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: sh141s@nih.gov

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.

Fiscal Year 2001 = $20,298 billionFiscal Year 2001 = $20,298 billionNIH BudgetNIH Budget

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

Navigating Your Way

Info: Computer Retrieval of Information on Scientific

Projects (CRISP)

http://crisp.cit.nih.gov/

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?

How to Write a Grant Application

NIH Website:http://www.niaid.nih.gov/ncn/grants/write/index.htm

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: pinedam@mail.nih.govWebsite: www.nih.gov/fic

Questions?Questions?

Macroeconomics and Health:Investing in Health for Economic

Development, 2001

• Investing in Knowledge• Operational research

• Development of new and improved

technologies

• Basic research in the developing world,

including epidemiology

• Training