社交媒体分析。然而，患者对于在社交媒体上使用不良药物事件患者报告相关伦理问题的看法尚不清楚。
本研究的目的是采用多方法途径探讨将社交媒体用于检测和监测不良事件以进行研究的伦理问题。
采用了多方法设计，包括对公众进行定性半结构式访谈（n = 24）、焦点小组讨论（n = 3）以及3次基于网络的讨论（n = 20）。近期一项关于使用社交媒体监测不良事件的系统评价结果提供了一个理论框架来解释本研究的结果。
确定了关于该研究的潜在益处和危害、隐私期望、知情同意以及社交媒体平台的观点。尽管大多数参与者支持将社交媒体内容用于不良事件研究，但少数参与者强烈反对这一想法。研究的潜在益处被认为是参与者是否会同意其数据用于研究的最有影响力的因素。人们对将其社交媒体数据用于研究目的的支持也存在一些限制条件：社交媒体平台的类型以及对社交媒体用户脆弱性的考虑。知情同意被认为难以获得，这在是否应该寻求知情同意的问题上存在意见分歧。
社交媒体用户总体上对其社交媒体数据用于研究目的持积极态度；特别是用于不良事件研究。然而，批准取决于研究的潜在益处以及确保个人免受伤害。需要进一步研究以确定何时需要个人同意才能使用其社交媒体数据。
