NIH and YOU: Building Partnerships in Biomedical & Behavioral Research

NIH and YOU: Building Partnerships in Biomedical & Behavioral Research Sally Rockey, Ph.D. Acting Director Office of Extramural Research National Institutes of Health December 4, 2009 1

The National Institutes of Health The 65-Year Mission of NIH Section 301 of the PHS Act The Secretary shall conduct in the Service and encourage, cooperate with, and render assistance to other appropriate public authorities, scientific institutions, and scientists in the conduct of, and promote the coordination of, research, investigations, experiments, demonstrations, and studies relating to the causes, diagnosis, treatment, control, and prevention of physical and mental diseases and impairments of man... 2

Science - The Endless Frontier July 25, 1945: Question from President Franklin D. Roosevelt to Vannevar Bush, Director, Office of Science Research & Development: With particular reference to the war of science against disease What can be done now to organize a program for continuing in the future the work which has been done in medicine and related sciences? 3

Establishing the NIH Model Response from Vannevar Bush to FDR in an article titled, Science - The Endless Frontier: The responsibility for basic research in medicine and the underlying sciences, so essential to progress in the war against disease, falls primarily upon the medical schools and universities The Government should extend financial support to basic medical research in the medical schools and universities. 4

Carrying Out the NIH Mission The NIH provides leadership and direction to programs designed to improve the health of the Nation by conducting and supporting research in the Causes, diagnosis, prevention, and cure of human diseases Processes of human growth and development Biological effects of environmental contaminants Understanding of mental, addictive and physical disorders Directing of programs for the collection, dissemination, and exchange of information in medicine and health Including the development and support of medical libraries Training of medical librarians and other health information specialists.) For more information, visit the NIH Almanac: http://nih.gov/about/almanac/index.html 5

Welcome to the NIH Campus THEN & NOW 1940 2009 6

Understanding the Dual Nature of NIH NIH is an institution (Intramural Research) ~Approx. 6,000 scientists ~Approx. 10% of NIH budget NIH supports institutions & people (Extramural Research) >3,000 institutions >300,000 scientists & research personnel ~Approx. 80% of the NIH budget 7

ARGENTINA AUSTRALIA BELGIUM BOTSWANA BRAZIL CAMBODIA CANADA CHILE CHINA COLUMBIA CZECH REPUBLIC DENMARK DOMINICAN REPUBLIC EGYPT ESTONIA FINLAND FRANCE GERMANY HAITI HONG KONG HUNGARY ICELAND IRELAND ISRAEL ITALY JAPAN NIH Supports Biomedical and Behavioral Research Around the Globe Including Scientists at Institutions in over 90 Countries! KENYA LEBANON MALAWI MEXICO NETHERLANDS NEW ZEALAND NIGERIA PAKISTAN PERU POLAND RUSSIA SENEGAL SINGAPORE SOUTH AFRICA SPAIN SWEDEN SWITZERLAND THAILAND TURKEY UNITED KINGDOM URAGUAY ZIMBABWE AND MORE 8

U.S. Dept. of Health & Human Services Secretary of Health and Human Services Administration for Children and Families (ACF) Administration on Aging (AoA) Food and Drug Administration (FDA) Health Resources and Services Administration (HRSA) Center for Medicare & Medicaid Services (CMS) Agency for Healthcare Research and Quality (AHRQ) Indian Health Services (IHS) National Institutes of Health (NIH) Centers for Disease Control and Prevention (CDC) Agency for Toxic Substances and Disease Registry (ATSDR) Substance Abuse and Mental Health Services Administration (SAMHSA) 9

National Institutes of Health Office of the Director Office of Extramural Research 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 Center on Minority Health and Health Disparities National Center for Complementary and Alternative Medicine Fogarty International Center National Center for Research Resources National Library of Medicine National Institute of Biomedical Imaging and Bioengineering NIH Clinical Center Center for Information Technology Center for Scientific Review No funding authority 10

Looking to the Future with the New NIH Director Francis S. Collins, Ph.D, MD 1. Taking advantage of advances in highthroughput technologies to understand the fundamentals of biology and how specific diseases are activated 2. Emphasizing the translation of research into medicine 3. Putting science to work for the benefit of health care reform through comparative effectiveness research, behavioral science, health information technology, health research economics, and further research on health disparities 4. Placing a greater focus on global health 5. Empowering the biomedical research community by considering future budgets, training, peer review, and workforce diversity. 11

Breakdown of FY 2010 President s Budget Request for NIH $30.8 Billion 10% 53% 11% $16.4 B 2% 5% 10% 6% 3% Research Project Grants (53%) Research Centers (10%) R&D Contracts (11%) Other Research (6%) Training (3%) Intramural Research (10%) Research Mgmt & Support (5%) All Other (2%) 12

NIH Congressional Appropriations FY1997- FY2009 (dollars in billions) $35.0 $30.0 $25.0 $27.1 $28.0 $28.4 $28.5 $29.0 $29.4 $30.4 $20.0 $20.5 $23.3 $15.0 $15.6 $17.8 $10.0 $12.7 $13.7 $5.0 $0.0 FY 1997 FY 1999 FY 2001 FY 2003 FY 2005 FY 2007 FY 2009 13

FY2008: Top 5 States Receiving NIH Awards #1 CALIFORNIA $3.1 B #2 MASSACHUSETTS$2.2 B #3 NEW YORK $1.9 B #4 PENNSYLVANIA $1.4 B #5 TEXAS $1.0 B FLORIDA $352 M Award Trend Information available at: http://report.nih.gov 14

Top 10 NIH Funded Florida Institutions Institution UNIVERSITY OF CENTRAL FLORIDA MAYO CLINIC COLLEGE OF MEDICINE, JACKSONVILLE JAEB CENTER FOR HEALTH RESEARCH, INC. FLORIDA INTERNATIONAL UNIVERSITY UNIVERSITY OF MIAMI CORAL GABLES FLORIDA STATE UNIVERSITY UNIVERSITY OF SOUTH FLORIDA H. LEE MOFFITT CANCER CENTER & RESEARCH INSTITUTION UNIVERSITY OF MIAMI SCHOOL OF MEDICINE FY2008 Total NIH $ Awarded* 7.6 M 10.6 M 13.1 M 13.7 M 14.6 M 16.3 M 23.6 M 35.4 M 88.7 M UNIVERSITY OF FLORIDA *Figures are approximate dollars awarded to each institution. http://report.nih.gov/award/trends/state_congressional/statedetail.cfm? State=Florida&Lon=-81.541183&Lat=27.975639 103.7 M 15

FUNDAMENTALS OF THE NIH GRANTS PROCESS: Mechanisms of Support 16

GRANT Assistance What is the Difference Between Grants and Contracts? Government is Patron or Partner Purpose: support and stimulate research Benefit a public purpose Investigator initiated $ $ $ $ $ $ $ $ $ $ $ $ $ CONTRACT Acquisition Government is Purchaser Purpose: acquire goods or services Benefit and use of the government Government initiated 18

NIH Grant Programs NIH funds grants, cooperative agreements, and contracts that support the advancement of fundamental knowledge about the nature and behavior of living systems to meet the NIH Mission. Research Grants Career Development Awards Institutional Research Training Grants Fellowships Loan Repayment Awards Small Business Awards (SBIR/STTR) 19

Award Mechanisms Research Project Grants Traditional R01 Small and Exploratory/Development Grants R03/R21/R33/R34 Program Project P01 Research Center Grants P41, P50 Small Business R41, R42, R43, R44 Cooperative Agreements Specialize mechanism with substantial NIH (i.e. program officer) involvement NIH initiated Visit: http://odoerdb2-2.od.nih.gov/oer/programs/coop/ 20

Research Project Grants (RPGs): Applications, Awards, and Success Rates More info available at: http://report.nih.gov 21 NEDB 21

Research Project Grants (RPGs): Average Size Constant (1998) $ is the inflation-adjusted average size, in 1998 dollars. More info available at: http://report.nih.gov 22 NEDB 22

Research Training and Career Awards Training Grants T Institutional Predoctoral and Postdoctoral Fellowships F Individual Predoctoral F31 Postdoctoral F32 Career Development Awards K 23

NIH OFFERS FUNDING PROGRAMS TO SUPPORT SCIENTISTS AT EVERY STAGE OF THEIR CAREER Approx. Stage of Research Training and Development GRADUATE/ MEDICAL STUDENT POST DOCTORAL Mechanism of Support Predoctoral Institutional Training Grant (T32) Predoctoral Individual NRSA (F31) Predoctoral Individual MD/PhD NRSA (F30) Postdoctoral Institutional Training Grant (T32) Postdoctoral Individual NRSA (F32) Small Grant (R03) EARLY NIH Pathway to Independence (PI) Award (K99/R00) Mentored Research Scientist Development Award (K01) Mentored Clinical Scientist Development Award (K08) Mentored Patient-Oriented RCDA (K23) Mentored Quantitative RCDA (K25) Research Project Grant (R01) Exploratory/Develop ment Grant (R21) CAREER MIDDLE Independent Scientist Award (K02) Midcareer Investigator Award in Patient-Oriented Research (K24) SENIOR Senior Scientist Award (K05) *Graph represents a small sample of NIH funding mechanisms available. 24

http://grants.nih.gov/grants/funding/funding_program.htm

EARLY STAGE & NEW INVESTIGATORS NIH fosters research independence of early career investigators. 26

2,000 NIH Exceeds New Investigator Goal in FY 2008 NIH First Time R01-Equivalent Awardees FY 1985-2008 1,800 1,600 1,809 1,684 1,400 Number of Awardees 1,200 1,000 800 600 400 FY 07 & 08: Target of 1,500 new R01 investigators 200 0 1985 1986 1987 1988 1989 1990 1991 1992 1993 1994 1995 1996 1997 1998 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 *R01-Equivalent awards include R01, R23, R29, and R37 grants. Fiscal Year 27 Note: Used rolling avg. of past 5 years to set new goals

New Investigator & ESI Definition The NIH remains committed to identifying and attracting new biomedical researchers and will continue to explore novel ways to encourage early transition to independence. Special considerations during peer review and IC funding decisions for those who meet the following definitions: New Investigator A Program Director or Principal Investigator (PD/PI) is considered a New Investigator if he/she has not previously competed successfully as a PD/PI for a significant independent NIH research grant (like an R01). Early Stage Investigator (ESI) A subset of New Investigators who are within 10 years of receiving terminal degree or end of medical residency, whichever occurred most recently (requests for extension will be considered). For more information: http://grants1.nih.gov/grants/new%5finvestigators/ 28

NIH Loan Repayment Program 29

NIH Loan Repayment Programs (LRP) NIH Loan Repayment Programs are a vital component of our nation's efforts to attract health professionals to careers in research. How they work: You: Commit to perform research for 2 years NIH: Repays up to $35,000 per year of your qualified educational debt and covers the resulting taxes Result: Increase the number of biomedical and behavioral research scientists 30 30

Five Extramural LRPs Clinical Research Pediatric Research Health Disparities Research Contraception and Infertility Research Clinical Research for Individuals from Disadvantaged Backgrounds Note: NIH employees in research positions are eligible for Intramural LRPs 31 31

Eligibility Doctoral degree (M.D., Ph.D., or equivalent) EXCEPTION: Eligibility for the Contraception and Infertility Research LRP includes nurses, physician assistants, graduate students, and postgraduate research fellows training in the health professions Funding for research at any domestic nonprofit, university, or government organization Educational loan debt must be at least 20% of applicant s annual salary Must conduct qualifying research for at least 20 hours/week U.S. Citizen or permanent resident **NIH grant or award support NOT required** 32 32

Online Information and Application http://www.lrp.nih.gov Application Deadline December 1 33 33

APPLICATION RECEIPT, REFERRAL, & PEER REVIEW 34

How Does NIH Solicit Applications? Federal Opportunity Announcements (FOA) published through - NIH Guide (http://grants.nih.gov/grants/guide/) - Grants.gov (www.grants.gov) Parent Announcements cover basic mechanisms - Investigator-initiated applications Special Opportunities to fill gaps - Requests for Applications (RFA): a one-time call with set aside funds - Program Announcement (PA) highlights areas of focus - Program Announcement with Special Review (PAR) for special consideration and protected review - Program Announcement with Set Aside (PAS) essentially, an RFA with multiple receipt dates 35

How Do I Apply Check out the OER Web Site at http://grants.nih.gov for helpful information to guide you through the NIH application process such as: Submitting Your Application: Electronic or Paper Format?. NIH Forms and Applications: Which form of the application to use and where do I find it electronically? Receipt Dates and Deadlines: When are applications due? Grants Process Overview: How long until an award is made and what s the key elements from pre-award through post-award management? Tracking Your Application Electronically: Where is my application in the process? For quick links to all these questions, visit: http://grants.nih.gov/grants/how_to_apply.htm 36

http://www.grants.nih.gov/ 37

Receipt and Referral of Applications Electronic SF424 R&R submitted through grants.gov to an NIH Institute (IC) CSR Referral Office assigns the application a unique identifier (application number) Application assessed for completeness & eligibility. Notice of assignment available in era Commons in 4 weeks. to Integrated Review Group (IRG) and then a study section (SRG) 1 st Month 2 nd Month 38

2 Level Review System for Grants Scientific Review Group (SRG) Independent outside review Evaluate scientific merit, significance Recommend length and level of funding 1st level Output: Priority Score and Summary Statement 3-7 months Output: Funding Recommendations Advisory Council Assess quality of SRG process Offer recommendation to Institute Staff Evaluate program priorities and relevance Advise on policy 2nd level 1-3 months Output: Awards or Resubmission Institute Director Make final decision based on Council input, programmatic priorities Must also pass Administrative Review 3 rd - 8th Month 39

Award Negotiation & Issuance Many steps between a funding decision and a grant award NIH grants management staff work closely with grantee and NIH program staff to complete this final process Funding approval from Program Final review & Negotiations Congressional Liaison Notified Award Issued Award Received by Grantee Investigator Begins Work 9th Month 10th Month 40

Receipt to Award Timeline for New Applications 1.31 1.9 91.6 Receipt Date Scientific Review Council Review Award Date February 5 July October December June 5 October January April October 5 March May July http://grants.nih.gov/grants/funding/submissionschedule.htm 41

GRANT WRITING FOR SUCCESS 42

What Determines If an Application is Funded? Factors Considered: Scientific Merit Contribution to Institute Mission Program Balance Availability of Funds 43

Principles of Success Understand the peer review process. Understand the agency mission. Every IC is different! Secure collaborators (mentors) to complement your expertise and experience. Don t compete collaborate! Learn and practice the skills of writing applications for grant funds. 44

Understand the Institute/Center Mission Reminder: NIH is comprised of 27 Institutes and Centers (ICs) - 24 of those have funding authority. Mission of each NIH IC is based and defined in law Authorizations (periodic) Appropriations (annual) ICs establish specific research emphases Legislative mission Current state of science Use the Web to find out! 45

www.nih.gov 46

The Mission 47

Getting to the Top: Writing Great Grants Components of successful applications Strong Idea Strong Science Strong Team Strong Presentation Match idea/science to the NIH Institute Every IC has specific mission Hone high-quality grant writing skills Communicate scientific content compellingly Follow all the instructions START EARLY & PLAN! 48

Tips from NIH Program Staff Lots of directions and opportunities at the NIH Monitor Institute websites and the NIH Guide (http://grants.nih.gov/grants/guide/) Get to know the Program Director for your scientific area Contact them about your research ideas - Fit with institute mission and priorities - Best grant mechanism or program - Best study section for review Participate in workshops and symposia Stay abreast of the latest NIH & OER news Participate in review of grant applications (study sections) 49

Additional Resources 50

http://www.nih.gov/ 51

OER Home Page Offers Valuable Links and Resources http://grants.nih.gov 52

http://www.grants.nih.gov/ 53

Summary of Helpful Web Resources Office of Extramural Research (OER) Web Page http://grants.nih.gov/grants/oer.htm NIH Searchable Database of RFAs, PAs, and Guide Notices http://grants.nih.gov/grants/guide/index.html NIH Grants Policy Statement (Rev. 12/03) http://grants.nih.gov/grants/policy/nihgps_2003/index.htm NIH Extramural Nexus Monthly newsletter (previously bimonthly) for the extramural community http://grants.nih.gov/grants/nexus.htm RePORTER - Search to analyze an Institute s portfolio of funded projects, research areas, and more http://projectreporter.nih.gov/reporter.cfm Grant Application Basics http://grants.nih.gov/grants/grant_basics.htm 55

STAY CONNECTED: NIH Listserv Addresses & Instructions Office of Biotechnology Activities (OBA): https://list.nih.gov/archives/oba_news.html Office of Human Research Protections (OHRP): http://www.hhs.gov/ohrp/news/distributionlist.html Office of Laboratory Animal Welfare (OLAW): http://grants.nih.gov/grants/olaw/references/list.htm esubmission: http://era.nih.gov/electronicreceipt/listserv.htm Separate listservs available for scientists and administrators NIH Guide for Grants and Contracts: http://grants.nih.gov/grants/guide/listserv.htm The official publication for NIH medical and behavioral research Grant Policies, Guidelines and Funding Opportunities 56

Grants Information: Who To Contact Institutional Resources First, utilize the expertise of your organization s Office of Sponsored Programs Application Specific Questions at NIH Administrative Contact the Grants Management Specialist listed on announcement or at awarding Institute/Center Scientific/Programmatic Contact the designated Program Official/Director listed on announcement or at awarding Institute/Center Review Questions Contact the assigned Scientific Review Officer listed on announcement or at awarding Institute/Center 57

Grants Information: Who to Contact! Grants Administration Staff at all NIH ICs: http://grants.nih.gov/grants/staff_list_grants_admin.htm NIH Chief Grants Management Officers: http://grants.nih.gov/grants/stafflist_gmos.htm Grants Policy Interpretation & Consultation: E-Mail: GrantsPolicy@mail.nih.gov Phone: 301-435-0949 Compliance Issues: E-Mail: GrantsCompliance@mail.nih.gov Phone: 301-435-0949 58

NIH Transforming medicine through discovery. 59