USC TCORS Call for Proposals. Pilot Projects Program for Tobacco Regulatory Science Research EXPANDING RO1 PROJECTS NEW START UP STUDIES/NOVEL METHODS

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1 USC TCORS Call for Proposals Pilot Projects Program for Tobacco Regulatory Science Research EXPANDING RO1 PROJECTS NEW START UP STUDIES/NOVEL METHODS e.g., ecological momentary assessment, health, spatial sciences RAPID RESPONSE STUDIES e.g., campaign for education on tobacco regulation The Pilot Program of the USC Tobacco Center of Regulatory Science (USC TCORS) aims to support new and innovative science in the field of tobacco regulatory science research. Over the course of the TCORS, the program will provide up to $40,000 to as many as three investigators per year to conduct short-term (one year) pilot studies in USC TCORS s priority areas of research. For this RFA, please note that there are three categories for you to choose from for your proposed project. 1

2 2014 TCORS Pilot Projects RFA Table of Contents LOI and LOI form and instructions for submission on GAP..3-4 Background of USC TCORS and RFA-specific background Review criteria and application requirements Application timeline and application portal link 12 Contact info..12 2

3 Letter of Intent Form and Instructions Please do the following before you upload your letter of intent: 1. Read the attachment USC TCORS Priorities to use as a reference for your letter. The document describes the research priorities for the USC TCORS. 2. Fill in all spaces on this form. Do not exceed 1 page total for the LOI. Save the file as TCORS 2014 Pilot Projects Letter of Intent and then upload to the Letter of Intent link. A letter of intent is required before a full application will be considered. Important Dates: MONDAY, JUNE 9 nd, 2014, 5PM PST: ALL LETTERS OF INTENT ARE DUE. The link will close after 5 PM. At this time, instructions and forms for full proposal applications will be posted so that potential applicants can review the information ahead of time. MONDAY, JUNE 23 th, 2014, 8 AM PST: Applicants will be notified whether a full proposal application should be submitted. Applicants with a go ahead for full proposal application are strongly encouraged to submit for IRB approval as early as possible. MONDAY, JULY 14 th, 2014, 5 PM PST: Full proposal applications are due. MONDAY, AUGUST 11 th, 2014, 8AM PST: Applicants will receive Notice of Award (NOA), and funds will be Available contingent on IRB project approval. MONDAY, SEPTEMBER 8 th, 2014, 8AM PST: Last date for release of funds contingent on IRB approval. 1. Proposed project title: 2. Your name, title, phone, and contact information: 3. As key investigator, are you: USC faculty Postdoctoral fellow Pre-doctoral student? If you are a fellow or student, please list the name and contact information of the faculty investigator who has agreed to supervise you. 4. Which CTP priority/priorities does your proposal address (you can list up to 3 by number, referring to the USC TCORS Aims and Priorities attachment). 5. Brief description of project aims, design, sample, sites, measures, analysis plan, and goals (1 line each): Aim(s): Design: Sample: 3

4 Site(s): Measure(s): Analysis Plan: Overall Goal: 6. Significance to tobacco regulatory science (1 sentence): 7. Innovation: (1 sentence) 8. Environment that you feel enables project completion within 12 months: 9. Readiness to secure IRB approval for the project by or before Sept. 8, Estimated budget between $10-40,000 total costs (please note that funding does NOT cover investigator salary support): 4

5 Background: The Pilot Program of the USC Tobacco Center of Regulatory Science (USC TCORS) aims to support new and innovative science in the field of tobacco regulatory science research. Over the course of the TCORS, the program will provide up to $40,000 to as many as three investigators per year to conduct short-term (one year) pilot studies in USC TCORS s priority areas of research. Priority areas of research Preference and highest priority will be given to projects involving any of the following: Initiatives that advance tobacco regulatory science Pilot studies that are likely to result in larger grant submissions to NIH or equivalent grants programs Projects that promote research careers in regulatory science, especially among women, individuals from underrepresented minority groups, and investigators who are in the early stages of their careers or more senior investigators who wish to transition to regulatory science Projects that develop collaboration within and across USC and other TCORS If responding to the Novel Methods request, please note that this award supports pilot studies leading to the development, validation, or application of both novel methodologies and innovative technologies. Novel methodologies are non-technological in nature, and could include: methods for monitoring tobacco use in certain communities; methods for evaluating the impact of clinical studies; and community based research methods including intervention design, data analysis, and dissemination of tobacco regulatory research. Innovative technologies are new techniques whose application will benefit multiple, diverse disciplines and enhance tobacco regulatory research. Plans for how the technology might be made available via a core resource should be presented. If responding to the Within and Across Cores request, please note that the USC TCORS is comprised of five cores, three of which are relevant to collaborating within and across cores: Research Training and Education Core: This core recruits and trains pre-doctoral and postdoctoral researchers and also identifies established investigators who will transition into research within the domain of tobacco regulatory science. Investigators from this core also develop courses in tobacco regulatory science, as well as a core curriculum and career development program. Population Core (PC): The PC provides tracking and retention of existing cohorts, recruitment of new cohorts, and outreach and networking to identify new populations for future research projects. Methods Core (MC): The MC offers services and consultation on identification, development and validation of instruments, and provision of state-of-the-art, culturally appropriate interview, physiological, psychosocial, behavioral community-based, archival, GIS, and observational measures, data management, statistical analysis, training and methodological and statistical consultation. MC core members bring expertise in discipline-specific measurement, design, and analytic techniques, such as advanced methodologies, statistical modeling, psychometrics 5

6 analysis, qualitative data analysis, community-based participatory research (CBPR) methods, and behavioral data collection. In order to stay at the cutting edge of innovation and research, USC recognizes the need for collaboration between disciplines. For this reason, USC TCORS offers awards for investigators who utilize research core facilities within USC, as well as working with investigators from diverse academic backgrounds and disciplines to meet their research goals. The Within and Across Cores award supports pilot studies that provide the following: Preliminary data Development of new test or service Novel, unfunded use of a core for an ongoing project Modification of existing core technology The Pilot Projects Program Core of the USC TCORS is designed to generate rapid dissemination of methods and results that can inform future tobacco regulatory practices, and recognizes the importance of encouraging a multidisciplinary approach to accomplish these goals. The Within and Across Cores award mitigates the financial burden on researchers and provides funding for studies in a core facility. Although the awards are available to all, there will be an emphasis on the research programs of any researcher, particularly junior faculty, seeking to enter an unfamiliar area in which a core can provide the most cost- and time-effective solution for the research. Projects that develop new collaborations between core personnel and researchers are particularly welcome. The expectation is that a successful award will lead to a long-term, funded research program in which continued use of the core facility helps to maintain both the research program and the core. For proposals which seek to expand currently funded TCORS R01 projects, please select one of the following three projects to extend with your own proposal: Project 1: Marketing and Communications Diffusion of Marketing Messages about Tobacco Products through Social Media (Co-PIs- Jennifer Unger, PhD; N. Tess Boley Cruz, PhD): The rapidly increasing use of the Internet and social media sites as a source of information presents an opportunity for tobacco promotions and normalization of emerging tobacco products before they can be regulated. Despite the rise in Internet use, there is limited understanding of the role of the Internet and social media sites in transmitting pro-tobacco marketing messages to tobacco users and potential users. More information is needed about the ways in which the tobacco industry places tobacco-related messages online, how individuals receive, perceive, and disseminate information about tobacco products, and how this information impacts their use of tobacco products. This study will provide a comprehensive understanding of the ways in which tobacco companies communicate with their customers and potential customers through social media, as well as the ways in which tobacco users transform and disseminate these messages through their social networks. This will provide important new information about how new tobacco products travel to vulnerable populations and which types of health education messages are needed to counter these influences. The proposed study will achieve the following aims: Document how the tobacco industry communicates with potential customers online. Understand how individuals transform tobacco messages online. 6

7 Describe the tobacco-related messages that individuals receive online. Project 2: Retailers Maximizing Retailers Responsiveness to FDA Regulatory Authority in Minority Communities (PI- Lourdes Baezconde-Garbanati, PhD MPH): For over 20 years most tobacco industry expenditures for advertising and promotions have been focused on the retail environment (FTC 2012 a, b,). This has been especially true in vulnerable communities heavily targeted by the tobacco industry. To correct this disparity, we need to understand the retail environment among vulnerable populations; since the enactment in 2009 of the Family Smoking Prevention and Tobacco Control Act (The Act) giving the Food and Drug Administration s (FDA) regulatory authority. For this reason, the specific aims of Project 2 are: 1) to examine knowledge, attitudes, beliefs and behaviors of small independent retailers in vulnerable communities regarding compliance with FDA; 2) to examine optimal non-traditional ways (social media sites, online videos, text messaging, blogs, smartphone applications, wireless communication, Facebook, Twitter, use of cell phones (iphones, Blackberry), and other mobile channels; and the confluence of traditional broadcast media, with voice and written communication and the Internet) that FDA can use to communicate with retailers and the public in vulnerable communities of predominantly African Americans (AA), Hispanic/Latinos (H/L), Koreans (K); and American Indians (AI); and 3) to examine factors that influence key community informant s public perception of the FDA as a credible source of tobacco product information in these communities. Using the Socio-ecological Model (SEM) as a backdrop, community based participatory principles, and engaging community lay health care workers and a cadre of promotores de salud (health promoters) in the conduct of the research, we will focus on the retail environment and on opinions from key community leaders in vulnerable minority communities engaged in this study. We will randomly select our sample from listings of the Board of Equalization, which contains 38,000 retailers in California with a license to sell tobacco, and based on Census tracts in vulnerable neighborhoods in the Greater Los Angeles area and beyond. Our key opinion leaders sample will be drawn from listings of community stakeholders that form part of tobacco control coalitions and organizations working with these vulnerable populations in California. We will conduct 16 focus groups (N=192), a retailer survey (N=600) (200 H/L, 200 AA, 100 K, 100 AI), store observations (200), and GIS/Environmental scans to respond to aims and determine retail density in vulnerable communities. We will analyze data, write periodic reports, manuscripts for scientific publications and share data with FDA, other TCORSs, and stakeholders. Project 3: Vulnerable Populations Adolescent smoking: Vulnerability to Tobacco Use and Marketing Across Life (PI- Rob McConnell, MD): Early initiation of smoking and rapid progression during the key adolescent and young adult period predict chronic and addicted smoking in adult life and high risk for health consequences. However, there has been little research on how adolescent smoking trajectories relate to future vulnerability to industry marketing and emerging products intended to sustain nicotine addiction. This project addresses the hypothesis that the early course of cigarette smoking is a key determinant of future nicotine dependence and vulnerability to point-of-sale and electronic marketing, resulting in future use of new non-cigarette products and poly-tobacco use. These questions are addressed using data from over 12,000 largely Hispanic and non-hispanic White participants recruited from Southern California schools into the Children s Health Study cohort between 1993 and Smoking data have been collected 7

8 yearly through high school graduation at age 18. Using these data and state-of-the-art statistical modeling, adolescent cigarette smoking trajectories will be characterized based on initiation and progression patterns. Associations of these trajectories with neighborhood and community environmental, demographic and social factors, and with marketing exposure, based on tobacco retailer proximity and density at home, school and a novel route to school metric, will be assessed. Samples of smokers and at-risk non-smokers in the younger wave of recruitment currently years of age (N=600) and of smokers from earlier waves now years of age (N=450) will be re-interviewed and followed prospectively to assess the relationships of early life smoking trajectory with tobacco product perception, attitudes and beliefs, persistence of use and difficulty quitting smoking. Specific types of tobacco marketing at point-of-sale, through electronic and social media, and interpersonal influences that amplify the risk of different trajectories of childhood tobacco use will be identified. A hierarchical modeling approach will integrate information on early life smoking trajectory, marketing, perceptions, attitudes and beliefs across life stages and over follow-up to elucidate the role of each in use of new tobacco products. The study will yield refined information on nature and characteristics of early life smoking phenotype trajectories and on response to marketing relevant to regulation and prevention among vulnerable populations. Further, it will clarify how early-life cigarette smoking serves as a gateway process to other forms of tobacco product use, which could be amplified by tobacco marketing. It addresses FDA research priorities: vulnerability, perceptions, attitudes and beliefs, understanding new product use, and marketing. Pilot project applications must address one or more of the USC TCORS priorities: USC TCORS Aims 1. Evaluate marketing, social influence, social media, and network influences on tobacco use and product choice, emphasizing vulnerable populations, with the ultimate aim of identifying ways to reverse or counteract these influences. 2. Examine tobacco product distribution and regulation among local vendors, whose stores are a key point for purchase, contact with industry marketing and promotion, and regulatory education initiatives. 3. Examine different topographies of tobacco use integrating USC TCORS Pilot Project Core Aims 1. Expansion of Research Questions Within the USC TCORS 2. New Start-up Studies Within and Across TCORSs 3. Rapid Response Studies Within and Across TCORSs 4. Across TCORSs Studies Involving Core Collaborations CTP Domains Addressed by USC TCORS 1. Understanding the Diversity of Tobacco Products 2. Understanding Adverse Health Consequences of Tobacco Use 3. Understanding Communications about Tobacco Products 4. Understanding Tobacco Product Marketing 5. Understanding Economics and Policies on Tobacco Use and Perceptions 8

9 phenotypic variables with personal, social, cultural and environmental variables to determine how future tobacco control initiatives may be tailored to different vulnerable groups. Requirements and Restrictions Each award will range from $5,000 to a maximum of $40,000. The award period will cover 12 months, beginning September 8, 2014 and ending August 31, Funds can be used to pay for study-related activities (e.g., equipment, supplies) but is not intended to serve as primary support of the awardee s salary. Awardees must obtain all regulatory and IRB approvals for study activities prior to the disbursement of funds. Each awardee will be assigned to at least one senior TCORS researcher in the pilot projects program as their primary contact person. Currently, these include: Mary Ann Pentz, Ph.D. Jonathan Samet, M.D. Rob McConnell, M.D. Lourdes Baezconde-Garbanati, Ph.D. Adam Leventhal, Ph.D. Steve Sussman, Ph.D. Jennifer Unger, Ph.D. Expectations Pilot studies are expected to: (1) lead to larger projects that will be appropriate for independent funding from a government agency or private foundation, and (2) result in at least one peer-reviewed publication to be submitted within six months of the end of the project funding period. Awardees will be required to confer with their TOCRS administrative contact person quarterly, to submit a mid-year progress report, and to provide a brief status report (upon request) to fulfill the NIH reporting requirement for inclusion in the TCORS progress report. 9

10 Eligibility requirements The applicant must hold a doctoral or other advanced degree and meet at least one of these qualifications: All USC and Los Angeles are a University faculty in any series (tenured/non-tenured) including adjunct and professional research series may apply. CHLA Investigators may apply with documentation of a faculty-equivalent appointment. Community partners are eligible to apply as Co-PI but MUST have a USC or SC CTSI affiliated institution PI as lead Graduate students and postdoctoral scholars with a TCORS faculty sponsor Applicants and sponsors need not be TCORS members Members of other TCORS Applicants must be affiliated with a research institution/organization (as defined by NIH) and must submit a letter from their institution confirming their eligibility to receive funds at that institution/organization. Awardees outside of USC are encouraged to request that their institution reduce or waive indirect costs. Applicants affiliated with USC are encouraged to apply. Minority researchers and researchers focused on health disparities are encouraged to apply. Individuals may submit only one application per announcement. There is no limit to the number of applications that may be submitted from an institution/organization. Prior applicants whose pilot proposals were not selected for funding may reapply. Budget Submission of budgets which do not reach the maximum amount ($40,000) are encouraged so as to increase the number of projects that can be awarded per cycle. Please note that applicants can propose project budgets of up to: $40,000 for faculty/scientific investigators $15,000 for postdoctoral fellows with a faculty sponsor $10,000 for a pre-doctoral student with faculty sponsor Review criteria Proposals will be reviewed by the USC TCORS Executive Committee and its advisors. Each proposal will be evaluated based upon these criteria: Significance e.g., does the project address an important problem or critical barrier to progress in the field? Does the study have potential to generate knowledge relevant to TCORS themes from a regulatory perspective? 10

11 Investigator e.g., 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? Innovation e.g., does the proposal utilize novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Approach e.g., 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? 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 subjects issues are likely to pose problems for study implementation. Application requirements Format Requirements Arial font, 11 pt. Margins: minimum 0.5 inch. No appendices. Include page numbers and table of contents. Proposal Please create one single PDF file including all of the following information: 1. Cover Sheet Please fill out the three cover sheets at the end of this document and submit as the first pages of your proposal. 2. Project Abstract (300 words or less) a brief summary of the project. 3. Specific Aims (1 page) concise goals of the proposed research and a summary of expected outcomes, including specific objectives. NOTE: The abstract and aims must also include the major aim and priority areas targeted by the USC TCORS, CTP, and the specific aim(s) proposed in the study. 4. Research Strategy (4 pages MAXIMUM) i. Significance 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 (1/2 page). ii. Innovation 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 practices (1/2 page). iii. Approach describe the overall strategy, methodology, and analyses to be used to accomplish specific aims, including how data will be collected. Discuss potential problems, alternative strategies, and benchmarks of success (3 pages). 5. Grant Potential (1 page) clear description of how a successful pilot project and/or expansion of the project will lead to an R01 (or equivalent) submission 6. Project Timeline (1 page) a proposed timeline of study performance should be included, identifying specific tasks and milestones in project progress for the 12-month period of performance 7. Budget an NIH-style budget table of labor, equipment, supplies, travel, and other estimated costs 11

12 to perform the proposed project: [Applicants may budget up to $40,000 for direct costs. Indirect (F&A) costs should be listed separately from direct costs.] 8. Budget Justification a detailed explanation and justification of the funding request 9. NIH-Format Biosketches- for the PI and co-investigators (4 page limit per investigator, including Other Support pages) 10. List of peer reviewers: Provide a list of up to 4 individuals (with contact information) who are appropriately qualified to review this proposal. Following NIH guidelines, excluded are individuals in the same lab, who share investigator status, or who have published regularly with the applicant. Reviewers can be internal or external to USC. 11. Letter(s) of Support: Please provide a letter of support from the department chair or other unit head for this proposed research. For junior investigators, department chairs/unit heads should comment on the independence of the applicant and availability of research space and other resources for the proposed research. Include the letter of support at the end of your PDF proposal and address it to TCORS Pilot Projects Core. If applicable, additional letters of support from consultants may be necessary, and should include consulting charges/rates, quotes, and core facilities). If you are a CHLA Investigator, the Letter of Support for your proposal should come from your division chief or program leader (not from your department chair). If you are a division chief, your letter of support should come from your department chair. If collaborators from other institutions are part of key personnel, a letter of commitment that clearly spells out their roles and commitment to the project is strongly encouraged. Key dates for this round Monday, June 9 nd, 2014 Letter of intent deadline Monday, June 23 th, 2014 Selected applicants are invited to submit a full application Monday, July 14 th, Full application deadline Monday, August 11 th, 2014 Anticipated award notification Monday, September 8 th, 2014 Anticipated start date for second round of pilot studies (funds to be disbursed on condition of IRB approval) Monday, August 31 th, 2015 Anticipated end date for second round of pilot studies Application procedures All materials may be submitted prior to the key dates noted above. All applications are submitted online using the following link: For any questions regarding technical assistance, please contact Andrew Zaw at andrewz@usc.edu For other administrative questions, please contact Hasmik Gasparyan at hasmikga@med.usc.edu 12