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Beyond Data Security: Promoting Confidentiality and Advancing Science

超越数据安全：促进保密并推动科学发展

基本信息

批准号：
9571466
负责人：
LAURA M. BESKOW
金额：
$ 17.79万
依托单位：
VANDERBILT UNIVERSITY MEDICAL CENTER
依托单位国家：
美国
项目类别：
财政年份：
2014
资助国家：
美国
起止时间：
2014-07-24 至 2018-10-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/9571466
关键词：
Beyond Data Security Promoting Confidentiality

项目摘要

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.

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，并且在这个“大数据”时代如何最好地进行尚不清楚。有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，人们对联邦和州法律所建立的现行保护“网络”的优缺点知之甚少。此外，新兴模式正在打破传统，将数据是否共享、与谁共享以及出于何种目的共享的控制权交给参与者。迫切需要更好地了解现有的各种法律的保护措施，了解它们如何适用于迅速变化的研究环境，以及如何最好地让潜在的参与者了解这些保护措施在不同情况下的程度和局限性。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，以探讨不同群体的思想领袖对基因组研究中的风险和保密性保护的看法;（2）对基因组研究中保护保密性的法律的工具进行广泛的分析（例如，（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。这些目标的实现将是高度一体化的，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补充，高质量的数据有关的优势和限制的法律的手段，以保护基因组研究的机密性，包括在新兴的方法来控制数据共享的背景下，以及如何风险和保护都是和应该被描述给潜在的参与者。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，以及对我们的模型同意语言进行严格的实证评估。

项目成果

期刊论文数量（8）

专著数量（0）

科研奖励数量（0）

会议论文数量（0）

专利数量（0）

Thought Leader Comparisons of Risks in Precision Medicine Research.

DOI：
10.1002/eahr.500059
发表时间：
2020-11
期刊：
Ethics & human research
影响因子：
0
作者：
Beskow LM;Hammack-Aviran CM;Brelsford KM
通讯作者：
Brelsford KM

The Web of Legal Protections for Participants in Genomic Research.

基因组研究参与者的法律保护网。

DOI：
发表时间：
2019
期刊：
Health matrix (Cleveland, Ohio : 1991)
影响因子：
0
作者：
Wolf,LeslieE;FuseBrown,Erin;Kerr,Ryan;Razick,Genevieve;Tanner,Gregory;Duvall,Brett;Jones,Sakinah;Brackney,Jack;Posada,Tatiana
通讯作者：
Posada,Tatiana

Thought leader perspectives on benefits and harms in precision medicine research.