ATRAC - Pilot Program Description

Updated:May 4,2015





 

American Heart Association Tobacco Regulation and Addiction Center (A-TRAC)
NIH/FDA Grant 1P50HL120163-02
Pilot Research Grants Program Description

Pilot Research Grants Program Objective

To fund innovative ideas and meritorious pilot research projects related to tobacco use and cardiovascular health that are focused on target areas consistent with the American Heart Association (AHA) Tobacco Regulation and Addiction Center (A-TRAC) mission of aiding in the development and evaluation of tobacco product regulation by the Food and Drug Administration (FDA) and thereby contributing towards the protection of public health and reduction of tobacco-related disease, disability and death. A-TRAC is part of the larger Tobacco Center of Regulatory Science (TCORS) funded through the National Institutes of Health (NIH) and the U.S. FDA.

Short term pilot projects with well-defined aims that could be accomplished in their entirety within the funded period will be considered for funding. Studies focused on assessing the mechanisms related to the adverse health outcomes of tobacco product use will not be considered responsive to the FDA specified aims of TCORS. However, studies assessing the varied cardiovascular effects across the spectrum of tobacco products will be considered.

Science Focus

Research broadly related to the FDA strategic research priorities:
  • Assess potential product standards in reference to addictiveness, cardiovascular toxicity and appeal: This can potentially lead to reduction of specific toxicants in the product or a better understanding of the product constituents that appeals to different segments of the population
     
  • Help develop a comprehensive FDA Nicotine Regulatory Policy on nicotine-containing products that can affect public health
     
  • Assesment of pre- and post-market controls of tobacco products
     
  • Ensure compliance and establish evidence-based enforcement of regulations
     
  • Public education with a focus on youth, vulnerable populations and other population segments (For more information, please refer to comprehensive FDA Research Priority List.

The project should have a high probability of leading to new policies related to tobacco use and cardiovascular health and add to the exisiting scientific body of knowledge. Tobacco regulatory research translates general scientific knowledge into the specific scientific findings which serve as the guide for regulatory decisions and actions. Proposal should highlight the specific rule or other regulatory decision that could potentially be made based on this research.

The Pilot Research Grant program aims to promote new and bold scientific ideas; hence, proposals need not include preliminary data. Proposed work may be an extension of a currently funded project without a budgetary overlap or an overlap in aims with the parent project. It could also be an entirely new project.

Disciplines

Submissions are encouraged from the entire spectrum of scientific disciplines including basic, translational, behavioral, population and epidemiological, community, and clinical investigations, relevant to research on the effects of tobacco use on  stroke and cardiovascular health and disease, as well as the application of the best available science to specific regulatory questions pertaining to tobacco use.

Eligibility Requirements

At the time of application the applicant must fulfill the eligibility requirements below   

  • The applicant/PI should be an employee of one of the TCORS member institutions (listed under “Location of Work”) or other CTP-funded institutions.
     
  • Investigators from TCORS member institutions other than A-TRAC affiliated institutions must have a collaborating A-TRAC investigator.
     
  • Collaborations with A-TRAC investigators are encouraged, however, the project must not have any overlap with any on-going A-TRAC supported project.
     
  • These grants are open to investigators at any rank, including but not limited to the following: postdocs, early career faculty and Associate or Assistant or Full Professors.
     
  • The A-TRAC investigators are committed to the career development of early career investigators. Hence, we encourage early career investigators and TCORS trainees to apply for pilot funds.
     
  • Applicant should have a Masters or post-baccalaureate doctoral degree, including MPH, RN., PharmD., MD., DO., or PhD. 
     
  • Interdisciplinary research teams are eligible, but a contact PI must be identified who will take responsibility for scientific and administrative oversight of the project.
     
  • Previous projects that were not funded are eligible for reapplication, but the project will be reviewed as a de novo submission.
     
  • Applicants with an existing A-TRAC pilot project can apply for an additional year of funding, however, they should clearly describe the progress made during the previous funding cycle.  Applications for continuation of a project will be evaluated as a competitive renewal grant  application and will be score relative to all other applications.
     
  • An investigator may hold another AHA award (affiliate or national) in concurrence with an A-TRAC pilot project as long as there is no budgetary or scientific overlap in the specific aims of the projects.

Percent Effort

While no minimum percent effort is specified, the PI must demonstrate that adequate time will be devoted to ensure successful completion of the proposed project. 

Citizenship
At the time of application, must have one of the following designations:

  • U.S. citizen or noncitizen national
  • Permanent resident
  • Pending permanent resident. Applicants must have applied for permanent residency and have filed form I-485 with the U.S. Citizenship and Immigration Services and have received authorization to legally remain in the United States (having filed an Application for Employment Form I-765)
  • E-3 - specialty occupation worker
  • F1 - student visa 
  • H1-B Visa - temporary worker in a specialty occupation
  • J-1 Visa - exchange visitor
  • O-1 Visa - temporary worker with extraordinary abilities in the sciences
  • TN Visa - NAFTA Professional
  • G-4 Visa - family member of employee of international organizations and NATO

Awardee must meet the American Heart Association citizenship criteria throughout the duration of the award.

Location of Work

Only applicants from the following TCORS may apply in this round of pilot project funding:
  • American Heart Association TCORS
  • University of California San Francisco TCORS
  • University of Vermont TCORS
  • University of North Carolina TCORS
  • Georgia State university TCORS
  • Pennsylvania State University TCORS
  • University of Pennsylvania TCORS
  • The Ohio State University TCORS
  • University of Maryland TCORS
  • University of Southern California TCORS
  • University of Texas TCORS
  • Virginia Commonwealth University TCORS
  • Yale University TCORS &
    Other Institutions conducting CTP-funded research

Budget Guidelines

Project Support:  Project-related expenses, such as salaries and fringe of technical personnel, consultant services, supplies, equipment, travel, subject costs, publication costs, within the following limits:

  • Direct -  $75,000 per year
  • Indirect -  10 percent of direct costs ($7,500 per year)
  • Total - $82,500 over one year (within September 1, 2015 - August 31, 2016)
Four projects will be selected for funding for this application cycle.

Peer Review Criteria

The A-TRAC Pilot Project Executive Committee will pre-screen all proposals in Phase I of application cycle to assess the responsivenss of the project to FDA’s research guidelines and the competitiveness of the application. Only projects selected in this phase will be invited to submit full research proposals for the final peer-review process. The Executive Committee will also make the final funding decision based on relevance to A-TRAC mission, FDA/ NIH research priorities and scientific merit. To judge the merit of the application, reviewers will comment on the following criteria. Please ensure that you fully address each of these in your full proposal in Phase II.

  1. Significance: Does the project address an important issue or a critical barrier in regulatory authority over tobacco products? If the aims of the project are achieved, how will regulatory science research be informed or regulation affected? How will successful completion of the aims have affect on the concepts, methods, technologies, or regulation of tobacco products? How does the project relate to the thematic focus of A-TRAC?
     
  2. Investigator(s): Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project? If Early Stage Investigators or New Investigators, or in the early stages of independent careers, do they have appropriate experience and training to carry out the proposed study aims? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD(s)/PI(s), do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?
     
  3. Innovation: Does the application challenge and seek to shift current research in the field of tobacco science as it relates to the manufacture, distribution, and marketing of tobacco products? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, or instrumentation proposed? Will the outcomes of the project provide new information to further develop the knowledge base that informs the manufacture, distribution, and marketing of tobacco products in order to protect public health?
     
  4. Approach: Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed? If the project involves clinical research, are the plans for 1) protection of human subjects from research risks, and 2) inclusion of minorities and members of both sexes/genders, as well as the inclusion of children, justified in terms of the scientific goals and research strategy proposed?
     
  5. Environment: Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?
     
  6. Impact:  How does this project relate to the mission of FDA to generate science that can inform and evaluate FDA’s prior, existing and prospective tobacco regulatory activities? What is the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved?

Restrictions

  • While this proposed project can include a new hypothesis and aims, or describe an outcome or natural progression of an already-existing project, this proposal should not have overlap with already-funded budgets or specific aims. Awards are not intended to duplicate currently funded work. Pilot projects may be extensions of currently funded projects but must demonstrate lack of duplication of the current project. 
     
  • If unfunded, an applicant will be allowed to resubmit the same or similar application during subsequent A-TRAC pilot project funding cycles.

Proposal Components and Format

  • This is a two-phase application cycle with the following requirements:

    • Phase I: Requires submission of a maximum two-page Letter of Intent (LOI) summarizing the significance of the proposed research, how it relates to the FDA tobacco regulatory research priorities, and outlining specific aims in detail. This document will be reviewed and scored based on the following criteria:

      • Responsiveness to FDA research funding guidelines
      • Competitiveness of the application compared to other applications

        If an application is deemed competitive and responsive, it will be moved to Phase II. A notification email will be sent out to the applicant with the details, deadlines and requirements for the next application phase.
         
    • Phase II: Applicant will be requested to submit a full proposal containing detailed research plan, budget, budget justification, letters of support, institutional assurances (IRB & IACUC), biosketch, collaborating investigator’s biosketch and research support documentation and consultants’ letter. These document templates will be available within the A-TRAC Funding Announcement during the second phase of the application cycle. The full proposals in this phase will be reviewed based on the Peer-Review Criteria section of this document and award notifications will be sent out. 
       
  • A final progress report detailing study achievements and progress towards the goals is required at the end of the grant year.
     
  • All applicants are expected to either present their research findings to the entire A-TRAC group in person at the 2016 annual A-TRAC meeting, or in the form of a Webinar to the entire A-TRAC investigator panel.