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》赋予了食品和药物管理局对烟草法规的授权 关于与新的新兴烟草产品有关的该法规的影响相对鲜为人知， 或它对多样化，脆弱人群的影响。跟上预期发生的快速变化 在烟草产品介绍和法规中，都需要一种机制来促进多种，创意， 可以相对较快实施的小规模研究。 USC TCORS试点项目计划 核心（PC）是这种机制。目的是：I.扩大解决的研究问题 在三项拟议的研究中； 2。资助创新领域的概念研究证明，例如 零售商对烟草消费者行为的影响； 3。资助快速响应研究 发生变化，例如针对零售商的加利福尼亚烟草监管活动，这是预期的 2014; 4。支持跨TCORS和整个核心的协作研究；和5。鼓励监管 正在研究和培训核心的科学学员开发可以用作的试点项目 以后提交NIH和类似机构提交的提案的初步研究。方法核心将 为PC提供测量和分析支持；人口核心将为参与者提供或 招募PC的新参与者。 PC还将与其中的三个主要研究项目互动 USC通过行政核心，尤其是针对AIM 1的试点研究。PC将 遵循遵循NIH指南的六阶段审查和操作过程，旨在生成 快速传播方法和结果，这些方法和结果为未来的烟草监管实践提供了信息。阶段 包括：1。鼓励来自广泛调查人员和一系列投入的申请； 2。 资助代表不同类型研究平衡的试点研究组合（目标1-4）； 3。评论 和资金； 4.协助加急IRB处理； 5。实施；和6。传播 TCORS内部和跨TCORS的发现。总共预计将有16项研究，其次是NIH赠款申请。 相关性（请参阅Instmctions）： 试点计划核心解决了P50公告TCORS所概述的要求。它是 相关性在于将烟草监管科学作为一门学科，产生新的研究和 假设监管科学，并最终告知策略以最大程度地提高烟草的影响 在不同种群中的现有和更换烟草控制的监管 容易受到烟草使用和成瘾的影响。