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NIH and You: 2010 and Beyond Building Partnerships in Biomedical and Behavioral Research Sally NIH and You: 2010 and Beyond Building Partnerships in Biomedical and Behavioral Research Sally Rockey, Ph. D. Acting Director of Extramural Research National Institutes of Health 1

Science, The Endless Frontier July 25, 1945: Question from President Roosevelt to Vannevar Bush, Science, The Endless Frontier July 25, 1945: Question from President Roosevelt to Vannevar Bush, Director, Office of Scientific Research and 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? ” 2

NIH: Steward of Medical and Behavioral Research for the Nation “Science in pursuit of NIH: Steward of Medical and Behavioral Research for the Nation “Science in pursuit of fundamental knowledge about the nature and behavior of living systems. . . and the application of that knowledge. 3

NIH Campus -- 1947 4 NIH Campus -- 1947 4

NIH Campus Today 5 NIH Campus Today 5

Why Extramural Research? “The responsibility for basic research in medicine and the underlying sciences, Why Extramural Research? “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. ” – Vannevar Bush Response to President Roosevelt, 1945 Extramural: outside the walls or boundaries, as of a city or town or a university: extramural teaching; an extramural church. . Or Extramural Research 6 6

Carrying Out the NIH Mission The NIH provides leadership and direction to programs designed 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 7

ARGENTINA AUSTRALIA BELGIUM BOTSWANA BRAZIL CAMBODIA CANADA CHILE CHINA COLUMBIA CZECH REPUBLIC DENMARK DOMINICAN 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

Understanding the Dual Nature of NIH is an institution (Intramural Research) ~Approx. 6, 000 Understanding the Dual Nature of NIH is an institution (Intramural Research) ~Approx. 6, 000 scientists NIH supports institutions & people ~Approx. 10% of NIH (Extramural Research) budget >4, 000 institutions >300, 000 scientists & research personnel 9 ~Approx. 80% of the NIH budget

U. S. Dept. of Health & Human Services Secretary of Health and Human Services U. S. Dept. of Health & Human Services Secretary of Health and Human Services Administration for Children and Families (ACF) Administration on Aging (Ao. A) 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) 10

National Institutes of Health Office of Extramural Research Office of the Director National Institute National Institutes of Health Office of Extramural Research Office of the Director National Institute on Aging National Institute on Alcohol Abuse and Alcoholism National Institute of Allergy and Infectious Diseases National Institute of Arthritis and Musculoskeletal and Skin Diseases National Cancer Institute National Institute of Child Health and Human Development National Institute on Deafness and Other Communication Disorders National Institute of Dental and Craniofacial Research National Institute of Diabetes and Digestive and Kidney Diseases National Institute on Drug Abuse National Institute of Environmental Health Sciences National Eye Institute National Institute of General Medical Sciences National Heart, Lung, and Blood Institute National Human Genome Research Institute National Institute of Mental Health National Institute of Neurological Disorders and Stroke National Institute of Nursing Research Fogarty International Center National Center for Research Resources National Center on Minority Health and Health Disparities National Center for Complementary and Alternative Medicine NIH Clinical Center for Information Technology National Library of Medicine Center for Scientific Review National Institute of Biomedical Imaging and Bioengineering No funding 11 authority

The NIH Extramural Team The Research Partnership Applicant Institution NIH Review Administrator Program Administrator The NIH Extramural Team The Research Partnership Applicant Institution NIH Review Administrator Program Administrator Grants Management Administrator Principal Investigator Authorized Institutional Official Sponsored Research Administrator 12

NIH Initiatives and Hot Topics • New NIH Leadership • The B Word: NIH NIH Initiatives and Hot Topics • New NIH Leadership • The B Word: NIH Budget • Focus on New Investigators • New Directions in Peer Review • Stem Cell Research • Assuring Objectivity in Research 13

Looking to the Future with the New NIH Director To better understand the direction Looking to the Future with the New NIH Director To better understand the direction of NIH, here’s some known (and little known) facts about the leader of NIH: Francis S. Collins, Ph. D. , MD No one can whistle a symphony; you need a team to make that kind of music! 1. NIH Director as of August 17, 2009 2. Former Director of the National Human Genome Research Institute, NIH 3. Leader of the Human Genome Project 4. Dr. Collins’ own lab discovered a number of important genes, including those responsible for cystic fibrosis, neurofibromatosis, Huntington's disease, a familial endocrine cancer syndrome, and most recently, genes for type 2 diabetes and the gene that causes Hutchinson-Gilford progeria syndrome. 5. New York Times best selling book author 6. Interest in the interfacing of science and faith. 7. Believes the value of the NIH community is one where hard work, laughter, and compassion allow the imagination to soar. 8. But that’s not all… 14

ROCK STARS OF SCIENCE (Rock S. O. S. ) Mission: To accelerate science from ROCK STARS OF SCIENCE (Rock S. O. S. ) Mission: To accelerate science from research bench to bedside. Motto: From cause to cure in our time. In our lifetime, we deserve to see: • Our brain span match our life span • Early diagnosis improve our odds • Our DNA become the blueprint for health • Research funding as a national priority 2010 Inductee: Dr. Francis Collins, Ph. D. , MD ~ Biggest misconceptions about me or my work: I sequenced the entire genome myself — it was done by 2, 500 people I had the privilege of leading. Longest med school study session: Twenty-four hours straight, studying for second-year finals. Best moment in medicine/research: Completing the human genome sequence. I lent my time to the “Rock Stars of Science” campaign because: I think it's a great idea to show that scientists are not all a bunch of oddball nerds. http: //www. rockstarsofscience. org/ mission. asp The hardest part about being a “Rock Star of Science” is: It was just a 15 photo shoot! I want to be on stage with Aerosmith!

Making $ense of Future NIH Research Endeavors 5 KEY THEMES: WHAT DOES IT MEAN Making $ense of Future NIH Research Endeavors 5 KEY THEMES: WHAT DOES IT MEAN FOR NIH & ITS INVESTIGATORS? Applying high throughput technologies to understand fundamental biology, and to uncover the causes of specific diseases. Goal is to encourage NIH scientists to pursue genomics and cutting edge technology to understand fundamental biology in an effort to uncover the causes of specific diseases. Translating basic science discoveries into new and better treatments. “…take advantage of the new discoveries of the causes of diseases to understand how life works and push that agenda forward to rapidly develop diagnostics and preventive strategies and therapeutics for the diseases we currently treat poorly or often can't even diagnose. " Private-public partnerships will play an important role in this area. Putting science to work for the benefit of health care reform. "We are being called upon increasingly at NIH to produce the data necessary to make wise decisions about health care and I don't think we should be reluctant to respond. " This includes the areas of comparative effectiveness research, personalized health agendas, health disparities research, and an influence on behavioral science decisionmaking. 16

Making $ense of Future NIH Research Endeavors 5 KEY THEMES: (Continued) WHAT DOES IT Making $ense of Future NIH Research Endeavors 5 KEY THEMES: (Continued) WHAT DOES IT MEAN FOR NIH & ITS INVESTIGATORS? Encouraging a greater focus on global health. • Expand efforts to include non-communicable diseases that affect regions around the world • Help develop research capacity In resource poor countries. Reinvigorating and empowering the Biomedical research community. Reinvigorate research through: • stable funding • high quality training programs • encouraging young investigators • ensuring the NIH peer review system rewards risky and innovative approaches • emphasis on a diverse workforce • supporting projects that fall outside the mandate of a single Institute or Center. 17

NIH BUDGET & RESEARCH INITIATIVES: STIMULATED BY ARRA 18 NIH BUDGET & RESEARCH INITIATIVES: STIMULATED BY ARRA 18

NIH Congressional Appropriations FY 1997 - FY 2009 (dollars in billions) 19 NIH Congressional Appropriations FY 1997 - FY 2009 (dollars in billions) 19

American Recovery and Reinvestment Act of 2009 ARRA NIH is grateful to President Obama, American Recovery and Reinvestment Act of 2009 ARRA NIH is grateful to President Obama, Congress, and the American people for the opportunity for NIH to play its part in improving the Nation’s health and economy. 20

ARRALANCHE!!! NIH 21 ARRALANCHE!!! NIH 21

NIH ARRA by the Numbers • Approximately $5 B has been awarded as of NIH ARRA by the Numbers • Approximately $5 B has been awarded as of January 5 – $4. 4 B in grants to over 13, 000 projects – Nearly $500 M in contracts to over 350 projects • 13, 000 grant awards • 1, 885 new investigators • 28 institutions are first time NIH awardees, 12 of which are small businesses • Estimated job creation/retention: 50, 000 over 2 years 22

NIH Budget FY 2010 & 2011 • NIH 2010 Budget $31. 2 B – NIH Budget FY 2010 & 2011 • NIH 2010 Budget $31. 2 B – Strategic priorities include: Cancer Research; Autism Research; Nanotechnology related Environment, Health and Safety Research; NIH Common Fund; Bioethics; Oversight • President’s 2011 Budget Request $32. 2 B – Increase of 3. 2% from FY 2010 – Increase will support Innovative high throughput technologies, including DNA sequencing, imaging, and computational biology 23 More at: http: //officeofbudget. od. nih. gov/br. html

FY 2009: Top 5 States Receiving NIH Awards #1 #2 #3 #4 #5 CALIFORNIA FY 2009: Top 5 States Receiving NIH Awards #1 #2 #3 #4 #5 CALIFORNIA MASSACHUSETTS NEW YORK PENNSYLVANIA TEXAS NEW MEXICO $3. 8 B $2. 3 B $1. 7 B $1. 3 B $131. 7 M Award Trend Information available at: http: //report. nih. gov 24

Research Project Grants (RPGs): The Mainstay of NIH Sponsored Research Awards as percentage of Research Project Grants (RPGs): The Mainstay of NIH Sponsored Research Awards as percentage of all research grants. More info available at: http: //www. report. nih. gov 25 NEDB 25

Research Project Grants (RPGs): Applications, Awards, and Success Rates More info available at: http: Research Project Grants (RPGs): Applications, Awards, and Success Rates More info available at: http: //report. nih. gov 26 NEDB 26

Research Project Grants (RPGs): Average Size Constant (1998) $ is the inflation-adjusted average size, 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 27 NEDB 27

NIH Offers Funding Programs to Support Scientists at Every Stage of Their Career Approx. NIH Offers Funding Programs to Support Scientists at Every Stage of Their Career Approx. Stage of Research Training and Development Mechanism of Support Predoctoral Institutional Training Grant (T 32) GRADUATE/ MEDICAL STUDENT Predoctoral Individual NRSA (F 31) Predoctoral Individual MD/Ph. D NRSA (F 30) Postdoctoral Institutional Training Grant (T 32) Postdoctoral Individual NRSA (F 32) POST DOCTORAL EARLY Research Project Grant (R 01) Exploratory/Develop ment Grant (R 21) CAREER Small Grant (R 03) MIDDLE NIH Pathway to Independence (PI) Award (K 99/R 00) Mentored Research Scientist Development Award (K 01) Mentored Clinical Scientist Development Award (K 08) Mentored Patient-Oriented RCDA (K 23) Mentored Quantitative RCDA (K 25) Independent Scientist Award (K 02) Midcareer Investigator Award in Patient-Oriented Research (K 24) SENIOR Senior Scientist Award (K 05) *Graph represents a small sample of NIH funding mechanisms available. 28

Opportunities for Tomorrow: Investing in Innovative Researchers • New Innovator Award – Supports small Opportunities for Tomorrow: Investing in Innovative Researchers • New Innovator Award – Supports small number of exceptionally creative new investigators – Provides up to $300, 000 in direct costs • Transformative R 01 – Common Fund initiative for exceptionally innovative, high risk, original and/or unconventional research projects – Supports both individuals and collaborative investigative teams – No budget limit per proposal up to budget cap for program as a whole ($25 million total costs per year for 5 years) • NIH Director’s Pioneer Award – Supports exceptionally creative individual scientists – Total funding ~ $5 million for 5 year period Opportunities for Tomorrow: NIH Investing in Transformative Ideas 29

EARLY STAGE & NEW INVESTIGATORS NIH fosters research independence of early career investigators. 30 EARLY STAGE & NEW INVESTIGATORS NIH fosters research independence of early career investigators. 30

Enhancing Peer Review A Self-Study by the NIH in Partnership with the Scientific Community Enhancing Peer Review A Self-Study by the NIH in Partnership with the Scientific Community to Strengthen Peer Review in Changing Times Keeping the Goal in Mind: “Fund the Best Science, by the Best Scientists, with the Least Administrative Burden. ” Former NIH Director, Dr. Elias A. Zerhouni 31

Summary of Recommendations More at: http: //enhancing-peer-review. nih. gov 32 Summary of Recommendations More at: http: //enhancing-peer-review. nih. gov 32

Enhancing Peer Review at NIH: Timeline Changes SO FAR January 2009 • Phase out Enhancing Peer Review at NIH: Timeline Changes SO FAR January 2009 • Phase out of A 2 applications • Identification of Early Stage Inv. applications May/June 2009 Changes NOW January 2010 Submissions • Alignment of • Enhanced review applications & criteria • New scoring system review criteria • Shorter • Criterion scoring • Structured critiques Research Plans • Clustering of New Inv. Applications • Score order review 33

Human Embryonic Stem Cells Executive Order 13505 Removing Barriers to Responsible Research Involving Human Human Embryonic Stem Cells Executive Order 13505 Removing Barriers to Responsible Research Involving Human Stem Cells March 9, 2009 34

NIH Guidelines for Human Stem Cell Research • • Effective July 7, 2009 Establish NIH Guidelines for Human Stem Cell Research • • Effective July 7, 2009 Establish criteria for NIH review of Human Embryonic Stem Cells (h. ESCs) to be included in new Registry as eligible for use in NIH funding • All h. ESCs must be: • Derived from embryos created by IVF for reproductive purposes and no longer needed for that purpose • Donated by individuals who sought reproductive treatment and who gave voluntary written consent for human embryos to be used for research purposes Centralize processes and procedures for NIH reviews of h. ESCs • 43 lines now approved on the Registry • Applicants will cite h. ESCs from the Registry in grant applications • NOT-OD-10 -056 - Review Considerations for Applications and Awards under the New NIH Guidelines for Human Stem Cell Research • NOT-OD-10 -063 - Status of Certain Human Embryonic Stem Cell Lines http: //hescregapp. od. nih. gov/comments/FR_Notice_2 -23 -2010. pdf More at: http: //stemcells. nih. gov 35

Financial Conflict of Interest (FCOI) 36 Financial Conflict of Interest (FCOI) 36

NIH Oversight of Extramural Financial Conflicts of Interest Health Service (PHS) Regulation 42 CFR NIH Oversight of Extramural Financial Conflicts of Interest Health Service (PHS) Regulation 42 CFR Part 50, Subpart F • Responsibility for the identification and management of investigators’ FCOI is placed with the institution, which oversees the investigator’s activities. • As the grantor agency, NIH has primary responsibility for overseeing institutional compliance with these requirements. Note: Use of the e. RA Commons FCOI module/reporting tool will be mandatory as of July 1, 2009 NIH Guide Notice NOT OD 09 072. html 37

 NIH Has Oversight… Institutions Manage Disclosure Compliance Investigator Compliance (including accurate & timely NIH Has Oversight… Institutions Manage Disclosure Compliance Investigator Compliance (including accurate & timely reporting) Institutional Policy Implementation Management Oversight Institution NIH PHS regulation 42 CFR Part 50, Subpart F 1995 Oversight 38

FCOI Resources and Contacts • Web Based Tutorial For Investigators: http: //grants. nih. gov/grants/policy/coi/tutorial/fcoi. FCOI Resources and Contacts • Web Based Tutorial For Investigators: http: //grants. nih. gov/grants/policy/coi/tutorial/fcoi. htm • New Pilot Program Announced for Reporting FCOI: http: //grants. nih. gov/grants/guide/notice files/NOT OD 09 001. html • Division of Grants Compliance and Oversight Home page with Updated FAQs: http: //grants. nih. gov/grants/compliance. htm • Dedicated e mail: [email protected] nih. gov 39

Future Challenges for NIH • • Accountability and Transparency Scientific Workforce Emerging Technologies and Future Challenges for NIH • • Accountability and Transparency Scientific Workforce Emerging Technologies and Data Needs Ethical and Social Implications of Research Economic Impact of Research Academic/Biomedical Industry Relationships Post ARRA Funding Issues 40

Additional Resources 41 Additional Resources 41

Stop, Look, & Listen: Tips from NIH…Starting Today Lots of directions and opportunities at Stop, Look, & Listen: Tips from NIH…Starting Today 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) 42

OER Home Page Offers Valuable Links and Resources http: //grants. nih. gov 43 OER Home Page Offers Valuable Links and Resources http: //grants. nih. gov 43

http: //Re. PORT. NIH. Gov Re. PORT & Re. PORTER (Formally known as CRISP): http: //Re. PORT. NIH. Gov Re. PORT & Re. PORTER (Formally known as CRISP): Finding Funded Research • Quick access to “Frequently Requested Reports” • Efficient search tools for locating data and reports • Links to funding estimates for certain research areas, conditions, & diseases. • Includes ARRA-specific data queries 44

Sub http scribe : //gr ants to the O 1. nih ER Nex. gov Sub http scribe : //gr ants to the O 1. nih ER Nex. gov us to /gra nts/n day! exus. htm 45

One Voice … “No one can whistle a symphony… you need a team to One Voice … “No one can whistle a symphony… you need a team to make that kind of music!” 46

NIH and YOU! Building Partnerships in Biomedical & Behavioral Research! The NIH supports research NIH and YOU! Building Partnerships in Biomedical & Behavioral Research! The NIH supports research endeavors worldwide, while providing opportunities for today and tomorrow’s researchers to share their vision and innovation. The future rests on your ideas and support of the process! 47