Finding & Applying to NIH Funding Announcements

1. Finding & Applying to NIH Funding Announcements By Katie Cook March 2009

2. What is the NIH? • The National Institutes of Health is the primary federal agency for conducting and supporting medical research in the United States. The NIH is comprised of 27 institutes and centers and is part of the U.S. Department of Health & Human Services.

3. What does NIH fund? NIH funds grants, cooperative agreements, and contracts that support the advancement of fundamental knowledge about the nature and behavior of living systems to meet the NIH mission of extending healthy life and reducing the burdens of illness and disability. http://grants.nih.gov/grants/grant_basics.htm

4. NIH Encourages • Projects of High Scientific CaliberNIH looks for grant proposals of high scientific caliber that are relevant to public health needs and are within NIH Institute and Center (IC) priorities. ICs highlight their research priorities on their Web sites. Applicants may want to contact the appropriate Institute or Center to discuss the relevancy and/or focus of the proposed research before submitting an application. NIH also has a number of broad NIH-wide initiatives that may be of interest. • Investigator-Initiated ResearchNIH strongly encourages investigator-initiated research across the spectrum of their mission. They issue hundreds of funding opportunity announcements (FOAs) in the form of Program Announcements (PAs) and requests for applications (RFAs) to stimulate research in particular areas of science.  Some PAs, called “Parent Announcements,” span the breadth of the NIH mission in order to ensure they have a way to capture “unsolicited” applications that do not fall within the scope of targeted announcements.  The majority of NIH applications are submitted in response to parent announcements. • Unique Research ProjectsProjects must be unique. By law, NIH cannot support a project already funded or pay for research that has already been done. Although you may not send the same application to more than one Public Health Service (PHS) agency at the same time, you can apply to an organization outside the PHS with the same application. If the project gets funded by another organization, however, it cannot be funded by NIH as well. http://grants.nih.gov/grants/grant_basics.htm

5. Eligibility Foreign Eligibility • In general, foreign institutions and international organizations, including public or private non-profit or for-profit organizations, are eligible to apply for research project grants. Foreign institutions and international organizations are not eligible to apply for Kirschstein-NRSA institutional research training grants, program project grants, center grants, resource grants, SBIR/STTR grants, or construction grants. However, some activity codes, such as program project grants (P01), may support projects awarded to a domestic institution with a foreign component. For purposes of this policy, a “foreign component” is defined as performance of any significant element or segment of the project outside the United States (U.S.) either by the grantee or by a researcher employed by a foreign institution, whether or not grant funds are expended. Proposed research should provide special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions in other countries that are not readily available in the U.S. or that augment existing U.S. resources. • Foreign applicants are strongly encouraged to review the Eligibility section of the Funding Opportunity Announcement (FOA) to determine whether their non-domestic (non-U.S.) entity (foreign organization) is eligible to respond to that particular FOA. Additional information on grants to foreign institutions, international organizations and domestic grants with foreign components is found in the NIH Grants Policy Statement. http://grants.nih.gov/grants/grant_basics.htm

6. Finding NIH Funding NIH solicitations or funding opportunity announcements (FOAs) can be found at Grants.Gov: http://www.grants.gov/applicants/find_grant_opportunities.jsp Three kinds of solicitations or FOAs: • Parent Announcement: Most common. These have standard receipt dates- http://grants.nih.gov/grants/funding/submissionschedule.htmand are investigator initiated. • Program Announcement: Normally on the standard receipt dates. Usually for a specific scientific need and investigator initiated. • Request for Applications (RFA): Specified receipt date. For a well defined scientific area. Specifies number of awards.

7. Selecting the right type of grant • Identify an institute within NIH that would possibly fund your research: http://www.nih.gov/icd/ • Contact a Program Official at that Institute to discuss your research • If investigator initiated, review & select from the NIH funding mechanisms or reply to a specific PA or RFA. Here are the main three research mechanisms that NIH funds: R01 NIH Research Project Grant Program (R01) • Used to support a discrete, specified, circumscribed research project • NIH's most commonly used grant program • No specific dollar limit unless specified in FOA • Advance permission required for $500K or more (direct costs) in any year • Generally awarded for 3 -5 years • All ICs utilize • See parent FOA at /grants/guide/pa-files/PA-07-070.html

8. Selecting the right type of grant, Cont… R21 • NIH Exploratory/Developmental Research Grant Award (R21) • Encourages new, exploratory and developmental research projects by providing support for the early stages of project development.  Sometimes used for pilot and feasibility studies. • Limited to up to two years of funding • Combined budget for direct costs for the two year project period usually may not exceed $275,000. • No preliminary data is generally required • Most ICs utilize • See /grants/guide/pa-files/PA-06-181.html R03 • NIH Small Grant Program (R03): • Provides limited funding for a short period of time to support a variety of types of projects, including: pilot or feasibility studies, collection of preliminary data, secondary analysis of existing data, small, self-contained research projects, development of new research technology, etc. • Limited to two years of funding • Direct costs generally up to $50,000 per year • Not renewable • Utilized by more than half of the NIH ICs • See parent FOA at /grants/guide/pa-files/PA-06-180.html For more mechanisms please visit: http://grants.nih.gov/grants/funding/funding_program.htm#RSeries

9. How to Apply to a NIH Solicitation 1) Read solicitation (PA, PAR, RFA) carefully!! - Is this application paper or electronic? - Restrictions? 2) Receipt Dates and Deadlines- Know timeline. For NIH standard deadlines visit: http://grants.nih.gov/grants/funding/submissionschedule.htm 3) Contact administrative person to help prepare budget • Budget must be prepared in US$. Please note that non-domestic institutions can NOT do a modular budget. • Non domestic institutions are allowed 8% indirect cost on the budget (minus equipment) unless otherwise restricted.

10. Electronic Application Process Grants.Gov • You do not have to register with Grants.Gov as the person applying. Only QUT needs to register • You DO need an eRA Commons (NIH’s post submission system) password which your Research Office can set you up with. Make sure to log into eRA Commons prior to submission and set up your Personal Profile • Download application package from Grants.Gov, which you will look up by your solicitation number • Must have Adobe Reader 8.1.3 on your computer before downloading package to your computer. Must have Adobe Reader set as default on computer so you don’t corrupt the file • Application is a file you save to your computer- NOT an online form

11. Electronic Application Process Cont.. • Complete forms in application package using the SF424 R&R & solicitation instructions http://grants.nih.gov/grants/funding/424/index.htm • Send required documents and application package to your Research Office for submission. Recommend sending prior to deadline due to possible electronic submission issues • Application is submitted and transmitted to Grants.Gov. Grants.Gov who has two days to process the application for errors • If no errors in the application package, NIH then retrieves the application package electronically from Grants.Gov using eRA Commons (technically has two days to do so) • NIH/eRA Commons checks application package for errors or warnings

12. Electronic Application Process- eRA Commons • To review these errors and/or warnings the applicant must log into eRA Commons and look under “Status” • If the application package receives any errors then the error has to be fixed in the application package (previously submitted) and has to be submitted again. This package then has to go back through Grants.Gov & eRA Commons. Please note that this still has to be before the deadline • If the application package receives warnings, then you do not have to resubmit but the warnings should be reviewed to make sure that we don’t want to resubmit • If no errors are received from the submission, the application package is posted in Commons for your review in one single PDF file

13. Electronic Application Process- eRA Commons Cont… • You have two days to review your proposal in eRA Commons prior to NIH officially processing it. Please note that if changes are needed you have to review and resubmit still prior to the deadline. This is one of the reasons why it is a good idea to submit early! • Summary Statements for proposal will be posted in eRA Commons for PI’s review

14. Paper Application Process • Some solicitations still request a paper application • To submit a paper application you must complete the PHS 398 forms-http://grants1.nih.gov/grants/funding/phs398/phs398.html • Rules are similar. Please follow the PHS 398 instruction manual which can be found at the above website

15. Other Considerations If you are collaborating with a US institution, most likely you will still have to provide (at least) the following prior to the other institution submitting: 1) Letter of Intent signed by an authorized official 2) Detailed budget and budget justification 3) Scope of Work 4) Bio-sketch 5) Facilities & Resource description

16. Other Considerations Cont… Multiple PI model http://grants.nih.gov/grants/multi_pi/ • Can be used for most NIH solicitations (please check your solicitation to be sure) • This is where you can have more than one PI. All PIs share responsibility and credit for the proposal even though only one institution submits the full proposal

17. New Investigator? Definition: In general, a Program Director/Principal Investigator (PD/PI) is considered a New Investigator if he/she has not previously competed successfully as PD/PI for a significant NIH independent research award.  Specifically, a PD/PI is identified as a New Investigator if he/she has not previously competed successfully for an NIH-supported research project otherthan the following small or early stage research awards: Pathway to Independence Award-Research Phase (R00); Small Grant (R03); Academic Research Enhancement Award (R15); Exploratory/Developmental Grant (R21) ; Clinical Trial Planning Grant (R34); Dissertation Award (R36); Small Business Technology Transfer Grant-Phase I (R41) ; Small Business Innovation Research Grant-Phase I (R43); Shannon Award (R55); NIH High Priority, Short-Term Project Award (R56); Competitive Research Pilot Projects (SC2, SC3)

18. Early Stage Investigator? ESIs are New Investigators who are within 10 years of completing their terminal research degree or within 10 years of completing their medical residency at the time they apply for R01 grants.  • Applications from ESIs will be given special consideration during peer review and at the time of funding. Peer reviewers will be instructed to focus more on the proposed approach than on the track record, and to expect less preliminary data than would be provided by an established investigator. • To be included PI must update eRA Commons Profile to include degree and residency completion dates