The Tobacco Control Act gives the Food and Drug Administration authority over tobacco regulation, yet relatively little is yet known about the impact of this regulation pertaining to new emerging tobacco products, or its impact on diverse, vulnerable populations. To keep pace with rapid changes that are expected to occur in both tobacco product introduction and regulation requires a mechanism to promote multiple, creative, small-scale studies that can be implemented relatively quickly. The USC TCORS Pilot Projects Program Core (PC) serves as this mechanism.
The aims are: I.To expand the research questions that are addressed in the three proposed research studies;2. To fund proof of concept studies in innovative areas such as real- time assessment of retailer impact on tobacco consumer behavior;3. To fund rapid response studies as changes occur such as the California tobacco regulatory campaign aimed at retailers, which is expected in 2014;4. To support collaborative studies across TCORSs and across cores;and 5. To encourage regulatory science trainees who are in the Research and Training Core to develop pilot projects that can be used as preliminary studies for later proposal submissions to NIH and similar agencies. The Methods Core will provide measurement and analytical support for the PC;the Population Core will provide participants or recruit new participants for the PC. The PC will also interact with the three main research projects within the USC TCORS through the Administrative Core, particularly for pilot studies that address Aim 1. The PC will follow a six-stage review and operations process that follows NIH guidelines and is designed to generate rapid dissemination of methods and results that c^n inform future tobacco regulatory practices. The stages include: 1. Encouraging applications from a wide range of investigators and from a range of inputs;2. Funding a portfolio of pilot studies that represent a balance of different types of studies (Aims 1-4);3. Review and funding;4. Assistance with expedited IRB processing;5. Implementation;and 6. Dissemination of findings within and across TCORSs. A total of 16 studies is expected, followed by NIH grant applications.
The Pilot Programs Core addresses the requirement outlined by the P50 announcement for TCORSs. Its relevance lies in advancing tobacco regulatory science as a discipline, generating new studies and hypotheses for regulatory science, and ultimately, informing strategies to maximize the impact of tobacco regulation-both existing and changing-on tobacco control among diverse populations that are considered vulnerable to tobacco use and addiction.
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