NIH International Opportunities — The Extramural Perspective Sharon H. Hrynkow, Ph.D. Deputy Director,Fogarty International Center National Institutes of Health — NIH International Opportunities — The Extramural Perspective Sharon H. Hrynkow, Ph.D. Deputy Director, Fogarty International Center National Institutes of Health Phone: Oslo, Norway — June 21, 2002

U.S. Department of Health and Human Services Administration for Children and Families (ACF) Administration for Children and Families (ACF) Food and Drug Administration (FDA) Food and Drug Administration (FDA) Health Resources and Services Administration (HRSA) Health Resources and Services Administration (HRSA) The Secretary Deputy Secretary The Secretary Deputy Secretary Administration on Aging (AoA) Administration on Aging (AoA) Health Care Financing Administration (HCFA) Health Care Financing Administration (HCFA) Indian Health Services (IHS) Indian Health Services (IHS) Centers for Disease Control and Prevention (CDC) Centers for Disease Control and Prevention (CDC) Substance Abuse and Mental Health Services Administration (SAMHSA) Substance Abuse and Mental Health Services Administration (SAMHSA) Program Support Center (PSC) Program Support Center (PSC) Agency for Toxic Substances and Disease Registry (ATSDR) Agency for Toxic Substances and Disease Registry (ATSDR) Agency for Health Care Policy and Research (AHCPR) Agency for Health Care Policy and Research (AHCPR) National Institutes of Health (NIH) National Institutes of Health (NIH)

Office of the Director National Institute on Alcohol Abuse and Alcoholism National Institute on Alcohol Abuse and Alcoholism National Institute of Arthritis and Musculoskeletal and Skin Diseases National Institute of Arthritis and Musculoskeletal and Skin Diseases National Cancer Institute National Cancer Institute National Institute of Diabetes and Digestive and Kidney Diseases National Institute of Diabetes and Digestive and Kidney Diseases National Institute of Dental and Craniofacial Research National Institute of Dental and Craniofacial Research National Institute on Drug Abuse National Institute on Drug Abuse National Institute of Environmental Health Sciences National Institute of Environmental Health Sciences National Institute on Aging National Institute on Aging National Institute of Child Health and Human Development National Institute of Child Health and Human Development National Institute on Deafness and Other Communication Disorders National Institute on Deafness and Other Communication Disorders National Eye Institute National Eye Institute National Human Genome Research Institute National Human Genome Research Institute National Heart, Lung, and Blood Institute National Heart, Lung, and Blood Institute National Institute of Mental Health National Institute of Mental Health National Institute of Neurological Disorders and Stroke National Institute of Neurological Disorders and Stroke National Institute of General Medical Sciences National Institute of General Medical Sciences National Institute of Nursing Research National Institute of Nursing Research National Library of Medicine National Library of Medicine Center for Information Technology Center for Information Technology Center for Scientific Review Center for Scientific Review National Center for Complementary and Alternative Medicine National Center for Complementary and Alternative Medicine National Institute of Allergy and Infectious Diseases National Institute of Allergy and Infectious Diseases National Center for Research Resources National Center for Research Resources Clinical Center Clinical Center National Center on Minority Health and Health Disparities National Center on Minority Health and Health Disparities National Institute of Biomedical Imaging and Bioengineering National Institute of Biomedical Imaging and Bioengineering Fogarty International Center Fogarty International Center National Institutes of Health

Mission To uncover new knowledge that will lead to better health for everyone

NIH fulfills its mission by: Conducting research in its own laboratories. Conducting research in its own laboratories. Supporting the research of non-Federal scientists in universities, medical schools, hospitals, and research institutions throughout the country and abroad. Supporting the research of non-Federal scientists in universities, medical schools, hospitals, and research institutions throughout the country and abroad. Helping in the training of research investigators in the U.S. and abroad. Helping in the training of research investigators in the U.S. and abroad. Fostering communication of medical and health sciences information in the U.S. and abroad. Fostering communication of medical and health sciences information in the U.S. and abroad.

Fiscal Year 2001 = $20,298 billion NIH Budget

NIH 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?

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 Grants

Most research funded by NIH is via traditional investigator initiated grants (R01). Foreign institutions are eligible. Possible 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. Definition

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 Possibilities

Fogarty International Center, NIH Mission: Promote and support scientific research and training internationally to reduce disparities in global health. “Science for Global Health”

Fogarty 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”

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 Center Division 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 Center Training 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 Center Support 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 Center Research Grants — 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 Center Program 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 Center Extramural 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 FIC Programs:

Fogarty International Center On the Horizon Brain Disorders in the Developing World Trauma and Injury Health, Environment, and Economic Development

NIH International Research Expenditures Dollars Fiscal Years 1994 to 2000

Fiscal Year 1999 NIH Research Awards by Region

Fiscal Year 1999 NIH Foreign Components of Domestic Awards Region Amount

$0 $1 $2 $3 $4 $5 $6 $7 $8 UKFranceGermanyNorwayItaly Grants & ContractsForeign Component of Domestic Awards 1999 NIH European Funding Levels Country U.S. Dollars (in millions)

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)

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 : 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?

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 at NIH Do?

NIH Priorities and Opportunities Evaluated 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 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 Solicited Applications?

Preparation Timeline Use 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 1 June 1 October 1 Application Receipt Dates: Solicited See RFA or PA

Receipt 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 Intended to Emphasize

Significance Approach Innovation Investigator Environment Research Project Evaluation Criteria (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? Significance

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 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? Approach

Commonly Heard Comments at 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 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)? Investigator

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 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? Environment

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 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 to Write a Grant Application NIH Website:

Section e. Human Subjects: 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: Is It Human Subjects Research? continued 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 Returned NIH 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 Returned - continued 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 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 Costs

The Funding Components for NIH  Homepages of the NIH Institutes and Offices:  The NIH Guide for Grants and Contracts Program Announcements (PAs) and Requests for Applications (RFAs): Useful Websites for NIH Applicants

NIH Websites National Institutes of Health Fogarty International Center, NIH Research and Training Opportunities at NIH CRISP database at NIH

The Application Process  NIH Grant Application (PHS 398) Instructions/ Guidelines and Forms:  NIH Modular Grant Information, Q&A, Sample Budget and Biosketch:  Application Receipt, Referral and Review: htm  Answers to Frequently Asked Questions about NIH Grants:  Grant Writing Tips: Useful Websites for NIH Applicants

The Review Process  The Five Review Criteria for Most NIH Applications:  Scientific Areas of Initial Review Groups at the Center for Scientific Review:  NIH Center for Scientific Review Study Section Roster: Useful Websites for NIH Applicants

Grants Information Resource Package for Foreign Grantees FIC Website: Coming soon!

For more information contact: Mr. Mark Pineda Program Officer for Western Europe Phone: Website: 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