Beyond Data Security: Promoting Confidentiality and Advancing Science

描述(由申请者提供)：针对基因组研究中的保密挑战，已经提出了一系列潜在的解决方案，如何最好地在这个“大数据”时代继续进行尚不清楚。一些人主张采取措施进一步限制对基因组信息的获取。其他人则主张加强禁止滥用的法律。与此同时，目前由联邦和州法律创建的保护网络的优势和劣势却鲜为人知。此外，新兴模式正在打破传统，将是否与谁以及出于什么目的共享数据的控制权拱手让给参与者。迫切需要更好地了解现有的一系列法律保护，它们如何适用于快速发展的研究环境，以及如何最好地向潜在参与者通报这些保护在不同情况下的范围和局限性。拟议研究的目的是收集关于适用于基因组研究的保密保护的实际范围(基本安全措施以外)的经验数据，以及如何向潜在参与者描述这些保护措施。为了实现这一目标，我们将：(1)进行深入的定性采访，以探索不同的思想领袖对基因组研究中的风险和保密保护的看法；(2)对基因组研究中保护保密的法律工具(例如，基因反歧视法律、数据共享政策和法规)进行广泛的分析，包括它们在现实研究情景中的应用，包括当前和不断发展的数据共享控制方法；以及(3)开发灵活的模型语言，简单而准确地描述基因组研究中的保密风险和保护，并收集思想领袖和研究参与者对语言的反馈。这些目标的实施将是高度整合的，每个目标都会告知其他目标，也会被其他目标告知。预期的结果将是大量补充的高质量数据，涉及保护基因组研究机密性的法律手段的优势和局限性--包括在控制数据共享的新方法的背景下--以及如何向潜在参与者描述风险和保护措施。这些数据将进一步支持未来研究的几个重要领域，包括调查参与者的意见和理解、基因组研究人员的观点，以及对我们的模式同意语言的严格实证评估。

DESCRIPTION (provided by applicant): A range of potential solutions has been proposed to the confidentiality challenges in genome research and how best to proceed in this era of "big data" is not known. Some advocate measures to further restrict access to genomic information. Others argue for strengthening laws that prohibit misuse. In the meantime, the strengths and weaknesses of the current "web" of protections created by federal and state law are poorly understood. In addition, emerging models are breaking from tradition by ceding control to participants over whether, with whom, and for what purposes their data are shared. There is an urgent need to better understand the existing constellation of legal protections, how they apply to a swiftly evolving research environment, and how best to inform prospective participants about the extent and limitations of these protections in different contexts. The objective of the proposed research is to gather empirical data regarding the actual scope of the confidentiality protections applicable to genome research (beyond basic security measures), as well as how these are and should be described to prospective participants. To achieve this objective, we will: (1) Conduct in-depth qualitative interviews to explore a diverse group of thought leaders' views of risks and confidentiality protections in genome research; (2) Carry out extensive analysis of the legal tools for protecting confidentiality in genome research (e.g., genetic anti-discriminatio laws, data sharing policies and regulations), including their application to realistic research scenarios encompassing both current and evolving approaches to control over data sharing; and (3) Develop flexible model language that simply and accurately describes the confidentiality risks and protections in genome research, and gather feedback on the language from thought leaders and research participants. The conduct of these aims will be highly integrated, with each one informing and being informed by the others. The expected outcome will be an extensive body of complementary, high quality data concerning the strengths and limitations of legal means to protect confidentiality in genome research-including in the context of emerging approaches to control over data sharing-and how the risks and protections both are and should be described to prospective participants. These data will further support several important areas of future research, including investigation of participant opinions and understanding, genome researcher perspectives, and rigorous empirical assessment of our model consent language.