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NIH and You: 2010 and BeyondBuilding Partnerships in Biomedical and Behavioral Research

Sally Rockey, Ph.D.Acting Director of Extramural Research

National Institutes of Health

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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?”

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“Science in pursuit of fundamental knowledge about the nature and behavior of living systems

and the application of that knowledge.

...

NIH: Steward of Medical and Behavioral Research for the Nation

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NIH Campus -- 1947

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NIH Campus Today

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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

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Extramural: outside the walls or boundaries, as of a city or town or a university: extramural teaching; an extramural church . . . .

Or Extramural Research

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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

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NIH SupportsBiomedical and Behavioral Research Around the Globe

Including Scientists at Institutions in over 90 Countries!

NIH SupportsBiomedical and Behavioral Research Around the Globe

Including Scientists at Institutions in over 90 Countries!

ARGENTINAAUSTRALIABELGIUMBOTSWANABRAZILCAMBODIACANADACHILECHINACOLUMBIACZECH REPUBLICDENMARKDOMINICAN REPUBLICEGYPTESTONIAFINLANDFRANCEGERMANYHAITIHONG KONGHUNGARYICELANDIRELANDISRAELITALYJAPAN

ARGENTINAAUSTRALIABELGIUMBOTSWANABRAZILCAMBODIACANADACHILECHINACOLUMBIACZECH REPUBLICDENMARKDOMINICAN REPUBLICEGYPTESTONIAFINLANDFRANCEGERMANYHAITIHONG KONGHUNGARYICELANDIRELANDISRAELITALYJAPAN

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…

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…

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Understanding the Dual Nature of NIH

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Data: Assoc of University Technology Managers (AUTM) Survey 2004

Alaska

NIH supports institutions & people(Extramural Research)

>4,000 institutions>300,000 scientists & research personnel~Approx. 80% of the NIH budget

NIH is an institution(Intramural Research)

~Approx. 6,000 scientists~Approx. 10% of NIH budget

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U.S. Dept. of Health & 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)

Secretary of Health and

Human Services

Secretary of Health and

Human Services

Administration onAging(AoA)

Administration onAging(AoA)

Center for Medicare &

Medicaid Services

(CMS)

Center for Medicare &

Medicaid Services

(CMS)

Indian HealthServices

(IHS)

Indian HealthServices

(IHS)

National Institutesof Health

(NIH)

National Institutesof Health

(NIH)

Agency for Healthcare

Research and Quality(AHRQ)

Agency for Healthcare

Research and Quality(AHRQ)

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)

Agency for ToxicSubstances andDisease Registry

(ATSDR)

Agency for ToxicSubstances andDisease Registry

(ATSDR)

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National Institutes of Health

National Instituteon Alcohol Abuseand Alcoholism

National Instituteof Arthritis andMusculoskeletal

and Skin Diseases

National CancerInstitute

National Instituteon Aging

National Instituteof Child Health

and HumanDevelopment

National Instituteof Allergy and

Infectious Diseases

National Instituteof Diabetes andDigestive and

Kidney Diseases

National Instituteof Dental andCraniofacial

Research

National Instituteon Drug Abuse

National Instituteof Environmental Health Sciences

National Institute onDeafness and Other

CommunicationDisorders

National EyeInstitute

National HumanGenome Research

Institute

National Heart,Lung, and Blood

Institute

National Instituteof Mental Health

National Instituteof NeurologicalDisorders and

Stroke

National Instituteof General

Medical Sciences

National Instituteof Nursing Research

National Libraryof Medicine

National Centerfor Complementary

and AlternativeMedicine

FogartyInternational

Center

National Centerfor ResearchResources

National Instituteof Biomedical Imaging and

Bioengineering

No funding authority

NIHClinical Center

Centerfor Information

Technology

Center for Scientific

Review

National Center on Minority Health

and Health Disparities

Office of the Director Office of Extramural Research

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Applicant Institution

Authorized Institutional

Official

Principal Investigator

Sponsored Research

Administrator

The Research Partnership

NIH

Review Administrator

ProgramAdministrator

Grants Management Administrator

The NIH Extramural Team

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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

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Looking to the Future with theNew NIH Director

1. NIH Director as of August 17, 20092. Former Director of the National Human Genome

Research Institute, NIH3. Leader of the Human Genome Project4. 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 author6. 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…

Francis S. Collins,

Ph.D., MD

No one can whistle a symphony; you need a team to make that kind of music!

To better understand the direction of NIH, here’s some known (and little known) facts about the leader of NIH:

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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.

The hardest part about being a “Rock Star of Science” is: It was just a photo shoot! I want to be on stage with Aerosmith!http://

www.rockstarsofscience.org/mission.asp

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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 intonew 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 decision-making.

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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 projects that fall outside the mandate of a single Institute or Center.

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NIH BUDGET & RESEARCH INITIATIVES: STIMULATED BY ARRA

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$12.7$13.7

$15.6

$17.8

$20.5

$23.3

$27.1$28.0 $28.4 $28.5 $29.0 $29.4

$30.4

$0.0

$5.0

$10.0

$15.0

$20.0

$25.0

$30.0

$35.0

FY1997

FY1999

FY2001

FY2003

FY2005

FY2007

FY2009

NIH Congressional AppropriationsFY1997- FY2009 (dollars in billions)

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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.

American Recovery and Reinvestment Act of 2009

ARRA

NIH

ARRALANCHE!!!

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NIH ARRA by the Numbers

• Approximately $5B has been awarded as of January 5

– $4.4B in grants to over 13,000 projects

– Nearly $500M 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

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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

More at: http://officeofbudget.od.nih.gov/br.html

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FY2009: Top 5 States Receiving NIH Awards

#1 CALIFORNIA $3.8 B #2 MASSACHUSETTS $2.8 B #3 NEW YORK $2.3 B #4 PENNSYLVANIA $1.7 B #5 TEXAS $1.3 B

NEW MEXICO $131.7 M

Award Trend Information available at: http://report.nih.gov

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NEDB 25

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

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NEDB 26

Research Project Grants (RPGs):Applications, Awards, and Success Rates

More info available at: http://report.nih.gov

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NEDB 27

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

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Predoctoral Individual NRSA (F31)Predoctoral Individual NRSA (F31)Predoctoral Individual MD/PhD NRSA Predoctoral Individual MD/PhD NRSA

(F30)(F30)

Postdoctoral Institutional Training Grant (T32) Postdoctoral Institutional Training Grant (T32)

Postdoctoral Individual NRSA (F32)Postdoctoral Individual NRSA (F32)

Small Grant (R03) Small Grant (R03)

Research Project Research Project Grant (R01)Grant (R01)

Independent Scientist Award (K02)Independent Scientist Award (K02)

Senior Scientist Award (K05Senior Scientist Award (K05) )

Approx. Stage of ResearchApprox. Stage of ResearchTraining and DevelopmentTraining and Development Mechanism of SupportMechanism of Support

GRADUATE/GRADUATE/MEDICALMEDICALSTUDENTSTUDENT

POSTPOSTDOCTORALDOCTORAL

EARLYEARLY

MIDDLEMIDDLE

SENIORSENIOR

CA

RE

ER

CA

RE

ER

Predoctoral Institutional Training Grant (T32)Predoctoral Institutional Training Grant (T32)

NIH Pathway to Independence (PI) Award (K99/R00)NIH Pathway to Independence (PI) Award (K99/R00)Mentored Research Scientist Development Award Mentored Research Scientist Development Award (K01)(K01)Mentored Clinical Scientist Development Award (K08)Mentored Clinical Scientist Development Award (K08)Mentored Patient-Oriented RCDA (K23)Mentored Patient-Oriented RCDA (K23)Mentored Quantitative RCDA (K25)Mentored Quantitative RCDA (K25)

Midcareer Investigator Award in Midcareer Investigator Award in Patient-Oriented Research (K24) Patient-Oriented Research (K24) Exploratory/Exploratory/

Development Grant Development Grant (R21) (R21)

NIH Offers Funding Programs to Support Scientists at Every Stage of Their Career

*Graph represents a small sample of NIH funding mechanisms available.

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Opportunities for Tomorrow:NIH Investing in Transformative Ideas

• New Innovator Award– Supports small number of exceptionally creative new

investigators– Provides up to $300,000 in direct costs

• Transformative R01– 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 costsper 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:Investing in Innovative Researchers

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EARLY STAGE & NEW INVESTIGATORS

NIH fosters research independence of early career investigators.

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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

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Summary of Recommendations

More at: http://enhancing-peer-review.nih.gov

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Enhancing Peer Review at NIH: Timeline

January 2009

May/June 2009

January 2010 Submissions

ChangesSO FAR

•Phase out of A2 applications•Identification of Early Stage Inv. applications

•Enhanced review criteria•New scoring system•Criterion scoring•Structured critiques•Clustering of New Inv. Applications•Score order review

ChangesNOW

•Alignment of applications & review criteria•Shorter Research Plans

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Executive Order 13505 Removing Barriers to Responsible Research Involving Human Stem

Cells - March 9, 2009

Human Embryonic Stem Cells

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NIH Guidelines for Human Stem Cell Research

Effective July 7, 2009 • Establish criteria for NIH review of Human Embryonic Stem Cells (hESCs) to be

included in new Registry as eligible for use in NIH funding

• All hESCs 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 hESCs

• 43 lines now approved on the Registry

• Applicants will cite hESCs 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

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Financial Conflict of Interest(FCOI)

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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 eRA Commons FCOI module/reporting tool will be mandatory as of July 1, 2009 - NIH Guide Notice NOT-OD-09-072.html

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NIH Has Oversight… Institutions Manage

Compliance(including accurate& timely reporting)Institutional Policy

ImplementationManagement

Oversight

Institution

DisclosureCompliance

Investigator

Oversight

NIH

PHS regulation 42 CFR Part 50, Subpart FPHS regulation 42 CFR Part 50, Subpart F19951995

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FCOI Resources and Contacts

• Web Based Tutorial For Investigators: http://grants.nih.gov/grants/policy/coi/tutorial/fcoi.htm

• New Pilot 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/compliance.htm

• Dedicated e-mail: FCOIcompliance@mail.nih.gov

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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

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Additional Resources

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Stop, Look, & Listen:Tips from NIH…Starting Today

• 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)

Lots of directions and opportunities at the NIHLots of directions and opportunities at the NIH

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OER Home Page Offers Valuable Links and Resources

http://grants.nih.gov

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http://RePORT.NIH.Gov

RePORT & RePORTER (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

Subscribe to the OER Nexus today!

http://grants1.nih.gov/grants/nexus.htm

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One Voice …

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

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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!