An Open Source Research Permissions Framework for South Carolina

描述（由申请人提供）：该项目旨在创建一个新颖的和全面的机制，用于管理知情同意和隐私授权的研究称为“研究许可管理系统”（RPMS），并在南卡罗来纳州（SC）广泛实施。它将简化知情同意和隐私授权（“研究许可”）的收集和管理，这些许可将通过个人与研究企业的直接和间接互动而获得。消费者越来越能够通过各种新技术和新环境表明他们参与研究各个方面的愿望。例如，通过互联网注册为临床研究志愿者，并同意就具体研究领域与之联系，是相对较新的能力，带来了法律的、伦理、社会和信息学方面的挑战。这给机构带来了巨大的负担，因为它们开始将基因组和生物标本与其临床数据整合用于研究目的。对于分布式临床试验网络来说，管理研究许可变得更加复杂，因为它们通常是合作机构的松散联系，而这些合作机构不是隐私法下的相互覆盖实体，就像许多完全集成的医疗保健提供网络一样。然而，随着美国将医疗保健重组为医院网络的网络，临床试验网络的数量和范围将增加。目前的大机会补助金将允许SC医疗质量经济卓越中心（CHQ）通过为SC开发RPMS来加速其计划的临床和转化研究网络。我们建议这在两年内是可行的，并最终将显着改善研究投资，公共卫生和医疗保健。我们将通过使用合理的信息学方法来做到这一点，例如为研究许可开发基础本体，使用专家行业和学术合作伙伴关系，并展示几种新技术。其目的是建立一个新的“研究许可档案”，使用户能够在互联网上管理自己的数据，在消费者选择方面取得重大进展。我们相信这将增加信任和受试者招募。该项目最终将导致许可框架，该框架将通过i2b2项目（整合生物学和床边的信息学）作为开源代码发布给一般研究社区，影响整个美国的临床和转化研究。健康科学南卡罗来纳州（HSSC）是根据SC大会的经济卓越研究中心法案成立的。该法案的目标是在该州的研究型大学设立捐赠讲座，以刺激知识经济。HSSC是三所主要研究型大学和四个主要卫生系统的合作伙伴。它是医疗质量中心（CHQ）的主要赞助商，其使命是创建一个集成的全州临床试验网络，促进临床和转化研究，影响SC的主要公共卫生问题。 公共卫生相关性：目前的大机会赠款将允许SC医疗质量经济卓越中心（CHQ）通过开发研究管理系统（RPMS）来加速其计划的临床和转化研究网络，该系统将显着增加生物医学研发的增长和投资，改善公共卫生，并影响南卡罗来纳州的医疗保健服务。本申请中提出的创新将使南卡罗来纳州成为临床和转化研究的典范，使研究人员能够探索疾病的基因组关联及其公共卫生影响的问题。通过开源社区推广这项工作，它有可能对加速整个美国的临床和转化研究具有更大的意义。

DESCRIPTION (provided by applicant): This project aims to create a novel and comprehensive mechanism for managing informed consents and privacy authorizations for research called a "Research Permissions Management System" (RPMS) and implement it widely in the State of South Carolina (SC). It will simplify the collection and management of informed consent and privacy authorizations ("research permissions") that will accrue to an individual through their direct and indirect interactions with the research enterprise. Consumers are increasingly able to indicate their desire to participate in diverse aspects of research through a variety of new technologies and circumstances. For example, registering as a volunteer for clinical research via the Internet and agreeing to be contacted about specific research areas, are relatively new capabilities which bring legal, ethical, social and informatics challenges. This is placing a significant burden on institutions as they begin to integrate genomic and biospecimens with their clinical data for research purposes. Managing research permissions becomes even more complicated for distributed clinical trials networks, as they are often loose affiliations of collaborating institutions that are not mutual covered entities under the privacy laws like many fully-integrated healthcare delivery networks. However, clinical trials networks will increase in number and scope as the US reorganizes healthcare into networks-of-networks of hospitals. The current Grand Opportunity grant will allow the SC Center of Economic Excellence in Healthcare Quality (CHQ) to accelerate its planned clinical and translational research network by developing an RPMS for SC. We propose that this is feasible in a two-year period and will eventually significantly improve research investment, public health and healthcare in the State. We will do this through the use of sound informatics approaches, such as the development of an underpinning ontology for research permissions, use expert industry and academic partnerships, and demonstrate several novel technologies. It is intended to create a new "research permissions profile" that will enable users to manage their own data on the Internet in a significant advance in consumer choice. We believe this will increase trust and subject recruitment. The project will eventually lead to permissions framework that will be released to the general research community as open source code through the i2b2 project (Informatics for Integrating Biology and the Bedside), impacting clinical and translational research throughout the US. Health Sciences South Carolina (HSSC) was established as a result of the SC General Assembly's Research Centers of Economic Excellence Act. The goal of the Act is to create endowed chairs at the state's research universities stimulating a knowledge-based economy. HSSC is a collaborative of three principal research universities and four major health systems. It is a major sponsor of the Center for Healthcare Quality (CHQ) with a mission to create an integrated, statewide clinical trials network and facilitate clinical and translational research, impacting SC's major public health issues. PUBLIC HEALTH RELEVANCE: The current Grand Opportunity grant will allow the SC Center of Economic Excellence in Healthcare Quality (CHQ) to accelerate its planned clinical and translational research network by developing a Research Permissions Management System (RPMS) that will significantly increase growth and investment in biomedical research and development, improve public health, and impact healthcare delivery in South Carolina. The innovations proposed in this application will allow South Carolina to become a model for clinical and translational research with the ability for researchers to explore questions of the genomic associations of disease and their public health implications. By generalizing this work through the open source community, it has the potential to have proportionally more significance for accelerating clinical and translational research throughout the US.