Workshop 3: Funding Opportunities

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• Workshop 3 Funding Opportunities
• Conducting HIV Treatment Research
• In Resource Poor Countries
• Workshops and Training Sessions
• October 20-21, 2003
• Baltimore, Maryland
• Joan Romaine, MPH
• Health Specialist
• Division of AIDS, Office of International
  Research
• National Institute of Allergy and Infectious
  Diseases
• National Institutes of Health
• United States Department of Health Human
  Services

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Overview

• Need for International Research
• Overview of CIPRA
• Mission/Goals
• 3 Grant Mechanisms
• Application Process and Timelines
• Other NIH Funding
• NIAID
• Grants, Contracts, Training
• Resource Guide for the Development of AIDS
  Therapies
• PA-03-062
• FIC
• AITRP
• ICOHRTA 1
• IRSDA
• GRIP
• Related Training
• NIH
• Grants and Funding Opportunities Web site
• NIH Guide Listserv

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Need for International Research on AIDS

• Rapidly expanding pandemic in the developing
  world
• Devastating effect on populations, economic
  development and national security
• Critical need for more effective and sustainable
  strategies to prevent and treat HIV/AIDS
• Need for local scientists to address their
  countrys research needs
• Global collaboration is essential

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Comprehensive International Program of Research
on AIDS

What is CIPRA? A grant program that supports
comprehensive research and development efforts at
organizations located in eligible nations to
develop practical, affordable, and acceptable
methods to prevent and treat HIV/AIDS in adults
and children.
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CIPRA Approach

• Research and infrastructure
• Enhance developing country capabilities and
  capacity to conduct research relevant to their
  populations
• Provide long-term support for epidemiologic,
  laboratory and clinical studies to lay the
  foundation for research on practical and
  affordable methods to prevent and treat HIV/AIDS

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Examples of CIPRA Research

• Clinical, and basic laboratory research
• Epidemiological studies of HIV transmission
• Therapeutic research
• Vaccine and prevention research

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CIPRA Who Can Apply

• Research or clinical care organizations in
  eligible countries
• Application must come from host country
  applicants only
• Eligible countries
• GNP per capita lt US 5,000 (World Bank)
• As of Dec 1, 2003 the most current Gross
  National Income (GNI) per capita data from the
  World Bank will be used for new applications. So
  GNI per capita lt US 5,000 (World Bank)

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CIPRA Grants and Timeline

• Planning Organizational
• 50,000/year for up to 2 years
• non-renewable
• Exploratory Developmental Research
• 500,000/year for up to 5 years
• non-renewable
• Multi-Project Research Program
• Program-determined budget, funding for 5 years
  with potential for competitive renewal

R03
U01
U19
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CIPRA Grants and Timelines
3 Grant Mechanisms
Descriptions
Multi-Project Research Program-determined
budget, funding for up to 5 years, with
potential for competitive renewal
U19
Exploratory/Developmental Research
500,000/year, up to 5 years, non-renewable
U01
R03
Planning and Organizational 50,000/year, up
to 2 years, non-renewable
Start here
CIPRA Support
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Current CIPRA Awards
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Current CIPRAs
R03 Planning and Organizational Grants

• Argentina (Buenos Aires) Argentinean National
  Ref Ctr AID
• Brazil (Caxias do Sul)
• University of Caxias do Sul
• Brazil (Porto Alegre)
• Centro de Estudos Luis Guedes
• Brazil (Rio de Janeiro)
• FIOTEC
• Cambodia (Phnom Penh)
• Cambodian Health Committee
• Congo (Brazzaville)
• National Lab of Public Health
• Dominican Republic (Puerto Plata)
• Cenro de Promoc Solidard Human
• Egypt (Cairo)
• Egyptian Ministry of Health and Population
• Georgia (Tbilisi)
• IDACIRC
• India (New Delhi)
• Indian Council of Medical Research

• Mexico (Cuernavaca Morelos) National Institute
  of Public Health
• Mozambique (Beira)
• Universidade Catolica de Mocambique
• Peru (Lima)
• Assoc Civil Impacta Salud y Education
• Russian Federation (St. Petersburg) Saint
  Petersburg Pavlov Med Univ
• Tanzania (Moshi)
• Kilimanjaro Christian Medical Center
• Thailand (Cihang Mai)
• Chiang Mai University
• Trinidad (Port of Spain)
• Med Res Fdn of Trinidad Tobago
• Vietnam (Ho Chi Minh City)
• Ho Chi Minh City AIDS Committee
• Zambia (Lusaka)
• Center for Infectious Disease
• Zambia (Ndola)
• Tropical Diseases Research Center
• Zimbabwe (Harare)

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Current CIPRAs
U01 Exploratory/Developmental Research Grants

• Senegal (Dakar) Univ of Cheikh Anta Diop

• U19 Multi-Project Research Grants
• China (Beijing) National Center AIDS
  Prevention and Control
• South Africa (Durban) CAPRISA
• South Africa (Johannesburg) Univ of
  Witwatersrand

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R03 Planning and Organizational Grant
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R03 Planning and Organizational Grant

• Types of activities
• Organize a research group
• Plan a research program
• Establish necessary collaborations
• Build and train administrative organization
• Develop skills and resources necessary to prepare
  a competitive application (U01 or U19)
• 50,000 (direct cost) per year, plus 8 indirect
  cost
• For up to 2 years
• Not renewable

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What Can A R03 Grant Support?

• Salaries of senior leadership/scientists, and
  support staff
• Travel
• Training Program
• Collaborations
• limited to less than or equal to 20 (outside
  host country)
• with established PIs

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CIPRA Grants (U01/U19)

• NIH Cooperative Agreements
• CIPRA Investigator responsibility
• research agenda
• project/study performance and analysis
• scientific publications
• NIH CIPRA Program Partner
• assist with scientific decisions/directions
• facilitate research with information and
  available resources
• provide appropriate level of coordination and
  monitoring

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U01 Exploratory and Developmental Research Grant
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U01 Exploratory / Developmental Research Grant

• Build and further develop from the R03 planning
  phase
• Types of Activities
• Expand and develop research group
• Plan and develop new research areas
• Further develop administrative organization
  (training and staff development)
• Expand infrastructure and collaborations
• Prepare for a comprehensive multi-project effort
  (U19)
• Implement a focused research project
• 500,000 cost per year for up to 5 years

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What Can a U01 Grant Support?

• Costs necessary to carry out a focused research
  project
• Develop Facilities (including equipment)
• Supplies
• Project Staff (including recruitment and
  training, etc.)
• Professional scientific, clinical
• Technical
• Administrative
• 
  Continued

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What Can a U01 Grant Support?

• Implementation of pilot studies to prepare for a
  multi-project grant
• Development of collaborations with other research
  institutions in the host country or region

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U19 Multi-Project Research Grant
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U19 Multi-Project Research Grant

• Comprehensive coordinated program
• includes treatment and prevention activities
• Multiple research projects
• two or more required
• Cores shared resources or facilities that
  support 2 or more projects
• administration, lab, etc.

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Principal Investigator (PI) of Multi-Project
CIPRAs

• Provides overall direction
• Scientific leadership
• Administration and management leadership
• Communication coordination
• among projects and cores
• with other research organizations NIH
• Responsibilities require significant time
  commitment of the PI

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Activities that could be included in a CIPRA Core

• May be in place or need development or
  enhancement
• Administrative management
• Clinical trials management oversight
• Communications systems
• Data management
• Statistical analysis
• Training
• Laboratory support

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CIPRA Multi-Project Cooperative Agreement (U19)
(Examples of Cores and Projects)

• Cores
• Administrative Support
• Good Clinical Practice (GCP) and budget oversight
• Ethical review
• Central Laboratory
• HIV and OI diagnosis
• Immunology
• Virology
• Animal testing
• Data Management/Statistics
• Regulatory/Pharmacy
• Community Affairs and Education

• Research Projects
• Epidemiology of HIV transmission
• Clinical/Laboratory research in preparation for
  HIV vaccine or prevention trials
• Therapeutic research on effective management of
  HIV/AIDS
• Preclinical HIV vaccine development
• Feasibility study for a microbicide trial

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CIPRA Training Plan

• Aim to build staff capability and expertise at
  every level to carry out CIPRA research
• Includes advanced training and mentoring for
  development of research leaders
• Training plans may be coordinated with Fogarty
  International Center AITRP

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Examples of Infrastructure Development

• Build administrative capacity for
• Oversight, coordination, organizing ethical
  review personnel, communications, training, Good
  Clinical Practice (GCP), fiscal management
• Research support
• Technical equipment and supplies, data
  management, literature accessibility, informatics
• Laboratory
• Acquire special equipment and personnel
• Staff Training and Development
• Alterations and Renovations

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Summary of CIPRA

• Comprehensive
• prevention and treatment components
• Multi-disciplinary research approaches
• integrated projects and aims
• International
• requires host country leadership
• addresses host country research needs
• develops sustainable infrastructure
• establishes national and/or international
  collaborations

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• CIPRA Application Process

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Step 1 CIPRA Web site

• Read information on the CIPRA Web site
  http//www.niaid.nih.gov/cipra

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• Note that the CIPRA Program has 3 grant
  mechanisms for funding
• R03 Planning and Organizational Grants
• U01 Exploratory/Developmental Research
• Grants
• U19 Multi-Project Research Grants

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Step 2 Letter of Interest (LOI)

• Eligibility
• Country has GNP per capita of less than or equal
  to 5,000 USD
• If eligible, prepare Letter of Interest (LOI)
• Briefly identify your proposed research
• Include a plan for the development of CIPRA
  activities/capabilities
• See LOI Instructions and Policy on Web site for
  more information
• Email LOI to cipra_at_niaid.nih.gov
• If email is not available you should mail your
  letter to
• Dr. Rodney HoffDivision of AIDSNational
  Institute of Allergy and Infectious
  DiseasesNational Institutes of HealthRoom 4157,
  MSC 7628Bethesda, MD 20892-7628USA
• Or, you may fax it to [phone]

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Step 3 CIPRA Point Person

• CIPRA Reference Number
• CIPRA Point Person
• CIPRA Team

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Step 4 Review of LOI and Outcomes

• Review of LOI by CIPRA Point Person
• Presentation of LOI to CIPRA Team
• CIPRA Team Recommendation
• Expected Outcomes
• an invitation to submit a CIPRA application is
  given (Letter of Eligibility)
• a request to revise and resubmit the LOI
  addressing specific questions about the LOI or
  improving it in some areas before an LOE is given
  and a CIPRA application is prepared
• a determination that the current LOI is
  non-responsive (without major revisions) and you
  are not eligible to submit a CIPRA application.
  A new LOI may be submitted if it incorporates
  major changes.

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Step 5 Letter of Eligibility (LOE)

• For those eligible, you will receive via fax and
  mail, with email confirmation, a Letter of
  Eligibility signed by Dr. Rodney Hoff.
• Letter of Eligibility must be included in all
  application packages.

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Step 6 CIPRA Review Cycle

• 2 application receipt dates
• 1 March and 1 November
• Average timeline from application to award,
  approximately 15 months

Please be aware that problems at any step would
result in delays further down in the schedule.
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Step 7 Post-award

• Scientific Reporting Requirements
• Maintain contact with NIAID Program
• Yearly Progress Reports
• Fiscal Responsibility

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CIPRA Contact Information

• CIPRA
• E-mail CIPRA Team at cipra_at_niaid.nih.gov
• Write to
• Dr. Rodney Hoff
• Division of AIDS
• National Institutes of Allergy and Infectious
  Diseases
• National Institutes of Health
• Room 4149, MSC-7628
• Bethesda, MD 20892-7628
• USA
• For courier or express delivery use zip code
  20817

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Additional NIH Funding Opportunities

• What are they
• and
• Where can I find out about them?

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NIAID / DAIDS
http//www.niaid.nih.gov/ncn/
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NIAID / DAIDS

• DAIDS Resource Guide for the Development of AIDS
  
• Therapies

http//www.niaid.nih.gov/daids/pdatguide/overview.
htm
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NIAID cont.

• PA-03-062
• Small Research (R03) Grants for International
  Research in Infectious Diseases at NIAID
  International Sites
• http//grants.nih.gov/grants/guide/pa-files/PA-03-
  062.html

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Fogarty International Center
http//www.fic.nih.gov

• AIDS International Training and Research Program
  (AITRP) supports research training for
  epidemiology, biomedical, behavioral, social
  sciences
• International Clinical, Operational and Health
  services Research Training Award (ICOHRTA 1)
  supports training for clinical, operational and
  health services research. Requires a parent
  grant from co-sponsoring NIH Institute
• International Research Scientist Development
  Award (IRSDA) career development award for
  junior US investigators for international
  research
• Global Health Research Initiative Program for New
  Foreign Investigators (GRIP) research program
  for foreign scientists trained at NIH
  (intramural) or received long term training
  through FIC research training program
• Related Training Programs bioethics, medical
  informatics, MCH, etc.

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NIH

• Grants Funding Opportunities
• http//grants1.nih.gov/grants/index.cfm
• Subscribe to NIH Guide listserv for weekly
  listings of TOC

http//grants1.nih.gov/grants/guide/listserv.ht
m
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Questions Answers

• Joan Romaine, MPH
• Phone [phone]
• Email JRomaine_at_niaid.nih.gov
• Thank you!