Addressing ELSI Issues in Unregulated Health Research Using Mobile Devices

解决使用移动设备的不受监管的健康研究中的 ELSI 问题

• 批准号: 9309157
• 负责人: MARK A ROTHSTEIN
• 金额: $ 67.66万
• 依托单位: UNIVERSITY OF LOUISVILLE
• 依托单位国家: 美国
• 财政年份: 2017
• 资助国家: 美国
• 起止时间: 2017-05-04 至 2020-04-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9309157
• 关键词: Address; Categories; Cellular Phone; Child; Computer software; Consensus; Data; Data Analytics; Data Collection; Educational workshop; Ensure; Ethical Issues; Ethics; Exclusion Criteria; Funding; Government Agencies; Grant; Health; Health Insurance Portability and Accountability Act; Health Technology; Incidental Findings; Informed Consent; Institutional Review Boards; Internet; Interview; Journals; Laws; Measures; Medicine; Methodology; Nonprofit Organizations; Participant; Patients; Play; Policies; Policy Maker; Precision Medicine Initiative; Privacy; Professional Organizations; Publications; Recommendation; Recruitment Activity; Regulation; Research; Research Ethics; Research Personnel; Risk; Security; Series; Social Welfare; State Government; Tablets; Technology; Translations; United States National Institutes of Health; Washington; cancer care; citizen science; common rule; data sharing; design; handheld mobile device; inclusion criteria; innovation; interest; mHealth; meetings; member; novel; patient advocacy group; programs; symposium; working group

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.

项目摘要 使用移动设备（例如智能手机和平板电脑）的健康研究变得越来越普遍。新的 硬件和软件可以将移动设备转换为复杂的数据收集和分析 平台。这些技术从根本上改变了健康研究，因为招聘，数据 收集和数据共享是在线进行的，没有研究人员与研究人员之间的任何面对面互动 研究参与者。 越来越多的研究人员也越来越多地进行了这项研究 不受共同规则，FDA研究法规和HIPAA隐私规则的约束。然而， 使用移动设备的不受管制的健康研究提出了许多重要的道德问题，包括外部 审查，招聘，包容和排除标准，知情同意，隐私和安全，偶然发现， 和数据共享。 该项目具有以下三个目标： 目标1：进行深入的定性访谈，以引起思想领袖对风险和 使用移动设备对不受管制的健康研究的参与者进行适当的保护。 AIM 2：通过一系列多种多样的会议对ELSI问题进行详细分析， 专家工作组，并使用共识建设方法来制定建议。 目标3：设计和实施教育计划和共识的翻译 建议。 Sub-aim 3-1：由于应用程序开发人员在移动健康创新中发挥关键作用，因此我们将持有2 专门针对设计移动健康应用程序的道德问题的专门针对视频设计的道德问题 互联网上发布的亮点。 Sub-aim 3-2：我们将在华盛顿特区举行一次会议，内容涉及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。 Sub-aim 3-3：工作组成员将起草20篇包含共识政策的文章 在《法律，医学杂志》杂志特别研讨会上发表的建议 伦理。 Sub-aim 3-4：我们将在消费者的会议上介绍我们的发现和建议， 专业人士和政策制定者。