Pilot Projects Program Core p309-321

《烟草控制法案》赋予食品和药物管理局对烟草监管的权力，但 人们对这一规定对新出现的烟草产品的影响知之甚少， 或者它对不同的弱势群体的影响。跟上预计将发生的快速变化的步伐 在烟草产品引进和监管方面都需要一种机制，以促进多元化、创造性、 可以相对较快实施的小规模研究。南加州大学TCORS试点项目计划 核心(PC)就是这种机制。目标是：一、扩大研究问题的范围 在三个拟议的研究研究中；2.资助创新领域的概念验证研究，如真实- 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 出现了一些变化，如针对零售商的加州烟草监管运动，预计将于#年 2014年；4.支持跨TCORS和跨核心的协作研究；5.鼓励监管 处于研究和培训核心的科学实习生，以开发可用作 为以后向美国国立卫生研究院和类似机构提交提案进行的初步研究。方法核心将 为个人计算机提供测量和分析支持；人口核心将为参与者或 为PC招募新参与者。PC还将与三个主要研究项目进行互动 USC TCORS通过管理核心，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运营流程，该流程遵循NIH指南，旨在生成 快速传播方法和结果，以便为未来的烟草监管实践提供参考。各阶段 包括：1.鼓励广泛的调查人员和各种投入提出申请； 为代表不同类型研究(目标1-4)平衡的一整套先导研究提供资金；3.审查 和资金；4.协助加快内部审查程序；5.执行；和6.传播 TCORS内部和跨TCORS的发现。预计将有16项研究，紧随其后的是NIH的拨款申请。 相关性(请参阅说明)： 试点计划核心满足了P50公告中对TCORS的要求。它的 相关性在于推动烟草监管科学作为一门学科，产生新的研究和 管制科学的假设，并最终为最大化烟草影响的战略提供信息 被考虑的不同人群中关于烟草控制的现有和不断变化的法规 容易受到烟草使用和上瘾的影响。

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.