The Application Process

1
The Application Process

• Jean L. Flagg-Newton, PhD
• Program Director
• Office of Capacity Building and Infrastructure

2
Definitions

• Applicant Institution
• Collaborating Institution
• Complementary Applications
• Complementary Budget

3
Selecting the Funding Mechanism

• R24 Resource Related Research Grant
• Four-year Institutions
• Four-year Institutions _at_ Masters Degree Programs

RESEARCH PROGRAMS ARE GENERALLY DEVELOPMENTAL AS
DETERMINED BY EXISTING RESEARCH SUPPORT
4
Selecting the Funding Mechanism

• P20 Exploratory Grant
• Have not had a comprehensive (P60) or specialized
  center (P50) grant funded by other NIH institutes
  and centers
• Eligible for support by the NCRR COBRE Program

DEVELOPMENT OF INTERDISCIPLINARY PROGRAMS THAT
OFFER POTENTIAL SOLUTIONS TO PROBLEMS OF SPECIAL
SIGNIFICANCE TO NCMHD
5
Selecting the Funding Mechanism

• P60 Comprehensive Center
• Have had NIH support through either the P60 or
  P50 mechanisms

INSTITUTIONS WITH SUBSTANTIAL FEDERAL FUNDING
SUPPORT AS JUDGED BY THE 1998 REPORT ON RESEARCH
INSTITUTIONS
6
Complementary Applications

• The Face Page
• Item 7a Combined Direct Costs of Partnering
  Institutions
• Item 7b Combined Total Costs of Partnering
  Institutions

7
Application Process

• Performance Site (Form Page 2)

IDENTICAL IN COMPLEMENTARY APPLICATIONS
8
Biographical Sketches

• All professional personnel consultants with
  percent effort applicant/collaborating
  institutions
• Arrange alphabetically
• Do not duplicate in individual component
  cores/pilots

IDENTICAL IN COMPLEMENTARY APPLICATIONS
9
Participating Faculty

• Provide listing in tabular format
• Name including degree
• Institution and department affiliation or
  equivalent
• Research or other interest (e.g., research
  component area, shared resource core, training,
  etc.)

IDENTICAL IN COMPLEMENTARY APPLICATIONS
10
Resources

• Resources format page
• Describe, by institution, the relevant resources
  available to the proposed export center/program

IDENTICAL IN COMPLEMENTARY APPLICATION
11
Overview/Description of EXPORT Center

• Describe scientific area of inquiry
• Specific aims and objectives
• Research
• Training
• Community outreach
• Infrastructure development (if applicable)

IDENTICAL IN COMPLEMENTARY APPLICATION
12
Overview/Description of EXPORT Center

• Background and Significance
• 25-page limit
• Establish the significance of proposed centers
  objectives (critical review/ synthesis of
  relevant research, theory, methods)
• Rationale and justification for the proposed
  institutional partnership (emphasizing how each
  institution will contribute and benefit)
• Plans to develop productive collaborations

13
Overview/Description of EXPORT Center

• Background and significance (contd)
• Preliminary studies
• Provide detailed description/discussion of funded
  research projects that constitute the proposed
  centers research base
• Establish relevance to minority health/health
  disparities issues and strengths and limitations
  of scientific foundation of specific aims

14
Overview/Description of EXPORT Center

• Background and Significance (contd)
• Present preliminary studies in tabular format
• Names and institutional affiliation of the PI
• Study title and grant number
• Percent effort
• Funding organization
• Period of committed support
• Direct costs for project period
• Current annual year direct costs
• May also present non-related funded research In
  tabular format

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Overview/Description of EXPORT Center

• Background and Significance (contd)
• Also include the following
• A description of the qualifications of the
  center director and co-director
• General plans for collaborations between the
  partnering institution

IDENTICAL IN COMPLEMENTARY APPLICATIONS
16
Administrative Core

• 15 page limit
• Provide the following
• Detailed description/discussion of the
  objectives, functions, and organizational
  infrastructure, administrative procedures
• Key personnel, including core director
• Relationships and lines of authority by
  appropriate officials at partnering institutions
• Diagram showing integration of export center in
  institutions administrative structure

17
Administrative Core (contd)

• Also provide the following
• Plans for assistance of a business official for
  fiscal matters
• Resources of the administrative core
• Committee structure, including a description of
  the qualifications for membership
• Discuss the institutional commitment and include
  letter(s) of commitment

IDENTICAL IN COMPLEMENTARY APPLICATIONS
18
Shared Resource Core(s)

• 15 page limit
• Provide detailed description/discussion
• Objectives, functions, organizational
  infrastructure
• Administrative procedures, key personnel,
  including the core director
• Resources of the shared resource core within
  context of overall center

SHARED FACILITIES THAT PROVIDE NEEDED SERVICES TO
CENTER INVESTIGATORS ENABLING THEM TO CONDUCT
THEIR FUNDED INDIVIDUAL RESEARCH PROJECTS MORE
EFFICIENTLY AND MORE EFFECTIVELY.
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Shared Resource Core(s) (contd)

• Also
• Delineate shared resource(s) to be provided at
  each participating institution
• Describe relationships and lines of authority at
  the partnering institutions
• If charge back system developed to help defray
  cost - provide justification for charge

IDENTICAL IN COMPLEMENTARY APPLICATIONS
20
Research Component Core(s)

• May establish multiple, interrelated research
  component cores, if feasible
• Each core should have a director and may include
  several investigators
• Conditions for establishing a research core
  strong research base in an area(s) of emphasis
• Can include research at other institutions if
  collaborations exist with scientists at applicant
  institution

21
Research Component Core(s) (contd)

• Provide the following
• Overview of area of emphasis provide in
  sufficient detail to allow reviewers to judge
  relevance to minority health/health disparities
• Detailed description and discussion of the
  specific aims/objectives as related to addressing
  health disparities
• Indication of how center will provide added
  dimensions (e.g., greater focus and increased
  cooperation, communication and collaboration)

15-PAGE LIMIT PER RESEARCH COMPONENT CORE
22
Research Component Core(s) (contd)

• Also
• Indicate the performance site and key personnel,
  including the research component core director
  use PHS Form 398 Form Page 2
• Provide a listing in tabular format of the funded
  research projects that comprise the research base
  of each research component core

IDENTICAL IN COMPLEMENTARY APPLICATIONS
23
Community Outreach and Information Dissemination

• Purpose
• Integration of export centers into local
  communities
• Focus
• Development and dissemination of culturally
  sensitive health information
• Encouraging/equipping for involvement in clinical
  studies and for participating in (or conducting)
  prevention and intervention activities
• Science education outreach activities

15-PAGE LIMIT
24
Community Outreach and Information Dissemination

• Provide the following
• Performance site(s) and proposed core director
• Overview of areas(s) of emphasis
• Target audience and participants
• Discussion of specific aims and objectives
• Discussion of relationships and lines of
  authority at partnering institutions
• Any committee structure and qualifications for
  committee

25
Community Outreach and Information Dissemination

• Provide the following
• Staffing plans and rationale for organization of
  component
• Methods, techniques and technologies to be used
• Issues of cultural sensitivity, if any
• Indication of how this component will assist in
  integrating center into the community

IDENTICAL IN COMPLEMENTARY APPLICATIONS
26
Pilot Project/Feasibility Study Core

• Purpose
• Provide modest research support (up to two years)
  to enable eligible investigators to explore the
  feasibility of a concept related to the Centers
  goal
• Focus
• Initial support for new investigators
• Exploration of innovative new leads or new
  directions
• Stimulate investigators from other areas to lend
  expertise to minority health/health disparity

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Pilot Project/Feasibility Study Core

• Part 1 Administrative Issues
• Describe/discuss
• Objectives, functions, organizational
  infrastructure, including lines of authority
• Administrative procedures
• Any committee structure and qualifications for
  membership
• Proposed resources of core
• Activities designed to facilitate development/
  completion of pilot/feasibility studies

15-PAGE LIMIT
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Pilot Project/Feasibility Study Core

• Part 2 - Proposed Pilot Project/Feasibility
  Study
• Each pilot/feasibility study proposed should
• Be on a topic related to the objectives of an
  area of emphasis for the Center
• Present a testable hypotheses
• Clearly delineate the question being asked
• Detail procedures to be followed
• Discuss how the data will be analyzed

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Pilot Project/feasibility Study Core

• Part 2 - Proposed Pilot Project/Feasibility
  Study
• Provide for each pilot/feasibility study
  proposed
• An abstract and listing of key personnel and
  performance site (form Page 2)
• Detailed budget
• Justification of eligibility of PI
• Justification of study as a pilot study,
  including how it fits into the Centers area of
  inquiry
• Scientific proposal as outlined in PHS 398
  (including justification for core use if
  applicable) 5-pages maximum

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Pilot Project/feasibility Study Core

• Part 2 - proposed pilot project/feasibility
  study
• Provide for each pilot/feasibility study
  proposed
• Information regarding human subjects or
  vertebrate animals, if applicable
• Literature cited

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Mentoring Core (R24)

• Describe/discuss
• Objectives, functions, organizational
  infrastructure, administrative procedures
• Key personnel, including the core director
• Resources of the mentoring component within
  context of the program
• Detailed description of core activities,
  resources, research opportunities designed to
  assist junior faculty in enhancing research
  skills and career trajectory

15-PAGE MAXIMUM
32
Mentoring (R24)

• Mentoring core (contd)
• Mentoring and training activities may include
• Didactics
• Opportunities to train in research laboratories
• Other activities designed to enhance
  competitiveness

33
Training (P20 and P60)

• Undergraduates and graduates activities
• Didactics
• Opportunities to train in research laboratories
• Other activities to enhance competitiveness

34
Training (P20 and P60)

• Describe/discuss
• Objectives, functions, and administrative
  procedures
• Organizational infrastructure,including lines of
  authority at both partnering institutions
• Any committee structures and membership
• Key personnel, including the core director
• Resources of the training component within the
  context of the Center

15-PAGE MAXIMUM
35
Training (P20 and P60)

• Training (contd)
• Also discuss/describe
• Core activities, resources and research
  opportunities designed to assist junior faculty
  in enhancing research skills and research career
  trajectories

TRAINING CORE IDENTICAL IN COMPLEMENTARY
ACTIVITIES
36
Health Disparities Education Core

• PURPOSE To augment existing or create new
  curricula among partners to apprise and
  culturally sensitize undergraduates, graduate
  students, post doctoral trainees in research,
  medicine, or public health of the need to reduce
  and eliminate disparities in health status

37
Health Disparities Education Core

• Describe/discuss
• Objectives, functions, administrative procedures
• Organizational infrastructure, including lines of
  authority at both partnering institutions
• Key personnel, including core director
• Any committee structure and membership
• Proposed core activities
• Resources available to core

15-PAGE MAXIMUM
38
The Application Process

• The application process has two steps
• Step 1. Complete the application packet
• Step 2. Deliver the application packet
• Watch out for that first step, its a doozy!

39
References and Letters of Support

• References
• Follow instructions in PHS 398
• List all references - include title, all authors,
  book or journal, volume number, page numbers, and
  year of publication
• Limit list to relevant and current literature
• Letters of Support
• Provide letters of support for the Applicant
  Institution, only

40
Consortium/Contractual Arrangements

• Follow instructions in PHS 398
• Explain the programmatic, fiscal, and
  administrative arrangements to be made between
  the applicant organization and the consortium
  organization(s)
• Obtain signature of authorized organizational
  official on the Face Page to signify
  understanding of NIH consortium agreement policy

41
Checklist

• Use Checklist Form Page in PHS 398, for Applicant
  Institution, only
• Identify type of application, check all that
  apply
• Include program income, if anticipated
• Obtain official signature for Assurances/Certifica
  tions
• Include established Facilities and Administrative
  (FA) cost rates
• Identify whether environment is smoke-free (no
  impact on funding)

42
Appendix Material

• Follow instructions in PHS 398, for Applicant
  Institution, only
• Include five collated sets (3 to CSR, 2 to NCMHD)
• No page numbering necessary
• Identify each item with the name of the Principal
  Investigator

43
Personal Data on Principal Investigator/Program
Director

• Use Personal Data Form Page in PHS 398
• Place this form at the end of the signed original
  copy of application
• Do not duplicate

44
Confidentiality of Information

• Proprietary information (trade secrets,
  privileged or confidential information) should be
  included ONLY if it is deemed essential to the
  application
• Any pages containing confidential information
  should be identified according to the PHS 398
  instructions
• Proprietary information is furnished to the
  Government in confidence with the understanding
  that the information will be used and disclosed
  only for evaluation of the application

45
Delivery Logistics

• Submit a signed, typewritten original of the
  application, including the Checklist, and three
  signed photocopies in one package to
• Center for Scientific Review
• National Institutes of Health
• 6701 Rockledge Drive, Room 1040,
• MSC 7710
• Bethesda, MD 20892-7710
• Bethesda, MD 20817 (for express/courier service)

• Submit two additional copies of the application
  to
• Dr. Jean L. Flagg-Newton
• Deputy Director, National Center on Minority
  Health and Health Disparities
• 6707 Democracy Blvd., Suite 800,
• MSC 5465
• Bethesda, MD 20892-5465
• Phone [phone] Fax [phone]
• E-mail Flaggnej_at_ncmhd.nih.gov

• Total number of applications to CSR plus NCMHD
  cannot exceed six

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Application Receipt

• CSR and NCMHD document receipt of packet
• Date and time of receipt are stamped on packet
• If received after specified date and time
• May be accepted if legible proof-of-mailing date
  no later than one week prior to deadline date
• Will be accepted if waiver request included, AND
  waiver approved after review
• Applications with receipt confirmations are
  submitted for review