Addressing ELSI Issues in Unregulated Health Research Using Mobile Devices

项目摘要 使用智能手机和平板电脑等移动的设备进行健康研究正变得越来越普遍。新 硬件和软件可以将移动终端转变为复杂的数据收集和分析系统， 平台这些技术从根本上改变了健康研究，因为招募，数据 收集和数据共享是在线进行的，研究人员之间没有任何面对面的互动， 研究参与者。 越来越多的研究人员没有得到任何联邦资助， 不受通用规则、FDA研究法规和HIPAA隐私规则的约束。然而， 使用移动的设备进行的不受监管的健康研究引发了许多重要的伦理问题，包括外部 审查、招募、入选和排除标准、知情同意、隐私和安全、偶然发现， 和数据共享。 该项目有以下三个目标： 目标1：进行深入的定性访谈，以了解思想领袖对风险的看法， 对使用移动的设备进行不受监管的健康研究的参与者提供适当的保护。 目标2：通过一系列4次会议， 专家工作组，并使用建立共识的方法来制定建议。 目标3：制定和实施教育方案，并将共识转化为现实 建议. 子目标3-1：由于应用程序开发人员在移动的健康创新中发挥着关键作用，我们将举办2 专门针对应用程序开发人员的讲习班，内容涉及设计移动的健康应用程序时的道德问题，并附有视频 在互联网上发布的亮点。 子目标3-2：我们将在华盛顿举行一次会议，讨论NIH感兴趣的政策问题， FDA、OHRP、FTC、国会工作人员、州政府、专业组织、研究人员， IRB、患者团体和其他利益相关者。 次级目标3-3：工作组成员将起草20条载有协商一致政策的条款 建议在《法律、医学和社会科学杂志》专题讨论会上发表 伦理 次级目标3-4：我们将在消费者会议上提出我们的调查结果和建议， 专业人士和政策制定者。

PROJECT SUMMARY Health research using mobile devices, such as smartphones and tablets, is becoming more common. New hardware and software can transform a mobile device into a sophisticated data collection and analytical platform. These technologies are fundamentally changing health research because the recruitment, data collection, and data sharing are conducted online without any face-to-face interaction between researchers and research participants. Increasingly, this research also is being conducted by researchers who do not receive any federal funding and are not subject to the Common Rule, the FDA research regulations, and the HIPAA Privacy Rule. Yet, unregulated health research using mobile devices raises numerous important ethical issues including external review, recruitment, inclusion and exclusion criteria, informed consent, privacy and security, incidental findings, and data sharing. This project has the following three aims: Aim 1: Conduct in-depth qualitative interviews to elicit thought leaders' perspectives on the risks and appropriate protections for participants in unregulated health research using mobile devices. Aim 2: Develop a detailed analysis of the ELSI issues through a series of 4 meetings by a diverse, expert working group, and use a consensus-building methodology to develop recommendations. Aim 3: Devise and implement educational programs and translation of the consensus recommendations. Sub-aim 3-1: Because app developers play a key role in mobile health innovations, we will hold 2 workshops exclusively for app developers on ethical issues in designing mobile health apps, with video highlights posted on the internet. Sub-aim 3-2: We will hold a conference in Washington, DC, on policy issues of interest to the NIH, FDA, OHRP, FTC, Congressional staffs, state governments, professional organizations, researchers, IRBs, patient groups, and other stakeholders. Sub-aim 3-3: Members of the working group will draft 20 articles containing consensus policy recommendations for publication in a special symposium issue of the Journal of Law, Medicine & Ethics. Sub-aim 3-4: We will present our findings and recommendations at meetings of consumers, professionals, and policy makers.