American Cancer Society-Institutional Research Grant ACS-IRG CYCLE 43 Spring 2018 DUE DATE: MONDAY, April 16, 2018 4:00 PM
INVESTIGATOR’S PRIMARY INSTITUTION	Moffitt
Ponce
USF
NEW PROPOSAL	RE-SUBMISSION (LIMITED TO 2)	COMPETING RENEWAL
1. PRINCIPAL INVESTIGATOR/PROGRAM DIRECTOR	PSYCHOSOCIAL RESEARCH No Yes
1a. NAME (Last, first, middle)	1f. CITIZENSHIP STATUS U.S. Citizen Non U.S. Citizen (Permanent Resident) * Must submit notarized evidence from U.S. Citizen and Immigration Services indicating status Non U.S. Citizen (Temporary Resident) * Must submit notarized evidence from U.S. Citizen and Immigration Services indicating status `
1b. POSITION TITLE / ACADEMIC RANK
1c. DEPARTMENT, SERVICE, LABORATORY, OR EQUIVALENT
1d. MAJOR SUBDIVISION	1g. MAILING ADDRESS (Street, city, state, zip code)
1e. TELEPHONE (Area code, number and extension) AND E-MAIL
TEL: E-MAIL:
2. TITLE OF PROJECT
3. HUMAN SUBJECTS RESEARCH No Yes	3b. Human Subjects Assurance No.	4. VERTEBRATE ANIMALS No Yes
3c. Clinical Trial No Yes	3d. NIH-defined Phase III Clinical Trial No Yes	4a. If “Yes,” IACUC approval Date	4b. Animal welfare assurance no.
3a. Research Exempt No Yes	If “Yes,” Exemption No.
5. DATES OF PROPOSED PERIOD OF SUPPORT (month, day, year—MM/DD/YY)	6. COSTS REQUESTED FOR PROPOSED BUDGET PERIOD (Indirect Costs not Allowed)	7. WILL THE PROJECT INCLUDE SUB- AWARDS OR SUB-CONTRACTS ?
From	Through	Direct Costs ($):	YES	NO
8. APPLICANT	10. PLEASE CHECK ALL SHARED RESOURCES TO BE UTILIZED IN THIS PROJECT: ANALYTICAL MICROSCOPY BIOSTATISTICS CANCER INFORMATICS CELL THERAPIES CHEMICAL BIOLOGY CLINICAL PROTOCOL & DATA MANAGEMENT/CTO COLLABORATIVE DATA SERVICES CORE FLOW CYTOMETRY GENE TARGETING IRAT MOLECULAR GENOMICS PROTEOMICS PROTOCOL REVIEW & MONITORING SYSTEM SAIL SURVEY METHODS TISSUE TRANSLATIONAL RESEARCH
PI NAME: _____________________________________________ _______________ SIGNATURE DATE VERIFICATION OF ELIGIBILITY by Department Chair (Applicants must be within six years of their first independent research or faculty appointment, must be salaried faculty with appropriate committed research facilities, and may not have may not have competitive national funding active at the start date of the proposed IRG allocation) CHAIR/PROGRAM LEADER NAME: _____________________________________________ _______________ SIGNATURE DATE
9. ADMINISTRATIVE OFFICIAL TO BE NOTIFIED IF AWARD IS MADE Name: Tel: Title: E-mail:
This is the first, second, third (final) submission of this proposal

Face Page

NOTE: Please use these form pages. All italics text throughout this application is instructions for the template or applicant and can be deleted prior to submission.

Specific Application Instructions

Use English, avoid jargon and spell out all abbreviations.

Applicants must use the templates provided.

Font size must be 11 or 12 point black font (e.g., Arial or Times New Roman).

Documents should be single-spaced with all text visible and within the .5 margins (all sides).

The Principal Investigator’s name should be shown in the header of all application pages.

All graphs, diagrams, tables, and charts presented in black ink. Do not include photographs, oversized documents, or materials that cannot be photocopied into the body of the application.

Observe a 4 ½ page limit for the section “Description of Research Proposed”.

APPLICATION FOR A PILOT PROJECT GRANT

AMERICAN CANCER SOCIETY-INSTITUTIONAL RESEARCH GRANT #IRG-17-173-22

BIOGRAPHICAL INFORMATION
PI First Name, Last name, Degree(s)
Academic Rank	Institution/University Department
School
Citizenship Status U.S. Citizen Non-U.S. citizen (permanent resident) Non-U.S. citizen (temporary resident)
Year last degree conferred:	Year of first independent position:

Education
Degree/year conferred	Institution/Location	Field of study

Training
Title	Mentor (If Applicable)	Institution/Location	Dates

PI First Name, Last Name:

Degrees:

Appointments
Title	Institution/Location	Dates

Other Research Support (Sponsor, Project Title, Project Number, PI, Project Dates, Your Effort, Annual Direct Costs, Brief Description of Major Goals)

For the PI and any co-investigators, please list their: (1) current active support; (2) applications and proposals pending review of funding; and (3) applications and proposals planned or being prepared for submission. Include all Federal, non-Federal, and institutional research, training, and other grant, contract, and fellowship support at the applicant organization and elsewhere. If effort is part of a larger project, identify the PI/program director and provide the data for both the parent project and the sub-project. All pharmaceutical research projects are to be included. If none, state "none".

Publications

PROJECT TITLE:

RESPONSE TO REVIEWER CRITIQUES/INTRODUCTION FOR COMPETING RENEWAL.

This section does NOT pertain to new applications. If you are submitting a revised application or requesting a second year of funding, please use one page to address the relevant items noted above. If you are submitting a new application, please disregard this page.

PROJECT TITLE:

DESCRIPTION OF RESEARCH PROPOSED (Sections A-F below, 4½ pages maximum – use continuation pages as necessary)

Sections A-F of the Research Plan should answer these questions:

What do you intend to do?

Why is the work important?

What has already been done?

How are you going to do the work?

What is the relevance of the work to cancer and future funding plans for this project?

A. Abstract (Limited to 300-500 words 1/2 page or less)

Provide a brief summary of the research, including Background, Objective/ Hypothesis, Specific Aim(s), Study Design and Cancer Relevance. The final sentence of the abstract should summarize the focus and cancer relevance of the project in non-scientific terms.

B. Specific Aims (suggested 1/2 page or less)

List the broad, long-term objectives that this research project is intended to accomplish. Clearly state the hypothesis to be tested. applicants are encouraged to include milestones for each of the specific aims.

C. Background and Significance (suggested 1 page or less)

Briefly present the background leading to the present research project, critically evaluating existing knowledge, and specifically identifying the gaps that the project is intended to fill.

D. Preliminary Data (suggested 1 page or less)

Use this section to provide an account of any relevant preliminary studies to establish the experience of the investigators or support the proposed science.

E. Research Design and & Methods (suggested 1- pages or less)

Summarize the study design and experiments that the project will conduct.

F. Cancer Relevance and Future Plans (suggested 1/2 page or less)

What is the relevance of the work to cancer and future funding plans for this project.

G. Human Subjects

If your project will involve human subjects, you must indicate this on the Proposal Face Page. If you have designated no exemptions from the regulations, you must succinctly address the following six points:

1.	Provide a detailed description of the proposed involvement of human subjects in the work previously outlined in the experimental design and methods section. Describe the characteristics of the subject population, including their anticipated number, age, ranges, sex, ethnic background, and health status. Identify the criteria for inclusion or exclusion. Explain the rationale for the involvement of special classes of subjects, if any, such as fetuses, pregnant women, children, human in vitro fertilization, prisoners or other institutionalized individuals, or others who are likely to be vulnerable.

2.	Identify the sources of research material obtained from individually identifiable living human subjects in the form of specimens, records, or data. Indicate whether the material or data will be obtained specifically for research purposes or whether use will be made of existing specimens, records, or data.

3.	Describe plans for the recruitment of subjects and the consent procedures to be followed, including the circumstances under which the consent will be sought and obtained, who will seek it, the nature of the information to be provided to prospective subjects, and the method of documenting consent.

4.	Describe potential risks -- physical, psychological, social, legal, or other -- and assess their likelihood and seriousness. Where appropriate, describe alternative treatments and procedures that might be advantageous to the subjects.

5.	Describe the procedures for protecting against or minimizing any potential risks, including risks to confidentiality, and assess their likely effectiveness. Where appropriate, discuss provisions for ensuring necessary medical or professional intervention in the event of adverse effects to the subjects. Also, where appropriate, describe the provisions for monitoring the data collected to ensure the safety of subjects.

6.	Discuss why the risks to subjects are reasonable in relation to the anticipated benefits to subjects and in relation to the importance of the knowledge that may reasonably be expected to result.

If a test article (investigational new drug, device, or biologic) is involved, name the test article, the sponsor, and state whether the 30-day interval has elapsed or has been waived and/or whether use of the test article has been withheld or restricted by the Food and Drug Administration.

H. Women & Minorities

Moffitt is committed to supporting diversity and equity to better serve the community. Briefly describe how women and minorities will be included in any human subject populations.

I. Vertebrate Animals

If your project will involve vertebrate animals, you must indicate this on the Moffitt Proposal Submission Form and succinctly address the following five points.

1.	Provided a detailed description of the proposed use of the animals in the work previously outlined in the experimental design and methods section. Identify the species, strains, ages, sex, and numbers of animals to be used in the proposed work.

2.	Justify the use of animals, the choice of species, and the numbers used. If animals are in short supply, costly, or to be used in large numbers, provide an additional rationale for their selection and numbers.

3.	Provide information on the veterinary care of the animals involved.

4.	Describe the procedures for ensuring that discomfort, distress, pain, and injury will be limited to that which is unavoidable in the conduct of scientifically sound research. Describe the use of analgesic, anesthetic, and tranquilizing drugs and/or comfortable restraining devices where appropriate to minimize discomfort, distress, pain and injury.

5.	Describe any euthanasia method to be used and the reasons for its selection. State whether this method is consistent with the recommendations of the Panel on Euthanasia of the American Veterinary Association. If not, present a justification for not following the recommendations.

J. Consultants/Collaborators (if any)

K. Consultants/Contractual Arrangements (if any)

L. Literature Cited

TOTAL AMOUNT REQUESTED*: $	PROJECT PERIOD: 7/1/18-6/30/19

*Maximum request $30,000 for 12 months

PROPOSED BUDGET ITEMS

Common Research Expenses
Allowable PI effort (cost-share only) should be proportional to effort on the project and is capped at 5% Research supplies and animal maintenance Technical assistance Domestic travel when necessary to carry out the proposed Research program Registration fees at scientific meetings Publication costs, including reprints Shared resources costs Special fees (pathology, photography, etc.) Stipends for graduate students and postdoctoral assistants if their role is to promote and sustain the project presented by the junior faculty member Equipment costing less than $2,000 (Special justification is necessary for items exceeding this amount and must be included in the proposal budget and justified for specific research purposes) In special circumstances computer purchases justified for specific scientific purposes may be allowed at the beginning of the award with prior approval. All equipment must be budgeted at the time of the application iPads, tablets and readers for specific scientific purposes and must be justified and budgeted in the application Tablets and e-readers for specific scientific purposes and must be justified and budgeted in the application. Data plans, if needed must also be justified. NOTE: Data plan costs for tablets and e-readers are not supported by the Institution.	Unallowable Facilities and Administrative Costs Secretarial/administrative salaries Tuition Foreign travel (special consideration given for attendance at scientific meetings held in Canada) Books and periodicals Membership dues Office and laboratory furniture Office equipment and supplies Most computer purchases Rental of office or laboratory space Recruiting and relocation expenses Non-medical services to patients Per-diem charges for hospital beds Construction, renovation, or maintenance of buildings/laboratories Honoraria and travel expenses for visiting lecturers
Salaries for the Principal Investigator and administrative support are not appropriate budget items. Cost-share of PI effort is capped at 5%. Salaries for support personnel (i.e., dishwashers, animal caretakers, histopathology technicians, research technicians or associates, and in some instances data management personnel) may be requested. Whether or not salaries are requested, list the names and roles of all personnel who will be involved in the project during the 12-month budget period.

BUDGET:

Please complete a budget for the entire 12 month period utilizing the PHS 398 Detailed Budget form page 4. http://grants2.nih.gov/grants/funding/phs398/phs398.html

BUDGET JUSTIFICATION:

Describe the specific functions of the personnel, consultants, and collaborators. Briefly explain and justify all items requested.

This section is critical to the evaluation process. Any item not sufficiently justified may be cut from the project budget.