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THE NIH GRANTS PROCESS from the “Macro” to the “Micro” Level and INFORMATION TECHNOLOGY: New Directions at the NIH. Thorsten A. Fjellstedt, Ph.D. Center for Information Technology National Institutes Of Health Bethesda (301) 496-3680 North Carolina (919) 967-0679 fjellst@mail.nih.gov.
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THE NIH GRANTS PROCESSfrom the“Macro” to the “Micro” LevelandINFORMATION TECHNOLOGY:New Directions at the NIH • Thorsten A. Fjellstedt, Ph.D. • Center for Information Technology • National Institutes Of Health • Bethesda (301) 496-3680 • North Carolina (919) 967-0679 • fjellst@mail.nih.gov
OVERALL OUTLINE The Federal Role of the NIH The NIH Mission How the NIH does its Job How the Institutes are organized and Why The Tools the NIH has to do its job Facts and statistics about the NIH The scale of the NIH enterprise The NIH application receipt, referral and review process (How extramural programs operate) The role of information technology in extramural programs Future directions
What is the Federal Role of the NIH? Congressional Appropriation Improved Public Health NIH
What is the Scientific role of the NIH ? Human Biology: Biological, Social and Behavioral Processes Medical Advances/Improved Public Health NIH At the intersection of Biology and Public Health
Why Are There So Many NIH Institutes? Public Health Need Congressional Interest Public Interest
Who are the Stakeholders? • Interest groups • Congress/geography focused • The general public and disease focused groups (survivors, etc.) • Granters • NIH—Institutes/Centers • Non-profit foundations • Grantee • Grantee—Institutions/Deans • Grantee—Investigators • Commercial • Biotechnology companies • Pharmaceutical companies • Other support offers
How Is The NIH Organized? NIH Extramural Funding Components CA—National Cancer Institute (NCI) HL—National Heart, Lung, and Blood Institute (NHLBI) DK—National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) LM—National Library of Medicine (NLM) HD—National Institute of Child Health and Human Development (NICHD) DC—National Institute of Deafness and Other Communication Disorders (NIDCD) ES—National Institute of Environmental Health Sciences (NIEHS) NS—National Institute of Neurological Disorders and Stroke (NINDS) AG—National Institute on Aging (NIA) AI—National Institute of Allergy and Infectious Diseases (NIAID) AR—National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) DE—National Institute of Dental and Craniofacial Research (NIDCR) EY—National Eye Institute (NEI) GM—National Institute of General Medical Sciences (NIGMS) MH—National Institute of Mental Health (NIMH) NR—National Institute for Nursing Research (NINR) AA—National Institute on Alcohol Abuse and Alcoholism (NIAAA) DA—National Institute on Drug Abuse (NIDA) AT—National Center for Complementary and Alternative Medicine (NCCAM) RR—National Center for Research Resources (NCRR) HG—National Human Genome Research Institute (NHGRI) EB—National Institute of Biomedical Imaging and Bioengineering (NIBIB) TW—John E. Fogarty International Center (FIC) MD—National Center on Minority Health and Health Disparities (NCMHD) OD—Office of the Director (NIH) CL—Warren Grant Magnuson Clinical Center (CC)* RR—Center for Scientific Review (CSR) WH—Office of Research on Women’s Health (ORWH) DS—Division of Safety (DS)* *Does not make Extramural Awards
How Are The NIH Institutes Organized? Director Intramural Director Extramural Director Intramural Program Extramural Program Research Laboratories on NIH Campus and Elsewhere Divisions/Centers/ Branches (Managing External Funding)
How Do The Institutes/Centers Support Research? Director Intramural Program Extramural Program Fund Research at Universities and Research Institute Supports Research Laboratories on NIH Campus and Elsewhere
What Tools Does The NIH Have To Support Extramural Research? Grants Cooperative Agreements Contracts Assistance to recipient Institution Same as above but with close coordination with NIH staff Procurement mechanism
The scale of the NIH enterprise Facts and Statistics About the NIH
Statistics about the NIH • NIH accounts for approximately 30% of the total national support for Health R&D. • NIH obligations account for approximately 79% of the Federal share of obligations for Health R&D . • Approximately 80% of the NIH Budget is devoted to extramural awards. • Over 90% of NIH’s extramural awards are grants.
What’s Involved • NIH budget of approximately $27 billion • Over 65,000 new or competing applications • Almost 10,000 new and competing grant awards • Over 38,000 grant awards • Operate 3,166 study section meetings • Support the 80 council meetings • Approximately 200 million pieces of paper • Maintain historical records (1973-Present) • Multiple reports and analysis
How does the NIH carry out its responsibility to Congress and to the Public? Two Key Responsibilities NIH must manage the budget NIH must manage and guide the biomedical research it supports
THE NIH PROCESS OVERVIEW Grantee Institution Non-competing application New Grant application NIH Guide Announcement Issue notice of grant award (NGA) Negotiate with other ICs Evaluate non-competing applications NIH Award Grants to successful applicants Develop research initiatives Monitor funded grants
Grant Application Cycle: The Individuals Principal Investigator and Grants Official NIH Program Administrator and Grants Management Staff Scientific Review Administrator and Grants Technical Assistant
Roles of the Scientific Program Manager Assess Portfolio Balance Identify Gaps in Scientific Programs Develop New Initiatives Work with Grantees/ Applicants Scientific Program Manager Coordinate with other ICs/Divisions/Groups Think about science Monitor Progress of Projects Browse Science Communicate with review staff on program matters Produce Reports
Roles of the Scientific Review Administrator Scientific ReviewAdministrator Nominate SRG members Produce Reports Manage SRG meetings Assign review responsibilities Select ad hoc reviewers and site visitors Communicate to Advisory Councils regarding SRG recommendations Think about science Communicate with program staff on review matters Provide orientation for SRG members Browse Science Prepare summary statements
Roles of the Grants Management Specialist Provide business guidance to applicants and reviewers Assist in developing program policy Interpret and apply grant policy Maintain official grant files Provide fiscal management of grants Grants Management Specialist Coordinate with other ICs/Divisions/Groups Attend SRG meetings as resource Participate with program staff in budget negotiations prior to and following award Manage Overall budget Produce Reports Award Grants
Budget “Balancing” Issuesat the NIH Balancing a VERY BIG Checkbook
Budgetary Issues to Consider NIH projects have future-year commitments (most projects have 4-5 future years of commitments) The NIH often does not have a budget at the beginning of the fiscal year (NIH is frequently on a continuing resolution at the beginning of the fiscal year) Sometimes funds are withheld at various levels Scientific initiatives take time to initiate and fund (It is frequently 9 to 12 months to go from a concept to a funded project) Congress often directs scientific initiatives The cost of supporting science inflates rapidly
Initiating new Science at the NIH Time Line “0” Months “3-4” Months Conceptualize Initiative Outside Input Develop Written Initiative (RFA/PA) Time Line (Continued) “3-4” Months “6-7” Months “9-10” Months “12” Months Publish Announcement Receive/Review Applications Council Meeting Develop Funding Plan Fund Applications
Funding Grants—It isn’t as easy as it appears Current Yr 1st Future Yr 2nd Future Yr 3rd Future Yr 4th Future Yr Type 1 Type 2 Awarded this Year Type 5 Awarded last Year Type 5 Awarded 2 Yrs Ago Type 5 This simple diagram depicts two assumptions that are not true 1)Future year commitments remain the same 2)The NIH funds the same dollar value of grants each year Awarded 3 Yrs Ago Type 5 Awarded 4Yrs Ago
Funding Grants—It isn’t as easy as it appears—Grant Cost Escalation Current Yr 1st Future Yr 2nd Future Yr 3rd Future Yr 4th Future Yr Type 1 Type 2 Awarded this Year Type 5 Awarded last Year Type 5 Awarded 2 Yrs Ago Type 5 Awarded 3 Yrs Ago Thus, the commitment of funds in the each future year is significantly greater than the current year for the same group of grants. (Example—1st Future yr) Type 5 Awarded 4Yrs Ago
NIH Budget AllocationsGrant Related Research Project Grants Research Centers Institutional Training Individual Training Other Research Related SBIR-STTR
The NIH Application Receipt, Referral and Review Process From the “Macro” to the “Micro”
THE NIH PROCESS OVERVIEW Grantee Institution Non-competing application New Grant application NIH Guide Announcement Issue notice of grant award (NGA) Negotiate with other ICs Evaluate non-competing applications NIH Award Grants to successful applicants Develop research initiatives Monitor funded grants
THE NIH PROCESS OVERVIEW Drilling Down in Detail RECEIPT REFERRAL REVIEW COUNCIL AWARD
Cycle 2 Receipt Council Review Award Referral Cycle 3 Receipt Council Review Award Referral Overall TimeframeSubmission to Award • There are three overlapping cycles per year : JAN FEB MAR APR MAY JUN JUL AUG SEP OCT NOV DEC JAN FEB MAR APR MAY JUN JUL Cycle1 Receipt Review Council Award Referral
Receipt Dates Depends on the Type of Application Jan 10 May 10 Sept 10 Institutional Training Applications Academic Research Enhancement Award Applications New Research Applications Revised Applications Competing Continuation Applications Supplemental Applications Small Business Technology Transfer Research Applications Small Business Innovation Research Applications Individual NRSA Applications AIDS Applications Jan 25 May 25 Sept 25 Feb 1 June 1Oct 1 Mar 1 July 1Nov 1 April 1 Aug 1 Dec 1 April 5 Aug 5 Dec 5 May 1 Sept 1 Jan 1
THE GRANTS PROCESS Time Line Grant Application Application submitted to Center for Scientific Review -- NIH Application submitted to Center for Scientific Review -- NIH Receipt Deadline Center For Scientific Review (CSR) Center For Scientific Review (CSR) 1 Month Assigned To Institutes Assigned To Initial Review Group (IRG) NIH CSR Referral Institutes Office Assignment to Program official within each Institute Initial Review Group 3-5 Months Scientific Review Administrator (SRA) Assigns application to reviewers Reviewers prepare written critique Applications Reviewed by IRG members SRA uploads scores into IMPAC Study Section Institute staff review summary statements using the Electronic Council Book Meeting 6 Months SRA prepares Summary Statement Council members access the Electronic Council Book Summary statement uploaded into IMPAC system Advisory 7 Months Committee Meeting Funding Decision by IC Award Grant to Notify Unsuccessful 9 - 22 Months Successful Applicants Applicants
THE GRANTS PROCESS Time Line Grant Application Application submitted to Center for Scientific Review -- NIH Receipt Deadline Center for Scientific Review (CSR) Assigned To Institutes 1 Month CSR Referral Office NIH Institutes Assigned To Initial Review Group (IRG) Assignment to Program official within each Institute Initial Review Group 3-5 Months Scientific Review Administrator (SRA) Assigns application to reviewers Reviewers prepare written critique Applications Reviewed by IRG members SRA uploads scores into IMPAC Study Section Institute staff review summary statements using the Electronic Council Book Meeting 6 Months SRA prepares Summary Statement Council members access the Electronic Council Book Summary statement uploaded into IMPAC system Advisory 7 Months Committee Meeting Funding Decision by IC Award Grant to Notify Unsuccessful 9 - 22 Months Successful Applicants Applicants
Flow of a Competing Grant Application Through the CSR Referral Section Project Control Unit: Receipt & Record Group (Process, Enter Skeletal Data into Computer, Print Status) Mailroom (Receive, Date Stamp, Preliminary Sort, Add Bar Code) Application (Original & 5 Copies) Assignment Unit: (Assign to Scientific Review Group and Awarding Organization) (Advance Copy) Scientific Review Group Project Control Unit: Review & Control Group (Add Labels, Send Data to IMPAC, Print Mailers, Distribute) (2 Copies) Scientific Review Group (Original) Print Shop (1 copy) OPERA EIS,DMC (1 copy) Project Control Files (35 copies) SRG (20 copies) Original Awarding Organization (1 copy) Project Control (1 copy) Research Documents (IC only)
Flow of a Competing Grant Application Through the CSR Referral Section Project Control Unit: Receipt & Record Group (Process, Enter Skeletal Data into Computer, Print Status) Mailroom (Receive, Date Stamp, Preliminary Sort, Add Bar Code) Application (Original & 5 Copies) Assignment Unit: (Assign to Scientific Review Group and Awarding Organization) (Advance Copy) Scientific Review Group Project Control Unit: Review & Control Group (Add Labels, Send Data to IMPAC, Print Mailers, Distribute) (2 Copies) Scientific Review Group (Original) Print Shop (1 copy) OPERA EIS,DMC (1 copy) Project Control Files (35 copies) SRG (20 copies) Original Awarding Organization (1 copy) Project Control (1 copy) Research Documents (IC only)
Flow of a Competing Grant Application Through the CSR Referral Section Project Control Unit: Receipt & Record Group (Process, Enter Skeletal Data into Computer, Print Status) Mailroom (Receive, Date Stamp, Preliminary Sort, Add Bar Code) Application (Original & 5 Copies) Assignment Unit: (Assign to Scientific Review Group and Awarding Organization) (Advance Copy) Scientific Review Group Project Control Unit: Review & Control Group (Add Labels, Send Data to IMPAC, Print Mailers, Distribute) (2 Copies) Scientific Review Group (Original) Print Shop (1 copy) OPERA EIS,DMC (1 copy) Project Control Files (35 copies) SRG (20 copies) Original Awarding Organization (1 copy) Project Control (1 copy) Research Documents (IC only)
Flow of a Competing Grant Application Through the CSR Referral Section Project Control Unit: Receipt & Record Group (Process, Enter Skeletal Data into Computer, Print Status) Mailroom (Receive, Date Stamp, Preliminary Sort, Add Bar Code) Application (Original & 5 Copies) Assignment Unit: (Assign to Scientific Review Group and Awarding Organization) (Advance Copy) Scientific Review Group Project Control Unit: Review & Control Group (Add Labels, Send Data to IMPAC, Print Mailers, Distribute) (2 Copies) Scientific Review Group (Original) Print Shop (1 copy) OPERA EIS,DMC (1 copy) Project Control Files (35 copies) SRG (20 copies) Original Awarding Organization (1 copy) Project Control (1 copy) Research Documents (IC only)
HOW ARE ASSIGNMENTS MADE? • TO STUDY SECTIONS BASED ON: • Specific Review Guidelines of Each Study Section • TO INSTITUTES BASED ON: • Overall Mission of The Institute • Specific Programmatic Mandates and Interests of the Institute
How Is The NIH Organized? NIH Extramural Funding Components CA—National Cancer Institute (NCI) HL—National Heart, Lung, and Blood Institute (NHLBI) DK—National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) LM—National Library of Medicine (NLM) HD—National Institute of Child Health and Human Development (NICHD) DC—National Institute of Deafness and Other Communication Disorders (NIDCD) ES—National Institute of Environmental Health Sciences (NIEHS) NS—National Institute of Neurological Disorders and Stroke (NINDS) AG—National Institute on Aging (NIA) AI—National Institute of Allergy and Infectious Diseases (NIAID) AR—National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) DE—National Institute of Dental and Craniofacial Research (NIDCR) EY—National Eye Institute (NEI) GM—National Institute of General Medical Sciences (NIGMS) MH—National Institute of Mental Health (NIMH) NR—National Institute for Nursing Research (NINR) AA—National Institute on Alcohol Abuse and Alcoholism (NIAAA) DA—National Institute on Drug Abuse (NIDA) AT—National Center for Complementary and Alternative Medicine (NCCAM) RR—National Center for Research Resources (NCRR) HG—National Human Genome Research Institute (NHGRI) EB—National Institute of Biomedical Imaging and Bioengineering (NIBIB) TW—John E. Fogarty International Center (FIC) MD—National Center on Minority Health and Health Disparities (NCMHD) OD—Office of the Director (NIH) CL—Warren Grant Magnuson Clinical Center (CC)* RR—Center for Scientific Review (CSR) WH—Office of Research on Women’s Health (ORWH) DS—Division of Safety (DS)* *Does not make Extramural Awards
Flow of a Competing Grant Application Through the CSR Referral Section Project Control Unit: Receipt & Record Group (Process, Enter Skeletal Data into Computer, Print Status) Mailroom (Receive, Date Stamp, Preliminary Sort, Add Bar Code) Application (Original & 5 Copies) Assignment Unit: (Assign to Scientific Review Group and Awarding Organization) (Advance Copy) Scientific Review Group Project Control Unit: Review & Control Group (Add Labels, Send Data to IMPAC, Print Mailers, Distribute) (2 Copies) Scientific Review Group (Original) Print Shop (1 copy) OPERA EIS,DMC (1 copy) Project Control Files (35 copies) SRG (20 copies) Original Awarding Organization (1 copy) Project Control (1 copy) Research Documents (IC only)
Flow of a Competing Grant Application Through the CSR Referral Section Project Control Unit: Receipt & Record Group (Process, Enter Skeletal Data into Computer, Print Status) Mailroom (Receive, Date Stamp, Preliminary Sort, Add Bar Code) Application (Original & 5 Copies) Assignment Unit: (Assign to Scientific Review Group and Awarding Organization) (Advance Copy) Scientific Review Group Project Control Unit: Review & Control Group (Add Labels, Send Data to IMPAC, Print Mailers, Distribute) (2 Copies) Scientific Review Group (Original) Print Shop (1 copy) OPERA EIS,DMC (1 copy) Project Control Files (35 copies) SRG (20 copies) Original Awarding Organization (1 copy) Project Control (1 copy) Research Documents (IC only)
Flow of a Competing Grant Application Through the CSR Referral Section Project Control Unit: Receipt & Record Group (Process, Enter Skeletal Data into Computer, Print Status) Mailroom (Receive, Date Stamp, Preliminary Sort, Add Bar Code) Application (Original & 5 Copies) Assignment Unit: (Assign to Scientific Review Group and Awarding Organization) (Advance Copy) Scientific Review Group Project Control Unit: Review & Control Group (Add Labels, Send Data to IMPAC, Print Mailers, Distribute) (2 Copies) Scientific Review Group (Original) Print Shop (1 copy) OPERA EIS,DMC (1 copy) Project Control Files (35 copies) SRG (20 copies) Original Awarding Organization (1 copy) Project Control (1 copy) Research Documents (IC only)
Sample Application Number Application Type Activity Code Institute Code Serial Number Support Year Extension 1 R01 CA 123456 01 A1 01 New Application Individual Research Grant National Cancer Institute Now Six Digits First Year First Amended Application Sub-project
Types of Scientific Review GroupsWhere are Applications Reviewed? GROUPS APPLICATIONS REVIEWED Research Projects CSR IRGs Academic Research Study Sections Enhancement Awards Postdoctoral Fellowships Special Emphasis Panels Small Business Innovation Research Shared Instrumentation INSTITUTES Program Projects Scientific Review Groups Centers Institutional Training Grants Conference Grants Career Awards Small Grants RFAs Contract Review Committees Contracts
THE GRANTS PROCESS Time Line Grant Application Application submitted to Center for Scientific Review -- NIH Receipt Deadline Center For Scientific Review (CSR) Assigned To Institutes 1 Month CSR Referral Office NIH Institutes Assigned To Initial Review Group (IRG) Assignment to Program official within each Institute Initial Review Group 3-5 Months Scientific Review Administrator (SRA) Assigns application to reviewers Reviewers prepare written critique Applications Reviewed by IRG members SRA uploads scores into IMPAC Study Section Meeting Institute staff review summary statements using the Electronic Council Book 6 Months SRA prepares Summary Statement Council members access the Electronic Council Book Summary statement uploaded into IMPAC system Advisory Committee Meeting 7 Months Funding Decision by IC Notify unsuccessful applicants Award Grants to successful applicants 9 - 22 Months
THE GRANTS PROCESS Time Line Grant Application Application submitted to Center for Scientific Review -- NIH Receipt Deadline Center For Scientific Review (CSR) Assigned To Institutes 1 Month CSR Referral Office NIH Institutes Assigned To Initial Review Group (IRG) Assignment to Program official within each Institute Initial Review Group 3-5 Months Scientific Review Administrator (SRA) Assigns application to reviewers Reviewers prepare written critique Applications Reviewed by IRG members SRA uploads scores into IMPAC Study Section Meeting Institute staff review summary statements using the Electronic Council Book 6 Months SRA prepares Summary Statement Council members access the Electronic Council Book Summary statement uploaded into IMPAC system Advisory Committee Meeting 7 Months Funding Decision by IC Notify unsuccessful applicants Award Grants to successful applicants 9 - 22 Months