THE NIH GRANTS PROCESS from the “Macro” to the “Micro” Level and INFORMATION TECHNOLOGY: New...

THE NIH GRANTS PROCESS from the Macro to the Micro Level and INFORMATION TECHNOLOGY: New Directions at the NIH Thorsten A. Fjellstedt, Ph.D. Thorsten A. Fjellstedt, Ph.D. Center for Information Technology Center for Information Technology National Institutes Of Health National Institutes Of Health Bethesda (301) 496-3680 Bethesda (301) 496-3680 North Carolina (919) 967-0679 North Carolina (919) 967-0679 [email protected] [email protected] Thorsten A. Fjellstedt, Ph.D. Thorsten A. Fjellstedt, Ph.D. Center for Information Technology Center for Information Technology National Institutes Of Health National Institutes Of Health Bethesda (301) 496-3680 Bethesda (301) 496-3680 North Carolina (919) 967-0679 North Carolina (919) 967-0679 [email protected] [email protected]

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 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? NIHNIH Improved Public Health Congressional Appropriation

What is the Scientific role of the NIH ? NIH At the intersection of Biology and Public Health NIH Medical Advances/Improved Public Health Human Biology: Biological, Social and Behavioral Processes Human Biology: Biological, Social and Behavioral Processes

Why Are There So Many NIH Institutes? Public Health Need Congressional Interest Public Interest 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.) GrantersNIHInstitutes/Centers Non-profit foundations GranteeGranteeInstitutions/DeansGranteeInvestigatorsCommercial Biotechnology companies Pharmaceutical companies Other support offers Interest groups Congress/geography focused The general public and disease focused groups (survivors, etc.) GrantersNIHInstitutes/Centers Non-profit foundations GranteeGranteeInstitutions/DeansGranteeInvestigatorsCommercial Biotechnology companies Pharmaceutical companies Other support offers

NIH Extramural Funding Components CANational Cancer Institute (NCI) HLNational Heart, Lung, and Blood Institute (NHLBI) DKNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) LMNational Library of Medicine (NLM) HDNational Institute of Child Health and Human Development (NICHD) DCNational Institute of Deafness and Other Communication Disorders (NIDCD) ESNational Institute of Environmental Health Sciences (NIEHS) NSNational Institute of Neurological Disorders and Stroke (NINDS) AGNational Institute on Aging (NIA) AINational Institute of Allergy and Infectious Diseases (NIAID) ARNational Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) DENational Institute of Dental and Craniofacial Research (NIDCR) EYNational Eye Institute (NEI) GMNational Institute of General Medical Sciences (NIGMS) MHNational Institute of Mental Health (NIMH) NRNational Institute for Nursing Research (NINR) AANational Institute on Alcohol Abuse and Alcoholism (NIAAA) DANational Institute on Drug Abuse (NIDA) ATNational Center for Complementary and Alternative Medicine (NCCAM) RRNational Center for Research Resources (NCRR) HGNational Human Genome Research Institute (NHGRI) EBNational Institute of Biomedical Imaging and Bioengineering (NIBIB) TWJohn E. Fogarty International Center (FIC) MDNational Center on Minority Health and Health Disparities (NCMHD) ODOffice of the Director (NIH) CLWarren Grant Magnuson Clinical Center (CC)* RRCenter for Scientific Review (CSR) WHOffice of Research on Womens Health (ORWH) DSDivision of Safety (DS)* CANational Cancer Institute (NCI) HLNational Heart, Lung, and Blood Institute (NHLBI) DKNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) LMNational Library of Medicine (NLM) HDNational Institute of Child Health and Human Development (NICHD) DCNational Institute of Deafness and Other Communication Disorders (NIDCD) ESNational Institute of Environmental Health Sciences (NIEHS) NSNational Institute of Neurological Disorders and Stroke (NINDS) AGNational Institute on Aging (NIA) AINational Institute of Allergy and Infectious Diseases (NIAID) ARNational Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) DENational Institute of Dental and Craniofacial Research (NIDCR) EYNational Eye Institute (NEI) GMNational Institute of General Medical Sciences (NIGMS) MHNational Institute of Mental Health (NIMH) NRNational Institute for Nursing Research (NINR) AANational Institute on Alcohol Abuse and Alcoholism (NIAAA) DANational Institute on Drug Abuse (NIDA) ATNational Center for Complementary and Alternative Medicine (NCCAM) RRNational Center for Research Resources (NCRR) HGNational Human Genome Research Institute (NHGRI) EBNational Institute of Biomedical Imaging and Bioengineering (NIBIB) TWJohn E. Fogarty International Center (FIC) MDNational Center on Minority Health and Health Disparities (NCMHD) ODOffice of the Director (NIH) CLWarren Grant Magnuson Clinical Center (CC)* RRCenter for Scientific Review (CSR) WHOffice of Research on Womens Health (ORWH) DSDivision of Safety (DS)* How Is The NIH Organized? *Does not make Extramural Awards

How Are The NIH Institutes Organized? DirectorDirector Intramural Program Extramural Program Research Laboratories on NIH Campus and Elsewhere Divisions/Centers/Branches (Managing External Funding) Divisions/Centers/Branches Intramural Director Extramural Director

How Do The Institutes/Centers Support Research? DirectorDirector Intramural Program Extramural Program Supports Research Laboratories on NIH Campus and Elsewhere Fund Research at Universities and Research Institute

What Tools Does The NIH Have To Support Extramural Research? Assistance to recipient Institution Same as above but with close coordination with NIH staff Procurement mechanism Assistance to recipient Institution Same as above but with close coordination with NIH staff Procurement mechanism GrantsCooperativeAgreementsContractsGrantsCooperativeAgreementsContracts

The scale of the NIH enterprise Facts and Statistics About the NIH

Statistics about the NIH 4 NIH accounts for approximately 30% of the total national support for Health R&D. 4 NIH obligations account for approximately 79% of the Federal share of obligations for Health R&D. 4 Approximately 80% of the NIH Budget is devoted to extramural awards. 4 Over 90% of NIHs extramural awards are grants. 4 NIH accounts for approximately 30% of the total national support for Health R&D. 4 NIH obligations account for approximately 79% of the Federal share of obligations for Health R&D. 4 Approximately 80% of the NIH Budget is devoted to extramural awards. 4 Over 90% of NIHs extramural awards are grants.

Fiscal Year 2002 Total Extramural Expenditures

Approximate Distribution of NIH Expenditures

Approximate Distribution of NIH Appropriation

Whats Involved l NIH budget of approximately $27 billion l Over 65,000 new or competing applications l Almost 10,000 new and competing grant awards l Over 38,000 grant awards l Operate 3,166 study section meetings l Support the 80 council meetings l Approximately 200 million pieces of paper l Maintain historical records (1973-Present) l Multiple reports and analysis l NIH budget of approximately $27 billion l Over 65,000 new or competing applications l Almost 10,000 new and competing grant awards l Over 38,000 grant awards l Operate 3,166 study section meetings l Support the 80 council meetings l Approximately 200 million pieces of paper l Maintain historical records (1973-Present) l Multiple reports and analysis

How does the NIH carry out its responsibility to Congress and to the Public? NIH must manage the budget NIH must manage and guide the biomedical research it supports NIH must manage the budget NIH must manage and guide the biomedical research it supports Two Key Responsibilities

Grantee Institution THE NIH PROCESS OVERVIEW Award Grants to successful applicants Monitor funded grants Non-competingapplication Evaluatenon-competingapplications Issue notice of grant award (NGA) Develop research initiatives Negotiate with other ICs NIH Guide Announcement New Grant application NIHNIH

Grant Application Cycle : The Individuals Grant Application Cycle : The Individuals Principal Investigator and Grants Official Principal Investigator and Grants Official Scientific Review Administrator and Grants Technical Assistant Program Administrator and Grants Management Staff NIHNIH

Roles of the Scientific Program Manager Scientific Program Manager Think about science Work with Grantees/ Applicants Coordinate with other ICs/Divisions/ Groups Browse Scienc e ProduceReports Monitor Progress of Projects Assess Portfolio Balance Identify Gaps in Scientific Programs Develop New Initiatives Communicate with review staff on program matters

Scientific Review Administrator Manage SRG meetings Select ad hoc reviewers and site visitors Nominate SRG members Assign review responsibilities Prepare summary statements Communicate with program staff on review matters Provide orientation for SRG members Communicate to Advisory Councils regarding SRG recommendations Roles of the Scientific Review Administrator Think about science Browse Scienc e ProduceReports

Roles of the Grants Management Specialist Grants Management Specialist Provide business guidance to applicants and reviewers Coordinate with other ICs/Divisions/ Groups ProduceReports Attend SRG meetings as resource Assist in developing program policy Interpret and apply grant policy Maintain official grant files ManageOverallbudget Provide fiscal management of grants Participate with program staff in budget negotiations prior to and following award Award Grants

Budget Balancing Issues at the NIH Balancing a VERY BIG Checkbook

How Does the NIH Manage the Budget? The NIH gets an appropriation each FY. All appropriated funds must be obligated in that FY. The appropriation doesnt always happen at the beginning of the FY. New grants are funded each year. Almost ALL grants request funds for multiple yearsnominally 3 to 5 years. The NIH gets an appropriation each FY. All appropriated funds must be obligated in that FY. The appropriation doesnt always happen at the beginning of the FY. New grants are funded each year. Almost ALL grants request funds for multiple yearsnominally 3 to 5 years. What are the major issues?

How Does the NIH Manage the Budget? It takes almost a year to launch a scientific initiative and get the projects submitted, reviewed and funded. The NIH commitment to a grant is based on the assumption that funds will be available for future years. It takes almost a year to launch a scientific initiative and get the projects submitted, reviewed and funded. The NIH commitment to a grant is based on the assumption that funds will be available for future years. What are the major issues? (Continued)

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 ConceptualizeInitiativeOutsideInput Develop Written Initiative (RFA/PA) PublishAnnouncementReceive/ReviewApplicationsDevelop Funding Plan CouncilMeetingFundApplications Time Line Time Line (Continued) 0Months3-4Months 3-4Months6-7Months9-10Months12Months

Funding GrantsIt isnt as easy as it appears Type 1 Type 2 Type 5 Awarded this Year Awarded last Year Awarded 2 Yrs Ago Awarded 3 Yrs Ago Awarded 4Yrs Ago Current Yr 1 st Future Yr 2 nd Future Yr 3 rd Future Yr 4 th Future Yr This simple diagram depicts two assumptions that are not true 1)Future year commitments remain the same remain the same 2)The NIH funds the same dollar value of grants each year value of grants each year

Funding GrantsIt isnt as easy as it appearsGrant Cost Escalation Type 1 Type 2 Type 5 Awarded this Year Awarded last Year Awarded 2 Yrs Ago Awarded 3 Yrs Ago Awarded 4Yrs Ago Current Yr 1 st Future Yr 2 nd Future Yr 3 rd Future Yr 4 th Future Yr Thus, the commitment of funds in the each future year is significantly greater than the current year for the same group of grants. (Example1 st Future yr)

NIH Budget Allocations Grant Related Research Project Grants Research Centers Institutional Training Individual Training Other Research Related SBIR-STTR 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

Grantee Institution THE NIH PROCESS OVERVIEW Award Grants to successful applicants Monitor funded grants Non-competingapplication Evaluatenon-competingapplications Issue notice of grant award (NGA) Develop research initiatives Negotiate with other ICs NIH Guide Announcement New Grant application NIHNIH

THE NIH PROCESS OVERVIEW RECEIPT REFERRAL REVIEW COUNCIL AWARD Drilling Down in Detail

Overall Timeframe Submission to Award There are three overlapping cycles per year : 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 ReviewCouncil Cycle 1 Receipt Referral Award Review Council Cycle 3 Receipt Referral Award Review Council Cycle 2 Receipt Award Referral

Receipt Dates 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 Depends on the Type of Application Jan 10 May 10 Sept 10 Jan 25 May 25 Sept 25 Feb 1 June 1 Oct 1 Mar 1 July 1 Nov 1 April 1 Aug 1 Dec 1 April 5 Aug 5 Dec 5 May 1 Sept 1 Jan 1

CSR Referral Office GrantApplication NIH Institutes Initial Review Group Study Section Meeting Assigned To Institutes Assigned To Initial Review Group (IRG) (IRG) Scientific Review Administrator (SRA) Assigns application to reviewers Reviewers prepare written critique Applications Reviewed by IRG members SRA prepares Summary Statement Advisory Committee Meeting Assignment to Program official within each Institute Institute staff review summary statements using the Electronic Council Book Council members access the Electronic Council Book SRA uploads scores into IMPAC Award Grant to Successful Applicants Funding Decision by IC Receipt Deadline 1 Month 3-5 Months 6 Months 7 Months 9 - 22 Months Time Line THE GRANTS PROCESS Application submitted to Center for Scientific Review -- NIH Center for Scientific Review -- NIH Notify Unsuccessful Applicants Summary statement uploaded into IMPAC system Application submitted to Center for Scientific Review -- NIH Center for Scientific Review -- NIH Center For Scientific Review (CSR)

Applications Receipt Room

Center for Scientific Review Scientific Review(CSR) CSR Referral Office GrantApplication NIH Institutes Initial Review Group Study Section Meeting Assigned To Institutes Assigned To Initial Review Group (IRG) Scientific Review Administrator (SRA) Assigns application to reviewers Reviewers prepare written critique Applications Reviewed by IRG members SRA prepares Summary Statement Advisory Committee Meeting Assignment to Program official within each Institute Institute staff review summary statements using the Electronic Council Book Council members access the Electronic Council Book SRA uploads scores into IMPAC Award Grant to Successful Applicants Funding Decision by IC Receipt Deadline 1 Month 3-5 Months 6 Months 7 Months 9 - 22 Months Time Line Application submitted to Center for Scientific Review -- NIH Center for Scientific Review -- NIH Notify Unsuccessful Applicants Summary statement uploaded into IMPAC system THE GRANTS PROCESS

Flow of a Competing Grant Application Through the CSR Referral Section Application (Original & 5 Copies) Mailroom ( Receive, Date Stamp, Preliminary Sort, Add Bar Code) Project Control Unit: Receipt & Record Group (Process, Enter Skeletal Data into Computer, Print Status) Assignment Unit: (Assign to Scientific Review Group and Awarding Organization) (Advance Copy) Scientific Review Group (2 Copies) Scientific Review Group Project Control Unit: Review & Control Group (Add Labels, Send Data to IMPAC, Print Mailers, Distribute) (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? l TO STUDY SECTIONS BASED ON: Specific Review Guidelines of Each Study Section l TO INSTITUTES BASED ON: Overall Mission of The Institute Specific Programmatic Mandates and Interests of the Institute l TO STUDY SECTIONS BASED ON: Specific Review Guidelines of Each Study Section l TO INSTITUTES BASED ON: Overall Mission of The Institute Specific Programmatic Mandates and Interests of the Institute

NIH Extramural Funding Components CANational Cancer Institute (NCI) HLNational Heart, Lung, and Blood Institute (NHLBI) DKNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) LMNational Library of Medicine (NLM) HDNational Institute of Child Health and Human Development (NICHD) DCNational Institute of Deafness and Other Communication Disorders (NIDCD) ESNational Institute of Environmental Health Sciences (NIEHS) NSNational Institute of Neurological Disorders and Stroke (NINDS) AGNational Institute on Aging (NIA) AINational Institute of Allergy and Infectious Diseases (NIAID) ARNational Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) DENational Institute of Dental and Craniofacial Research (NIDCR) EYNational Eye Institute (NEI) GMNational Institute of General Medical Sciences (NIGMS) MHNational Institute of Mental Health (NIMH) NRNational Institute for Nursing Research (NINR) AANational Institute on Alcohol Abuse and Alcoholism (NIAAA) DANational Institute on Drug Abuse (NIDA) ATNational Center for Complementary and Alternative Medicine (NCCAM) RRNational Center for Research Resources (NCRR) HGNational Human Genome Research Institute (NHGRI) EBNational Institute of Biomedical Imaging and Bioengineering (NIBIB) TWJohn E. Fogarty International Center (FIC) MDNational Center on Minority Health and Health Disparities (NCMHD) ODOffice of the Director (NIH) CLWarren Grant Magnuson Clinical Center (CC)* RRCenter for Scientific Review (CSR) WHOffice of Research on Womens Health (ORWH) DSDivision of Safety (DS)* CANational Cancer Institute (NCI) HLNational Heart, Lung, and Blood Institute (NHLBI) DKNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) LMNational Library of Medicine (NLM) HDNational Institute of Child Health and Human Development (NICHD) DCNational Institute of Deafness and Other Communication Disorders (NIDCD) ESNational Institute of Environmental Health Sciences (NIEHS) NSNational Institute of Neurological Disorders and Stroke (NINDS) AGNational Institute on Aging (NIA) AINational Institute of Allergy and Infectious Diseases (NIAID) ARNational Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) DENational Institute of Dental and Craniofacial Research (NIDCR) EYNational Eye Institute (NEI) GMNational Institute of General Medical Sciences (NIGMS) MHNational Institute of Mental Health (NIMH) NRNational Institute for Nursing Research (NINR) AANational Institute on Alcohol Abuse and Alcoholism (NIAAA) DANational Institute on Drug Abuse (NIDA) ATNational Center for Complementary and Alternative Medicine (NCCAM) RRNational Center for Research Resources (NCRR) HGNational Human Genome Research Institute (NHGRI) EBNational Institute of Biomedical Imaging and Bioengineering (NIBIB) TWJohn E. Fogarty International Center (FIC) MDNational Center on Minority Health and Health Disparities (NCMHD) ODOffice of the Director (NIH) CLWarren Grant Magnuson Clinical Center (CC)* RRCenter for Scientific Review (CSR) WHOffice of Research on Womens Health (ORWH) DSDivision of Safety (DS)* How Is The NIH Organized? *Does not make Extramural Awards

Flow of a Competing Grant Application Through the CSR Referral Section Application (Original & 5 Copies) Mailroom ( Receive, Date Stamp, Preliminary Sort, Add Bar Code) Project Control Unit: Receipt & Record Group (Process, Enter Skeletal Data into Computer, Print Status) Assignment Unit: (Assign to Scientific Review Group and Awarding Organization) (Advance Copy) Scientific Review Group (2 Copies) Scientific Review Group Project Control Unit: Review & Control Group (Add Labels, Send Data to IMPAC, Print Mailers, Distribute) (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 1 R01CA12345601A1 01 1 R01CA12345601A1 01 ApplicationTypeActivityCodeInstituteCodeSerialNumberSupportYearExtension NewApplicationIndividualResearchGrantNationalCancerInstituteNowSixDigitsFirstYearFirstAmendedApplicationSub-project

GROUPS CSR IRGs Study Sections Special Emphasis Panels INSTITUTES INSTITUTES Scientific Review Groups Contract Review Committees APPLICATIONS REVIEWED Research Projects Academic Research Academic Research Enhancement Awards Postdoctoral Fellowships Small Business Innovation Research Shared Instrumentation Program Projects Centers Institutional Training Grants Conference Grants Career Awards Types of Scientific Review Groups Where are Applications Reviewed? Small Grants RFAs Contracts

Center For Scientific Review Scientific Review(CSR) CSR Referral Office GrantApplication NIH Institutes Initial Review Group Study Section Meeting Assigned To Institutes Assigned To Initial Review Group (IRG) Scientific Review Administrator (SRA) Assigns application to reviewers Reviewers prepare written critique Applications Reviewed by IRG members SRA prepares Summary Statement AdvisoryCommittee Meeting Meeting Assignment to Program official within each Institute Institute staff review summary statements using the Electronic Council Book Council members access the Electronic Council Book SRA uploads scores into IMPAC Award Grants to successful applicants successful applicants Funding Decision by IC Receipt Deadline 1 Month 3-5 Months 6 Months 7 Months 9 - 22 Months Time Line Application submitted to Center for Scientific Review -- NIH Center for Scientific Review -- NIH Notify unsuccessful applicants Summary statement uploaded into IMPAC system THE GRANTS PROCESS

Center For Scientific Review Scientific Review(CSR) CSR Referral Office GrantApplication NIH Institutes Initial Review Group Study Section Meeting Meeting Assigned To Institutes Assigned To Initial Review Group (IRG) Scientific Review Administrator (SRA) Assigns application to reviewers Reviewers prepare written critique Applications Reviewed by IRG members SRA prepares Summary Statement AdvisoryCommittee Meeting Meeting Assignment to Program official within each Institute Institute staff review summary statements using the Electronic Council Book Council members access the Electronic Council Book SRA uploads scores into IMPAC Award Grants to successful applicants successful applicants Funding Decision by IC Receipt Deadline 1 Month 3-5 Months 6 Months 7 Months 9 - 22 Months Time Line Application submitted to Center for Scientific Review -- NIH Center for Scientific Review -- NIH Notify unsuccessful applicants Summary statement uploaded into IMPAC system THE GRANTS PROCESS

Center For Scientific Review Scientific Review(CSR) CSR Referral Office GrantApplication NIH Institutes Initial Review Group Study Section Meeting Assigned To Institutes Assigned To Initial Review Group (IRG) Scientific Review Administrator (SRA) Assigns application to reviewers Reviewers prepare written critique Applications Reviewed by IRG members SRA prepares Summary Statement AdvisoryCommittee Meeting Meeting Assignment to Program official within each Institute Institute staff review summary statements using the Electronic Council Book Council members access the Electronic Council Book SRA uploads scores into IMPAC Award Grants to successful applicants successful applicants Funding Decision by IC Receipt Deadline 1 Month 3-5 Months 6 Months 7 Months 9 - 22 Months Time Line Application submitted to Center for Scientific Review -- NIH Center for Scientific Review -- NIH Notify unsuccessful applicants Summary statement uploaded into IMPAC system THE GRANTS PROCESS

Center For Scientific Review Scientific Review(CSR) CSR Referral Office GrantApplication NIH Institutes Initial Review Group Study Section Meeting Assigned To Institutes Assigned To Initial Review Group (IRG) Scientific Review Administrator (SRA) Assigns application to reviewers Reviewers prepare written critique Applications Reviewed by IRG members SRA prepares Summary Statement AdvisoryCommittee Meeting Meeting Assignment to Program official within each Institute Institute staff review summary statements using the Electronic Council Book Council members access the Electronic Council Book SRA uploads scores into IMPAC Award Grants to successful applicants successful applicants Funding Decision by IC Receipt Deadline 1 Month 3-5 Months 6 Months 7 Months 9 - 22 Months Time Line THE GRANTS PROCESS Application submitted to Center for Scientific Review -- NIH Center for Scientific Review -- NIH Notify unsuccessful applicants Summary statement uploaded into IMPAC system

Electronic Tools for Extramural Staff and Applicants CommonsAdministrative Module CGAPCompetitive Grant Application Process RRReceipt and Referral Module CMCommittee Management Module REVReview Module ECB/CAMElectronic Council Book/Council Administration Module Early Concurrence Module GMGrants Management Module ICOInstitute and Center Operation Module E-SNAPStreamlined Non-Competing Award Process i-EdisonInvention Reporting Module QVRQuery/View/Reporting System IC-STOReIC Search, Track, Order and Report (Shared Module) ICDIC Specific Data System StatusApplicant status system CommonsAdministrative Module CGAPCompetitive Grant Application Process RRReceipt and Referral Module CMCommittee Management Module REVReview Module ECB/CAMElectronic Council Book/Council Administration Module Early Concurrence Module GMGrants Management Module ICOInstitute and Center Operation Module E-SNAPStreamlined Non-Competing Award Process i-EdisonInvention Reporting Module QVRQuery/View/Reporting System IC-STOReIC Search, Track, Order and Report (Shared Module) ICDIC Specific Data System StatusApplicant status system RED = Applicant Tools YELLOW = Staff Tools GREEN = Staff and Council

Center for Scientific Review (CSR) CSR Referral Office NIH Institutes Study Section Meeting Assigned To Institutes Assigned To Initial Review Group (IRG) Initial Review Group (IRG) Scientific Review Administrator (SRA) Assigns application to reviewers Reviewers prepare written critique Applications Reviewed by IRG members SRA prepares Summary Statement Assignment to Program official within each Institute Institute staff review summary statements using the Electronic Council Book Council members access the Electronic Council Book SRA uploads scores into IMPAC Award Grants to Successful Applicants Funding Decision by IC Receipt Deadline 1 Month 3-5 Months 6 Months 7 Months 9 - 22 Months Time Line THE GRANTS PROCESS and IMPAC APPLICATIONS Application submitted to Center for Scientific Review -- NIH Center for Scientific Review -- NIH Notify Unsuccessful Applicants Summary statement uploaded into IMPAC system NIH Commons Receipt and Referral Review** ECB/CAM Early Concurrence GrantsManagement GrantApplication Initial Review Group AdvisoryCommitteeMeeting Committee Management QVR System CGAP Status eSNAP iEdison

Grantee Institution THE GRANTS PROCESS and IMPAC APPLICATIONS Award Grants to successful applicants Monitor funded grants Non-competingapplication Evaluatenon-competingapplications Issue notice of grant award (NGA) Develop research initiatives Negotiate with other ICs NIH Guide Announcement Grants Management Responsibilities ProgramResponsibilities New Grant application NIHNIH

Grantee Institution THE GRANTS PROCESS and IMPAC APPLICATIONS Award Grants to successful applicants Monitor funded grants Non-competingapplication Evaluatenon-competingapplications Notice of grant award (NGA) Develop research initiatives Negotiate with other ICs NIH Guide Announcement Grants Management Responsibilities ProgramResponsibilities New Grant application NIHNIH Grants Management Module IC Operations Module Query/View/Reporting System (QVR) System (QVR)IC-STORe eSNAP

Some Added Complexities That Need IT Solutions 901 Change of Assignment ARA Awaiting Receipt of Assignment RFAs Request for Applications PA Program Announcement Just in Time Joint Funding Secondary Assignments Sub-projects 901 Change of Assignment ARA Awaiting Receipt of Assignment RFAs Request for Applications PA Program Announcement Just in Time Joint Funding Secondary Assignments Sub-projects

Challenges and Hurtles Inertia of Rest We have been doing business like this for years--Why change now? Training of Busy Extramural Staff Training of Busy IRG and Council Members Inertia of Rest We have been doing business like this for years--Why change now? Training of Busy Extramural Staff Training of Busy IRG and Council Members Connections to Our Grantee Customers The NIH Commons Connections to Our Grantee Customers The NIH Commons

The Electronic Council Book One Example of the future of the NIH Presentation to the NIEHS Advisory Council September 11, 2001 Presentation to the NIEHS Advisory Council September 11, 2001

Advisory Council--Then and Now Council books contained ALL summary statements generally sorted in alphabetical order l Difficult for the council members to analyze by topic l Council members must request analysis from IC staff (time delay) l Council members can analyze information in a variety of ways Instantly by: - Scientific topic - Priority/percentile score - Funding mechanism - Special areas such as clinical trials, AIDS Before the ECB Using the ECB

Advisory Council--Then and Now One Institutes Experience l Collect and print summary statements as they become available l Prepare mailings to each council member (18 to 20 members) l Generally, three mailings per council member per council round (160 FEDEX packages per year for the NIEHS) l Late material delivered to hotel the night before council l Notify Council members that the information is available on the ECB website l All summary statements available INSTANTLY l Website has ALL information pertaining to the council meeting including the agenda material--even the Metro map l Allows for archiving previous council rounds Before the ECB Using the ECB

Advisory Council Savings and Efficiencies One Institutes Experience EACH COUNCIL ROUND Copy approximately 450 summary statements sixty copies of each set 60 foot high stack of paper EACH COUNCIL ROUND Copy approximately 450 summary statements sixty copies of each set 60 foot high stack of paper ELIMINATION OF STAFF TIME and COSTS Duplication of materialsDuplication of materials Collating of materialsCollating of materials Preparation of mailingsPreparation of mailings FedEx expensesFedEx expenses Filing of Institute copiesFiling of Institute copies Duplication of materialsDuplication of materials Collating of materialsCollating of materials Preparation of mailingsPreparation of mailings FedEx expensesFedEx expenses Filing of Institute copiesFiling of Institute copies

Advisory Councils Savings and Efficiencies The NIH Experience THREE COUNCIL ROUNDS PER YEAR 40,000+ summary statements copied in approximately 60 sets Estimate 34 MILLION impressions ONE mile high stack of paper Approximately 1400 express packages to council members to council members Estimate 34 MILLION impressions ONE mile high stack of paper Approximately 1400 express packages to council members to council members

Improved Effectiveness of Council Members The system is simple to use--short learning time. The system is simple to use--short learning time. Council members can easily query the system. Council members can easily query the system. Council members can focus their attention on Council members can focus their attention on applications of particular interest to them. applications of particular interest to them. Staff can assign particular applications to Staff can assign particular applications to council members for review--council members council members for review--council members can easily retrieve that information. can easily retrieve that information. Users can access the system from any location. Users can access the system from any location. The system is simple to use--short learning time. The system is simple to use--short learning time. Council members can easily query the system. Council members can easily query the system. Council members can focus their attention on Council members can focus their attention on applications of particular interest to them. applications of particular interest to them. Staff can assign particular applications to Staff can assign particular applications to council members for review--council members council members for review--council members can easily retrieve that information. can easily retrieve that information. Users can access the system from any location. Users can access the system from any location.

Goals for Extramural Programs Applications in Electronic Format (Currently have Scanned Applicationselectronic submission of applications under development)Applications in Electronic Format (Currently have Scanned Applicationselectronic submission of applications under development) Electronic Review of Applications (Web-based review use by several ICsElectronic Review of Applications (Web-based review use by several ICs Virtual Initial Review Group Meeting (Currently used where appropriate)Virtual Initial Review Group Meeting (Currently used where appropriate) Early Council Concurrence (In production)Early Council Concurrence (In production) Virtual Council Meeting (Feasible now)Virtual Council Meeting (Feasible now) Applications in Electronic Format (Currently have Scanned Applicationselectronic submission of applications under development)Applications in Electronic Format (Currently have Scanned Applicationselectronic submission of applications under development) Electronic Review of Applications (Web-based review use by several ICsElectronic Review of Applications (Web-based review use by several ICs Virtual Initial Review Group Meeting (Currently used where appropriate)Virtual Initial Review Group Meeting (Currently used where appropriate) Early Council Concurrence (In production)Early Council Concurrence (In production) Virtual Council Meeting (Feasible now)Virtual Council Meeting (Feasible now)

Overall Timeframe Submission to Award Where can we improve the efficiency of the process? Where can we improve the efficiency of the process? JAN FEB MAR APR MAY JUN JUL AUG SEP OCT NOV DEC ReviewCouncilReceipt Referral Award NIHCommonsElectronicApplicationsElectronicReviewandVirtual Review Meetings BusinessIntelligenceinReferralProcessEarlyCouncilConcurrenceElectronic Council Book InternalAndExternalElectronicAwardProcessing

Future Considerations Videos in Applications Elimination of Receipt Dates Federal Grant Application Security Freedom of Information Requests Videos in Applications Elimination of Receipt Dates Federal Grant Application Security Freedom of Information Requests

The NIH Since September 11, 2001 EIGHTEEN ADVISORY COUNCILS MET ON OR WERE SCHEDULED TO MEET AFTER THAT INFAMOUS DATE The Electronic Council Book And IMPAC system allowed NIH to conduct its important business allowed NIH to conduct its important business The Electronic Council Book And IMPAC system allowed NIH to conduct its important business allowed NIH to conduct its important business

THANK YOU

The NIH Extramural Team Scientific Review ScientificProgramsScientificProgramsGrantsManagementGrantsManagement

PROGRAM ADMINISTRATOR l Develop program initiatives l Provide guidance and assistance to applicants l Interpret program policy and guidelines for reviewers l Attend Scientific review group (SRG) meetings as program resource person(s) l Present SRG recommendations to council l Communicate results of review to applicants l Make funding recommendations l Participate in identifying prospective SRG and Council nominees l Evaluate programs l Communicate with review staff on program matters l Monitor progress during the award period l Develop program initiatives l Provide guidance and assistance to applicants l Interpret program policy and guidelines for reviewers l Attend Scientific review group (SRG) meetings as program resource person(s) l Present SRG recommendations to council l Communicate results of review to applicants l Make funding recommendations l Participate in identifying prospective SRG and Council nominees l Evaluate programs l Communicate with review staff on program matters l Monitor progress during the award period

GRANTS MANAGEMENT SPECIALIST l Provide business guidance to applicants and reviewers as necessary l Participate with program staff in budget negotiations prior to and following award l Attend SRG meetings as resource person(s) l Maintain official grant files l Assist in developing program policy l Provide fiscal management of grants l Interpret and apply grant policy l Provide business guidance to applicants and reviewers as necessary l Participate with program staff in budget negotiations prior to and following award l Attend SRG meetings as resource person(s) l Maintain official grant files l Assist in developing program policy l Provide fiscal management of grants l Interpret and apply grant policy

SCIENTIFIC REVIEW ADMINISTRATOR l Nominate SRG members l Select ad hoc reviewers and site visitors l Provide orientation for SRG members l Explain and interpret NIH review policy and procedures l Assign review responsibilities l Manage project site visits l Manage SRG meetings l Prepare summary statements l Attend council meetings to provide requested information in support of committee recommendations l Communicate with program staff on review matters l Nominate SRG members l Select ad hoc reviewers and site visitors l Provide orientation for SRG members l Explain and interpret NIH review policy and procedures l Assign review responsibilities l Manage project site visits l Manage SRG meetings l Prepare summary statements l Attend council meetings to provide requested information in support of committee recommendations l Communicate with program staff on review matters

Typical Timeline for a New Individual Research Project Grant Application (R01) Submit in February (June, October) Review in June (October, February) Council in September (January, May) Earliest award in December (April, July) Submit in February (June, October) Review in June (October, February) Council in September (January, May) Earliest award in December (April, July) Cycle 1---- Cycle 2---- Cycle 3---- Cycle 1---- Cycle 2---- Cycle 3---- There are three overlapping cycles per year:

NIH Grant Receipt, Review, and Award Schedule Jan-May Jan-May May-SeptReceipt Dates May-SeptReceipt Dates Sept-Jan Sept-Jan June-July June-July Oct-NovReview Dates Oct-NovReview Dates Feb-Mar Feb-Mar Sept-Oct Sept-Oct Jan-FebNational Advisory Council Board Dates Jan-FebNational Advisory Council Board Dates May-June May-June Dec 1 Dec 1 Apr 1Earliest Possible Beginning Date Apr 1Earliest Possible Beginning Date July 1 July 1

THE NIH GRANTS PROCESS from the “Macro” to the “Micro” Level and INFORMATION TECHNOLOGY: New...

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