The NCATS Human Subjects Research (HSR) Prior Approval (PA) process for KL2 Scholar Projects and certain Pilot Projects has been challenging for CTSA institutions to navigate. The Indiana CTSI will create a dedicated Quality Assurance/Quality Control (QA/QC) Project Manager role to improve quality and facilitate the HSRPA process. The long-term goal is to improve the quality of human subjects research submissions, make the overall process more efficient, and provide quality assurance for the ongoing conduct of research at the Indiana CTSI, with a particular emphasis on young investigators. The objectives are to decrease the review timeline from the time of award to study startup by supporting the education of young investigators and to ensure research conducted is at the highest quality so that important clinical research discoveries can positively impact patient outcomes more quickly.
The specific aims are to: (1) Create a dedicated QA/QC position within the Indiana CTSI to perform quality reviews of CTSA-related submissions to NCATS, submit to the HSS, and manage the overall process; (2) Support applications by interfacing with KL2 Scholars and Pilot Project awardees throughout the IRB submission process; (3) Monitor funded projects once approved to ensure data quality and compliance; and (4) Offer QA/QC support to other K-funded young investigators. Accomplishing the above aims will enable measurable improvements in all stages of the HSRPA process and study conduct for KL2 Scholar Projects and certain Pilot Projects. In particular, individualized support to young investigators throughout their project will greatly enhance their training and preparation for a productive career in clinical research.

Public Health Relevance

It is essential that the next generation of researchers have the ability to navigate complex policies and regulations. This project will provide hands-on guidance for federal and local policy and regulatory requirements to early-career researchers and other researchers who receive certain NIH funding. It will also support researchers by ensuring that their research is conducted according to the highest quality standards.

National Institute of Health (NIH)
National Center for Advancing Translational Sciences (NCATS)
Linked Specialized Center Cooperative Agreement (UL1)
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Davis Nagel, Joan
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Indiana University-Purdue University at Indianapolis
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United States
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Takemura, Hiromasa; Pestilli, Franco; Weiner, Kevin S (2018) Comparative neuroanatomy: Integrating classic and modern methods to understand association fibers connecting dorsal and ventral visual cortex. Neurosci Res :
Filippelli, Gabriel M; Adamic, Jessica; Nichols, Deborah et al. (2018) Mapping the Urban Lead Exposome: A Detailed Analysis of Soil Metal Concentrations at the Household Scale Using Citizen Science. Int J Environ Res Public Health 15:
Ogbemudia, Blessing; Raymond, Jodi; Hatcher, LaRanna S et al. (2018) Assessing outpatient follow-up care compliance, complications, and sequelae in children hospitalized for isolated traumatic abdominal injuries. J Pediatr Surg :
Qiao, Nan; Carroll, Aaron E; Bell, Teresa Maria (2018) Factors affecting the Affordable Care Act Marketplace stand-alone pediatric dental plan premiums. J Public Health Dent 78:360-364
Feng, Shan; Cheng, Xi; Zhang, Lin et al. (2018) Myeloid-derived suppressor cells inhibit T cell activation through nitrating LCK in mouse cancers. Proc Natl Acad Sci U S A 115:10094-10099
Alghnam, Suliman; Towhari, Jawaher; Alkelya, Mohamed et al. (2018) The effectiveness of introducing detection cameras on compliance with mobile phone and seatbelt laws: a before-after study among drivers in Riyadh, Saudi Arabia. Inj Epidemiol 5:31
Davis, Sharon K; Xu, Ruihua; Gebreab, Samson Y et al. (2015) Association of ADIPOQ gene with type 2 diabetes and related phenotypes in African American men and women: the Jackson Heart Study. BMC Genet 16:147
Unthank, Joseph L; Miller, Steven J; Quickery, Ariel K et al. (2015) Delayed Effects of Acute Radiation Exposure in a Murine Model of the H-ARS: Multiple-Organ Injury Consequent to <10 Gy Total Body Irradiation. Health Phys 109:511-21
Orman, Eric S; Perkins, Anthony; Ghabril, Marwan et al. (2015) The confusion assessment method for the intensive care unit in patients with cirrhosis. Metab Brain Dis 30:1063-71
Luo, J; Hendryx, M; Virnig, B et al. (2015) Pre-existing diabetes and breast cancer prognosis among elderly women. Br J Cancer 113:827-32

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