NIH International Opportunities NIH International Opportunities ——The Extramural PerspectiveThe Extramural Perspective
Sharon H. Hrynkow, Ph.D.Sharon H. Hrynkow, Ph.D.
Deputy Director,Deputy Director, Fogarty International CenterFogarty International CenterNational Institutes of HealthNational Institutes of Health
Phone: 301-496-1415E-mail: [email protected]
Oslo, Norway —— June 21, 2002
U.S. Department of Health and Human Services
Administration forChildren and Families
(ACF)
Administration forChildren and Families
(ACF)
Food and DrugAdministration
(FDA)
Food and DrugAdministration
(FDA)
Health Resourcesand Services
Administration(HRSA)
Health Resourcesand Services
Administration(HRSA)
TheSecretary
Deputy Secretary
TheSecretary
Deputy Secretary
Administration onAging(AoA)
Administration onAging(AoA)
Health Care FinancingAdministration
(HCFA)
Health Care FinancingAdministration
(HCFA)
Indian HealthServices
(IHS)
Indian HealthServices
(IHS)
Centers for Disease Controland Prevention
(CDC)
Centers for Disease Controland Prevention
(CDC)
Substance Abuse andMental Health Services
Administration(SAMHSA)
Substance Abuse andMental Health Services
Administration(SAMHSA)
Program SupportCenter(PSC)
Program SupportCenter(PSC)
Agency for ToxicSubstances andDisease Registry
(ATSDR)
Agency for ToxicSubstances andDisease Registry
(ATSDR)
Agency for Health Care Policy
and Research(AHCPR)
Agency for Health Care Policy
and Research(AHCPR)
National Institutesof Health
(NIH)
National Institutesof Health
(NIH)
Office of the DirectorOffice of the Director
National Instituteon Alcohol Abuseand Alcoholism
National Instituteon Alcohol Abuseand Alcoholism
National Instituteof Arthritis andMusculoskeletal
and Skin Diseases
National Instituteof Arthritis andMusculoskeletal
and Skin Diseases
National CancerInstitute
National CancerInstitute
National Instituteof Diabetes andDigestive and
Kidney Diseases
National Instituteof Diabetes andDigestive and
Kidney Diseases
National Instituteof Dental andCraniofacial
Research
National Instituteof Dental andCraniofacial
Research
National Instituteon Drug Abuse
National Instituteon Drug Abuse
National Instituteof Environmental Health Sciences
National Instituteof Environmental Health Sciences
National Instituteon Aging
National Instituteon Aging
National Instituteof Child Health
and HumanDevelopment
National Instituteof Child Health
and HumanDevelopment
National Institute onDeafness and Other
CommunicationDisorders
National Institute onDeafness and Other
CommunicationDisorders
National EyeInstitute
National EyeInstitute
National HumanGenome Research
Institute
National HumanGenome Research
Institute
National Heart,Lung, and Blood
Institute
National Heart,Lung, and Blood
Institute
National Instituteof Mental Health
National Instituteof Mental Health
National Instituteof NeurologicalDisorders and
Stroke
National Instituteof NeurologicalDisorders and
Stroke
National Instituteof General
Medical Sciences
National Instituteof General
Medical Sciences
National Instituteof Nursing Research
National Instituteof Nursing Research
National Libraryof Medicine
National Libraryof Medicine
Center for InformationTechnology
Center for InformationTechnology
Center for Scientific Review
Center for Scientific Review
National Centerfor Complementary
and AlternativeMedicine
National Centerfor Complementary
and AlternativeMedicine
National Instituteof Allergy and
Infectious Diseases
National Instituteof Allergy and
Infectious Diseases
National Centerfor ResearchResources
National Centerfor ResearchResources
Clinical Center
Clinical Center
National Center on Minority Health andHealth Disparities
National Center on Minority Health andHealth Disparities
National Institute of Biomedical Imagingand Bioengineering
National Institute of Biomedical Imagingand Bioengineering
FogartyInternational
Center
FogartyInternational
Center
National Institutes of Health
National Institutes of HealthNational Institutes of Health
MissionMission
To uncover new knowledge that will To uncover new knowledge that will
lead to better health for everyonelead to better health for everyone
NIH fulfills its mission by:NIH fulfills its mission by:
• Conducting research in its own laboratories.Conducting research in its own laboratories.
• Supporting the research of non-Federal scientists Supporting the research of non-Federal scientists in universities, medical schools, hospitals, and in universities, medical schools, hospitals, and research institutions throughout the country and research institutions throughout the country and abroad.abroad.
• Helping in the training of research investigators in Helping in the training of research investigators in the U.S. and abroad.the U.S. and abroad.
• Fostering communication of medical Fostering communication of medical and health sciences information in the and health sciences information in the U.S. and abroad.U.S. and abroad.
NIH AuthorityNIH Authority
• To award grants to foreign institutions
• To support foreign collaborations
NIH is committed to supporting the best biomedical research regardless of location
Special resources and/or populations may be located abroad
The interdisciplinary nature of modern biology demands extensive collaborations
The internet transcends international boundaries and facilitates collaborations
Disease knows no boundaries
Why Foreign Grants?Why Foreign Grants?
A foreign scientist is eligible to apply as P.I. or
co-investigator to pursue research in any area
normally funded by NIH.
NIH Research GrantsNIH Research Grants
Most research funded by NIH is via traditional investigator initiated
grants (R01).
Foreign institutions are eligible.
Possible MechanismsPossible Mechanisms
A substantial foreign component of a grant to a U.S. institution is defined as:
The use of grant funds to provide support to any significant scientific element or segment of the project which is to be performed outside of the U.S. either by the grantee project staff or by a researcher employed by a foreign institution.
DefinitionDefinition
• Collaborations with US Scientists Can be done as subcontracts to grants to
U.S. institutions
• Individual Postdoctoral Fellowships
• Special programs from the Fogarty International Center
Other PossibilitiesOther Possibilities
Fogarty International Center, NIHFogarty International Center, NIH
Mission:Promote and support
scientific research and training internationally to reduce disparities in
global health.
““Science for Global Health”Science for Global Health”
Fogarty International Center, NIHFogarty International Center, NIH
FIC fulfills its mission by:Advancing research and research training that prepares current and future health scientists to meet global health challenges.
““Science for Global Health”Science for Global Health”
• Extramural Training Grants — 12 Programs
• Research Grants — 5 Programs
• International Training Grants for U.S. citizens* Minority International Research Training Grant (MIRT)* Scientist Development fellowship (post-doc)* Foreign-funded fellowship (Japan)
Fogarty International CenterFogarty International CenterDivision of International Training and ResearchDivision of International Training and Research
HIV/AIDS Building Capacity in Support of ICIDR sites Emerging Infectious Diseases Environmental and Occupational Health FIC-NLM Medical Informatics Maternal and Child Health Population and Health Tuberculosis Research Bioethics Malaria Clinical, Operational, and Health Services Research Tobacco and Health Research
Fogarty International CenterFogarty International CenterTraining Grants for Developing CountriesTraining Grants for Developing Countries
• Masters and Doctoral Degrees * Tuition, Stipends, Travel, Related Expenses
• Post-doctoral Fellowships* Tuition, Stipends, Travel, Related Expenses
• Short Courses (in U.S. or In-country)* Tuition, Travel, Per diem
• Training-related In-country research grants, Re-entry grants
• Limited salary, Administrative support for U.S. university
Fogarty International CenterFogarty International CenterSupport Available Through Training GrantsSupport Available Through Training Grants
• Ecology of Infectious Diseases
• Fogarty International Research Collaboration Award (FIRCA)
• HIV-AIDS and Related Illnesses Collaboration Award (AIDS-FIRCA)
• International Cooperative Biodiversity Groups (ICBG)
• International Studies on Health and Economic Development
• Proposed Global Health Research Initiative Program (GRIP) for New Foreign Investigators
• International Tobacco and Health Research and Capacity Building Program
Fogarty International CenterFogarty International CenterResearch Grants Research Grants — 7 Programs— 7 Programs
A systematic approach
Stability and Long-term Commitment
Response to Local Needs and Priorities
Long-term Mentoring
Mutual Reinforcement of Investments in Training and Research
Individual and Institutional Partnerships
Long-term mentoring
Advanced In-country Research (re-entry grants)
Empowerment and mutual respect
Networking
Flexibility
Leverage
Fogarty International CenterFogarty International CenterProgram CharacteristicsProgram Characteristics
• Generally institutional training grant to U.S. universities and non-profit research institutions in response to a specific request for applications (RFA)
• Awardees are generally current NIH grant recipients with demonstrated research collaboration with foreign research institutions
• Purpose — support training for research-capacity building for scientists from developing nations
Fogarty International CenterFogarty International CenterExtramural Training GrantsExtramural Training Grants
• Stigma – New
• Clinical, Operational and Health Services Research Training on AIDS/TB - New
• Small Grants Program on AIDS
European PIs may participate in European PIs may participate in FIC Programs:FIC Programs:
Fogarty International Center
On the Horizon
• Brain Disorders in the Developing World
• Trauma and Injury
• Health, Environment, and Economic Development
0
20,000,000
40,000,000
60,000,000
80,000,000
100,000,000
120,000,000
140,000,000
1994 1995 1996 1997 1998 1999 2000
Visiting Program
Direct Foreign Research Awards
Foreign Components of Domestic Awards
Training Grants
NIH International Research ExpendituresNIH International Research ExpendituresD
olla
rs
Fiscal Years 1994 to 2000Fiscal Years 1994 to 2000
Fiscal Year 1999Fiscal Year 1999
NIH Research Awards by RegionNIH Research Awards by Region
Africa15%
Asia17%
Middle East4%
Latin America and Caribbean
10%
South Asia2%
NIS1%
Western Europe and Canada
50%
Central and Eastern Europe
1%
Fiscal Year 1999Fiscal Year 1999 NIH Foreign Components of NIH Foreign Components of
Domestic AwardsDomestic Awards
$2,270,000(25)
$2,428,000(41)
$38,328,000 (505)
$11,475,000 (154)
$1,375,000(41)
$1,671,000(46)
$18,104,000(107) $15,701,000
(134)
$-
$5,000,000.00
$10,000,000.00
$15,000,000.00
$20,000,000.00
$25,000,000.00
$30,000,000.00
$35,000,000.00
$40,000,000.00
$45,000,000.00
Africa LatinAmerica
andCaribbean
Asia Central andEasternEurope
WesternEurope and
Canada
MiddleEast
NIS South Asia
Region
Am
ou
nt
Region
Am
ou
nt
4.1
0.7 0.50
0.6
6.7
1.42
0.40.7
$0
$1
$2
$3
$4
$5
$6
$7
$8
UK France Germany Norway Italy
Grants & Contracts Foreign Component of Domestic Awards
1999 NIH 1999 NIH European Funding LevelsEuropean Funding Levels
Country
U.S
. Do
llars
(in
mill
ion
s)
Examples of NIH-European Collaborations
• Multi-site studies on environmental risk factors for cancer
• Structural biology
• Phase III clinical trials
• Twin studies
Use CRISP to learn:Use CRISP to learn:
1. What’s funded in your area?
2. Who’s funded to work in your area?
3. What NIH institutes support work similar to what you want to do?
4. What study sections review (and like) it?
Hints for CRISP :Hints for CRISP :
1. CRISP includes only funded projects; all information is public.
2. Format help is under the ? button for each field.
3. Abstracts are provided by the investigator at the beginning of the project.
4. Other DHHS agency awards are included (e.g., CDCP, FDA). Intramural projects at NIH and FDA are included.
• The Division of Receipt & Referral at the Center for Scientific Review (CSR) of NIH
• Over 40,000 Applications a Year
Where Do NIH Applications Go?Where Do NIH Applications Go?
• Data Entry from the Face Page of the Application or Page 1
• Assignment to the Initial Review Group (IRG)• Assignment to the NIH Institute or Center (IC)• Information Resource for Applicants and NIH
Extramural Staff• Process and Arbitrate Requests for IRG and IC
assignments
What Does Receipt & Referral What Does Receipt & Referral at NIH Do?at NIH Do?
NIH Priorities and Opportunities NIH Priorities and Opportunities Evaluated in Peer ReviewEvaluated in Peer Review
Ideas in the Form of Research Proposals
NIH receives over 25,000 research proposals each year (~1/3 in response to targeted themes)
Scientific Review
Applications are evaluated in a competitive peer review system.
Institute Advisory Councils
Scientists and public members examine the institute portfolio.
• Assess programs
• Approve applications
• Provide policy advice
NIH Grantees
Annual progress and fiscal reports are mandatory and reviewed by NIH staff.
• For Unsolicited Applications: Mostly R01, R15, and some R21 proposal
About 75% of total NIH applications
• Assignment to Institute(s) or Center(s) for Potential Funding
• Assignment to IRG for Review by Study Section or Scientific Review Group (SRG) at CSR
What Assignments are Made for What Assignments are Made for Unsolicited Applications?Unsolicited Applications?
• Solicited Applications are responsive to: PAs (Program Announcements) RFAs (Request for Applications)
About 25% of Total Applications
• Assignment to Specific NIH Institutes or Centers Requesting Applications for both:
Institute Review and
Institute Funding
What Assignments are Made for What Assignments are Made for Solicited Applications?Solicited Applications?
Preparation TimelinePreparation TimelineUse this timeline as a guide to plan how much time you'll need to complete your application, or work backward from the due date to calculate your prep time. Find receipt dates for all grant types at NIH's Standard Receipt Dates and Review and Award Cycles.
• Unsolicited:3 times per year:
February 1June 1October 1
Application Receipt Dates:Application Receipt Dates:
•Solicited
See RFA or PA
Receipt to Review TimelineReceipt to Review Timeline
This timeline gives you an idea of what to expect after you send NIH your application
I M P A C T
The Five Review Criteria are The Five Review Criteria are Intended to EmphasizeIntended to Emphasize
• Significance
• Approach
• Innovation
• Investigator
• Environment
Research Project Evaluation CriteriaResearch Project Evaluation Criteria (listed in Form PHS 398)(listed in Form PHS 398)
• Does this study address an important problem?
• If the aims of the application are achieved, how will scientific knowledge be advanced?
• What will be the effect of these studies on the concepts or methods that drive the field?
SignificanceSignificance
• Will the study fill a big gap in the field?• Is this important work only a few people are
doing?• Why didn’t I think of this?• Even if all experiments work, no one will
care or use the data.• The results will generate limited interest and
not be applicable to other systems/organisms.
Commonly Heard Comments at Commonly Heard Comments at Study Meetings:Study Meetings:
• Are the conceptual framework, design, methods, and analyses adequately developed, well-integrated, and appropriate to the aims of the project?
• Does the applicant acknowledge potential problem areas and consider alternative tactics?
ApproachApproach
Commonly Heard Comments at Commonly Heard Comments at NIH Study Section Meetings:NIH Study Section Meetings:
• This grant was a pleasure to read because it was well thought out and well written.
• The proposed experiments are clear, logical and creative.
• The experiments do not appropriately test the hypothesis.
• The experiments are hard to follow.
Innovation
• Does the project employ novel concepts, approaches or methods?
• Are the aims original and innovative?
• Does the project challenge existing paradigms or develop new methodologies or technologies?
• The PI will develop new approaches to answer previously unanswerable questions.
• This is a novel mechanism to explain previously perplexing results.
• The methods are standard, but the questions asked are novel and the results will have wide impact.
• The questions and approaches have been asked and used by other laboratories.
Commonly Heard Comments at Commonly Heard Comments at NIH Study Section Meetings:NIH Study Section Meetings:
• Is the investigator appropriately trained and well suited to carry out this work?
• Is the work proposed appropriate to the experience level of the principal investigator and other researchers (if any)?
InvestigatorInvestigator
• The PI has a strong record of research productivity in the field.
• The PI is known for careful, rigorous, and exciting research.
• The collaborators and PI have a longstanding research relationship.
• The expertise of the collaborators is complementary to that of the PI.
• The PI’s postdoc experience should prepare him to conduct the studies, however, the single publication listed makes this difficult to assess.
• There are no letters from the listed collaborators.• The collaborator appears to be very busy, questioning
his commitment to the proposed research.
Commonly Heard Comments at Commonly Heard Comments at NIH Study Section Meetings:NIH Study Section Meetings:
• Does the scientific environment in which the work will be done contribute to the probability of success?
• Do the proposed experiments take advantage of unique features of the scientific environment or employ useful collaborative arrangements?
• Is there evidence of institutional support?
EnvironmentEnvironment
• The Institution has provided all resources necessary for the PI to succeed.
• Institutional support through reduced teaching load for the PI and through equipment purchase.
• Resources at home institution are limited, PI will use facilities at other institutions or nearby company.
• Concern that limited access to equipment will affect potential productivity.
• PI has not taken advantage of potential collaborators available at the same institution.
Commonly Heard Comments at Commonly Heard Comments at NIH Study Section Meetings:NIH Study Section Meetings:
• Understand and FOLLOW GUIDELINES for the Preparation of your Application
• Include a Cover Letter with the Following: Research Area and Hypotheses/Question Methods and Approaches Areas of Special Expertise Required Potential Conflicts Possible Interest to 1-2 ICs Possible Review by 1-2 SRGs
How Can You Help Yourself?How Can You Help Yourself?
Section e. Human Subjects: Section e. Human Subjects: Is It Human Subjects Research?Is It Human Subjects Research?
If you're studying materials from identifiable people, your work probably qualifies as human subjects research, even if you're not seeing patients. NIH defines human subjects research as research involving living persons with whom an investigator directly interacts, intervenes, or obtains identifiable, private information.
Our advice: try to avoid this area. If your research comes under the NIH definition, you will need to fulfill a host of application and reporting requirements. Some research using human tissue is exempt, e.g., if the samples are from people who cannot be identified. See our list of exemptions in our human subjects glossary.
Section e. Human Subjects: Section e. Human Subjects: Is It Human Subjects Research?Is It Human Subjects Research?
continuedcontinued
Also, see the decision trees reviewers use to determine whether your research involves human subjects and what is required if it does.
If you must conduct human subject research, get help in applying from your business office and experienced grantees. If you are not conducting human subject research, indicate "Not applicable" in this section of the research plan.
If you're not studying human subjects but your collaborators are, you'll still need to make sure the assurances are in place.
If Your Score Was Not Fundable or You Were Not Scored
• What if you submit a grant application to NIH and it does not get funded? You're in good company! Competition has become increasingly tough, and it is very common not to succeed at the first attempt. The good news is that more people succeed on their second try than on their first; and still more on their third. Over half of all NIH applicants eventually get funded.
• Be prepared to have to try again-consider resubmission the next logical step in the process. Because success falls off rapidly after the third try, NIH limits you to two resubmissions. Even then, you're still not out of the game -- see our article “Did your Application Get Three Strikes? You’re Not Necessarily Out!”
If Your Score Was Not Fundable or You Were Not Scored - continued
• When you hear the news, you'll probably feel angry at being rejected and may feel that some of the criticism from the reviewers is off the mark. It very well may be. Wait until you can address the matter calmly and objectively before deciding what to do next. Sending an angry letter to the study section or an institute would definitely not be
productive.
Common Fixable Problems
Problem: Poor writing.Solution: Rewrite, get help.
Problem: Insufficient information, experimental details, or preliminary data.Solution: Assess what's missing; add it to the research plan.
Problem: Significance not convincingly stated.Solution: Beef up that section; show importance to NIAID mission, public health.
Problem: Research not shown to be feasible by the proposed staff.Solution: Get consultants with the required expertise.
Problem: Insufficient discussion of obstacles and alternatives approaches.Solution: Write what you'll do if you get negative results or an approach doesn't pan out; include decision trees.
Problem: Reviewers are not interested in the subject.Solution: They are not the proper peers; request a different review group
You Can Revise Twice
• Most applicants don't succeed at first try -- so they try again. Most people do and it pays off-many people succeed on the second or third try.
• NIH allows you two revisions within two years of the date you originally sent in your proposal. If you don't succeed by then, you can change the name -- so NIH recognizes it as new -- and revise the application significantly.
If Problems Are Fixable, You Have Several Options
• Once you've determined whether your problems are fixable, you have four options.
• You can: 1) Revise the application and resubmit it to the same study section. 2) Revise the application and resubmit it to a different study section.
3) Create a "new" application out of the original one and request a new study section.4) Create a truly new application.
• To gauge whether an application would be considered "new" or revised, use this rule of thumb: if you revise more than 50 percent, it's a new application. If less, you must follow the rules for a revised application.
Avoid Having Your Application ReturnedAvoid Having Your Application ReturnedNIH may return your application for various reasons without a review.
• Information included you are supposed to submit 'just in time,' i.e., when NIH requests it. Applies to other support and several items for human subjects research: certification of IRB approval, OHRP assurance type and number, and the letter stating all key personnel have been trained in protecting human subjects.
• Insufficient human or animal documentation, including missing data, assurances, or other required documentation (be sure to complete PHS 398 sections e and f of the research plan).
• No preapproval documentation for an application requesting more than $500,000.
Avoid Having Your Application Avoid Having Your Application Returned - Returned - continuedcontinued
• Detailed rather than modular budget if requesting less than $250,000, for investigator-initiated R01, R03, R21, or R15 awards.
• Improper formatting, including font size and margins.
• Hand delivered.
• Does not meet RFA or PA requirements, if responding to an initiative. (This is decided by NIAID program staff when they receive a copy of your application.)
• Contact of reviewer by applicant.
• Lack of required signatures.
• All proposals with significant foreign components require U.S. State Department approval.
• Awards cannot be made until HHS Human and Animal Subject Protections are satisfied.
Other ConsiderationsOther Considerations
8% for Administrative costs, exclusive of equipment costs:
• Beginning with awards issued in FY2002
• Provided on competing grants to foreign institutions and international organizations and foreign components on grants.
• For the support of costs incurred to provide for compliance with DHHS and NIH requirements including but not limited to: the protection of human subjects, the welfare of animals, financial conflict of interest, and invention reporting.
• No funds are provided for Facility costs.
Policy: Administrative CostsPolicy: Administrative Costs
The Funding Components for NIH
Homepages of the NIH Institutes and Offices:http://www.nih.gov/icd/
The NIH Guide for Grants and ContractsProgram Announcements (PAs) and Requests for Applications (RFAs):http://grants.nih.gov/grants/guide/index.html
Useful Websites for NIH Applicants
NIH Websites
• National Institutes of Healthhttp:/www.nih.gov
• Fogarty International Center, NIHhttp:/www.nih.gov/fic
• Research and Training Opportunities at NIHhttp:/www.training.nih.gov
• CRISP database at NIHhttp:/www.nih.gov/grants/award/crisp.htm
The Application ProcessNIH Grant Application (PHS 398) Instructions/ Guidelines and
Forms: http://grants.nih.gov/grants/forms.htm
NIH Modular Grant Information, Q&A, Sample Budget and Biosketch: http://grants.nih.gov/grants/funding/modular/modular.htm
Application Receipt, Referral and Review:http://grants.nih.gov/grants/funding/submissionschedule.htm
Answers to Frequently Asked Questions about NIH Grants: http://grants.nih.gov/grants/funding/giofaq.htm
Grant Writing Tips: http://grants.nih.gov/grants/grant_tips.htm
Useful Websites for NIH Applicants
The Review Process
The Five Review Criteria for Most NIH Applications: http://grants.nih.gov/grants/guide/notice-files/not97-010.html
Scientific Areas of Initial Review Groups at the Center
for Scientific Review: http://www.csr.nih.gov/review/irgdesc.htm
NIH Center for Scientific Review Study Section Roster:
http://www.csr.nih.gov/committees/rosterindex.asp
Useful Websites for NIH ApplicantsUseful Websites for NIH Applicants
Grants Information Resource Package for
Foreign Grantees
FIC Website:www.nih.gov/fic/programs/grants.html
Coming soon!
For more information contact:
Mr. Mark PinedaProgram Officer for Western EuropePhone: 301-496-4784E-mail: [email protected]: www.nih.gov/fic
Questions?Questions?