Web-based Research Implementation and Management System for Human Participants

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.