UL1 TR001114-03 Pilot Study Award Application Application Guidelines and Instructions Overview The Scripps Translational Science Institute's Pilot Study Award is an NIH funded internal study award program to assist investigators in developing preliminary data that will have significant impact potential on the understanding, prevention and treatment of disease as a translational medicine focus. A robust collaboration between basic and clinical researchers is required to be considered for funding. Recipients of the pilot study awards must adhere to all Federal, state and local guidelines with respect to scientific conduct, conflict-of-interest policies, participation of human subjects, the use of animals, hazardous or radioactive materials and recombinant DNA in their research studies. The review and notification process will be completed within sixty (60) days from the deadline of the receipt of applications. All proposals will receive a written critique and, for those awarded funding, a Notice of Award. Eligibility and Criteria for Review TSRI Faculty Investigators or Scripps Health affiliated physicians, residents, and fellows will be eligible to apply for pilot project funding. All pilot projects must have a translational science and/or a clinical discipline Liaison. The Criteria for funding is as follows: Multi-disciplinary; connecting basic and clinical science Likelihood of having an impact to change medicine Soundness of hypothesis, research methodology and statistical considerations Track record of the Applicant and the Co-Investigator(s) Likelihood of leading to future independent funding and scientific publication Integration or impact of community engagement aspects into protocol design (see http://www.stsiweb.org/) We highly recommend submission from individuals of under-represented minorities. Application Submission and Deadlines Letter of Intent Due Date: Application Due Date: Study Section Meeting: Notice of Awards: Project Period Award Date: Last day of JANUARY Last day of FEBRUARY Mid- March, 2015 Early April, 2015 May 1 through April 30 of each grant year Request application submission forms from STSI@scripps.edu. NOTE: Applications headed up by a TSRI investigator must be sent through The Scripps Research Institute Office of Sponsored Programs RACO review prior to submitting to STSI. Be sure to allow adequate time for RACO in order to meet the application deadline date. Applications headed up by a Scripps Health investigator must be sent for SHARCS review with the Senior Director, Research, 858-554-5713 prior to submitting to STSI. Be sure to allow 5 working days for SHARCS. To submit your final application once all administrative reviews have been completed: Convert your application into a PDF file Use the file naming convention: lastname_Firstinitial_application.pdf, lastname_Firstinitial_biosketch.pdf, etc. Email to STSI@scripps.edu by the deadlines BE ADVISED: The NCATS division of NIH does not approve carry forward requests against UL1 funding. All awarded pilot funding must be expended from May 1 through April 30 in each grant year without exception. Unobligated pilot grant funds at April 30 will not be available for non-funded extension requests. Annual Progress Report: Every awarded pilot will be required to submit an annual or final progress report by January 31 of each grant year. These reports are compulsory for inclusion in the main U program grant progress report. A progress report form will be sent to the PI in early December. All awards that will involve “Applicable Clinical Trials” are required to register on clinicaltrials.gov before enrollment of the first subject. For more information visit: http://prsinfo.clinicaltrials.gov/fdaaa.html Contact Information Scripps Translational Science Institute 3344 North Torrey Pines Court Suite 300, La Jolla, CA 92037 USA TELE: 858-554-5708 stsi@scripps.edu alcorn.mike@scrippshealth.org mmilller@scripps.edu Specific Instructions Letter of Intent (due by 01/31/15) – (required) The required Letter: addressed to STSI, outlining project objectives, specific aims and Liaison/Collaborator connections emailed to STSI@scripps.edu . Application Components Cover Page – Complete all fields as accurately as possible, including Translational/Research and Clinical Liaisons. A scanned or Adobe digital signature for the cover page is acceptable. If you have more than one Prime Investigator (“PI”), please list them under Co-Investigator. It is required by NIH that you supply eRA user commons names for PI and co-PI. If you do not have a registered eRA user commons name, contact the Sponsored Research Office (or equivalent) at your Institution to receive one. If you cannot locate the appropriate person for your Institution, contact the NIH eRA Commons Help Desk at commons@od.nih.gov. Regulatory Approvals If the proposed pilot project will involve humans, animals, or stem cells, the appropriate institutional regulatory approvals must be secured prior to any funding being released. If the pilot will be connected to a currently active regulatory approval, supply the regulatory approval number and send a PDF of the approval notice in with the application. If not and the project is awarded funding, then a copy of the approval notices will be REQUIRED within 30 days of the pilot funding Notice of Award. Abstract, Relevance to Disease/Health, and Community Engagement Abstract should be in lay format and should be kept to approximately 500 words. Relevance to Disease/Health and Community Engagement plan/potential should be in lay format and should be kept to approximately 200 words. Project/Research Proposal Succinctly describe the proposed specific aim(s), background or significance, preliminary data, design and methods. Do not exceed three pages. Budget and Justification Applications may be submitted for one (1) year projects only. Projects may request direct costs up to a maximum of $50,000. KL2 Scholar applications are limited to $35,000 maximum. Succinctly supply a Budget Justification in the sections as appropriate. To leverage the pilot study funding, candidates are encouraged to solicit matching funds. Sources of matching funds would be patient advocacy programs and societies, industry collaborations and /or unrestricted grants. If there are Matching Funds available for this application, please include the Source of the funds and amount. Literature Cited and Other Support List references for your proposal and any Other Support for the Prime and/or Co-Investigator. Additional Information to include in a PDF formatted file with Final Application Current NIH Biosketch(s) for all key/senior personnel shown on the cover page or Budget that are assigning effort to the project, whether funded or not (i.e., a KL2 mentor). Letters of Support (Translational and Clinical Liaisons, Additional Collaborators, etc.). IRB or IACUC Just in Time form with approval signatures. Certificate(s) of Completion of required human, animal, or stem cell safety training (if applicable) for any person connected with the project, whether funded or not. Letter of Staff Appointment for applications submitted by TSRI Postdoctoral Fellows. According to the TSRI Administrative Guidelines, postdoctoral fellows cannot apply for grants, either as a principal investigator or coprincipal investigator, without prior approval from the corresponding departmental chair. Even in those circumstances the intent is for the postdoctoral fellow to carry the grant forward to an independent investigator position.