nih fund

Fundamentals of the NIH Grants Process: 

Fundamentals of the NIH Grants Process NIH Regional Seminar on Program Funding and Grants Administration Research Triangle Park, NC April 25 – 26, 2007

Slide2: 

Harold Perl, PhD Center for the Clinical Trials Network National Institute on Drug Abuse Eileen Natoli Grants Management Branch National Cancer Institute

Topics: 

Topics Introduction to NIH History Mission & Organization NIH Funding Facts Fundamentals of the Grants Process Types of Grants Roles & Responsibilities Grantee Institution Team NIH Extramural Team Scientific Review Process NIH Staff Roles: Pre-Award & Post-Award Program Officials Grants Management Specialists Notice of Grant Award Web Resources and Links

Slide4: 

Introduction to the NIH

Birthplace of the NIH: 1887: 

Birthplace of the NIH: 1887 Up in the attic of the Marine Hospital Staten Island, New York

Slide6: 

October 31, 1940: President Franklin Roosevelt dedicates the first six buildings of NIH

NIH in 2007: 

NIH in 2007 One of 11 agencies under the Department of Health and Human Services (HHS) Comprised of 27 Institutes and Centers (IC)

Slide8: 

U. S. Department of Health and Human Services

NIH Mission: 

NIH Mission NIH is the steward of medical and behavioral research for the Nation Our mission: to acquire new knowledge to help prevent, detect, diagnose, and treat disease and disability—from the rarest genetic disorder to the common cold

Fulfilling the NIH Mission: 

Fulfilling the NIH Mission Conducting research in our own labs Supporting the research of non-Federal scientists throughout the country and abroad Helping in the training of research investigators Fostering communication of medical and health sciences information

Slide11: 

Office of the Director National Institute on Alcohol Abuse and Alcoholism National Institute of Arthritis and Musculoskeletal and Skin Diseases National Cancer Institute National Institute of Diabetes and Digestive and Kidney Diseases National Institute of Dental and Craniofacial Research National Institute on Drug Abuse National Institute of Environmental Health Sciences National Institute on Aging National Institute of Child Health and Human Development 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 Library of Medicine Center for Information Technology Center for Scientific Review National Center for Complementary and Alternative Medicine National Institute of Allergy and Infectious Diseases Fogarty International Center National Center for Research Resources Clinical Center National Institute of Biomedical Imaging and Bioengineering National Center on Minority Health and Health Disparities

Slide12: 

NIH Campus Today

Slide13: 

Amazing Facts @ NIH

Did You Know?: 

Did You Know? NIH is the Nation’s leading medical research agency NIH Bethesda campus is world’s largest research organization 6,000 scientists (18,000 employees) Over 50 members of the National Academy of Sciences, 5 Nobel Prizes 11 of 27 IC Directors are members of the Institute of Medicine … and 3 members of the Office of the Director NIH Extramural Research Program More than 105 Nobel Prize winners trained & funded by NIH Represents more than half of all American Nobel prizes

NIH gets 1% of the FY 2007 U.S. Budget ($ in Billions): 

NIH gets 1% of the FY 2007 U.S. Budget ($ in Billions)

What Stays at NIH? What Goes Elsewhere?: 

What Stays at NIH? What Goes Elsewhere? 84% Outside NIH > 325,000 Scientists > 3,000 Organizations Worldwide 16% Inside NIH $2.9 B Intramural Research (10%) $1.2 B Workers and Buildings (4%) $0.6 B Other (2%) Total Budget $29.2 Billion

Slide18: 

Data: Assoc of University Technology Managers (AUTM) Survey 2004 Alaska NIH Funding Across the U.S.

NIH Grant Statistics: 

NIH Grant Statistics More than 75,000 grant applications received (all mechanisms) 46,144 research grants awarded ($19.6 billion) 73% of NIH extramural awards go to institutions of higher education Fiscal Year 2006:

NIH Funding StatsResearch Project Grants: 

NIH Funding Stats Research Project Grants Fiscal Year 2006: Reviewed Awarded Success $$$ Rate New Applications 38,220 6,390 16.7% 2.17 B Continuation Applications 7,320 2,694 36.8% 1.17 B Competing Supplements 148 44 29.7% 0.01 B ___________________________________________ Totals 45,688 9,128 20.0% 3.36 B

Fundamentals of the NIH Grants Process:Grant Mechanisms: 

Fundamentals of the NIH Grants Process: Grant Mechanisms

What’s the Difference Between a Grant and a Contract?: 

What’s the Difference Between a Grant and a Contract? GRANT Assistance Government is Partner/Patron Purpose: to support and stimulate research Benefit a public purpose Investigator initiated CONTRACT Acquisition Government is purchaser Purpose: to acquire goods or services The direct benefit and use of the government Government initiated

Award Mechanisms:Research Project Grants: 

Award Mechanisms: Research Project Grants Traditional – R01 Exploratory/Development Grants – R03/R21/R33/R34 Program Project – P01 Research Center Grants – P50 Small Business – R41, R42, R43, R44

Research Training and Career Awards: 

Research Training and Career Awards Training Grants – T Institutional Predoctoral and Postdoctoral Fellowships – F Individual Predoctoral – F31 Postdoctoral – F32 Career Development Awards – K

Cooperative Agreements (U): 

Cooperative Agreements (U) Specialized Grant mechanism Substantial NIH staff involvement in program and science Typically initiated by NIH Cooperative Agreement Kiosk http://odoerdb2-2.od.nih.gov/oer/programs/coop/

Fundamentals of the NIH Grants Process:Team Players: 

Fundamentals of the NIH Grants Process: Team Players

Slide27: 

The Grantee Institution Team

The Grantee Institution: 

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

Responsibilities of the Authorized Organization Representative (AOR) [aka Authorized Organizational Official (AO)][aka Signing Official (SO)]: 

Responsibilities of the Authorized Organization Representative (AOR) [aka Authorized Organizational Official (AO)] [aka Signing Official (SO)] Designated representative of the grantee institution Accountable for appropriately utilizing Federal funds and for the performance of a project Signs all official correspondence to NIH, including the grant application

Responsibilities of the Principal Investigator(s) (PIs): 

Responsibilities of the Principal Investigator(s) (PIs) Designated by the grantee institution Responsible for the scientific and technical aspects of project Assures scientific compliance by maintaining contact with the Program Director Ensures Federal support is acknowledged in publications Can have Multiple Principal Investigators Leadership Plan

Responsibilities of the Research Administrator: 

Responsibilities of the Research Administrator Acts as an agent of the Principal Investigator and the Authorized Institutional Official 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 Official or the PI

Slide32: 

The NIH Extramural Team Program Staff Review Staff Grants Management

If someone needs help with their application before the review?…Who They Gonna’ Call?: 

If someone needs help with their application before the review?… Who They Gonna’ Call?

Scientific Review Administrator(SRA): 

Scientific Review Administrator (SRA) Responsible for the scientific and technical review of applications.

Slide35: 

SRA’s responsibilities to NIH AND THE FEDERAL GOVERNMENT Ensure fair and unbiased evaluation of the scientific and technical merit of the proposed research in accordance with all applicable laws, regulations, rules, policies and guidelines that govern the evaluation of grant applications, cooperative agreements and R&D contracts Provide and accurate summary of the evaluation to the NIH funding component so that they can provide the information to the National Advisory Councils who make recommendations to the institute so that Institutes can make the decision to fund or not to fund.

If someone needs help with scientific and technical aspects of their application?…Who They Gonna’ Call?: 

If someone needs help with scientific and technical aspects of their application?… Who They Gonna’ Call?

Program Administrator (aka Program Officer, Program Director or Program Official): 

Program Administrator (aka Program Officer, Program Director or Program Official) Responsible for the programmatic, scientific, and/or technical aspects of a grant

If someone needs help with business aspects of their application?…Who They Gonna’ Call?: 

If someone needs help with business aspects of their application?… Who They Gonna’ Call?

Chief Grants Management Officer (CGMO): 

Chief Grants Management Officer (CGMO) Responsible for ensuring that all required business management actions are performed by the grantee and the federal government in a timely and appropriate manner both prior to and after award.

The Grants Management Specialist can help to…: 

The Grants Management Specialist can help to… Answer questions about completing application forms Provide guidance on the administrative and fiscal aspects of an award Help navigate NIH grants management information on the Web

Fundamentals of the NIH Grants Process: Scientific Review : 

Fundamentals of the NIH Grants Process: Scientific Review

Center for Scientific Review (CSR): 

Center for Scientific Review (CSR) Serves as central receipt point for most PHS applications Electronic via Grants.gov Paper via delivery service Assigns application to NIH Institute/Center Assigns application to peer review group CSR: Integrated Review Group/Study Section IC: Scientific Review Group CSR conducts initial scientific merit review of most NIH research applications

2 Level System for Application Review : 

2 Level System for Application Review National Advisory Council Assesses Quality of SRG Review Makes Recommendation to Institute Staff on Funding Evaluates Program Priorities and Relevance Advises on Policy Scientific Review Group (SRG) Independent outside reviewers Evaluate scientific merit & significance Recommend length and level of funding 1st Level 2nd Level

Receipt and Referral of Applications: 

Receipt and Referral of Applications CSR assigns application to Integrated Review Group (Legacy paper process) Application submitted to CSR CSR Referral Office CSR assigns application to NIH Institute CSR assigns application number 1st Month 2nd Month Application assessed for completeness & eligibility Notice of assignment available in eRA Commons in 4 weeks. NEW: Application on SF424 R&R submitted through grants.gov

Review of Applications: 

Review of Applications 23 CSR Integrated Review Groups 220 Standing Study Sections 319 Special Emphasis Panels in 2005 Review groups at each Institute Dozens of Standing Study Sections Several hundred SEP meetings 3rd Month 4th Month

Who Reviews Grant Applications?: 

Who Reviews Grant Applications? Scientists with appropriate expertise are recruited by SRA Assigned to applications based on specific content 4 year term typical Temporary reviewers sought as needed

1st Level Review: 

1st Level Review Standing study section typically has 12-24 members 3 face-to-face meetings each year Review 60 - 100 applications at each meeting

After 1st Level Review: 

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 Available 4-6 weeks after review meeting Only via the eRA Commons 5th Month 6th Month 7th Month

2nd Level Review: 

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

Who Makes Actual Funding Decisions?: 

Who Makes Actual Funding Decisions? The Institute Director! Factors Considered: Scientific Merit Contribution to Institute Mission Program Balance Availability of Funds

Timeline: New Applications: 

Timeline: New Applications Receipt Date February 5 June 5 October 5 Scientific Review July October March Council Review October January May Award Date December April July 2.5 1.7 2.2

Slide52: 

http://grants.nih.gov/grants/funding/submissionschedule.htm

SF424 (R&R) Application and Electronic Submission: 

SF424 (R&R) Application and Electronic Submission Get More Information http://era.nih.gov/ElectronicReceipt http://grants.nih.gov/grants/guide/notice-files/NOT-OD-05-067.html The Time is Now!

Slide54: 

Program Staff: Pre-Award and Post-Award

Program Officials’ Role in Application Development: 

Program Officials’ Role in Application Development Develop concepts for IC Initiatives Communicate goals of IC Initiatives Advise applicants on funding mechanisms Provide application writing advice and study section information Advise on application procedures, requirements and general grant policy

Do I Contact NIH Before Applying?: 

Do I Contact NIH Before Applying? Mandatory: Applications with budgets >$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

Program Officials’ Role At & After Review Meetings: 

Program Officials’ Role At & After Review Meetings Attend and Observe Review Meetings Note Reviewer Concerns and Enthusiasms Discuss Summary Statements and Issues Raised with Applicants Discuss Appeal Issues with Applicant and the SRA

Program Officials’ Role at Council Meetings: 

Program Officials’ Role at Council Meetings Report and address any unresolved review concerns Address foreign institution requirements Prepare appeal packages for council review

 Program Officials’ Role in Funding Decisions : 

Program Officials’ Role in Funding Decisions Prepare Recommendations for Institute Director Priority Score/Percentile Areas of Emphasis Portfolio Balance

Attending to Overlap Issues: 

Attending to Overlap Issues Both the Program Official and the Grants Management Specialist are responsible for determining the appropriate time and effort for personnel overlapping support of related research duplicated budgetary items, such as equipment Overlap may be on a funded or pending grant, from any source Questions of overlap must be resolved with the grants management staff and the PI Appropriate budgetary adjustments must be made prior to an award

Human Subjects Protection: 

Human Subjects Protection Office of Human Subjects Research Protections (OHRP) oversees all issues for Federally funded research involving people Independent office within DHHS Refer to website for information and resources http://www.hhs.gov/ohrp/

Post-Award Grant Stewardship  by Program Officials : 

Post-Award Grant Stewardship by Program Officials Reviews annual non-competing renewal applications Evaluates scientific portions of renewal documents Assists grantees during award period

Non-Competing Continuation Progress Reports (Form 2590): 

Non-Competing Continuation Progress Reports (Form 2590) PO 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? Invention that must be reported? Other issues that must be resolved?

Slide64: 

Grants Management: Pre-Award and Post-Award

Budget Review: 

Budget Review Modular budget vs. Categorical budget Modular in $25,000 increments up to $250,000 Budget Justification Type 2 Cap (if applicable) * Type 2 is a competitive renewal application

Grants Management Issues: 

Grants Management Issues Assurances in Place – Office of Human Research Protections (humans) Office of Laboratory Animal Welfare (animals) Financial Status Report - (FSR) - (SF 269-long form) – if applicable Human Subjects Education Performance Site(s)/Consortium(s) information Checklist completeness Just-In-Time Information (see next slide)

Just-In-Time Information: 

Just-In-Time Information IRB* Approval within 1 year Certification of Education on Human Subjects IACUC** Approval within 3 years Other Support of Key Personnel *IRB: Institutional Review Board (human subjects) **IACUC: Institutional Animal Care & Use Committee

Grants Management: Special Issues: 

Grants Management: Special Issues For Example: Are there bars to the award? (Code 44 for Human Subjects) (Code 44 for Animal Subjects) Is there Foreign Involvement?

Award Negotiation & Issuance: 

Award Negotiation & Issuance 9th Month 10th Month Funding approval from Program Award Issued Final review & Negotiations Congressional Liaison Notified Award Received by Grantee Investigator Begins Work

Slide70: 

The Notice of Grant Award Content Overview of Terms and Conditions

Notice of Grant Award (NGA): Overview: 

Notice of Grant Award (NGA): Overview LEGALLY BINDING DOCUMENT Award Data & Fiscal Information Grant Payment Information OIG* Hotline Information Terms and Conditions * Office of the Inspector General

Grantee Acceptance: 

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.

Slide73: 

After the NGA… What Next?

 Administrative and Fiscal Monitoring: 

Administrative and Fiscal Monitoring Annual Progress Report (PHS 2590) Annual Financial Status Reports (FSR)

Slide75: 

Web-based Resources

Resources/Links (1): 

Resources/Links (1) Office of Extramural Research Grants Home Page: http://grants.nih.gov/grants/oer.htm NIH Grants Policy Statement (12/03): http://grants.nih.gov/grants/policy/nihgps_2003/index.htm NIH Guide: http://grants.nih.gov/grants/guide/index.html SF 424 (R&R): http://grants.nih.gov/grants/funding/424/index.htm PHS 398 Application (form pgs are PDF-fillable): http://grants1.nih.gov/grants/funding/phs398/phs398.html

Resources/Links (2): 

Resources/Links (2) PHS 2590 Progress Report (Form pgs are PDF-fillable): http://grants.nih.gov/grants/funding/2590/2590.htm Grants Administration Information Sources (Contact information for Grants Administration staff at all NIH ICs): http://grants.nih.gov/grants/policy/grants_info.pdf eRA Website: http://era.nih.gov/ Contact list for NIH Chief Grants Management Officers: http://grants.nih.gov/grants/stafflist_gmos.htm

Resources/Links (3): 

Resources/Links (3) OER Help and Other Resources (Includes Organizational Charts) http://grants.nih.gov/grants/welcome.htm#new Handy Reference: Activity Code, Organization Codes and Definitions Used In Extramural Programs http://grants.nih.gov/grants/funding/ac.pdf Grants Administration Manual 4204-204B Peer Review Process http://www3.od.nih.gov/oma/manualchapters/grants/4204-204B/ Center for Scientific Review (CSR) http://cms.csr.nih.gov/