1 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
Jan 15, 2016
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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 ResearchNational 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 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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$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
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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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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
*Figures are approximate dollars awarded to each institution.
http://report.nih.gov/award/trends/State_Congressional/StateDetail.cfm?State=Texas&Lon=-100.076790&Lat=31.168989
http://www.oecd.org/dataoecd/48/2/44210876.pdf
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NEDB 24
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 25
Research Project Grants (RPGs):Applications, Awards, and Success Rates
More info available at: http://report.nih.gov
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NEDB 26
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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NIH Priority: New Investigators & Early Stage Investigators (ESIs)
• New InvestigatorA 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.
The NIH remains committed to identifying and attracting new biomedical researchers and will continue to explore novel ways to encourage early transition to independence.
For more information: http://grants1.nih.gov/grants/new%5Finvestigators/
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1,684
1,809
0
200
400
600
800
1,000
1,200
1,400
1,600
1,800
2,000
1985 1986 1987 1988 1989 1990 1991 1992 1993 1994 1995 1996 1997 1998 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008
Fiscal Year
Nu
mb
er o
f Aw
ard
ees
NIH First Time R01-Equivalent Awardees FY 1985-2008
NIH Exceeds New Investigator Goal in FY 2008
*R01-Equivalent awards include R01, R23, R29, and R37 grants.
FY ’07 & ‘08: Target of 1,500
new R01 investigators
Note: Used rolling avg. of past 5 years to set new goals
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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
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
• 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 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: [email protected]
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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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Summary of Helpful Web Resources
• Office of Extramural Research (OER) Web Pagehttp://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 communityhttp://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
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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 organization’s 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_admin.htm
• NIH Chief Grants Management Officers: – http://grants.nih.gov/grants/stafflist_gmos.htm
• Grants Policy Interpretation & Consultation:– E-Mail: [email protected]– Phone: 301-435-0949
• Compliance Issues:– E-Mail: [email protected]– Phone: 301-435-0949
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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!