Web-based Research Implementation & Management System for Human Participants

本申请涉及恢复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，使发现可以更快，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），直接解决这些研究优先事项，该系统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。迫切需要开发经过充分测试、研究人员认可的网络工具，为广泛领域的科学家提供支持。RIMS将提供一套集成的工具，用于与人类参与者进行研究所需的许多任务，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。本项目第一阶段将实现三个具体目标：（1）与公务员事务局研究人员开展利益相关者工作组（项目执行干事、项目协调员和研究助理）确定将纳入RIMS的特点和功能;（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，以及（3）通过第二组研究人员对原型进行现场测试，收集定量和定性数据，评估拟议产品的价值、创新性、可行性、可用性和质量。以第一阶段为基础，第二阶段将涉及全面开发和测试RIMS。第二阶段的实地测试将与广泛领域的研究团队一起进行，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，专门设计，以满足公务员事务局研究人员的需要。多年来，我们与科学家的合作突显了对这些工具和服务的巨大未满足需求。RIMS将在一个没有类似的基于网络的产品存在的大市场中提供独特的、急需的资源。 公共卫生相关性：NIH的使命是改善所有人的健康结果，强调需要加快和加强临床和转化研究。技术可以通过基于网络的工具为研究人员实现这一目标发挥至关重要的作用，使他们能够更有效地进行，传播和翻译他们的研究，质量更高。临床，行为和社会研究人员在理解和预防公共卫生问题，保持健康和治疗疾病方面发挥着关键作用。治疗和预防糖尿病、肥胖、药物滥用、暴力和无数其他公共卫生问题取决于具有成本效益和有效转化的良好研究。拟议的研究实施管理系统（RIMS）将提供一套在线研究工具，以简化与人类参与者进行临床，社会和行为研究所需的各种活动，包括招募，筛选和随机化，人类参与者保护，措施建设，数据收集和数据库管理。该产品将根据研究人员的需要进行开发和测试，以大大提高他们的生产力，以及他们的研究质量和效率。RIMS的基础网络技术基础设施将广泛适用，提供可定制的工具，可以很容易地集成到一个研究协议。RIMS将为研究机构支持较少的研究人员提供平等获得负担得起的灵活技术的机会，从而消除地理障碍。实际上，该SBIR将能够支持多个NIH研究所的临床，社会和行为研究，特别是与国家精神卫生研究所（NIMH），国家药物滥用研究所（NIDA），国家老龄化研究所（NIA）和国家儿童健康与人类发展研究所（NICHD）有关。将RIMS产品推向市场将广泛支持NIH的使命，即通过加强临床和转化科学的能力来改善公共卫生结果。

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.