NIH OFFICE OF EXTRAMURAL RESEARCH Making Connections: NIH Grants Process NIH Regional Seminar April 15, 2009 – Philadelphia, PA Cheryl Anne Boyce, Ph.D. Chief, Behavioral and Brain Development Branch (BBDB) and Associate Director for Child and Adolescent Research, Division of Clinical Neuroscience and Behavioral Research (DCNBR) NIDA/NIH/DHHS Emily Linde Policy Analyst, Division of Grants Policy Office of Policy for Extramural Research Administration (OPERA) OER/OD/NIH/DHHS

Today’s Topics NIH & Funding Facts Fundamentals of the Grants Process Types of Support Roles & Responsibilities: Yours & Ours Applications & Scientific Review Program & Grants Staff Actions The Notice of Award (and after) Web Resources 2

FDR Dedicates NIH Campus October 31, 1940

NIH INTRAMURAL Campus Today NIH Campus Today 4

Research Triangle Park, NC NIH EXTRAMURAL Sites Executive Plaza South and North Rockledge 1 & 2 Neuroscience Center NIEHS Campus Research Triangle Park, NC Democracy 1 & 2

U. S. Dept. of Health and Human Services Secretary of Health and Human Services Administration for Children and Families (ACF) Administration on Aging (AoA) 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) 6

NIH is organized into: 27 Separate Institutes & Centers (IC) each with different: missions & priorities budgets ways of deciding which grants to fund NIGMS International Center Clinical Center 7

NIH FY2010 Budget Total = $31.2 B NCI NIAID NHLBI NIDDK NIGMS NIH divides most of its investment according to the interests of the component parts (i.e. Institutes or Centers) NEI NCCAM OD NIEHS NIAMS NIAAA NHGRI NIDCD NIDCR NLM NIBIB NCMHD NINR FIC Total = $31.2 B NCI NIDA NIA NIAID NCRR NHLBI NIDDK NIGMS NICHD NIMH NINDS About 85% distributed via Extramural grants, contracts, cooperative agreements

Breakdown of FY 2011 President’s Budget Request for NIH – $32 Breakdown of FY 2011 President’s Budget Request for NIH – $32.2 Billion $16.4 B 9

Fundamentals of the Grants Process NIH OFFICE OF EXTRAMURAL PROGRAMS Fundamentals of the Grants Process Grant Mechanisms 10

What’s the Difference Between Grants and Contracts? $ Assistance Acquisition Government is Patron or Partner Government is Purchaser Purpose: support and stimulate research Purpose: acquire goods or services Benefit a public purpose Benefit and use of the government Investigator initiated Government initiated Attend “R& D Contracts” at 8:00am tomorrow or “Budget Basics for investigators at 8:00am tomorrow. 11

How Does NIH Solicit Applications? Federal Opportunity Announcements (FOA) published through the NIH Guide (http://grants.nih.gov/grants/guide/) at grants.gov Parent Announcements cover basic mechanisms investigator-initiated applications Special Opportunities to fill gaps Requests for Applications (RFA), a one-time call with set aside funds Program Announcement (PA) highlights areas of focus Program Announcement with Special Review (PAR) for special consideration and “protected” review Program Announcement with Set Aside (PAS) essentially, an RFA with multiple receipt dates

Award Activity Codes: Research Project Grants Traditional – R01 Small Research – R03 Exploratory Development Grants – R21/R33 Program Project – P01 Research Center Grants – P50 Small Business – R41, R42, R43, R44 Cooperative Agreements – Us Substantial NIH staff involvement in program and science Typically initiated by NIH Attend “Prime Time with NIH Program” RPGs” at 12:45pm tomorrow or “Takin’ Care of Business: SBIR/STTRs” 1:30pm today. 13

Research Training and Research Career Development Awards Training Grants – T Institutional Predoctoral and Postdoctoral Trainees must be U.S. citizens Fellowships (U.S. Domestic only) – F Individual Fellows must be U.S. citizens Predoctoral – F31 Postdoctoral – F32 Career Development Awards – K Attend “Research Training Awards” at 12:45pm tomorrow. 14

Fundamentals of the Grants Process NIH OFFICE OF EXTRAMURAL PROGRAMS Fundamentals of the Grants Process Roles and Responsibilities 15

The Grantee Institution Actual recipient of award Legally responsible for proper conduct and execution of grant Provides fiscal management Provides oversight on allocation decisions Assures compliance with Federal, NIH, and organization-wide requirements 16

Grantee Institution Authorized Organizational Reps Research Program Administrator Program Director/ Principal Investigator 17

The Grantee Authorized Organizational Representative [a.k.a Signing Official in eRA] Designated representative of the grantee organization for award and administration of NIH grants Accountable for appropriately utilizing Federal funds and for the performance of a project Signs all official correspondence to NIH, including grant applications, financial reports, assurances, and certifications. 18

The Grantee Program Director/Principal Investigator (PD/PI) Individual designated by grantee Responsible for the scientific and technical aspects of project Directly manages the project on a day-to-day basis Assures scientific compliance by maintaining contact with the NIH Program Officer Coordinates with other PDs/PIs on projects with multiple PDs/PIs 19

The Grantee Research Administrator Acts as an agent of the PD/PI and the Authorized Organizational Representative Gathers information needed to ensure compliance with Federal regulations, as well as organization-wide requirements Provides essential grant-related support Cannot assume responsibilities assigned to the Authorized Organizational Representative or the PD/PI 20

The NIH Extramural Team Review Staff Grants Management Program Staff 21

The NIH Scientific Review Officer Responsible for the scientific and technical review of applications Ensure fair and unbiased evaluation of the scientific and technical merit of the proposed research Provide accurate summaries of the evaluation for National Advisory Councils and Institute Directors Applicants Review applications for completeness and conformance with application requirements Point of contact for applicants during the review process 22

[aka Program Officer or Program Director] The NIH Program Official [aka Program Officer or Program Director] Responsible for the programmatic, scientific, and/or technical aspects of a grant Development of Research and Research Training Programs for IC’s Mission Post-Award Administration 23

Grants Management Officer The NIH Grants Management Officer Ensures performance of business management actions by the grantee and the federal government. Evaluates grant applications for administrative content and compliance with statutes, regulations, and guidelines. Interprets grants administration policies Negotiates Awards 24

Grants Management Specialist The NIH Grants Management Specialist Acts as an agent of the GMO Assist GMOs/CGMOs in managing grants Day-to-day management of portfolio of grants Answer applicant questions about completing application forms Provide guidance on the administrative and fiscal aspects of an award 25

Fundamentals of the Grants Process NIH OFFICE OF EXTRAMURAL PROGRAMS Fundamentals of the Grants Process Grant Application and Scientific Review 26

The Grants Process Overview http://grants. nih

Getting to the Top: Writing Great Grants Components of successful applications Strong Idea Strong Science Strong Team Strong Presentation Match idea/science to the NIH Institute Every IC has specific mission Hone high-quality grant writing skills Communicate scientific content compellingly Follow all the instructions Attend “Grant Writing for Success” at 1:30pm today. 28

Writing a Grant Application Research plan answers 4 essential questions What do you intend to do? Why is the work important? What has already been done? How are you going to do the work? Successful applications typically are: Well-focused and explicitly written Not overly ambitious Understandable by a naïve reader

Receipt and Referral of Applications Electronic SF424 R&R submitted through grants.gov to an NIH Institute (IC) CSR Referral Office assigns the application… a unique identifier (application number) to Integrated Review Group (IRG) and then a study section (SRG) Application assessed for completeness & eligibility Notice of assignment available in eRA Commons in 4 weeks. 1st Month 2nd Month 30

Decoding Your NIH Grant Number Years of Continuous Funding Application Type Activity Code Institute Code Serial Number Support Year Extension 1 R01 EB 12345 01 A1 1 = new 2 = renewal 3 = supplement 5 = non- competing continuation R = Research project P = Program project or Center T = Training (institutional) F = Fellowship (individual) K = Career Development U = Cooperative agreement Unique, up to six digits Years of Continuous Funding AA = NIAAA AG = NIA AI = NIAID AR = NIAMS AT = NCCAM CA = NCI DA = NIDA DC = NIDCD DE = NIDCR DK = NIDDK EB = NIBIB ES = NIEHS EY = NEI GM = NIGMS HD = NICHD A1 = first resubmission A2 = second HG = NHGRI HL = NHLBI LM = NLM MD = NCMHD MH = NIMH NR = NINR NS = NINDS RR = NCRR TW = FIC

Review System for Grants Scientific Review Group (SRG) Independent outside review Evaluate scientific merit, significance Recommend length and level of funding 1st level Output: Priority Score and Summary Statement Advisory Council assess quality of SRG process offers recommendation to Institute Staff evaluates program priorities and relevance advises on policy 3 - 7 months 2nd level Output: Funding Recommendations Institute Director makes final decision based on Council input, programmatic priorities Must also Pass Administrative Review 1 - 3 months Output: Awards or Resubmission Attend “A Peer into the NIH Review Process” at 10:30am today. 32

Review Who Reviews Grant applications? Scientist peers with appropriate expertise -- recruited by the Scientific Review Officer Assigned to specific applications based on content 4 year term typical Temporary reviewers sought as needed 33

1st Level Review Standing study sections typically have 12-24 members: scientist peers 3 face-to-face meetings per year, and a 4 year term of service. 60 – 100 applications to review at each meeting 3rd Month 4th Month Attend “For Your Review: NIH Mock Study Section” at 3:15pm today. 34

After 1st Level Review Priority Scores recorded Summary Statements prepared Overall Resume and Summary of Review Discussion Essentially Unedited Critiques Priority Score and Percentile Ranking Budget Recommendations Administrative Notes Viewable 4-6 weeks after review meeting Only available through the eRA Commons 5th Month 6th Month 7th Month Attend “For Your Review: NIH Mock Study Section” at 3:15pm today. 35

2nd Level Review National Advisory Council or Board assesses quality of 1st level review Concurs with or modifies IRG reocmmended action Reads summary statements only Can also designate application as “High” or “Low” program priority 8th Month 36

The Institute Director has the final funding decision. Funding Decisions The Institute Director has the final funding decision. Factors Considered in Funding Selections: Scientific Merit Contribution to Institute Mission Program Balance Availability of Funds 37

Timeline: New Applications 1 – 9 1.3 1.9 1.6 Receipt Date February 5 June 5 October 5 Scientific Review July October March Council Review October January May Award Date December April July http://grants.nih.gov/grants/funding/submissionschedule.htm 38

Fundamentals of the Grants Process NIH OFFICE OF EXTRAMURAL PROGRAMS Fundamentals of the Grants Process Program Staff Pre- and Post-Award 39

Do I Contact NIH Before Applying? Mandatory: Application with budget >$500,000 direct costs for any single year R13 Conference Grants Optional: When RFA’s request a Letter of Intent Recommended: When you think about applying for any grant “Working with NIH Program Officials: PreAward & PostAward at 9:45am tomorrow. 40

Program Officials’ Role At Review Meeting Note reviewer enthusiasms and concerns After Review Meeting Discuss Summary Statements with applicants Advise on resubmission process At Advisory Council Report and address any unresolved review concerns Human Subjects Animal Welfare Address requirements for foreign applications 41

Program Officials’ Role After Advisory Council Make funding recommendations to IC Director based on: Impact/Priority Score and Percentile Areas of Emphasis Portfolio Balance Resolve overlap issues with GMS After Award Evaluate Progress Report Make recommendations on prior approval requests 42

Non-Competing Continuation Progress Reports (Form 2590) Program Official evaluates progress report Satisfactory progress? Change in the scope, goals, or objectives? Change in key personnel or level of effort? Evidence of scientific overlap? Human subject issues or concerns? Animal welfare issues or concerns? Genome-Wide Association Study sharing? Biohazard reporting? Invention that must be reported? Adherence to Public Access Policy? Other issues that must be resolved? 43

Fundamentals of the Grants Process NIH OFFICE OF EXTRAMURAL PROGRAMS Fundamentals of the Grants Process Grants Management Pre- and Post-Award 44

Grants Management’s Role Prior to Award Review Applications Budgets Just-In-Time Information FSR (if applicable) Assure compliance with Federal law and NIH and IC policies and procedures Apply IC funding policies Prepare Notice of Award After Award Review Progress Report Provide official response to prior approval requests 45

Just-In-Time Information Not required for review, but required to make an award. JIT Information Certification of Education on Human Subjects Institutional Review Board (IRB) approval Required within 1 year and before any human subjects research begins. Institutional Animal Care and Use Committee (IACUC) Approval Required within 3 years and before animal research begins. Information on “Other Support” received by Senior/Key Personnel 46

Award Negotiation & Issuance Many steps between a funding decision and a grant award Grants management staff work closely with grantee and NIH program staff to complete this final process Funding approval from Program Award Received by Grantee Final review & Negotiations Investigator Begins Work Congressional Liaison Notified Award Issued 9th Month 10th Month 47

Human Subjects Protection Safeguarding the rights and welfare of individuals who participate as subjects in research based on DHHS regulations and established, internationally recognized ethical principles DHHS Office of Human Subjects Research Protections (OHRP) oversees all issues for Federally-funded research involving people Refer to website for information and resources OHRP Office of Human Research Protections www.hhs.gov/ohrp Attend ““Research Involving Human Subjects Primer for Investigators” at 9:45am tomorrow. 48

Humane Animal Research Grantees are responsible for the humane care and treatment of animals under NIH-supported activities. NIH Office of Laboratory Animal Welfare (OLAW) oversees policies for humane animal care and use. Refer to website for information and resources grants.nih.gov/grants/olaw “Attend Research Involving… “at 3:15pm today or 2:30pm tomorrow. 49

Fundamentals of the Grants Process NIH OFFICE OF EXTRAMURAL PROGRAMS Fundamentals of the Grants Process Notice of Award (and after) 50

LEGALLY BINDING DOCUMENT Notice of Award (NoA) LEGALLY BINDING DOCUMENT Award Data & Fiscal Information Grant Payment Information OIG* Hotline Information Terms and Conditions * Office of the Inspector General Attend “Common Compliance Pitfalls and Strategies for Success…” at 3:15pm today or 12:45 tomorrow. 51

Grantee Acceptance The grantee indicates acceptance of the terms and conditions of the award by drawing down funds against the grant from the Payment Management System. 52

After the Award… Administrative and Fiscal Monitoring Requirements Annual Progress Report (PHS 2590) Annual Financial Status Reports (FSR) Invention Reporting Yearly Audits (as applicable) Final Closeout Reports Attend “After the Award is Made…Then What” at 3:15pm today or 2:30pm tomorrow. 53

Take Home Messages Lots of directions and opportunities at the NIH Monitor IC 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 IC mission and priorities Best grant mechanism or program Best study section for review Participate in workshops and symposia Participate in review of grant applications (study sections)

Path to Success at NIH Step #1: Do your homework; learn a bit about the grant process and the options. Office of Extramural Research: Basics - http://grants.nih.gov/grants/grant_basics.htm Overview - http://grants.nih.gov/grants/grants_process.htm IC priorities: http://www.nih.gov/icd/index.html NIH Guide Provides Weekly Updates on Funding Opportunities: http://grants.nih.gov/grants/guide/ Step #2: Contact us…we’re here to help you.