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RESEARCH GRANT - University of South Alabama

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RESEARCH GRANT - University of South Alabama Powered By Docstoc
					                        USA Cancer Research Fund
                        Grant Application                                                Proposal Number                           Date Received
              Do not exceed character length restrictions indicated.
1. TITLE OF PROJECT (Do not exceed 81 characters, including spaces and punctuation.)




2. RESPONSE TO SPECIFIC REQUEST FOR APPLICATIONS OR PROGRAM ANNOUNCEMENT OR SOLICITATION

                                 Title:               USA Cancer Research Fund
3. PROGRAM DIRECTOR/PRINCIPAL INVESTIGATOR
3a. NAME (Last, first, middle)                                                           3b. DEGREE(S)


3c. POSITION TITLE                                                                       3d. MAILING ADDRESS (Street, city, state, zip code)


3e. DEPARTMENT, SERVICE, LABORATORY, OR EQUIVALENT


3f. MAJOR SUBDIVISION


3g. TELEPHONE AND FAX (Area code, number and extension)                                  E-MAIL ADDRESS:
TEL:                                           FAX:
4. HUMAN SUBJECTS RESEARCH                              4a. Research Exempt              If “Yes,” Exemption No.
        No       Yes                                         No          Yes
4b. Federal-Wide Assurance No.                          4c. Clinical Trial                                     4d. NIH-defined Phase III Clinical Trial
    FWA00001602                                              No         Yes                                         No         Yes
5. VERTEBRATE ANIMALS                     No          Yes                                5a. Animal Welfare Assurance No.          A3288-01
6. DATES OF PROPOSED PERIOD OF                              7. COSTS REQUESTED FOR INITIAL                       8. COSTS REQUESTED FOR PROPOSED
   SUPPORT (month, day, year—MM/DD/YY)                         BUDGET PERIOD                                        PERIOD OF SUPPORT

From                      Through                           7a. Direct Costs ($)         7b. Total Costs ($)     8a. Direct Costs ($)    8b. Total Costs ($)


       8/1/2011                     7/31/2012

9. APPLICANT ORGANIZATION
Name     University of South          Alabama
Address      Department:______________________
             307 University Blvd
             Mobile, AL 36688-0002
                                                                                         11. ENTITY IDENTIFICATION NUMBER
                                                                                         63-0477348
                                                                                         DUNS NO. 172750234                     Cong. District   AL-001
PRINCIPAL INVESTIGATOR/PROGRAM DIRECTOR ASSURANCE. I certify that the                             SIGNATURE OF PRINCIPAL INVESITGAOR .(In          DATE
statements herein are true, complete and accurate to the best of my knowledge. I am               ink. “Per” signature not acceptable.)
aware that any false, fictitious, or fraudulent statements or claims may subject me to
criminal, civil, or administrative penalties. I agree to accept responsibility for the scientific
conduct of the project and to provide the required progress reports if a grant is awarded as
a result of this application.




                                                                             Face Page                                                               Form Page 1
             Program Director/Principal Investigator (Last, First, Middle):

PROJECT SUMMARY (Describe the rationale, hypothesis, specific aims, outcome and significance):




RELEVANCE (Provide a lay summary of the impact on understanding basic cancer cell biology, therapeutics or clinical management):




PROJECT/PERFORMANCE SITE(S) (if additional space is needed, use Project/Performance Site Format Page)

Project/Performance Site Primary Location

Organizational Name:University of South Alabama
DUNS:       172750234
Street 1:                                                                     Street 2:

City:   Mobile                                                      County:   Mobile                        State:   AL
Province:                                           Country: USA                                 Zip/Postal Code:    36695
Project/Performance Site Congressional Districts:       AL-001
Additional Project/Performance Site Location

Organizational Name:

DUNS:

Street 1:                                                                     Street 2:

City:                                                               County:                                 State:

Province:                                           Country:                                     Zip/Postal Code:

Project/Performance Site Congressional Districts:
                                                                         Page 2                                                    Form Page 2
           Program Director/Principal Investigator (Last, First, Middle):

SENIOR/KEY PERSONNEL. See instructions. Use continuation pages as needed to provide the required information in the format shown below.
Start with Program Director(s)/Principal Investigator(s). List all other senior/key personnel in alphabetical order, last name first.
Name                                     Email                                  Organization               Role on Project




OTHER SIGNIFICANT CONTRIBUTORS
Name                                                Organization                                  Role on Project




                                                                       Page 3
              Program Director/Principal Investigator (Last, First, Middle):
          The name of the program director/principal investigator must be provided at the top of each printed page and each continuation page.

                                                                         RESEARCH GRANT
                                                                      TABLE OF CONTENTS
                                                                                                                                                               Page Numbers
Face Page ..................................................................................................................................................           1
Description, Project/Performance Sites, Senior/Key Personnel, Other Significant Contributors ...
                                                                                                                                                                       2
Table of Contents .....................................................................................................................................
Detailed Budget for Initial Budget Period ..............................................................................................


Budget Justification .................................................................................................................................
Biographical Sketch – Program Director/Principal Investigator (Not to exceed four pages each) .........
Other Biographical Sketches (Not to exceed four pages each – See instructions)...............................
Resources .................................................................................................................................................


Research Plan ...........................................................................................................................................

1. Introduction to Resubmission Application, if applicable, or Introduction to Revision Application,
   if applicable * ......................................................................................................................................            NA
2. Specific Aims (1 page) ........................................................................................................................
3. Research Strategy (6 pages) ..............................................................................................................
4. Bibliography and References Cited/Progress Report Publication List (no limit) ..................................
5. Protection of Human Subjects (no limit)...............................................................................................
6. Inclusion of Women and Minorities (no limit) .......................................................................................
7. Targeted/Planned Enrollment Table (no limit) .....................................................................................
8. Inclusion of Children (no limit)..............................................................................................................
9. Vertebrate Animals (no limit, address all five points of care and use of animals) ...............................
10. Select Agent Research ........................................................................................................................
11. Letters of Support (e.g., Consultants) ..................................................................................................




                                                                                   Page                                                                           Form Page 3
          Program Director/Principal Investigator (Last, First, Middle):

                                                                                             FROM             THROUGH
           DETAILED BUDGET FOR INITIAL BUDGET PERIOD
                      DIRECT COSTS ONLY                                                      8/1/2011         7/31/2012
List PERSONNEL (Applicant organization only)
Use Calendar, Academic, or Summer to Enter Months Devoted to Project
Enter Dollar Amounts Requested (omit cents) for Salary Requested and Fringe Benefits

                                        ROLE ON           Cal.      Acad. Summer INST.BASE     SALARY     FRINGE
              NAME                      PROJECT          Months     Months Months  SALARY    REQUESTED   BENEFITS       TOTAL

                                          PD/PI




                                     SUBTOTALS
CONSULTANT COSTS


EQUIPMENT ( Less than $10,000)




SUPPLIES (Itemize by category)




CLINICAL LABORATORY TESTS
OTHER EXPENSES (Itemize by category)




TOTAL DIRECT COSTS FOR INITIAL BUDGET PERIOD                                                                        $
                                                                     Page                                               Form Page 4
       Program Director/Principal Investigator (Last, First, Middle):

                                                    BUDGET JUSTIFICATION


PERSONNEL:


CONSULTANT COSTS:


EQUIPMENT:


SUPPLIES:


CLINICAL LABORATORY TESTS:


OTHER EXPENSES:
            Program Director/Principal Investigator (Last, First, Middle):



                                                         BIOGRAPHICAL SKETCH
                               Provide the following information for the key personnel and other significant contributors.
                                        Follow this format for each person. DO NOT EXCEED FOUR PAGES.

  NAME                                                                        POSITION TITLE
  EXAMPLE
  eRA COMMONS USER NAME


  EDUCATION/TRAINING (Begin with baccalaureate or other initial professional education, such as nursing, and include postdoctoral training.)
                                                                                DEGREE
                   INSTITUTION AND LOCATION                                                         YEAR(s)                  FIELD OF STUDY
                                                                             (if applicable)




         NOTE: The Biographical Sketch may not exceed four pages. Follow the formats and instructions below.
 A. Personal Statement
     Briefly describe why your experience and qualifications make you particularly well-suited for your role (e.g., PD/PI,
     mentor, participating faculty) in the project that is the subject of the application. Within this section you may, if you
     choose, briefly describe factors such as family care responsibilities, illness, disability, and active duty military
     service which may have affected your scientific advancement or productivity.


 B. Positions and Honors.

List in chronological order your previous positions, concluding with the present position. List any honors. Include present
membership on any Federal Government public advisory committee.


Positions and Employment
1969-1971    Medical Residency, Internal Medicine, Harvard Medical School
1971-1973    EIS Officer, Hospital Infection Section, Bacterial Diseases Branch, CDC, Atlanta, GA
1973-1974    Instructor and Fellow in Medicine, Hematology, Massachusetts General Hospital, Boston, MA
1974-1975    Instructor in Infectious Diseases, Massachusetts General Hospital, Boston, MA
1978-        Senior Associate in Infectious Diseases, Children’s Hospital, Boston, MA
1978-1984    Assistant Professor of Pediatrics, Harvard Medical School
1985-1998    Chief, Hemostasis Laboratory, Children’s Hospital, Boston, MA
1993-        Professor of Pediatrics, Harvard Medical School, Boston, MA
1998-        Professor, Dept. of Infectious Diseases, Harvard School of Public Health

Other Experience and Professional Memberships
1972-1973    Acting Chief, National Mucosal Infections Study
1975-2000    Director of Infectious Diseases Laboratory
1975-present Hospital Epidemiologist (Medical Director Infection Control 2000-present), Children’s Hospital,
             Boston
1981-1982    President, Society of Hospital Epidemiologists of America
1988         Member, Society for Pediatric Research
1989-present Medical Director Quality Assurance, Children’s Hospital, Boston, MA
1991-1993    Director, American Society for Microbiology, Division F
1991-1997    Hospital Infection Control Practices Advisory Committee, Centers for Disease Control
          Program Director/Principal Investigator (Last, First, Middle):


1998-present Vice-Chair for Health Outcomes, Dept. of Medicine, Children’s Hospital
1998-2001    Steering Committee, NACHRI/CDC Pediatric Prevention Network

Honors
1982             SERC Advanced Research Scholarship, Infectious Disease Society of America
2001             Anthony Steinway Award for Excellence in Teaching (Children’s Hospital)

C. Selected peer-reviewed publications (in chronological order).

Applicants are encouraged to limit the list of selected peer-reviewed publications or manuscripts in press to no more
than 15. Include manuscripts submitted or in preparation. The individual may choose to include selected publications
based on recency, importance to the field, and/or relevance to the proposed research.

(Publications selected from 133 peer-reviewed publications)

1. Luciani JM, Casper J, Goodman BF, Shaw CM, Carlucci JL. Prevention of respiratory virus infections
   through compliance with frequent hand-washing routines. N Engl J Med 1988; 318:389-394.
2. Gussmann J, Pratt R, Sideway DG, Sinclair JM, Emmerson MF, Carlucci JL. Coagulase-negative
    staphylococcal bacteremia in the changing neonatal intensive care unit population. Is there an epidemic?
    JAMA. 1988; 158:1548-1552.
3. Gussmann J, Carlucci JL, McGovern JE, Jr., Methodologic issues in nursing home epidemiology. Rev
    Infect Dis. 1989; 11:1119-1141.
4. Gussmann J, Emmerson MF, Smyth NE, Platt RI, Sidebottom DG, Carlucci JL. Early hospital release and
    antibiotic usage with nosocomial staphylococcal bacteremia in two neonatal intensive care unit populations.
    Amer. J Dis. Child 1991; 149:325-339.
5. Murphy JA, Black RW, Schroeder LC, Weissman ST, Gussman JM, Carlucci JL, Short CJ. Quality of
    care for children with asthma: the role of social factors and practice setting. Pediatrics 1996; 98:379-84.
6. Gussmann J, Carlucci JL, McGovern JE, Jr. Incidence of Staphylococcus epidermis catheter-related
    bacteremia by infusions. J Infect Dis. 1996; 172:320-4.
7. Carlucci JL, Huskins WC. Control of nosocomial antimicrobial-resistant bacteria A strategic priority for
    hospitals worldwide. Clin Infect Dis. 1997; S139-S145.
8. Corning WC, Saylor BM, O’Steen C, Gulapagos L, O’Reilly EJ, Carlucci JL. Hospital infection prevention
    and control: A model for improving the quality of hospital care in low income countries. Infect Control Hosp
    Epi. 1999; 13:123-35.
9. Handler CJ, Marriott B, Clearwater PT, Carlucci JL. Quality of care at a children’s hospital: the child’s
    perspective. Arch Pediatric Adolescence Med. 1999; 143:1120-7.
10. McKinney D, Poulet KL, Wong Y, Murphy V, Ulright M, Dorling G, Long JC, Carlucci JL, Piper GB.
    Protective vaccine for Staphylococcus aureus. Science 1999; 214:1421-7.
11. Gulazzii L, Kispert ZT, Carlucci JL, Corning WC. Risk-adjusted mortality rates in surgery: a model for
    outcome measurement in hospitals developing new quality improvement programs. J Hosp Infect 2000;
    24:33-42.
12. Huebner J, Qui A, Krueger WA, Carlucci JL, Pier GB. Prophylactic and therapeutic efficacy of antibodies
    to a capsular polysaccharide shared among vancomycin-sensitive and resistant enterococci. Infect Immun.
    2000; 68:4631-6.
13. Levitan O, Sissy RB, Kenney J, Buchwald E, Maccharone AB, Carlucci JL. Enhancement of neonatal
    innate defense: Effects of adding an recombinant fragment of bactericidal protein on growth and tumor
    necrosis factor-inducing activity of gram-positive bacteria tested in vivo. Immun. 2000; 38:3120-25.
14. Garletti JS, Harrison MC, Collin PA, Miller CD, Otter D, Shaker C, Wren M, Carlucci JL, Makato DG. A
    randomized trial comparing iodine to a alcohol impregnated dressing for prevention of catheter infections in
    neonates. Pediatrics. 2001; 127:1461-6.
15. Corning WC, Barillo K, Festival MR, Lingonberry S, Lumbar P, Peters A, Pursons M, Carlucci JL, Tella JE.
    A national survey of practice variation in the use of antibiotic prophylaxis in heart surgery. J Hosp Infect.
    2001; 33:121-5.
           Program Director/Principal Investigator (Last, First, Middle):



D. Research Support

List both selected ongoing and completed research projects for the past three years (Federal or non-Federally-supported).
Begin with the projects that are most relevant to the research proposed in the application. Briefly indicate the overall goals
of the projects and responsibilities of the key person identified on the Biographical Sketch. Do not include number of
person months or direct costs.


Ongoing Research Support
R01 HS35793 Carlucci (PI)                                    9/01/99-8/30/04
AHRQ
Reducing Antimicrobial Resistance in Low-Income Communities: A Randomized Trial.
This study is a randomized trial of interventions to reduce antimicrobial usage and resistance in low-income
communities.
Role: PI

Completed Research Support
            Program Director/Principal Investigator (Last, First, Middle):

                                                                   RESOURCES
                     (Describe the space, key equipment and core services available for the project)
Laboratory:



Clinical:

Animal:
Computer:


Office:


Other:



Scientific Environment:




MAJOR EQUIPMENT
(Suggested categories, edit as appropriate for the project)

Cell Culture:


Biochemistry/Molecular Biology:


Electron Microscopy:

Cell Physiology:


Microscopy and Imaging:




                                                                      Page
        Program Director/Principal Investigator (Last, First, Middle):


SPECIFIC AIMS. (1 page)
       Program Director/Principal Investigator (Last, First, Middle):



RESEARCH STRATEGY. (6 pages)
                                                              Significance




                                                                Innovation
         Program Director/Principal Investigator (Last, First, Middle):




                                                 Approach (recommend 4-5 pages)
AIM 1:
Preliminary Studies Supporting Aim 1: (optional)




Rationale:
    (Define the problem/hypothesis)




Experimental Protocol:
   (Describe the experiments that will address the problem/hypothesis)




Anticipated Outcome:




Problems and alternate approaches:




Interpretation:
         Program Director/Principal Investigator (Last, First, Middle):




       1b.
Rationale:


Experimental Protocol:




Anticipated Outcome:




Problems and alternate approaches:



Interpretation:
         Program Director/Principal Investigator (Last, First, Middle):



AIM 2:
Preliminary Studies supporting Aim 2: (optional)



Rationale:




Experimental Protocol:




Anticipated Outcome:




Problems and alternate approaches:



Interpretation:
         Program Director/Principal Investigator (Last, First, Middle):



       2b.

Rationale:




Experimental Protocol:




Anticipated Outcome:




Problems and alternate approaches:



Interpretation:
       Program Director/Principal Investigator (Last, First, Middle):




BIBLIOGRAPHY AND REFERENCES CITED:
       Program Director/Principal Investigator (Last, First, Middle):




PROTECTION OF HUMAN SUBJECTS:



INCLUSION OF WOMEN AND MINORITIES:



TARGETED/PLANNED ENROLLMENT TABLE:



INCLUSION OF CHILDREN:
         Program Director/Principal Investigator (Last, First, Middle):




VERTEBRATE ANIMALS: (EXAMPLE)
1. Detailed description of the proposed use of animals:




2. Justify the use of animals, the choice of species and the numbers used: (EXAMPLE)

Use

Species
Numbers
3. Veterinary care of the animals:




4. Procedures for limiting discomfort, distress, pain, and injury:


5. Method of euthanasia:
       Program Director/Principal Investigator (Last, First, Middle):




SELECT AGENT RESEARCH:



LETTERS OF SUPPORT:
            Program Director/Principal Investigator (Last, First, Middle):

                                          Targeted/Planned Enrollment Table
                                    (Submit this table only if there are human subjects in the study)

              This report format should NOT be used for data collection from study participants.

Study Title:

Total Planned Enrollment:


                                    TARGETED/PLANNED ENROLLMENT: Number of Subjects

                                  Ethnic Category                                                Females            Males            Total

Hispanic or Latino

Not Hispanic or Latino

Ethnic Category: Total of All Subjects *

                                 Racial Categories

American Indian/Alaska Native

Asian

Native Hawaiian or Other Pacific Islander

Black or African American

White

Racial Categories: Total of All Subjects *
* The “Ethnic Category: Total of All Subjects” must be equal to the “Racial Categories: Total of All Subjects.”




                                                                      Page                          Targeted/Planned Enrollment Table Format Page

				
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