NIH Fundamentals

KEYS TO SUCCESSNCURA Region IV

Spring MeetingApril 27 – 30, 2014

© 2014 National Council of University Research Administrators

NIH Fundamentals

National Council of University Research Administrators

NCURA Region IV Spring MeetingApril 27 – 30, 2014

@ 2014 National Council of University Research Administrators

Charlie Giese, Program Manager, University of Wisconsin-Madison

Perry M Kirkham, PhD, Project Coordinator, Purdue University



NIH As A Grant-Making Organization

• NIH is an agency within the Public Health Service (PHS), which is under the umbrella of the Department of Health & Human Services (HHS)

• NIH’s mission is to improve human health by increasing scientific knowledge related to disease & health.

• NIH is made up of 24 Institutes and Centers (IC’s), each with its own mission and functions, separate appropriations and statutory authorities.

• They are loosely organized under the Office of the NIH Director, with broad authority to set their own policies and make their own grant funding decisions.



NIH’s Extramural Research Program• The NIH conducts its own Intramural

Research Program utilizing staff scientists on its Bethesda campus.

• The NIH Extramural Research Grants Program funds research nationally at universities and research centers through grants, cooperative agreements and contracts.



NIH Office of Extramural Research• The OER website is the best place to start when looking for information

about NIH grants: http://grants1.nih.gov/grants/oer.htm



Understanding the NIH Grants Process• NIH receives over 86,000 competing grant

applications per year.• The Center for Scientific Review (CSR) receives about

56,000 of those though the use of 16,000 reviewers and 240 Scientific Review Officers

• NIH funded about 12,900 applications in FY13.

• The success rate for competing R01 applications hovers around 19.3%.



NIH Grant Peer Review Process

• Applications received at NIH are sorted by Referral Officers at CSR to determine which Integrated Review Group(IRG) would be most appropriate for assessment of scientific merit. IRGs are clusters of study sections that review similar science.

• Once the IRG is identified, the application is then assigned to one of the constituent study sections within the IRG.

• In addition to the IRG assignment, Referral Officers also identify which Institute(s)/Center(s) (I/C) of the NIH would be most suitable to fund the application, should it be considered sufficiently meritorious.

• Once the I/C is identified, a unique application number is assigned to each application. The Referral Office seriously considers written requests from applicants for both study section and Institute assignments (just include a cover letter with the application).



NIH Peer Review Process• After an application is assigned to a Study Section, the Scientific Review

Administrator (SRA) assigns it to 2 or 3 members to read.• Those applications believed to rank in the lower half of the group of applications are

“streamlined” or “triaged” i.e., they are returned to the applicant “without review.” The applicant may revise the application and re-submit it for a later deadline.

• The Study Section reviews and ranks applications, assigning a “priority score” to each proposal.

• Priority scores and percentile rankings are transmitted to the funding institutes, where Program Officials make funding recommendations to the Institute’s National Advisory Council. The Advisory Council conducts a second level of review and makes final funding decisions.

• It generally takes at least 10 months for a grant to be funded after it is submitted to NIH. A proposal submitted on February 1 will not be funded before December.



Application Forms

• SF424 (R&R) • Includes application guides and forms to be used with all competing

applications for Research, Career Development, Institutional Training Awards and SBIR/STTR Awards

• PHS 398• To be used for all competing applications for Cooperative Agreements and

Complex Mechanisms• PHS 2590

• Continuation – Progress Report for a PHS grant• RPPR

• Continuation – Research Performance Progress Report for an NIH Grant



SF 424 (R&R) Requirements and Guidelines• Institution registered with SAM (System for award Management)• PI registered in eRA Commons (soon to be all personnel)• Cover Letter (optional)• File Names: saved as 50 character or less and include letters,

numbers, hyphens, periods, and underscores• Text Size: Helvetica, Arial, Palatino Linotype, or Georgia typeface

at least 11 Point /15 Characters Per Inch / 6 Lines Per Vertical Inch in black color

• Margins at minimum of 0.5 inches• Watch page limitations on Research Plan



Page Limits• Introduction to Resubmission Application – 1 page• Introduction to Revision Application – 1 page• Specific Aims – 1 page• Research Strategy – 6 or 12 pages depending on FOA instructions• Plan for Instruction in the Responsible Conduct of Research – 3 pages for

Training grants, 1 page for Individual Career Development grants• Biosketch – 4 pages• Career Development Award (K) Application – 12 pages• Institutional Research Training and Career Development Applicants,

Including Ruth L. Kirschstein NRSA Application – 25 pages



Funding Opportunity Announcements• Description• Eligibility• Funding• Restrictions• Due Dates• Specific Announcement Criteria• Contacts



Grants, Contracts, and Cooperative Agreements

• NIH Grants are considered financial assistance to support activities in the public interest. NIH assumes that the grantee would have conducted the activity/research regardless of whether or not NIH funded it. Generally, the grantee controls all scientific aspects of the project under grant funding.

• NIH utilizes the Cooperative Agreement when it wishes to retain control over the scientific and programmatic aspects of the project. While cooperative agreements are considered a financial assistance mechanism, the rules governing the use of funds and conduct of the activity are more restrictive than those governing standard research grants. (They normally are not under FDP or Expanded Authorities.)

• The Contract mechanism is used when NIH wishes to purchase a product or service. Contracts are not financial assistance. The contract is a procurement mechanism by which the government purchases goods or services that it needs.

– NIH issues a Request for Proposals (RFP) inviting proposals for contract opportunities. The RFP number will look different from grant request numbers. Contract proposals must follow the instructions in the RFP and generally are NOT submitted on the standard NIH grant application forms. Contract proposals require both a technical plan and a business plan. The business plan includes Representations and Certifications which must be signed by institution submitting the contract proposal.



NIH Grant Numbers

1 R01 CA123456-01A1• The NIH application number or grant number has several points and can tell

you a lot about the type of application submitted.• The first digit indicates the Type of Application i.e., new(1), non-competing

continuation (5), competing renewal (2), supplemental (3), or transfer(7). • The second set of three characters indicates the Activity Code, i.e., R01 is a

Research Project Grant.• The two-letter code tells you the funding institute, i.e., HG is the National

Human Genome Research Institute (NHGRI).• The six-digit code is the NIH serial number. • The two digits following the dash indicate the year of funding.• Suffixes after the year may indicate that the application is amended/revised

(A) or is a supplement (S) to an existing grant.



Activity Codes

• NIH uses a variety of funding mechanisms, including: grants, cooperative agreements & contracts.

• Grants & Cooperative Agreements are classified by “Activity Codes” that indicate the kind of activity that will be conducted under the project:

• The R-series indicates Research Project Grants, e.g., R01, R03, R21.• The P-series indicates Program Project Grants, e.g., P01, P30, P50.• The T-series indicates institutional NRSA training grants.• The K-series indicates career development awards.• The F-series indicates individual NRSA fellowships



NIH Grant Definitions

• Competitive Segment: The initial project period recommended for support (up to 5 years) or each extension of a project period resulting from a competing continuation award that establishes a new competitive segment for the project.

• Budget Period: The intervals of time, usually 12 months each, into which a project period is divided for budgetary and funding purposes.

• Project Period: The total time for which NIH approves support of a project. The total project period is comprised of the initial competitive segment, any subsequent competitive segment resulting from competing continuation awards, and non-competing extensions.

• New Application: A grant application for a new project that has not previously been submitted to NIH for funding consideration.

• Revised Application: An application which was previously not funded by NIH and which the PI has revised to address the concerns of peer reviewers.

• Competing Continuation/Renewal: An application that requests funding of an additional several years for a project that was previously funded for a period of several years by NIH. The renewal application must compete with all other new, revised and competing continuation applications, i.e., it receives no special consideration for funding.

• Non-competing Continuation: An application that must be submitted each year within the competitive segment in order to receive the next budget year of funding. This application includes the PI’s annual progress report on the science of the project. This application does not compete with others for funding, since the funding was already committed by NIH at the beginning of the competitive segment.



Just in Time• Commonly referred to as JIT• Request from NIH to submit pertinent information before they make

funding decisions• Consists of submitted several forms to agency typically via eRA

Commons• Other Support• Budget (if revised from original submission)• Human Subject Education• Applicable protocols (Human Subjects, Animal Subjects, Biosafety, Stem Cell,

etc.• Should only be submitted if requested by agency. Submission of JIT

information is not a clear indicator that one may be funded



Notice of Award• Grant Number• Dates• Amount• Terms• Special Terms• Contacts



Research Performance Progress Report (RPPR)

• Due approximately 45 days prior to end of budget period• Sections

• Cover Page• Accomplishments• Products• Participants• Impact• Changes• Special Reporting Requirements• Budget



RPPR

• Initiates in eRA Commons• Includes data such as:

• award and institutional contacts• Performance sites• Technically reports• Major goals• How results will be disseminated• Plans of accomplishment for next period• Products: publications, manuscripts, inventions• Participants: all people identified that have devoted at least 1 month of time or is PI• Changes in Other Support• Other changes to the project going forward• Financial progress of project and any income• Budget (if applicable)



Award CloseoutAt the end of a competitive cycle forms must be filed with NIH to complete obligations under the award• Final Progress Report• Final Inventions Statement• Federal Financial Report (FFR)


Funding MechanismsResearch Projects (R01, R03, R21)

Solicited vs. Unsolicited

Program Projects (P01)

Cooperative Agreements (U01, U19)

Resource Grants (U24, R24)

Training and Fellowships (F and K)

Center Proposals

Assignment by CSR Receipt and Referral

Solicited Unsolicited

RFA PA

Assigned to persons prescribed in FOA

Program Review

Institute IRG

Program Officer Study section

Scientific Review Officer


27 NIH Institutes and Centers (ICs)

Directorbudgeting, strategic planning, congressional mandatesProgram

portfolio management, concept/RFA writingReview

proposal reviewAdvisory Council

strategic planning, concept clearance, final proposal review


What ideas or fields are funded by the NIH in general and an institute in specific?

Council reportsDirector’s budget requests

RePORTER dataProgram officer



Role of IC advisory councilSecond level of review (usually a rubber stamp)

Advice on future funding opportunitiesPermission to fund RFAs/Pas

Select pay and bridge funding



QUESTIONS?



Charlie Giese, Program Manager, University of Wisconsin-Madison

Perry M Kirkham, PhD, Project Coordinator, Purdue University

NIH Fundamentals

Documents

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