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 June 23, 2010 – Portland, OR

2. Data Source: NIH Office of Budget What is NIH’s primary mission? –To improve the health of the Nation How is that mission accomplished? –By supporting and conducting research How do we support extramural Research? –By issuing grants and contracts How do you apply for grants? –Grants.gov or paper applications* Who is involved in the application process and what are their roles? –Applicant and NIH staff NIH OFFICE OF EXTRAMURAL PROGRAMS

3. Data Source: NIH Office of Budget 27 Separate Institutes & Centers (IC) each with different:  missions & priorities  budgets  funding strategies NIH is organized into: NIGMS Clinical Center International Center

4. 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 initiatedGovernment initiated

5. Data Source: NIH Office of Budget How Does NIH Solicit Applications?  Funding Opportunity Announcements (FOA) published through ­NIH Guide ( http://grants.nih.gov/grants/guide/) http://grants.nih.gov/grants/guide/ ­Grants.gov Type of FOAGeneral Description Parent Announcements Investigator initiated for basic mechanisms Program Announcements highlights areas of focus Requests for Applications (RFA) a one-time call with set-aside

6. Data Source: NIH Office of Budget Roles and Responsibilities NIH OFFICE OF EXTRAMURAL PROGRAMS

7. 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

8. Data Source: NIH Office of Budget Grantee Institution Research Administrator Authorized Organizational Reps Program Director/ Principal Investigator

9. 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.

10. 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

11. 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

12. Data Source: NIH Office of Budget Program Staff Review Staff Grants Management The NIH Extramural Team

13. 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

14. 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

15. 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

16. 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

17. Data Source: NIH Office of Budget Grant Application and Scientific Review NIH OFFICE OF EXTRAMURAL PROGRAMS

18. Data Source: NIH Office of Budget The Grants Process Overview http://grants.nih.gov/grants/grants_process.htm http://grants.nih.gov/grants/grants_process.htm

19. 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.

20. 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

21. 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) 1 st Month2 nd Month Application assessed for completeness & eligibility Notice of assignment available in eRA Commons in 4 weeks. Electronic SF424 R&R submitted through grants.gov

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

23. 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 Review Output: 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.

24. 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

25. 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 1 st Level Review 3 rd Month4 th Month 60 – 100 applications to review at each meeting Attend “For Your Review: NIH Mock Study Section” at 3:15pm today.

26. Data Source: NIH Office of Budget After 1 st 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 5 th Month6 th Month7 th Month Attend “For Your Review: NIH Mock Study Section” at 3:15pm today.

27. Data Source: NIH Office of Budget 2 nd Level Review National Advisory Council or Board assesses quality of 1 st level review –Concurs with or modifies IRG recommended action –Reads summary statements only Can also designate application as “High” or “Low” program priority 8 th Month

28. 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

29. 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 1.31.91.6 1 – 9

30. Data Source: NIH Office of Budget Program Staff Role Pre- and Post-Award NIH OFFICE OF EXTRAMURAL PROGRAMS

31. 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.

32. 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

33. 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

34. 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?

35. Data Source: NIH Office of Budget Grants Management Role Pre- and Post-Award NIH OFFICE OF EXTRAMURAL PROGRAMS

36. 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

37. 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

38. 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 Month10th Month Funding approval from Program Award Issued Final review & Negotiations Congressional Liaison Notified Award Received by Grantee Investigator Begins Work

39. 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. OHRP Office of Human Research Protections

40. 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.

41. Data Source: NIH Office of Budget Notice of Award (and after) NIH OFFICE OF EXTRAMURAL PROGRAMS

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

43. 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.

44. 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)

45. Data Source: NIH Office of Budget Take Home Messages Monitor IC websites and the NIH Guide (http://grants.nih.gov/grants/guide/)http://grants.nih.gov/grants/guide/ Get to know 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)

46. 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.htmhttp://grants.nih.gov/grants/grant_basics.htm Overview - http://grants.nih.gov/grants/grants_process.htmhttp://grants.nih.gov/grants/grants_process.htm IC priorities: http://www.nih.gov/icd/index.htmlhttp://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.