A new Human Subject Research prior approval submission process for Clinical Translational Science Award hubs was implemented in early 2019. The activation of the new eRA Human Subjects System (HSS) provided an opportunity to consolidate and simplify the submission, review and approval process for Prior Approval requests involving human subjects research. Although, the HSS system afforded teams a centralized method for submission, it did create new challenges at the NIH review level. In order to improve the process for our researchers as well as the reviewers at the NIH, the integrated Translational Health Research Institute of Virginia (iTHRIV), a collaboration of public and private institutions across the Commonwealth of Virginia, proposes the addition of a dedicated quality assurance/ quality control position. The new iTHRIV Research Quality Manager will perform quality reviews of CTSA-related submissions to NCATS, submissions to the eRA Human Subjects System, and manage the overall prior approval process. Training the iTHRIV workforce in quality and regulatory best practices of human subject submissions is another objective which we plan to extend to include our partner sites, as well as share with the broad CTSA national network. The Research Quality Manager will harmonize quality measures and processes across the iTHRIV partners including incorporating best practices for all NCATS submission (Aim1), develop and disseminate training programs for human subject research submission processes (Aim 2) and actively participate in the national working groups sharing insights and best practices across the CTSA network (Aim 3). The addition of a Research Quality Manager will provide training programs to fill a key educational need of our research community to further develop the skills and knowledge of our workforce and enable iTHRIV to meet its primary aims of workforce development, collaboration and integration, methods and processes and allow streamlining through the iTHRIV Commons.
The addition of a Research Quality Manager will improve the process and quality of submissions to NCATS, thereby decreasing overall reviewer burden and need for additional amended submissions. Additionally, it will also provide researchers with much needed education and support for all human subject NIH submissions.
