Making Connections: The NIH Grants Process

703
-1

Published on

0 Comments
0 Likes
Statistics
Notes
  • Be the first to comment

  • Be the first to like this

No Downloads
Views
Total Views
703
On Slideshare
0
From Embeds
0
Number of Embeds
1
Actions
Shares
0
Downloads
17
Comments
0
Likes
0
Embeds 0
No embeds

No notes for slide

Making Connections: The NIH Grants Process

  1. 1. Data Source: NIH Office of Budget NIH OFFICE OF EXTRAMURAL RESEARCH Making Connections: NIH Grants Process 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 NIH Regional Seminar April 15, 2009 – Philadelphia, PA
  2. 2. Data Source: NIH Office of Budget 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
  3. 3. Data Source: NIH Office of Budget FDR Dedicates NIH Campus October 31, 1940
  4. 4. Data Source: NIH Office of Budget NIH Campus TodayNIH INTRAMURAL Campus Today
  5. 5. Data Source: NIH Office of Budget NIH EXTRAMURAL Sites Rockledge 1 & 2 Neuroscience Center Executive Plaza South and North Democracy 1 & 2 NIEHS Campus Research Triangle Park, NC
  6. 6. Data Source: NIH Office of Budget U. S. Dept. of Health and Human Services Administration for Children and Families (ACF) Administration for Children and Families (ACF) Food and Drug Administration (FDA) Food and Drug Administration (FDA) Health Resources and Services Administration (HRSA) Health Resources and Services Administration (HRSA) Secretary of Health and Human Services Secretary of Health and Human Services Administration on Aging (AoA) Administration on Aging (AoA) Center for Medicare & Medicaid Services (CMS) Center for Medicare & Medicaid Services (CMS) Indian Health Services (IHS) Indian Health Services (IHS) National Institutes of Health (NIH) National Institutes of Health (NIH) Centers for Disease Control and Prevention (CDC) Centers for Disease Control and Prevention (CDC) Substance Abuse and Mental Health Services Administration (SAMHSA) Substance Abuse and Mental Health Services Administration (SAMHSA) Agency for Toxic Substances and Disease Registry (ATSDR) Agency for Toxic Substances and Disease Registry (ATSDR) Agency for Healthcare Research and Quality (AHRQ) Agency for Healthcare Research and Quality (AHRQ)
  7. 7. Data Source: NIH Office of Budget 27 Separate Institutes & Centers (IC) each with different:  missions & priorities  budgets  ways of deciding which grants to fund NIH is organized into:NIH is organized into: NIGMS Clinical Center International Center
  8. 8. Data Source: NIH Office of Budget NIH FY2010 BudgetNIH FY2010 Budget NIH divides most of its investment according to the interests of the component parts (i.e. Institutes or Centers) NCI NIAID NHLBI NIGMSNIDDK NINDS NIMH NICHD NCRR NIA NIDA NEI NCCAM OD NIEHS NIAMS NIAAA NHGRI NIDCD NIDC R NL M NIBIB NCMHD NINR FIC Total = $31.2 B About 85% distributed via Extramural grants, contracts, cooperative agreements
  9. 9. Data Source: NIH Office of Budget Breakdown of FY 2011 President’s Budget Request for NIH – $32.2 Billion 53.2% 5.8% 2.6% 11.0% 10.5% 4.7%2.6% 9.6% Research Project Grants (53.2%) Research Centers (9.6%) Other Research (5.8%) Research Training (2.6%) R&D Contracts (11.0%) Intramural Research (10.5%) Research Mgmt & Support (4.7%) All Other (2.6%) $16.4 B
  10. 10. Data Source: NIH Office of Budget Fundamentals of the Grants Process Grant Mechanisms NIH OFFICE OF EXTRAMURAL PROGRAMS
  11. 11. Data Source: NIH Office of Budget What’s the Difference Between Grants and Contracts? Attend “R& D Contracts” at 8:00am tomorrow or “Budget Basics for investigators at 8:00am tomorrow. $ $ $ $ $ $ $ $ $ $ $ $ $ GRANT CONTRACT • 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
  12. 12. Data Source: NIH Office of Budget 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
  13. 13. Data Source: NIH Office of Budget 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.
  14. 14. Data Source: NIH Office of Budget Research Training and Research Career Development Awards Attend “Research Training Awards” at 12:45pm tomorrow. •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
  15. 15. Data Source: NIH Office of Budget Fundamentals of the Grants Process NIH OFFICE OF EXTRAMURAL PROGRAMS Roles and Responsibilities
  16. 16. Data Source: NIH Office of Budget 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
  17. 17. Data Source: NIH Office of Budget Grantee Institution Research Administrator Authorized Organizational Reps Program Director/ Principal Investigator
  18. 18. Data Source: NIH Office of Budget 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.
  19. 19. Data Source: NIH Office of Budget 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
  20. 20. Data Source: NIH Office of Budget 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
  21. 21. Data Source: NIH Office of Budget Program Staff Review Staff Grants Management The NIH Extramural Team
  22. 22. Data Source: NIH Office of Budget 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
  23. 23. Data Source: NIH Office of Budget 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
  24. 24. Data Source: NIH Office of Budget 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
  25. 25. Data Source: NIH Office of Budget 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
  26. 26. Data Source: NIH Office of Budget Fundamentals of the Grants Process Grant Application and Scientific Review NIH OFFICE OF EXTRAMURAL PROGRAMS
  27. 27. Data Source: NIH Office of Budget The Grants Process Overview http://grants.nih.gov/grants/grants_process.htm
  28. 28. Data Source: NIH Office of Budget 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.
  29. 29. Data Source: NIH Office of Budget 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
  30. 30. Data Source: NIH Office of Budget Receipt and Referral of Applications to Integrated Review Group (IRG) and then a study section (SRG) CSR Referral Office assigns the application… to an NIH Institute (IC) a unique identifier (application number) 1st Month 2nd Month Application assessed for completeness & eligibility Notice of assignment available in eRA Commons in 4 weeks. Electronic SF424 R&R submitted through grants.gov
  31. 31. Data Source: NIH Office of Budget Decoding Your NIH Grant Number 11 R01 EB 12345 01 A1R01 EB 12345 01 A1 Application Type Activity Code Institute Code Serial Number Support Year Extension 1 = new1 = new 2 = renewal2 = renewal 3 = supplement3 = supplement 5 = non-5 = non- competingcompeting continuationcontinuation R = Research projectR = Research project P = Program projectP = Program project or Centeror Center T = TrainingT = Training (institutional)(institutional) F = FellowshipF = Fellowship (individual)(individual) K = CareerK = Career DevelopmentDevelopment U = CooperativeU = Cooperative agreementagreement AA = NIAAAAA = NIAAA AG = NIAAG = NIA AI = NIAIDAI = NIAID AR = NIAMSAR = NIAMS AT = NCCAMAT = NCCAM CA = NCICA = NCI DA = NIDADA = NIDA DC = NIDCDDC = NIDCD DE = NIDCRDE = NIDCR DK = NIDDKDK = NIDDK EB = NIBIBEB = NIBIB ES = NIEHSES = NIEHS EY = NEIEY = NEI GM = NIGMSGM = NIGMS HD = NICHDHD = NICHD HG = NHGRIHG = NHGRI HL = NHLBIHL = NHLBI LM = NLMLM = NLM MD = NCMHDMD = NCMHD MH = NIMHMH = NIMH NR = NINRNR = NINR NS = NINDSNS = NINDS RR = NCRRRR = NCRR TW = FICTW = FIC Unique,Unique, up to sixup to six digitsdigits Years ofYears of ContinuousContinuous FundingFunding A1 = firstA1 = first resubmissionresubmission A2 = secondA2 = second resubmissionresubmission
  32. 32. Data Source: NIH Office of Budget Review System for Grants Advisory Council • assess quality of SRG process • offers recommendation to Institute Staff • evaluates program priorities and relevance • advises on policy Scientific Review Group (SRG) • Independent outside review • Evaluate scientific merit, significance • Recommend length and level of funding Output: Priority Score and Summary Statement Output: Funding Recommendations Institute Director • makes final decision based on Council input, programmatic priorities • Must also Pass Administrative ReviewOutput: Awards or Resubmission 3 - 7 months 1 - 3 months 1st level 2nd level Attend “A Peer into the NIH Review Process” at 10:30am today.
  33. 33. Data Source: NIH Office of Budget 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
  34. 34. Data Source: NIH Office of Budget • 12-24 members: scientist peers • 3 face-to-face meetings per year, and a 4 year term of service. Standing study sections typically have 1st Level Review 3rd Month 4th Month • 60 – 100 applications to review at each meeting Attend “For Your Review: NIH Mock Study Section” at 3:15pm today.
  35. 35. Data Source: NIH Office of Budget 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.
  36. 36. Data Source: NIH Office of Budget 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
  37. 37. Data Source: NIH Office of Budget 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
  38. 38. Data Source: NIH Office of Budget Timeline: New Applications Scientific Review July October March Council Review October January May Award Date December April July Receipt Date February 5 June 5 October 5 http://grants.nih.gov/grants/funding/submissionschedule.htm 1.3 1.9 1.61 – 9
  39. 39. Data Source: NIH Office of Budget Fundamentals of the Grants Process Program Staff Pre- and Post-Award NIH OFFICE OF EXTRAMURAL PROGRAMS
  40. 40. Data Source: NIH Office of Budget 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.
  41. 41. Data Source: NIH Office of Budget 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
  42. 42. Data Source: NIH Office of Budget 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
  43. 43. Data Source: NIH Office of Budget 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?
  44. 44. Data Source: NIH Office of Budget Fundamentals of the Grants Process Grants Management Pre- and Post-Award NIH OFFICE OF EXTRAMURAL PROGRAMS
  45. 45. Data Source: NIH Office of Budget 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
  46. 46. Data Source: NIH Office of Budget 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
  47. 47. Data Source: NIH Office of Budget 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 9th Month 10th Month Funding approval from Program Award Issued Final review & Negotiations Congressional Liaison Notified Award Received by Grantee Investigator Begins Work
  48. 48. Data Source: NIH Office of Budget 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 www.hhs.gov/ohrp Attend ““Research Involving Human Subjects Primer for Investigators” at 9:45am tomorrow. OHRPOffice of Human Research Protections
  49. 49. Data Source: NIH Office of Budget 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.
  50. 50. Data Source: NIH Office of Budget Fundamentals of the Grants Process Notice of Award (and after) NIH OFFICE OF EXTRAMURAL PROGRAMS
  51. 51. Data Source: NIH Office of Budget 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.
  52. 52. Data Source: NIH Office of Budget 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.
  53. 53. Data Source: NIH Office of Budget After the Award… Administrative and Fiscal Monitoring Requirements Attend “After the Award is Made…Then What” at 3:15pm today or 2:30pm tomorrow. – Final Closeout Reports – Yearly Audits (as applicable) – Invention Reporting – Annual Financial Status Reports (FSR) – Annual Progress Report (PHS 2590)
  54. 54. Data Source: NIH Office of Budget Take Home Messages • 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) Lots of directions and opportunities at the NIHLots of directions and opportunities at the NIH
  55. 55. Data Source: NIH Office of Budget Step #1: Do your homework; learn a bit about the grant process and the options. Path to Success at NIH 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.

×