Pilot Projects Program Core p309-321

试点项目核心计划 p309-321

• 批准号: 8595440
• 负责人: MARY ANN PENTZ
• 金额: $ 19.34万
• 依托单位: UNIVERSITY OF SOUTHERN CALIFORNIA
• 依托单位国家: 美国
• 财政年份: 2013
• 资助国家: 美国
• 起止时间: 2013-09-19 至 2018-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8595440
• 关键词: Address; Affect; Applications Grants; Area; California; Cigarette; Collaborations; Communication; Data; Discipline; Equilibrium; Funding; Future; Guidelines; Industry; Institutional Review Boards; Label; Marketing; Measurement; Measures; Methods; N.I.H. Research Support; Participant; Pilot Projects; Population; Population Heterogeneity; Principal Investigator; Process; Protocols documentation; Randomized; Reaction; Recruitment Activity; Regulation; Reporting; Research; Research Design; Research Personnel; Research Project Grants; Research Training; Resources; Sales; Sampling; Science; Site; Staging; TNFRSF5 gene; Testing; Time; Tobacco; Tobacco Dependence; Tobacco Industry; Tobacco use; Training; United States Food and Drug Administration; United States National Institutes of Health; Validation; Vendor; Vulnerable Populations; Work; authority; career; consumer behavior; design; emerging adult; innovation; member; method development; operation; programs; research study; response; social; tobacco control; training project

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. RELEVANCE (See instmctions): 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.

《烟草控制法》赋予食品和药物管理局对烟草监管的权力， 关于这一法规对新兴烟草产品的影响还知之甚少， 或其对各种弱势群体的影响。为了跟上预期会发生的快速变化， 在烟草产品的引进和管理方面，需要一种机制，以促进多种，创造性的， 小规模的研究，可以相对快速地实施。USC TCORS试点项目计划 核心（PC）就是这种机制。其目的是：一、扩大所处理的研究问题 在三项研究中; 2。资助创新领域的概念验证研究，如真实的- 零售商对烟草消费者行为影响的时间评估; 3.资助快速反应研究， 发生变化，如加州针对零售商的烟草监管运动，预计将在 2014年; 4.支持跨TCORS和跨核心的协作研究; 5.鼓励监管 科学受训人员谁是在研究和培训核心开发试点项目，可用于 初步研究，以便以后向NIH和类似机构提交提案。核心方法将 为PC提供测量和分析支持;人口核心将为参与者或 为PC招募新的参与者。PC还将与以下三个主要研究项目进行互动： 南加州大学TCORS通过行政核心，特别是针对目标1的试点研究。PC将 遵循六个阶段的审查和操作过程，该过程遵循NIH指南，旨在生成 快速传播方法和结果，为未来的烟草监管实践提供信息。阶段 有：1.鼓励广泛的调查人员和各种投入的应用; 2. 资助一系列试点研究，平衡不同类型的研究（目标1-4）;审查 资金; 4。协助快速IRB处理; 5.执行; 6。传播 TCORS内部和跨TCORS的发现。预计共有16项研究，其次是NIH赠款申请。 相关性（见说明）： 试点计划核心解决了P50宣布的TCORS要求。其 相关性在于推进烟草监管科学作为一门学科，产生新的研究， 监管科学的假设，并最终为最大限度地发挥烟草影响的战略提供信息 现有的和正在变化的关于在被认为是 易受烟草使用和成瘾的影响。