Round 3 Pilot Grant RFA

Clinical and Translational Research Infrastructure Network (CTR-IN)
Funding Opportunity Announcement: Pilot Grant Program

Overview: The CTR-IN Pilot Grant Program is a Limited Competition,Mentored Career Development funding opportunity. The missionof the CTR-IN is to build clinical and translational research capacity, and facilitate extramural funding success, among investigators with faculty appointments at the 13 universities in the Mountain West Research Consortium.

The program provides research funding, and a mentored pathway of milestones leading to publication and expansion of research skills, to help faculty achieve independent investigator status as reflected in the submission of an NIH R-type grant proposal (or equivalent) in clinical or translational research.

Pilot Grant support can be transformative in the Mountain West by helping existing programs reach national competitiveness, by addressing regional health disparities, and by helping new investigators and established basic scientists achieve success in clinical or translational research.

Funding Source: National Institute of General Medical Sciences (NIGMS, U54GM104944).

Key Dates:

Final day for Submission of Nominating Packets by the institutional OSP 28 January 2015
Invitations to investigators to submit full applications will be issued by 06 February 2015
Pilot Grant Applications Due Date 08 April 2015 5:00 PM PDT
Announcement of Pilot Grant Awards 12 June 2015
Earliest Start Date 15 July 2015

Project Duration: One year (July 2015 through June 2016). No carryover beyond project period allowed.

Eligibility Requirements: Applicants must be nominated by their respective institution and subsequently invited by CTR-IN to submit a full application. Potential applicants must contact their local CTR-IN Concierge CTR-IN Concierge Network for instructions on the nominating process.
• Faculty members with at least a .5 FTE position at one of the 13 CTR-IN partner institutions are eligible to apply (see Eligible Mountain West Research Consortium Institution).
• Projects must be Clinical or Translational Research, the CTR-IN is unable to fund pre-clinical or basic science research.
• Awardees must devote at least 20% effort (2.4 person months) to the Pilot Grant project. Per IDeA program policy, an awardee may not concurrently receive research funding through other IDeA mechanisms (e.g., COBRE or INBRE).
• Only one proposal per investigator will be considered.Multi-PI projects are not allowable but co-investigators may be included.
• Early or New Stage Investigators (click here … ) are encouraged to apply.
• Established researchers intending to move from basic science into translational or clinical research are eligible to apply.
• Nominated applicants must upload a researcher profile in VIVO, the researcher network supported by CTR-IN (see CTR-IN VIVO SITE).

Funding Level and Allowable Expenses: Direct costs of up to $60,000 per year may be requested. Permitted expenses include support for half of the salary and benefits associated with the PI’s effort, salaries for research personnel, research supplies, and participant expenses. All expenses must be allowable under NIH guidelines.

The following are not allowable: Equipment costs over $5,000, significant foreign participation, and subcontracts to institutions located in non-IDeA states.

Services provided in non-IDeA states can be purchased on a fee-for-service basis.Travel expenses are allowed, if necessary,for conducting field work as part of the project, or accessing experts or other resources. Travel expenses may be requested for the PI to present this work at one national or regional meeting,providing the meeting date is far enough into the project period for data to be available.

Budgets must include costs for the PI to attend the CTR-IN Annual Meeting at Las Vegas in June 2016. For further details on allowable expenses see Budgets for allowable expenses. Applicants may request support to cover expenses of their Mentor, such as travel and consultant fees. Applicants are encouraged to work with their Office of Sponsored Projects and the CTR-IN Education,Mentoring and Career Development KCA (CREMCaD), see CREMCaD portal to ensure that their budget forms are properly completed.

Poorly completed budgets, or budgets requesting substantial support for elements that are not aligned with the CTR-IN mission to promote the PI’s development as an independent investigator, will be returned without review.

Eligible Mountain West Research Consortium Institutions:

Boise State University
Idaho State University
Montana State University
New Mexico State University
University of Alaska, Anchorage
University of Alaska, Fairbanks
University of Hawaii
University of Idaho
University of Montana
University of New Mexico
University of Nevada Las Vegas
University of Nevada Reno
University of Wyoming

APPLICATION PROCESS: Applicants are strongly encouraged to visit the CTR-IN website for further details and answers to Frequently Asked Questions (see Frequently Asked Questions).

Limited competition nomination of applicants from eligible institutions: Interested applicants must coordinate with their respective institution’s Research Office and CTR-IN Concierge (see CTR-IN Concierge Network). Each institution may nominate up to four applicants. Nominating Packets must be submitted by the institution’s Office of Sponsored Programs. Submission will be electronic through the CTR-IN Pilot Grant Application Portal at: Pilot Grant Evaluation Interface and initial packets must be received by 5:00 PM PST on January 28, 2015. Nominating Packets must include the following for each applicant:

• An NIH format Biographical Sketch for the proposed PI including the required Personal Statement. See (http://grants.nih.gov/grants/funding/2590/biosketchsample.pdf)
• An NIH format Other Support document for the proposed PI. See http://grants.nih.gov/grants/funding/2590/Non-competing_othersupport.pdf
• A summary of the proposed research of not more than one page with sufficient detail to establish that the research is clinical or translational.
• A summary of the IRB status (IRB proposal in preparation, submitted, or approved with a copy of the approval). If IRB approval is not required, the reason must be documented.
• A letter of support signed by an appropriate institutional official committing to provide support for half of the requested PI effort if the CTR-IN Pilot Grant is awarded.
• Identification of the project mentor, and a letter of support from the proposed mentor indicating willingness to work with the prospective PI. For assistance in identifying a mentor, see (Mentoring)

Invitation to submit pilot grant application: Nominating Packets will undergo administrative review to ensure that they are responsive to this announcement. Administrative reviews will be conducted on a rolling basis within 7 business days of submission. OSP representatives will be notified of any rejections. A Nominating Packet that is rejected as non-responsive to this RFA may be replaced with another while the Nomination phase is open through 5:00 PM PST on January 28, 2015. Early submission of Nominating Packets is encouraged in order to allow adequate time to prepare a replacement for any that are rejected. Applicants with approved Nominating Packets will be invited to submit a full application.

Full application: Invited applicants will submit materials electronically through the CTR-IN Pilot Grant Application Portal in collaboration with their Office of Sponsored Programs. The portal is located at: Pilot Grant Evaluation Interface Applications must use the PHS 398 forms (where indicated). Instructions on the use of those forms are available at: http://grants.nih.gov/grants/funding/phs398/phs398.html. Applications must conform to standard NIH formatting requirements with regard to fonts, size and margins (e.g., Arial, 11 point, ½” margins).The following items should be included in your submission:

1. Face Page (Form Page 1). http://grants.nih.gov/grants/funding/phs398/phs398.html

2. Checklist with F&A cost breakdown at 10% http://grants.nih.gov/grants/funding/phs398/phs398.html (Checklist Form Page)

3. Project Summary and Relevance, Listing of Key Personnel, and Project/Performance Site (Form Page 2).http://grants.nih.gov/grants/funding/phs398/phs398.html

4. Detailed Budget (Form Page 4). Note: Facilities and Administration Costs are limited to 10%. http://grants.nih.gov/grants/funding/phs398/phs398.html
Special requirements regarding PI support: Pilot Grant Principal Investigators must devote at least 20% effort to the proposed research; up to 50% effort may be proposed. While the budget narrative must reference the full amount of effort required to accomplish the proposed scope of work, the budget may request CTR-IN funds for not more than half of the PI effort. The balance of PI effort is to be covered by institutional support in the form of release from teaching, direct salary support, assignment of time provided to pursue scholarly activity, or other mechanism appropriate to the institution. This support is not formal cost share and no recording/reporting requirements exist. Budgets should list the full PI effort proposed as appropriate for their appointment in calendar months, or academic and summer months. Support requested may not exceed half of that value.

5. NIH format Biographical Sketch for Key Personnel only (four page maximum per individual).

6. Detailed budget justification. For additional guidance on budget and allowable expenses please see FAQs.

7. Introduction—for resubmissions only. Prior, unfunded applicants are encouraged to include an Introduction page to address prior external reviewer comments and to indicate specific changes that have been made to the application in response to reviewer comments(not to exceed 1 page).

8. Progress Report—for current Pilot Grant awardees only. Current CTR-IN Pilot Grant awardees applying for competitive renewal must include a one-page progress report describing the achievements to-date of their current project.

9. Specific Aims (not to exceed one page).

10. Research Strategy (not to exceed four pages). Research Strategy should include:
10.1. Significance
10.2. Innovation
10.3. Approach. Note—in addition to research methods, the approach section should include the following:
10.3.1. Project timeline
10.3.2. Interim milestones
10.3.3. Plans for future extramural grant application

11. Literature Cited (no page limit).

12. Targeted/Planned Enrollment Table (if applicable) must use this form: http://grants.nih.gov/grants/funding/phs398/CumulativeInclusionEnrollmentReport.pdf

13. Protection of Human Subjects section (no page limit) must use this form: http://grants.nih.gov/grants/funding/424/SupplementalInstructions.pdf#Part_II

14. Mentor Support: Up to $2,000 may be budgeted to covermentor consultant feesand mentor travel costs. This item should be listed in the detailed budget as a separate line item. It will not count against the $60,000 research budget limit. It should, however, be added to your total Direct Costs. Contact your Office of Sponsored Projects to assist with your budget.

15. Fully executed Memorandum of Agreement between PI and Mentor (see Mentoring). For questions regarding the MOA, please contact Bruce Shiramizu at bshirami@hawaii.edu

Special Note Regarding Human Subjects Research: IRB approval letter (or IRB exemption letter) and documentation of human subjects training for key personnel (e.g., CITI) must be available upon request during the Just In Time phase (May 15, 2015 – June 30, 2015). Projects without IRB approval as of July 1, 2015 may be passed over.

CTR-IN Resources to Assist Applicants:
• Frequently Asked Questions (FAQs) about the Pilot Grant Program can be found at: Frequently Asked Questions.
• Each participating institution has a biostatistician supported by CTR-IN to assist prospective investigators in developing their research ideas. This biostatistical support is provided free of charge. Participation of the CTR-IN biostatistician in the drafting of proposals, and as the biostatistical co-investigator, is mandatory (see CTR-IN Biostat Support Contacts).
• The CTR-IN provides mentorship and educational support to assist researchers at partner institutions (see Mentoring).
• The CTR-IN currently funds pilot award investigators at each of the Mountain West institutions. A list of current awardees and their projects can be found at: Pilot Grants Awarded.
• Any questions about the Pilot Grant Program can be directed to Curtis Noonan (curtis.noonan@umontana.edu) and William Shuttleworth (bshuttleworth@salud.unm.edu).

To download the Word document version of this FOA, Click here …