Working with NIH Program Officials: Pre-Award & Post-Award Shawn Gaillard, NIGMS and Francisco Sy, NIMHD 2013 NIH Regional Seminar, Baltimore, MD
Dec 26, 2015
Working with NIH Program Officials: Pre-Award & Post-Award
Shawn Gaillard, NIGMSand
Francisco Sy, NIMHD2013 NIH Regional Seminar, Baltimore, MD
NIH Overview
Pre-award: Communication w/ Program Staff
Post-award: Communication w/ Program Staff
OUTLINE
NIH Overview
“To win the future, America
needs to out-educate,
out-innovate, and out-build
the rest of the world.” President Barack Obama,
Weekly Address February 5, 2011
U.S. Dept. of Health & Human Services5
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)
NIGMS
~$31 Billion~$31 BillionFiscal Year 2013Fiscal Year 2013
Annual BudgetAnnual Budget
Intramural Research
R&D Contracts
Research Centers
Other Research
All Other Training
Mgmt & Support3%
3%
5%
6% Research Project
Grants (RPG)53% 10%
11%
11%
The mission of the NIH is to uncover new knowledge that will lead to better health for everyone by:
Conducting research in our own laboratories (Intramural)Providing support for research outside of our labs (Extramural)Training future research investigatorsCommunicating medical information to public
National Institutes of Health
NIGMS
Office of the Director Office of the Director
National Libraryof Medicine
National Libraryof Medicine
Center for InformationTechnology
Center for InformationTechnology
Center for Scientific Review
Center for Scientific Review
FogartyInternational
Center
FogartyInternational
Center
National Instituteof Arthritis andMusculoskeletal
and Skin Diseases
National Instituteof Arthritis andMusculoskeletal
and Skin Diseases
National Instituteof Diabetes andDigestive and
Kidney Diseases
National Instituteof Diabetes andDigestive and
Kidney Diseases
National Instituteof Dental andCraniofacial
Research
National Instituteof Dental andCraniofacial
Research
National Institute onDeafness and Other
CommunicationDisorders
National Institute onDeafness and Other
CommunicationDisorders
National EyeInstitute
National EyeInstitute
National Heart,Lung, and Blood
Institute
National Heart,Lung, and Blood
Institute
National Instituteon Alcohol Abuseand Alcoholism
National Instituteon Alcohol Abuseand Alcoholism
National CancerInstitute
National CancerInstitute
National Instituteon Drug Abuse
National Instituteon Drug Abuse
National Instituteof Environmental Health Sciences
National Instituteof Environmental Health Sciences
National Instituteof Mental Health
National Instituteof Mental Health
National Instituteof NeurologicalDisorders and
Stroke
National Instituteof NeurologicalDisorders and
Stroke
National Instituteof Allergy and
Infectious Diseases
National Instituteof Allergy and
Infectious Diseases
National Center on Minority Health and Health Disparities
National Center on Minority Health and Health Disparities
National Instituteon Aging
National Instituteon Aging
National Instituteof Child Health
and HumanDevelopment
National Instituteof Child Health
and HumanDevelopment
National HumanGenome Research
Institute
National HumanGenome Research
Institute
National Instituteof Nursing Research
National Instituteof Nursing Research
National Centerfor Complementary
and AlternativeMedicine
National Centerfor Complementary
and AlternativeMedicine
National Centerfor ResearchResources
National Centerfor ResearchResources
Clinical Center
Clinical Center
National Institute of Biomedical Imaging and Bioengineering
National Institute of Biomedical Imaging and Bioengineering
National Instituteof General
Medical Sciences
National Instituteof General
Medical Sciences
no fundingauthority
27 Institutes and Centers (IC)
Dual Nature of NIH8
NIH Extramural Research~ 90K applications/year~ 45K ongoing awards/year~ 3K institutions> 300K scientists & researchers ~ 83% of the NIH budget
NIH Intramural Research
~ 6K scientists & researchers~ 10% of NIH budget
5
Data: Assoc of University Technology Managers (AUTM) Survey 2004
Alaska
Pre-award: Communication w/Program Staff
CSR assigns to IC, SRG
SRG 1st level of Review
2nd level of Review = Council
Not Fundable
Applicant Evaluates SS
Revised Application (x1)
Prepared
Applicant Notified and Given Feedback
Application to NIH
Summary Statement (SS) to Applicant
NIH NIH Application Application Process Process OverviewOverview
Application to NIH via CSR
IC Makes Award
Award Ends,Renewal Application Prepared
Fundable
Time to Talk w/ NIH Program Officer
Progress Reports
Communication: Means to Funding
Communicate with: NIH staff – esp., PROGRAM OFFICIALS
Your Fellow Investigators
Your Institutional Administrators
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Applicant Institution
Authorized Institutional
Official
Principal Investigator
Sponsored Research
Administrator
NIH
Review Officer
ProgramOfficer
Grants Management Administrator
TEAMS
Program Official
aka Program Director or Program Officer Both a Scientist and Administrator Responsible for the programmatic,
scientific, and technical aspects of a grant
Program Official Responsibilities
Provide technical assistance to applicants Observe scientific review meetings Discuss review issues with applicants Prepare funding recommendations Manage scientific research/training portfolios Review annual research/training progress of grantees Report scientific progress and program accomplishments Identify opportunities and needs of science specific to an Institute’s
mission Communicate program priorities
- Funding Opportunity Announcements (FOA)- Request for Applications (RFA)
Program Official (PO)
Principal liaison between investigators & NIH
Your most important contact
Contact us early … Contact us often!
How to Meet a Program Officer? Meet PO at Your Favorite Scientific or
Professional Meeting Institute Booths Mingling thru the Crowds Institute sponsored Workshops
Ask your Colleagues Search NIH Institute Websites or Directory View names/contact info on FOAs and RFAs
Why Contact a Program Officer?
To Direct You to:
The appropriate Institute- 24 Institutes have granting authority
The appropriate Division/Office- Basic, clinical, behavioral, translational, training
The appropriate Program Official- Extramural research portfolio
Must I Contact the NIH Before Applying? --- YES!
Mandatory:Application with >$500K budget DC/yearR13 Conference Grants
Optional:When RFAs request a Letter of Intent
Recommended:When you think about applying for ANY grant
Benefits of Making Contact
To develop a relationship with a potential program official
To assure that your application has a home (appropriate Institute)
Developing Your Application
Search NIH RePORT http://projectreporter.nih.gov/reporter.cfm
NIH Guide – FOAs and RFAs http://grants.nih.gov/grants/guide/index.html
Search Institute Web Sites www.nih.gov/icd/
Contact Institute Staff http://ned.nih.gov/
Before You Submit – Talk to PO Organize your thoughts for productive conversation
Grant Purpose: Want a grant from which IC to do what? Problem/Background: Explain why you to think this topic
needs study. Demonstrate you know Institute priorities. Significance: Explain why this is important in the field. Question: What hypotheses will you test and what model will
guide your hypotheses? Design/Analysis: What is the study design that will enable
testing your hypotheses? What statistical approach? Team: Who will be the key participants (co-investigators and
organizations) on the project? Miscellaneous: Other issues that may be relevant
Program Officials…
… are not done after you submit your
application
PO Attends Review Meeting
Observes the review group meeting Is a liaison to Scientific Review Officer
(SRO) (e.g., provide clarification of FOA to the panel, if requested by the SRO)
Is able to answer your questions about the review (especially useful if your application is unscored)
Review Meeting
Review Meeting (or called Study Sections) are managed by NIH personnel called Scientific Review Official who is a PhD-level professional with scientific background close to the expertise of the study section
Each standing study section has 12 - 24 members who are primarily from academia
As many as 60 - 100 applications are reviewed at each study section meeting
After Peer Review Applicants receive a Summary Statement (SS)
Written Account of Essentially Unedited Critiques Overall Resume and Summary of ReviewPriority Score & Percentile RankingBudget Recommendations
Contact PO to inquire about likelihood of funding If you disagree with facts on SS; contact your
Program Official (PO). PO may submit an appeal to Council (2nd level of review)
PO- prepares funding recommendations
What Determines Funding?
Scientific Merit (Review Group)
Program Considerations (Program Official, Advisory Council, IC Director)
Availability of funds
NIGMS
* URM as indicated in FOA. *^ Honors as defined by applicant institution, typically GPA
Impact Scores & Meanings
Consult with program officer on possible next steps
Respond to reviewer concernsRevise application and resubmit
Not Funded?
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Write a clear Introduction section Address all criticisms thoroughly Respond constructively: don’t be
argumentative, abrasive or sarcastic! Acknowledge and accept the help of reviewer
comments
Revise and Resubmit
Post-award: Communication w/Program Staff
Funded, Now What?
Notice of Award (NoA)Legally binding documentAward data and fiscal informationGrant payment infoTerms and conditions of awardGrantee accepts terms and conditions of
award when draw down funds
PO: Grant Oversight
Serve as resource and liaison
Answer technical questions
Monitor progress of study
You Submit Annual Non-competing Renewals
Monitor scientific progress
Confirm policy adherence
Evaluate changes in key personnel or levels of effort
Communicate your exciting results
PO: Grant Oversight – Progress Reports
A clear and concise presentation of major highlights and/or problems encountered and possible resolutions
Summary of your accomplishments Specific aims (as funded) Results (during reporting period) Significance Plans for next budget period
List of publications generated by project Explain any changes in Human Subjects or Vertebrate Animal
Research Report on gender and minority inclusion
Annual Progress Reports
Annual Progress Reports
Due 60 days prior to budget period start date eSNAP - due date is the 15th day of the month
preceding the month in which the current budget period ends
Submit Preferred via NIH eRA Commonshttps://commons.era.nih.gov/commons/index.jsp
or to
Centralized NIH Receipt Point http://grants2.nih.gov/grants/guide/notice-files/NOT-OD-04-063.html
Progress Report Checklist for PO Program Looks to See :
Is progress satisfactory? (If no, explain.) Add Comment Is there a change in the scope, goals, or objectives of the project? If yes, does this change benefit the project and is it approved? (If
not, explain.) Is there a change in key personnel or their level of effort? (If yes,
describe.) If there are changes/concerns in the Multiple PI leadership plan,
is the new plan acceptable? Is there evidence of scientific overlap? (If yes, explain.) ….. If a progress report for a supplement is required, is progress
reported and acceptable? Are there other issues that should be resolved prior to issuing an
award? (If yes, provide details.) If any issues have not been resolved, should a restricted award
be made?
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PO: Grant Oversight – Actions Requiring Prior Approval
Change in ScopeSignificant change in aims, methodology,
approach, or other aspects of project objectivesReflects significant change from the project as
reviewed and approvedExamples:
Change in specific aims Change to a different animal model Any change from the approved use of animals
or human subjects Shift of research emphasis to a different
disease area
Desired Change of Grantee InstitutionProgram Official assesses:
If Grant mechanism permits Progress to date Adequacy of new resources and environment Availability of expertise (key personnel) Potential problems (e.g., equipment)
Contact NIH Program Officer early!
PO: Grant Oversight – Actions Requiring Prior Approval
Desired Change in Status of PIChange of PI>25% change in PI effortPI absence of 90 days or more
Note: A project cannot be converted from a single PI to a Multiple PI project during a non-competing phase
PO: Grant Oversight – Actions Requiring Prior Approval
NIH Resource Web Links:
Overview of Electronic Submission http://era.nih.gov/ElectronicReceipt/
Frequently Asked Questions http://era.nih.gov/ElectronicReceipt/faq.htm
Avoiding Common Errors http://era.nih.gov/ElectronicReceipt/avoiding_errors.ht
Office of Extramural Research Grants Home Page: http://grants.nih.gov/grants/oer.htm
PHS2590 Progress Report (form pgs are PDF-fillable): http://grants.nih.gov/grants/funding/2590/2590.htm
Questions?