Web-based Research Implementation & Management System for Human Participants

描述（由申请人提供）：本申请解决了复苏法案有限竞争的研究目标：加速创新研究的小企业催化剂奖（R43）。NCRR的战略重点强调需要扩大技术的发展，以建立基础、临床和转化研究的研究能力，从而使研究成果能够更快、更有效地转化为临床实践。该SBIR项目将通过开发和测试一种创新的基于网络的技术，研究实施和管理系统（RIMS），专门用于推进和支持临床、社会和行为（CSB）科学家的研究工作，直接解决这些研究重点。迫切需要开发经过良好测试的、经研究人员批准的基于网络的工具，这些工具将支持广泛领域的科学家。RIMS将为与人类参与者一起进行研究所需的许多任务提供一套集成的工具，包括招募、筛选和随机化、人类参与者保护、测量构建、数据收集和跟踪以及数据库管理。该项目的第一阶段将实现三个具体目标：(1)与CSB研究人员（项目负责人、项目协调员和研究助理）开展利益相关方工作组，以确定将纳入rim的特性和功能；(2)根据利益相关者的建议和咨询委员会成员的意见创建RIMS原型；(3)通过第二组研究人员对原型进行实地测试，收集定量和定性数据，评估拟议产品的价值、创新、可行性、可用性和质量。以第一阶段为基础，第二阶段将全面开发和测试rim。第二阶段的现场测试将由研究团队在广泛的领域进行，以确保RIMS产品的有效性和广泛适用性。我们的市场分析显示，没有软件或基于网络的产品提供全面的研究支持包，专门为满足CSB研究人员的需求而设计。多年来，我们与科学家的合作强调了对这些工具和服务的巨大需求尚未得到满足。rim将提供一个独特的，非常需要的资源，在一个巨大的市场，没有类似的基于网络的产品存在。

DESCRIPTION (provided by applicant): This application addresses the research objectives of the Recovery Act Limited Competition: Small Business Catalyst Awards for Accelerating Innovative Research (R43). NCRR's Strategic Priorities emphasize the need to expand the development of technologies to build up research capacity for basic, clinical, and translational research so findings can be more quickly and effectively translated into clinical practice. This SBIR project will directly address these research priorities by developing and testing an innovative web-based technology, Research Implementation and Management System (RIMS), specifically designed to advance and support the research efforts of clinical, social, and behavioral (CSB) scientists. There is a critical need to develop well-tested, researcher-approved web-based tools that will support scientists across a broad range of fields. RIMS will offer an integrated suite of tools for the many tasks required to conduct research with human participants, including recruitment, screening and randomization, human participant protections, measure construction, data collection and tracking, and database management. Phase I of this project will accomplish three specific aims: (1) conduct stakeholder workgroups with CSB researchers (PIs, projects coordinators, and research assistants) to establish the features and functions to be included in RIMS; (2) create the RIMS prototype based on stakeholder recommendations and input from the Advisory Board members, and (3) field-test the prototype through a second set of researchers, gathering quantitative and qualitative data assessing the value, innovation, feasibility, usability, and quality of the proposed product. Using Phase I as a foundation, Phase II will involve full development and testing of RIMS. Phase II field testing will be conducted with research teams across a broad range of fields to ensure the effectiveness and broad applicability of the RIMS product. Our market analysis revealed no software or web-based product offering a comprehensive research support package specifically designed to meet the needs of CSB researchers. Our work with scientists over the years underscores the large unmet demand for these tools and services. RIMS will provide a unique, much needed resource within a large market where no comparable web-based product exists. PUBLIC HEALTH RELEVANCE: NIH's mission to improve health outcomes for all people emphasizes the need to accelerate and strengthen clinical and translational research. Technology can play a vital role in achieving this goal through web-based tools for researchers that allow them to conduct, disseminate, and translate their research more efficiently and with higher quality. Clinical, behavioral, and social researchers play a critical role in understanding and preventing public health problems, maintaining good health, and treating disease. The treatment and prevention of diabetes, obesity, and drug abuse, violence, and myriad other public health concerns depend on good research that is conducted cost-effectively and translated efficiently. The proposed Research Implementation Management System (RIMS) will offer a suite of on-line research tools to streamline the various activities needed to conduct clinical, social, and behavioral research with human participants, including recruitment, screening and randomization, human participant protections, measure construction, data collection, and database management. This product will be developed and tested in response to the needs of researchers to significantly advance their productivity, and the quality and efficiency of their studies. The underlying web-based technology infrastructure of RIMS will be broadly applicable, providing customizable tools that can be easily integrated into a research protocol. RIMS will bridge geographic barriers by giving researchers with fewer institutional supports for research equal access to affordable, flexible technology. In effect, this SBIR will be able to support clinical, social, and behavioral research across multiple NIH Institutes, with particular relevance for the National Institute for Mental Health (NIMH), National Institute on Drug Abuse (NIDA), National Institute on Aging (NIA), and the National Institute of Child Health and Human Development (NICHD). Bringing the RIMS product to market would broadly support NIH's mission to improve public health outcomes through strengthening capacity for clinical and translational science.