PCORI Grant Application Full Set11 by Pb4J22

VIEWS: 89 PAGES: 19

									                                                                                        LEAVE BLANK—FOR PCORI USE ONLY.
                                     Patient-Centered Outcomes                          Type         Activity      Number
                                                                                        Review Group               Formerly
                                          Research Institute
                            Form A: Grant Application                                   Council/Board (Month, Year)                Date Received

1. TITLE OF PROJECT (Do not exceed 81 characters, including spaces and punctuation.)


2. RESPONDING TO THE FOLLOWING PCORI FUNDING ANNOUNCEMENT:
Number:    PI-12-001                     Title:   PCORI PILOT PROJECTS
3. PROGRAM DIRECTOR/PRINCIPAL INVESTIGATOR
3a. NAME (Last, first, middle)                                                          3b. DEGREE(S)                           3h. eRA Commons User Name


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


3e. ORGANIZATION & DEPARTMENT, SERVICE, 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. RESERVED                                           4d. RESERVED


5. RESERVED                                                                             5a. RESERVED
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 ($)       8b. Total Costs ($)



9. APPLICANT ORGANIZATION                                                               10. TYPE OF ORGANIZATION
Name                                                                                            Public:          Federal               State          Local
Address                                                                                         Private:         Private Nonprofit

                                                                                                For-profit:      General               Small Business
                                                                                                Woman-owned         Socially and Economically Disadvantaged

                                                                                        11. ENTITY IDENTIFICATION NUMBER
                                                                                                                                Cong. District

12. ADMINISTRATIVE OFFICIAL TO BE NOTIFIED IF AWARD IS MADE                             13. OFFICIAL SIGNING FOR APPLICANT ORGANIZATION

Name                                                                                    Name

Title                                                                                   Title
Address                                                                                 Address




TEL:                                              FAX:                                  TEL:                                        FAX:

E-Mail:                                                                                 E-Mail:

14. APPLICANT ORGANIZATION CERTIFICATION AND ACCEPTANCE: I certify that                        SIGNATURE OF OFFICIAL NAMED IN 13.                     DATE
the statements herein are true, complete and accurate to the best of my knowledge, and         (In ink. “Per” signature not acceptable.)
accept the obligation to comply with PCORI terms and conditions if a grant is awarded as a
result of this application. I am aware that any false, fictitious, or fraudulent statements or
claims may subject me to criminal, civil, or administrative penalties.



PCORI Grant Application (Rev. 09/11)                                          Page 1                                                             Form A: Face Page
Program Director/Principal Investigator (Last, First, Middle):

                                             FORM B: PCORI GRANT APPLICATION
                                                           TABLE OF CONTENTS

                                                                                                                                           Page
                                                                                                                                          Numbers
Form A: Face Page ..................................................................................................................        1
Form B: Table of Contents .......................................................................................................           2
Form C: Description .................................................................................................................       3
Form D: Project/Performance Sites ..........................................................................................
Form E: Senior and Key Personnel and Other Significant Contributors ....................................
Form F: Consolidated Budget Summary for Entire Proposed Project Period ............................
Form G: Direct Costs Budget Summary(ies) (for Applicant Organization) ........................................
Forms G-1—G-7 Direct Costs Budget Details (for Applicant Organization) ......................................
Form G: Direct Costs Budget Summary(ies) (for Consortium/Contracts) ........................................
Forms G-1—G-7 Direct Costs Budget Details (for Consortium/Contracts) ......................................
Form H: Resources ..................................................................................................................
Form I: Biographical Sketches .................................................................................................
Form J: Checklist .....................................................................................................................
Addendum Forms (only as required by the specific PFA) .........................................................
Research Plan .........................................................................................................................
     1. Specific Aims ................................................................................................................
     2. Research Strategy ........................................................................................................
     3. References Cited .........................................................................................................
     4. Protection of Human Subjects ....................................................................................
     5. Consortium/Contractual Arrangements .......................................................................
     6. Letters of Support .......................................................................................................
     7. Resource Sharing Plan(s) ...........................................................................................




PCORI Grant Application (Rev. 09/11)                                       Page 2                                                               Form B
Program Director/Principal Investigator (Last, First, Middle):

                                                          FORM C: DESCRIPTION
PROJECT SUMMARY (See instructions)




RELEVANCE (See instructions)




PCORI Grant Application (Rev. 09/11)                             Page 3         Form C
Program Director/Principal Investigator (Last, First, Middle):

                                        FORM D: PROJECT/PERFORMANCE SITE(S)
                                               (Duplicate this page as needed for additional responses)


Project/Performance Site Primary Location

Organizational Name:

Street 1:                                                                   Street 2:

City:                                                            County:                                        State:

Province:                                           Country:                                          Zip/Postal Code:

Project/Performance Site Congressional District:
Additional Project/Performance Site Location

Organizational Name:

Street 1:                                                                   Street 2:

City:                                                            County:                                        State:

Province:                                           Country:                                          Zip/Postal Code:

Project/Performance Site Congressional District:
Additional Project/Performance Site Location

Organizational Name:

Street 1:                                                                   Street 2:

City:                                                            County:                                        State:

Province:                                           Country:                                          Zip/Postal Code:

Project/Performance Site Congressional Districts:
Additional Project/Performance Site Location

Organizational Name:

Street 1:                                                                   Street 2:

City:                                                            County:                                        State:

Province:                                           Country:                                          Zip/Postal Code:

Project/Performance Site Congressional District:
Additional Project/Performance Site Location

Organizational Name:

Street 1:                                                                   Street 2:

City:                                                            County:                                        State:

Province:                                           Country:                                          Zip/Postal Code:

Project/Performance Site Congressional District:
Additional Project/Performance Site Location

Organizational Name:

Street 1:                                                                   Street 2:

City:                                                            County:                                        State:

Province:                                           Country:                                          Zip/Postal Code:

Project/Performance Site Congressional District:




 PCORI Grant Application (Rev. 09/11)                                  Page                                              Form D
Program Director/Principal Investigator (Last, First, Middle):

                                             FORM E: SENIOR & KEY PERSONNEL
                         (Use continuation pages as needed to provide the required information in the format shown below.)
Name                                      Organization                      Role on Project




OTHER SIGNIFICANT CONTRIBUTORS
Name                          Organization                                  Role on Project




PCORI Grant Application (Rev. 09/11)                                 Page                                                    Form E
Program Director/Principal Investigator (Last, First, Middle):



              FORM F: BUDGET SUMMARY FOR ENTIRE PROPOSED PROJECT PERIOD

                                                                                                                5th ADDITIONAL
                                      INITIAL BUDGET         2nd ADDITIONAL    3rd ADDITIONAL  4th ADDITIONAL
     BUDGET CATEGORY                                                                                                YEAR OF
                                          PERIOD            YEAR OF SUPPORT   YEAR OF SUPPORT YEAR OF SUPPORT
         TOTALS                                                                                                    SUPPORT
                                                               REQUESTED         REQUESTED       REQUESTED
                                                                                                                  REQUESTED
SECTION 1: DIRECT COSTS

PERSONNEL: (Salary and fringe
benefits)


CONSULTANT COSTS


EQUIPMENT


SUPPLIES


TRAVEL


OTHER EXPENSES

CONSORTIUM/
CONTRACTUAL DIRECT
COSTS

SUBTOTAL DIRECT COSTS


TOTAL DIRECT COSTS FOR ENTIRE PROPOSED PROJECT PERIOD
                                                                                                                $
SECTION 2: INDIRECT COSTS

APPLICANT AGENCY
INDIRECT COSTS

CONSORTIUM/
CONTRACTUAL INDIRECT
COSTS

TOTAL COSTS


TOTAL COSTS FOR ENTIRE PROPOSED PROJECT PERIOD
                                                                                                                $




PCORI Grant Application (Rev. 09/11)                                Page                                                Form F
 Program Director/Principal Investigator (Last, First, Middle):

                                      FORM G: DIRECT COSTS BUDGET SUMMARY
                                                       (FOR A SINGLE BUDGET YEAR)


    BUDGET FOR:                                      BUDGET YEAR:                   START DATE      END DATE




                                                                                             PROPOSED
                                                       BUDGET CATEGORY
                                                                                               COSTS
                                                      DIRECT COSTS TOTALS
                   Line

                     1    PERSONNEL COSTS (Salary and fringe benefits)


                     2    CONSULTANT COSTS


                     3    EQUIPMENT COSTS


                     4    SUPPLY COSTS


                     5    TRAVEL COSTS


                     6    OTHER DIRECT COSTS


                     7    DIRECT CONSORTIUM/CONTRACTUAL COSTS


                     8    TOTAL DIRECT COSTS




PCORI Grant Application (Rev. 09/11)                                Page                                       Form G
Program Director/Principal Investigator (Last, First,Middle):

                             FORM G-1: DIRECT PERSONNEL COSTS BUDGET DETAIL
                                                       (FOR A SINGLE BUDGET YEAR)

                                                 ROLE ON         % TIME ON   INST.BASE     SALARY     FRINGE
               NAME                              PROJECT         PROJECT      SALARY     REQUESTED   BENEFITS   COST

                                                   PD/PI




SUBTOTAL FOR PERSONNEL COSTS


BUDGET JUSTIFICATION:




PCORI Grant Application (Rev. 09/11)                            Page                                             Form G-1
 Program Director/Principal Investigator (Last, First, Middle):

                            FORM G-2: DIRECT CONSULTANT COSTS BUDGET DETAIL
                                                       (FOR A SINGLE BUDGET YEAR)


                                                        ORGANIZATIONAL   Expected
               CONSULTANT NAME                            AFFILIATION     Hours     Fees   Travel   Other   COST




 SUBTOTAL FOR CONSULTING COSTS


BUDGET JUSTIFICATION:




PCORI Grant Application (Rev. 09/11)                              Page                                       Form G-2
 Program Director/Principal Investigator (Last, First, Middle):

                             FORM G-3: DIRECT EQUIPMENT COSTS BUDGET DETAIL
                                                       (FOR A SINGLE BUDGET YEAR)



                                             ITEM OF EQUIPMENT                      COST




 SUBTOTAL FOR EQUIPMENT COSTS


BUDGET JUSTIFICATION:




PCORI Grant Application (Rev. 09/11)                              Page                     Form G-3
Program Director/Principal Investigator (Last, First, Middle):

                                 FORM G-4: DIRECT SUPPLY COSTS BUDGET DETAIL
                                                        (FOR A SINGLE BUDGET YEAR)



                                              SUPPLY CATEGORY                        COST




SUBTOTAL FOR SUPPLY COSTS


BUDGET JUSTIFICATION:




PCORI Grant Application (Rev. 09/11)                             Page                       Form G-4
Program Director/Principal Investigator (Last, First, Middle):

                                 FORM G-5: DIRECT TRAVEL COSTS BUDGET DETAIL
                                                        (FOR A SINGLE BUDGET YEAR)


                                                                                      NUMBER OF
                              PURPOSE                                   DESTINATION    PEOPLE     COST




 SUBTOTAL FOR TRAVEL COSTS


BUDGET JUSTIFICATION:




PCORI Grant Application (Rev. 09/11)                             Page                                    Form G-5
 Program Director/Principal Investigator (Last, First, Middle):

                                 FORM G-6: DIRECT OTHER COSTS BUDGET DETAIL
                                                       (FOR A SINGLE BUDGET YEAR)



                                                    ITEMIZED EXPENSE                COST




 SUBTOTAL FOR OTHER DIRECT COSTS


BUDGET JUSTIFICATION:




PCORI Grant Application (Rev. 09/11)                              Page                     Form G-6
Program Director/Principal Investigator (Last, First, Middle):

            FORM G-7: DIRECT CONSORTIUM & CONTRACTUAL COSTS BUDGET DETAIL
                                                        (FOR A SINGLE BUDGET YEAR)



                       CONSORTIUM MEMBER ORGANIZATION OR CONTRACTOR                  COST




 SUBTOTAL FOR CONSORTIUM & CONTRACTUAL COSTS


BUDGET JUSTIFICATION




PCORI Grant Application (Rev. 09/11)                             Page                       Form G-7
 Program Director/Principal Investigator (Last, First, Middle):

                                                          FORM H: RESOURCES

RESOURCES:




 PCORI Grant Application (Rev. 09/11)                             Page        Form H
Program Director/Principal Investigator (Last, First, Middle):

                                                FORM I: BIOGRAPHICAL SKETCH
           (Provide the following information for the Senior/key personnel and other significant contributors in the order listed on Form E.
                                      Follow this format for each person. Do not exceed four pages per person.)


NAME                                                                         POSITION TITLE



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




SKETCH (use headings found in the instructions, adding continuation sheets, as needed, up to 4 total pages)




PCORI Grant Application (Rev. 09/11)                                    Page                                                                   Form I
Program Director/Principal Investigator (Last, First, Middle):


                                                            FORM J: CHECKLIST

1. TYPE OF APPLICATION. (Check all that apply.)

     NEW application. (This application is being submitted to PCORI for the first time.)

     RESUBMISSION of application. (This replaces an unfunded version.) Enter original application no:

     RENEWAL of grant. (Requests additional funding beyond current year.) Enter current grant no:

     SUPPLEMENT to grant. (Requests additional funding for current year.) Enter current grant no:

     CHANGE of principal investigator. (Enter name of former PI in the following box)

     CHANGE of grantee organization. (Enter name of former organization in the following box)

     FOREIGN application            Domestic grant with foreign involvement (Enter countries involved)


2. PATIENT-FOCUSED AREAS. (Select all patient-centered questions applicable to proposed research)

     ―Given my personal characteristics, conditions and preferences, what should I expect will happen to me?‖

      ―What are my options, and what are the benefits and harms of those options?‖

      ―What can I do to improve the outcomes that are most important to me?‖

      ―How can the health care system improve my chances of achieving the outcomes I prefer?‖


3. TARGET POPULATIONS. (Select all populations that the proposed research will specifically target)

     Underserved or disadvantaged populations

     Specific ethnic or cultural populations

     Disabled populations

     Urban                                Rural                                Both Urban and Rural

     Other (enter information):

     Not applicable


4. CERTIFICATION
In signing the application Face Page, the authorized organizational representative agrees to comply with
the policies, assurances and/or certifications listed in the application instructions and PFA, including all    Check to certify agreement
references within them, when applicable. If unable to certify compliance, where applicable, provide an
explanation and place it after this page.
PCORI Grant Application (Rev. 09/11)                             Page                                              Form J


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


                     ADDENDUM FORM: PCORI PILOT PROJECTS AREAS OF INTEREST


Eligible projects under this PFA must address one or more of the following PCORI areas of interest. Please check all
that apply to the proposed research project:

         Developing, testing, refining, and/or evaluating new or existing methods (qualitative and quantitative) and
         approaches that can inform the process of establishing and updating national priorities f or the conduct of
         patient-centered outcomes research (PCOR). This may include research prioritization approaches (such as
         Value of Information (VOI), burden of illness, peer review/expert opinion/Delphi approaches) or methods for
         incorporating the perspectives of patients or other stakeholders into the development of national priorities.
         Developing, testing, and/or refining existing methods for bringing together patients, caregivers, clinicians
         including non-traditional partners, and other stakeholders in all stages of a multi-stakeholder research
         process, from the generation and prioritization of research questions to the conduct and analysis of a study to
         dissemination of study results – including methods for training participants in participatory research and the
         potential use of new technologies to facilitate engagement.
         Developing, refining, testing, and/or evaluating patient-centered approaches, including decision-support
         tools, for translating evidence-based care into health care practice in ways that account for individual patient
         preferences for various outcomes. This may include developing or comparing conceptual models of
         translation or dissemination of CER research findings from the patient perspective.
         Developing, refining, testing, and/or evaluating methods to identify gaps in CE knowledge such as tools for
         the ongoing collection and assessment of gaps as perceived by patients and providers. Of special interest
         are gaps that are particularly relevant to vulnerable populations, including but not limited to, low-income
         populations; minorities; children; the elderly; women; and people with disabilities, chronic, rare, and/or
         multiple medical conditions.
         Identifying, testing, and/or evaluating patient-centered outcomes instruments. This may include predictive
         tools (e.g.: instruments that measure or predict outcomes of interest to patients) or identifying standards for
         measurement properties of patient-reported outcomes for use in comparative effectiveness research, across
         a variety of interventions and patient populations.
         Identifying, testing, and evaluating methods that can be used to assess the patient perspective when for
         researching behaviors, lifestyles, and choices within the patient’s control that may influence their outcomes.
 Identifying, testing, refining and/or evaluating methods for studying the patient care team interaction in
 situations where multiple options for wellness, prevention, diagnosis or treatment exist. Of special interest
 are strategies that respect patient autonomy and promote informed decision-making, incorporating the best
 health care knowledge into the application of care.
 Advancing analytical methods for CER. Examples include but are not limited to the incorporation of mixed
 methods research designs (qualitative/quantitative), identifying existing methodology to statistically
 accommodate irregularly spaced multivariate longitudinal data, the use of instrumental variables; and
 potential solutions for assessing treatment heterogeneity in observational and randomized CER studies.




PCORI Pilot Projects                           Page                                             Addendum Form

								
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