RFA for Pilot Research Projects in Tobacco Regulatory Science

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The Pilot Projects Program of the USC Tobacco Center of Regulatory Science (TCORS) is requesting applications that propose high impact research that informs federal regulation of tobacco products by the U.S. Food and Drug Administration (FDA) Center for Tobacco Products (CTP). This mechanism is dedicated to early career researchers who can use the pilot project to advance research on tobacco regulatory science.   All early career researchers from predoctoral level through early associate professor level are eligible and it is hoped that the pilot projects will increases the pool of talented tobacco regulatory scientists.

Due to COVID-19 Pandemic, this call focuses only on research projects that do not require new in-person face-to-face data collection.  Studies can involve:

  1. New questions addressed in analyses of existing data sets
    1. Publicly available resources (e.g., PATH Study, NYTS, NHIS, MTF, TUS-CPS)
    2. Data sources from one of the TCORS projects—including USC TCORS Adolescent and Young Adult Longitudinal Survey Cohorts (see Appendix USC TCORS Investigator Roster and Project Descriptions)
    3. Econometric or modeling resources
    4. Administrative data
    5. Other data sources with data relevant to tobacco regulatory science (e.g., social media, Nielsen sales).
  2. New studies involving remote data collection from research participants (e.g., web-based)

Science Focus

To be eligible, proposed studies must be responsive generally to one or more of the following research interest areas established by the FDA CTP: (https://www.fda.gov/tobaccoproducts/publichealthscienceresearch/research/ucm311860.htm)

 

  1. Toxicity- understanding how tobacco products and changes to tobacco product characteristics affect their potential to cause morbidity and mortality
  2. Addiction- understanding the effect of tobacco product characteristics on addiction and abuse liability
  3. Health effects- understanding the short- and long-term health effects of tobacco product use
  4. Behavior- understanding the knowledge, attitudes, and behaviors related to tobacco product use and changes in tobacco product characteristics
  5. Communications- understanding how to effectively communicate to the public and vulnerable populations regarding nicotine and the health effects of tobacco products, including media campaigns and digital media
  6. Marketing influences- understanding how industry marketing strategies increase susceptibility to using tobacco products among never users and transitions to regular use and dual use
  7. Impact analysis- understanding the impact of potential FDA regulatory actions

 

Project that do not address one of these areas or address topics fall outside of the purview of the FDA CTP will be considered non-responsive. 

 

Application Deadlines and Key Dates

  • July 27th, 2020 – Full application due
  • August 17th, 2020– Anticipated award notification
  • Project Period: 12-18 months from project start date (project start date dependent on IRB approval and disbursement of funds).

 

Eligibility and Restrictions

Early career researchers at faculty, postdoctoral, and pre-doctoral levels are eligible to apply.  Prior to submitting their application, applicants that are not members of USC TCORS must reach out to one of the USC TCORS faculty investigators to include them as a co-investigator on the newly proposed pilot project (see Appendix USC TCORS Investigator Roster and Project Descriptions). The reason for this requirement is to ensure that the project is designed and conducted in a fashion that meets FDA CTP priorities. Consult the TCORS website for additional information about relevant TCORS investigator collaborators to include on your project.  Award funds are intended for study-related activities (e.g., supplies, participant incentives, staff salaries) and are NOT intended to serve as primary support of awardees’ salaries.  Investigator support will be limited up to 30% of salary for the applicant PI and Co-Is. All regulatory and IRB approvals for study activities must be obtained prior to the disbursement of funds.

 

Expectations and Requirements of Selected Studies

Leverage preliminary findings and data to support larger projects appropriate for independent investigator-initiated studies from NIH or other government agencies or private foundations, and to facilitate career development.

 

Review Criteria

Proposals will be reviewed by the USC TCORS Pilot Programs Review Committee, as well as by selected external reviewers.  Scoring of proposals will be based on the standard NIH 9-point scoring system.  Each proposal will be evaluated based on the following criteria:

  • Significance (i.e., does the project address an important problem or critical barrier to progress in the field? Does the study have potential to generate new knowledge relevant to TCORS themes from a regulatory perspective?)
  • Investigator(s) (i.e., if applicant is an early stage or new investigator, does he or she have appropriate experience and training? Is there evidence of productivity and/or potential to become an independent investigator in the area of tobacco regulatory science research?) Is there evidence that project timelines are likely to be met?
  • Innovation (i.e., does the proposal utilize novel theoretical concepts, approaches or methodologies, instrumentation?)
  • Approach (i., are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Are study limitations acknowledged and addressed?)
  • Communication Plan (i.e., proposed communication and decision-making process, how any disputes will be resolved).
  • Research Products (i.e., planned publications, potential for a future grant application involving multiple TCORS, dissemination of findings and methods.
  • Responsiveness to FDA CTP Priorities

 

The review committee will also consider whether the proposed budget and timeline are appropriate for the scope and pilot nature of the project and whether human subject issues are likely to pose problems for study implementation.

 

Application Procedures: Please send full application to krowshan@usc.edu and tcors@usc.edu. For any assistance, please contact Kiana Rowshan at  krowshan@usc.edu.

 

Instructions for Submission of the Full Proposal

Please create one single PDF file that includes the sections listed below.

Format Requirements

  • Arial font, 11 pt.
  • Margins: minimum 0.5 inch.
  • No appendices.
  • Include page numbers and Table of Contents.

 

  1. Cover Sheet with project title – (If template needed, email krowshan@usc.edu)

 

  1. Project Abstract (300 words or less) – a brief summary of the project.

 

  1. Specific Aims (1 page) – concise goals of the proposal research and a summary of expected outcomes, including specific objectives. NOTE: This section should include the targeted CTP priority research area (by number).

 

  1. Research Strategy (6 MAXIMUM)
    1. Significance section – describe the importance of the problem or critical barrier that the project addresses, and explain how the project will improve scientific knowledge, technical capability, or clinical practice if the proposed aims are achieved. List the Center for Tobacco Products (CTP) research priorities addressed in the project.
    2. Innovation section – describe how the proposed research seeks to shift research practice paradigms and how any methodologies or theoretical concepts that are being developed or used in the project may have an advantage over existing
    3. Approach section – describe the study design, procedures, data source / sample, methodology, measures, data analysis plan, and timeline, including clear description of timing of benchmarks, expectations of potential barriers and possible solutions and alternative strategies, an assurance that the study will be completed within the project time period without needs for extension.

 

  1. Grant Potential (1 page) – clear description of how a successful pilot project and/or expansion of the project will lead to a subsequent grant submission (e.g., F31/F32/K99/K01 for pre-doc, F32/K99/K01/R21/R01 for post-doc, R01 for faculty).

 

  1. Human subject protections (no page limit) – a description of the potential benefits and risks associated with conducting the study and protections in case to mitigate risks to human participants or to society. If de-identified or non-human subjects research will be conducted that should be explicitly stated.

 

  1. Planned Enrollment Table – (NIH Template)

 

  1. Budget – an NIH-style budget table of labor, equipment, supplies, travel and other estimated costs to perform the proposed project (applicants may budget up to $35,000 direct costs for pre-doctoral trainees over the entire 12-18 month period, $65,000 for post docs over the entire 12-18 month period, and up to $125,000 for months 1-12 and $50,000 for months 13-18 for early career faculty). Up to 30% of funds can be spent on salary support for the trainee; indirect (F&A) costs are included). Final amounts subject to committee approval.

 

  1. Budget Justification and Personnel– a detailed explanation and justification of the funding request, including description of the investigators and personnel and their roles on the project.

 

  1. NIH-Format Biosketches – required for all PI’s and Co-Investigators (4 page limit per investigator, including Other Support pages).

 

  1. Letter(s) of Support –the applicant’s department chair/unit head should comment on the applicant’s ability to carry out the research and availability of resources needed to carry out the proposed research. Include the letter(s) of support at the end of your PDF proposal and address it to “USC TCORS Career Enhancement Core.”

If applicable, additional letters of support from consultants may be necessary and should include consulting charges/rates, quotes, and core facilities.

 

Reporting Requirements and Timeline

 

Written progress reports are due on the following:

  1. 6 months after award onset date One paragraph update with enrollment tables sent to tcors@usc.edu

 

  1. 12 months after award onset date One paragraph update with enrollment tables sent to tcors@usc.edu

 

  1. Within 3 months after award end ate Final report due with enrollment table sent to tcors@usc.edu and presentation of project and final results to USC TCORS team.

 

 

The University of Southern California's Tobacco Center of Regulatory Science (USC TCORS) for Vulnerable Populations is one of 9 Tobacco Centers of Regulatory Science in the U.S. We were created to serve in the production of relevant scientific data to inform the regulatory decision making at the Food and Drug Administration's (FDA) Center for Tobacco Products. Additionally, we are here to educate and train the next generation of tobacco regulatory scientists.

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