OER PPT

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NIH and You Mission Possible 2010 and
Beyond Building Partnerships in Biomedical and
Behavioral Research Della M. Hann, Ph.D. Acting
Deputy Director, Office 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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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.
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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
  universitiesthe 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
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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 GlobeIncluding Scientists at
Institutions in over 90 Countries!

• ARGENTINA
• AUSTRALIA
• BELGIUM
• BOTSWANA
• BRAZIL
• CAMBODIA
• CANADA
• CHILE
• CHINA
• COLUMBIA
• CZECH REPUBLIC
• DENMARK
• DOMINICAN REPUBLIC
• EGYPT
• ESTONIA
• FINLAND
• FRANCE
• GERMANY
• HAITI

KENYA LEBANON MALAWI MEXICO NETHERLANDS NEW
ZEALAND NIGERIA PAKISTAN PERU POLAND RUSSIA SENEGA
L SINGAPORE SOUTH AFRICA SPAIN SWEDEN SWITZERLAND
THAILAND TURKEY UNITED KINGDOM URAGUAY ZIMBABWE AN
D MORE
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Understanding the Dual Nature of NIH
NIH supports institutions people (Extramural
Research)
gt4,000 institutions gt300,000 scientists
research personnel Approx. 80 of the NIH budget
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U.S. Dept. of Health Human Services
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National Institutes of Health
Office of the Director
Office of Extramural Research
National Institute on Alcohol Abuse and Alcoholism
National Institute of Arthritis
and Musculoskeletal and Skin Diseases
National Cancer Institute
National Institute on Aging
National Institute of Child Health and
Human Development
National Institute of Allergy and Infectious
Diseases
National Institute of Dental and Craniofacial Rese
arch
National Institute of Diabetes and Digestive
and Kidney Diseases
National Institute on Drug Abuse
National Institute of Environmental Health
Sciences
National Institute on Deafness and
Other Communication Disorders
National Eye Institute
National Human Genome Research Institute
National Heart, Lung, and Blood Institute
National Institute of Mental Health
National Institute of Neurological Disorders
and Stroke
National Institute of General Medical Sciences
National Institute of Nursing Research
National Institute of Biomedical Imaging and
Bioengineering
National Center on Minority Health and Health
Disparities
National Center for Complementary and
Alternative Medicine
National Library of Medicine
Fogarty International Center
National Center for Research Resources
No funding authority

NIH Clinical Center
Center for Information Technology
Center for Scientific Review
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The NIH Extramural Team
The Research Partnership
Applicant Institution
NIH
Authorized Institutional Official
Principal Investigator
Program Administrator
Review Administrator
Sponsored Research Administrator
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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
To better understand the direction of NIH, heres
some known (and little known) facts about the
leader of NIH

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 thats not all

Francis S. Collins, Ph.D., MD No one can
whistle a symphony you need a team to make that
kind of music!
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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 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 decision-making.
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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NIH Congressional AppropriationsFY1997- FY2009
(dollars in billions)
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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 Nations health
  and economy.

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NIH ARRA by the Numbers

• Approximately 5B has been awarded as of January
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• 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
• Presidents 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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NIH Grant Funding in the Paso del Norte Region,
US-Mexico
Institution FY2008 Total NIH Awarded
Los Alamos National Lab (NM) 13.3 M
University of Texas El Paso (TX) 8.5 M
New Mexico State University Las Cruces (NM) 7.8 M
New Mexico Highlands University (NM) 1 M
El Paso Community College (TX) .5 M
National Center for Genome Resources (NM) .5 M
Santa Fe Institute (NM) .5 M
Caldera Pharmaceuticals, Inc. (NM) .3 M
New Mexico Institute of Mining Technology .2 M
Southwest Sciences, Inc. (NM) .1 M
Vista Photonics, Inc. (NM) .1 M
http//www.oecd.org/dataoecd/48/2/44210876.pdf
Figures are approximate dollars awarded to each
institution. http//report.nih.gov/award/trends/St
ate_Congressional/StateDetail.cfm?StateTexasLon
-100.076790Lat31.168989
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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

NEDB 24
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Research Project Grants (RPGs)Applications,
Awards, and Success Rates
More info available at
http//report.nih.gov
NEDB 25
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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

NEDB 26
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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 (T32)
GRADUATE/ MEDICAL STUDENT
Predoctoral Individual NRSA (F31) Predoctoral
Individual MD/PhD NRSA (F30)
Postdoctoral Institutional Training Grant (T32)
Postdoctoral Individual NRSA (F32)
POST DOCTORAL
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)
EARLY
Small Grant (R03)
Research Project Grant (R01)
Independent Scientist Award (K02)
MIDDLE
CAREER
Midcareer Investigator Award in
Patient-Oriented Research (K24)
Exploratory/Development Grant (R21)
SENIOR
Senior Scientist Award (K05)
Graph represents a small sample of NIH funding
mechanisms available.
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Opportunities for TomorrowNIH Investing in
Transformative Ideas
Opportunities for TomorrowInvesting in
Innovative Researchers

• 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 Directors Pioneer Award
• Supports exceptionally creative individual
  scientists
• Total funding 5 million for 5 year period

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EARLY STAGE NEW INVESTIGATORS
NIH fosters research independence of
early career investigators.
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NIH Priority New Investigators
Early Stage
Investigators (ESIs)
The NIH remains committed to identifying and
attracting new biomedical researchers and will
continue to explore novel ways to encourage early
transition to independence.

• 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).
• Identification of ESIs will occur in the Personal
  Profile section of the eRA Commons.
• Investigators who enter degree and residency
  completion dates will be notified of their ESI
  status by email.

For more information http//grants1.nih.gov/gran
ts/new5Finvestigators/
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NIH Exceeds New Investigator Goal
in FY 2008
FY 07 08 Target of 1,500 new R01
investigators
Note Used rolling avg. of past 5 years to set
new goals
R01-Equivalent awards include R01, R23, R29, and
R37 grants.
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Setting New Investigator Goals

• Over the past three years, about 25 percent of
  all competing R01 awards have gone to New
  Investigators
• Goals based on rolling average for previous 5
  years
• Numeric Goal for FY 2009 was 1,650 awards to New
  Investigators
• ICs are directed to maintain comparable success
  rates for
• Established investigators submitting new (Type 1)
  grant applications, and New Investigators
• In addition, a majority of New Investigators will
  be Early Stage Investigators (ESIs)
• Encourage New Investigators to apply for R01s
  (not R21s or R03s)

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Enhancing Peer Review
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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
Changes SO FAR
Changes NOW
January 2009
May/June 2009
January 2010 Submissions

• Alignment of
• applications
• review criteria
• Shorter
• Research Plans

• 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

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Human Embryonic Stem Cells
Executive Order 13505 Removing Barriers to
Responsible Research Involving Human Stem Cells
- March 9, 2009
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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
• New web-based Form 2890, separate from the grant
  application, will be used for organizations to
  submit information about hESCs for potential
  inclusion in the Registry
• Applicants will cite hESCs from the Registry in
  grant
  applications

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
  investigators 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
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FCOI Resources and Contacts

• Web Based Tutorial For Investigators
  http//grants.nih.gov/grants/policy/coi/tutorial/f
  coi.htm
• New Pilot New Pilot Program Announced for
  Reporting FCOI http//grants.nih.gov/grants/guid
  e/notice-files/NOT-OD-09-001.html
• Division of Grants Compliance and Oversight Home
  page with Updated FAQs http//grants.nih.gov/gran
  ts/compliance/compliance.htm
• Dedicated e-mail FCOIcompliance_at_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

The Past...Present...Future
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Additional Resources
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Stop, Look, ListenTips from NIHStarting 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)

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

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Subscribe to the OER Nexus today! http//grants1.n
ih.gov/grants/nexus.htm
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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.h
  tml
• NIH Grants Policy Statement (Rev. 12/03)
  http//grants.nih.gov/grants/policy/nihgps_2003/in
  dex.htm
• NIH Extramural Nexus Monthly newsletter
  (previously bimonthly) for the extramural
  community
• http//grants.nih.gov/grants/nexus.htm
• RePORTER - Search to analyze an Institutes
  portfolio of funded projects, research areas, and
  more http//projectreporter.nih.gov/reporter.cfm
• Grant Application Basics http//grants.nih.gov/gra
  nts/grant_basics.htm

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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

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Grants Information Who To Contact

• Institutional Resources
• First, utilize the expertise of your
  organizations Office of Sponsored Programs
• Application Specific Questions at NIH
• Administrative
• Contact the Grants Management Specialist at the
  awarding Institute/Center
• Scientific/Programmatic
• Contact the designated Program Official/Director
  at awarding Institute/Center
• Review Questions
• Contact the assigned Scientific Review Officer

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Grants Information Who to Contact

• Grants Administration staff at all NIH ICs
• http//grants.nih.gov/grants/staff_list_grants_adm
  in.htm
• NIH Chief Grants Management Officers
• http//grants.nih.gov/grants/stafflist_gmos.htm
• Grants Policy Interpretation Consultation
• E-Mail GrantsPolicy_at_mail.nih.gov
• Phone [phone]
• Compliance Issues
• E-Mail GrantsCompliance_at_mail.nih.gov
• Phone [phone]

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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
tomorrows researchers to share their vision and
innovation. The future rests on your
ideas and
support of the process!