National Institute of Allergy and
Infectious Diseases
Karl A. Western, MD, DTPH
Asst. Director for International Research
Director, Office of Global Affairs
U.S. Department of Health and Human Services
The
Secretary
Deputy Secretary
Administration for
Children and Families
(ACF)
Administration on
Aging
(AoA)
Food and Drug
Administration
(FDA)
Centers for
Medicare and
Medicaid Services
(CMS)
Agency for
Health Care Policy
and Research
(AHCPR)
Indian Health
Services
(IHS)
Centers for
Disease Control
and Prevention
(CDC)
Agency for Toxic
Substances and
Disease Registry
(ATSDR)
Substance Abuse and
Mental Health Services
Administration
(SAMHSA)
Health Resources
and Services
Administration
(HRSA)
National Institutes
of Health
(NIH)
Program Support
Center
(PSC)
National Institutes of Health
Office of the Director
National Institute
on Aging
National Institute
on Alcohol Abuse
and Alcoholism
National Institute
of Allergy and
Infectious Diseases
National Institute
of Arthritis and
Musculoskeletal
and Skin Diseases
National Cancer
Institute
National Institute
of Child Health
and Human
Development
National Institute on
Deafness and Other
Communication
Disorders
National Institute
of Dental and
Craniofacial
Research
National Institute
of Diabetes and
Digestive and
Kidney Diseases
National Institute
on Drug Abuse
National Institute
of Environmental
Health Sciences
National Eye
Institute
National Institute
of General
Medical Sciences
National Heart,
Lung, and Blood
Institute
National Human
Genome Research
Institute
National Institute
of Mental Health
National Institute
of Neurological
Disorders and
Stroke
National Institute
of Nursing Research
National Institute of
Biomedical Imaging
and Bioengineering
National Center
for Complementary
and Alternative
Medicine
Fogarty
International
Center
National Center
for Research
Resources
National Library
of Medicine
National Center on
Minority Health and
Health Disparities
Clinical Center
Center for
Information
Technology
Center for
Scientific Review
NIH fulfills its mission by:

INTRAMURAL: Conducting research in its
own laboratories.
 EXTRAMURAL: Supporting the research
of non-Federal scientists in universities,
medical schools, hospitals, and research
institutions throughout the USA and
abroad.
 Supporting the training of research
investigators.
 Fostering communication of medical
and health sciences information.
NIH Roadmap Strategy
Interdisciplinary
Research
Innovator Award
Nanomedicine
Training
Public Private
Partnerships
Bench
Building Blocks
Pathways
Molecular Libraries
Bioinformatics
Computational
Biology
Bedside
Clinical
Research
Informatics
Translational
Research
Initiatives
NIH Clinical Research
Associates
Practice
Integrated Research
Networks
Clinical outcomes
The NIAID Mission
NIAID strives to understand, treat,
and ultimately prevent infectious,
immunological, and allergic
diseases that threaten hundreds of
millions of people worldwide.
Major Areas of NIAID
Investigation

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
Acquired Immunodeficiency Syndrome
(AIDS)
Asthma and Allergic Diseases
Biodefense
Emerging Diseases
Enteric Diseases
Genetics and Transplantation
Immunologic Diseases
Malaria and Other Tropical Diseases
Sexually Transmitted Diseases
Vaccine Development
NIAID Divisions and Offices (simplified)
Board of Scientific Counselors
Associate Director for
Management & Operations
Office of
Financial
Management
Office of
Management for
New Initiatives
Office of
Human Resources
Management
Office of
Administrative
Services
Office of
Technology
Information
Systems
Office of
the Director
National Advisory Allergy &
Infectious Disease Counselors
Office of Biodefense
Research
Office of
Global Affairs
Office of
Clinical Research
Office of
Policy Analysis
Office of Ethics
Office of
Technology
Development
Division of Acquired
Immunodeficiency
Syndrome
Office of
Communications &
Public Relations
Division of Allergy,
Immunology &
Transplantation
Division of
Microbiology &
Infectious Diseases
Office of Equal
Employment
Opportunities
Division of
Extramural
Activities
Dale & Betty
Bumpers Vaccine
Research Center
Division of
Intramural
Research
Guiding Principles of NIAID Global
Health Research Plan
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Target research efforts to the needs of
developing countries
Develop multidisciplinary research
programs
Build and sustain research capacity incountry
Stimulate scientific collaboration and global,
multi-sector partnerships
Develop training, communication and
outreach programs
How NIAID Supports
International Research (1)

Intramural
-

Foreign Awards
-

Research Training
Collaboration
Investigator Initiated
Clinical/Vaccine Trials
Domestic Awards with Foreign Component
-
Funding
No Funding
How NIAID Supports
International Research (2)

Bilateral Programs
-

Multilateral Programs
-

Science and Technology
Health
WHO
UNAIDS
European Union
Interagency Agreements
-
CDC
Army, Navy
USAID
State
NIAID Strategy to Develop
International Programs (1)

Research Training
-
NIAID: Domestic Training
FIC: International Training

International Partnerships
 Increase Pool of Investigators
Program Announcements (PAs)
- Contracts
- Reagents and Repositories
-
NIAID Strategy to Develop
International Programs (2)

Develop Domestic Multidisciplinary
Centers of excellence
-
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Develop Linkage Programs
-
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Requests for Applications (RFAs)
Requests for Applications (RFAs)
Request for Proposals (RFPs)
Direct Support to International Sites
-
Requests for Applications (RFAs)
Request for Proposals (RFPs)
Intramural Research Training
and Collaborative Research

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Provides opportunities for foreign
scientists to train and conduct
collaborative research at NIH.
Open to scientists at all career levels.
Appointment must be requested by a
senior NIH intramural scientist on behalf
of the foreign scientist.
Intramural Opportunities

Two paid positions for foreign scientists
through the NIH visiting program:
1. Visiting fellow
–
Open to applicants with a doctoral degree or
equivalent and 5 years or less of research
experience
2. Visiting scientist
–

Open to applicants with a doctoral degree or
equivalent and at least 6 years of research
experience
Appointments through NIH senior scientists
in same research field as applicant
Major NIAID Programs in
International Health

International Centers for Tropical Disease Research
-

International Collaboration in Infectious Disease Research
Tropical Medicine Research Centers
Tropical Disease Research Units
Intramural Center for International Disease Research
Tuberculosis Research Unit
 HIV Vaccine Trials Network, HIV Prevention Trials
Network
 Multilateral Initiative on Malaria
 International Training and Research in Emerging
Infectious Diseases
 Comprehensive international Program for Research on
AIDS (CIPRA)
CIPRA
(Comprehensive International Program of
Research on AIDS)
2 Funding stages:


Planning and Organizational (R03):
up to $50,000 per year for one or two
years
Exploratory/Developmental Research
(U01): up to $500,000 per year for up
to five years
IRID
(International Research in Infectious Diseases) (1)
• Aims
– Advance development of local scientific
expertise
– Increase collaborative research partnerships at
NIAID international sites
– Lead to submission of applications for
independent research funding
• Preliminary or pilot studies
• Direct funding to investigators who do not
currently have NIAID funded grant awards
for research projects
IRID
(International Research in Infectious Diseases) (2)
• Topics of interest
– Tuberculosis; Malaria; HIV/AIDS; Sexually
transmitted diseases; Diarrheal, respiratory,
and enteric diseases; Viral hemorrhagic fevers;
Viral encephalitides; Parasitic diseases; and
Vector-borne diseases
• Mechanism of support
– Up to $50,000 annual direct costs for up to 3
years
NIH Extramural Program
Grant
Patron
(assistance, encouragement)
Cooperative
Agreement
Partner
(assistance but substantial
program involvement)
Contract
Purchaser
(procurement)
WORLD CLASS PEER REVIEW SYSTEM
Ideas from
Individual
Scientists
NIH receives
~43,000 research
project grant
Applications each
year
Scientific
Review
Group of Scientists
Evaluate
Scientific Merit
Institute
National Advisory
Councils
•Access programs
•Approve applications
•Public Members
•Provide policy advice
NIH
Grantees
~30 percent of
NIH applications
succeed in gaining
research funding
PEER REVIEW:
Center for Scientific Review
• CSR Study Sections are managed by a
Scientific Review Administrator (SRA)
who is a professional, usually at the Ph.D.
level, whose scientific background is
close to the expertise of the study section
• Each CSR standing study section has 12 24 members who are primarily from
academia
• Generally 60 - 100 applications are
reviewed at each study section meeting
Dual Review System for Grant Applications
First Level of Review
Scientific Review Group (SRG)
 Provides Initial Scientific Merit
Review of Grant Applications
 Rates Applications and Makes
Recommendations for
Appropriate Level of Support
and Duration of Award
Second Level of Review
Council
 Assesses Quality of SRG Review of
Grant Applications
 Makes Recommendation to Institute
Staff on Funding
 Evaluates Program Priorities and
Relevance
 Advises on Policy
SCIENTIFIC REVIEW
ADMINISTRATOR
Designated Federal official with overall responsibility
for the review process, including:
• Performing administrative and technical review of
applications to ensure completeness and accuracy
• Selecting reviewers based on broad input
• Managing study section meetings
• Preparing summary statements
• Providing any requested information about study
section recommendations to Institutes and National
Advisory Councils/Boards
REVIEW CRITERIA
• SIGNIFICANCE: Does the study address an
important problem? How will scientific knowledge be
advanced?
• APPROACH: Are design and methods welldeveloped and appropriate? Are problem areas
addressed?
• INNOVATION: Are there novel concepts or
approaches? Are the aims original and innovative?
• INVESTIGATOR: Is the investigator appropriately
trained?
• ENVIRONMENT: Does the scientific environment
contribute to the probability of success? Are there
unique features of the scientific environment?
ADDITIONAL IMPORTANT
CONSIDERATIONS
• Research involving human subjects
– Protection from risks
– Inclusion of women, minorities, children
•
•
•
•
Animal Welfare
Biohazards
Data Sharing Plans
Appropriateness of Budget
RESULTS OF REVIEW
• Unscored (approximately bottom half) or
priority score
• Score (generally between 100 and 300)
• Percentile ranking (if scored)
• Deferral (very rare)
• Not Recommended for Further
Consideration (very rare; serious
concerns)
• Notification of Principal Investigator
• Summary Statement
AWARD
DETERMINATIONS
• Scientific merit
• Program considerations,
priorities, special
initiatives
• Availability of funds
SUMMARY STATEMENT
• Study Section Recommendation
• Resume and Summary of Discussion (if
scored)
• Description (Abstract)
• Essentially unedited comments of
reviewers
– Organized by review criteria
• Administrative notes
• Budget Recommendations
• Coding for human subjects, animals,
gender, minorities, children
• Institute/Center contact information –
Program Director
COMMON PROBLEMS
• Lack of new or original ideas
• Absence of an acceptable scientific rationale
• Lack of experience in the essential
methodology
• Questionable reasoning in experimental
approach
• Uncritical approach
• Diffuse, superficial, or unfocused research pla
• Lack of sufficient experimental detail
• Lack of knowledge of published relevant work
• Unrealistically large amount of work
• Uncertainty concerning future directions
COUNCIL REVIEW AND
FUNDING DECISIONS
• Handled by the Institutes and
Centers
• Second Level Review by Council
– Concurrence with study section
– Modification (budget, time)
– Deferral for rereview
• Consider IC priorities, national health
needs
NIH Internet Resources
• National Institutes of Health (http://www.nih.gov)
– Office of Extramural Research
(http://www.nih.gov/grants/oer.htm)
– Grants Policy (http://www.nih.gov/grants/policy/policy.htm)
• Center for Scientific Review (http://www.csr.nih.gov)
– Referral and Review (http://www.csr.nih.gov/refrev.htm)
– Overview of Peer Review Process (http://www.
csr.nih.gov/review/peerrev.htm)
– CSR Study Section Rosters
(http://www.csr.nih.gov/committees/rosterindex.asp)
– NIH Peer Review Notes
(http://www.csr.nih.gov/prnotes/prnotes.htm)
NIH Research Grants (RO1s)
A foreign scientist is eligible to apply
as principal investigator (P.I.) or
co-investigator
to pursue research in any area
normally funded by NIH.
NIH Research Grants (RO1s)
The foreign P.I. must demonstrate a
special opportunity to further health
research not readily available in the U.S.
Special opportunities include:
expertise or access to equipment,
resources, or populations not available
in the U.S.
Requests for Applications (RFA)
• Announcement describing an institute
initiative in a well-defined scientific area
• Invitation to the field to submit research
grant applications for a one-time time
competition
• Set-aside of funds for a certain number of
awards
• Applications generally reviewed within the
issuing institute
Program Announcement
• Invites grant applications in a given
research area
• May describe new or expanded interest in
a particular extramural program
• May be a reminder of a continuing interest
in a particular extramural program
• Generally has no funds set aside
• Applications reviewed in CSR along with
unsolicited grant applications
NIH/NIAID Grants and Funding
Opportunities
 http://grants1.nih.gov/grants/
 http://www.niaid.nih.gov/ncn/
NIAID International Grants and Contracts
 http://www.niaid.nih.gov/ncn/grants/int/def
ault.htm
“Technology Transfer is the process by
which technology developed by the
Government or Academic Sector is
transferred to the Private Sector.”
Two Major Mechanisms to
Transfer Technology
• Patenting and
Licensing of new
inventions
• Developed
Technology
• Research
Collaborations
• Formal
• Informal
• Early stage
technology that
needs cooperation
to develop
Informal Research
Collaborations
• Exchange of Materials
• Scientist to scientist contact,
– Long Stays
– Short term visits
– Presentation at international meetings
• Publication
(peer recognition)
• International grants and programs
• Mostly with Academic Institutions
Formal Research Collaborations
•
•
•
•
•
•
Mostly with Industry
Pre-agreed research goals
Timelines
Financial terms
Responsibilities of parties
Legal contract
Formal (Industry) Collaborations:
Advantages & Challenges
• Direct way of transferring
technology /knowledge
• Joint Learning and
problem solving
experience
• Motivation: long term
relationships, alliances,
joint ownership of IP,
recruitment and
placement
• Confidentiality
• Contract
negotiation on IP
• Accessibility of
cross-licensed
technology
Intramural NIH Technology
Transfer
• Over 300 new invention reports/yr.
• Over 2,000 patents
• Over 1,500 active licenses
• Nearly 200 technologies in the market
• $ 54 million royalty income FY2000
• Over 84% licenses are non-exclusive
• About 14% licenses with non-US firms
• Over 52% licenses with small companies
Further Questions?
Contact information:
Karl A. Western, MD, DTPH
Director, Office of Global Affairs (OGA)
E-mail: KW18Q@NIH.GOV
Telephone: (301) 496-6721
NIAID Website
http: //www.niaid.nih.gov
www.niaid.nih.gov