Beyond Data Security: Promoting Confidentiality and Advancing Science

描述（由申请人提供）：针对基因组研究中的保密性挑战，已经提出了一系列潜在的解决方案，但如何在这个“大数据”时代最好地进行尚不清楚。一些人主张采取措施进一步限制获取基因组信息。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”的优点和缺点，人们知之甚少。此外，新兴模型正在打破传统，将是否共享、与谁共享以及出于何种目的共享数据的控制权交给参与者。迫切需要更好地了解现有的法律保护，它们如何适用于快速发展的研究环境，以及如何最好地告知潜在参与者这些保护在不同背景下的程度和局限性。拟议研究的目的是收集有关适用于基因组研究的保密保护的实际范围（超出基本安全措施）的经验数据，以及如何向潜在参与者描述这些数据。为了实现这一目标，我们将：(1)进行深入的定性访谈，探讨不同思想领袖对基因组研究风险和保密保护的看法；(2)对保护基因组研究机密性的法律工具（如基因反歧视法律、数据共享政策和法规）进行广泛分析，包括将其应用于现实的研究场景，包括当前和不断发展的数据共享控制方法；(3)开发灵活的模型语言，简单准确地描述基因组研究中的保密风险和保护措施，并收集思想领袖和研究参与者对该语言的反馈。这些目标的实施将高度结合，每一个目标都向其他目标提供信息，并由其他目标提供信息。预期的结果将是一个广泛的互补、高质量的数据体，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。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，基因组研究者的观点，以及对我们的模型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.