Date: ______________ Time: ______________ ORSA#: ____________ Med. Ctr. Fin.#: _____ Saint Louis University Office of Research Services Administration (ORSA) Transmittal Form Applications should be submitted for review 7 days prior to agency deadline. To Be Completed by ORSA INVESTIGATOR / CO-INVESTIGATOR INFORMATION and PROPOSAL TITLE Completion of this form is required prior to ORSA review of proposals. All of the data requested is necessary for approving, tracking, and analyzing proposal and award activity. Please carefully describe the proposal characteristics, especially any potential liabilities that the University should be prepared to address. Please call ORSA at 977-2241 or 977-7742 (Medical Center) if you need assistance. Present SLU Fund#: Contact: Name Phone Existing ORSA#: Email if known Co-PI names are not needed for drug or device agreements Last Name First Name Date of application: School/Dept/Div % of effort % of salary recovery Primary PI: Co-PI: Co-PI: If there are additional SLU co-investigators, please provide each person’s name: Proposal Title (256 Characters Max): __________________________________________________________________________________________________________ Lay summary attached. (This summary is recommended but NOT REQUIRED at the time of submission. Please see instruction sheet.) SPONSOR INFORMATION Agency/Sponsor: Grant Deadline: Contracting Institution: Clinical Research Organization: Total Amount Requested Direct: Indirect: Proposal Type: Check all that apply New contract New grant SBIR Phase # STTR Phase # Competitive renewal Subcontract Letter of intent Confidentiality Agreement IC Rate: Category: Check all that apply Amendment Continuation Extension Modification # Revision # Supplement # Other: Funding Source: Check all that apply Academic support Applied research Basic research Clinical research Drug/Device study Institutional support Instruction/Training Public service Student services Scholarship/Fellowship Training facilities/equipment Is SLU subcontracting any portion of this project to another institution: % Federal government Federal passthrough State government Local government Foundation/Non-profit Industry/For profit Internally funded International agency Yes No Subcontracted Institution(s): (Approved institutional paperwork must be included. Please see instruction sheet.) Location Description(s): 1st Site: 2nd Site: 3rd Site: Total Project Period Start Date: Off-Campus Off-Campus Off-Campus On-Campus On-Campus On-Campus Total Project Period End Date: Current Budget Period Start Date: Current Budget Period End Date: If this is related to an existing project, indicate the funding agency award number: 612944746 Page 1 Created on 3/6/2014 SPECIAL REQUIREMENTS (Check all conditions that apply to the proposal) Commitment of resources beyond the project end date Additional space for project staff or special facilities Creation of a new organization or unit Involve/Require research/client confidentiality Involve/Require construction/renovation Potential of program income being generated Matching/Cost sharing (M/CS) from a third party Equipment ONLY project Additional ITS Support ARE SLU MATCHING FUNDS INCLUDED IN THIS PROPOSAL? Matching requirements: 1. How much SLU match is specified in the proposal? 2. What is (are) the source(s) of the matching funds: already budgeted department funds – Fund No.: already budgeted school funds – Fund No.: Provost matching fund number: Other (specify): 3. Succinct explanation of request for matching funds: 4. Amount requested from Provost: $ 5. Date matching funds would be needed if award is received: Yes No Provost approval date: If award received, will SLU incur on-going fiscal or programmatic responsibility after award termination? Yes No On-going SLU responsibility (please explain): RESEARCH COMPLIANCE (Check all conditions that apply to the proposal) Animal Use: Protocol #: Yes No Species: VA Protocol Review Pending Yes No Check if applicable Pathogens Carcinogens Yes No The Institutional Review Board must approve all research involving human subjects. Approval Date: Health Hazards: Human Subjects: Toxins Recombinant Organisms or DNA Research in concept (protocol not fully developed). Please attach “Research in Concept” IRB form. IRB#: Approved Date: If exempt, list exemption category(ies): Blood/Clinical specimen shipment? Yes No Additional covered IRB protocols (please identify on separate sheet) Yes No Radionuclide Use: Permit Holder Name: Non-Human Use; RSC Approval Date: Human Subjects; RDRC Approval Date: Animal Subjects: RSO Approval Date: EXPORT CONTROLS Does this proposal involve: 1 Shipping materials or equipment to a foreign country? Yes No 2 Working with foreign nationals/colleagues in the U.S. or foreign countries? Yes No 3 Training foreign nationals in using equipment? Yes No 4 Working with a country subject to a U.S. Boycott? Yes No 612944746 Page 2 Created on 3/6/2014 CONFLICT OF INTEREST IN RESEARCH CERTIFICATION: CHECK ALL APPROPRIATE BOXES A conflict of interest in research as defined by federal regulations involves a significant financial interest with a sponsoring or related entity including but not limited to anything of monetary value exceeding $10,000 or over 5% equity interest. For a detailed definition, please see Saint Louis University’s Conflict of Interest in Research Policy. INVESTIGATOR/DIRECTOR: 1 The annual conflict of Interest in Research Disclosure Form has been submitted for the current year. Please check one: No apparent or actual conflict exists If a conflict of interest exists, please choose one: 2 A Conflict of Interest Management Plan has been approved 3 Yes No Yes No A conflict of interest exists. ; is pending ; has not been initiated According to the Saint Louis University Conflict of Interest in Research Policy, Principal Investigators are responsible for informing any co-investigators, staff or students involved in the design, conduct or reporting of the externally sponsored research project that they are required to complete a disclosure form. Have you informed co-investigators, staff, or students of their requirement to complete a Conflict of Interest in Research Disclosure Form? Note: In signing this form, the INVESTIGATOR/DIRECTOR certifies that he/she has read the University’s Conflict of Interest in Research Policy and has checked the appropriate box above. In addition, the INVESTIGATOR/DIRECTOR certifies that, to the best of his/her knowledge, no person working on this project at SLU has a conflict of interest or if a conflict of interest does exist, an appropriate management plan is in place. By their signatures, the CHAIR and DEAN certify that, to their knowledge, no conflict of interest exists or a conflict does exist for which a management plan has been approved or is under review. SIGNATURES: By this signature the PI accepts responsibility for the scientific/technical conduct of the study, including required technical reports and/or materials. The PI certifies that no one associated with this project is known to be debarred from doing business with Federal, State or local government entities, or is delinquent on Federal debt. The PI certifies that the information provided in this proposal is true, complete and accurate to the best of my knowledge and that he/she will direct the project in compliance with Saint Louis University policies governing research including those published in the Faculty Research Handbook and subsequent amendments, with the terms and conditions of the sponsor, and with all applicable laws and regulations of the responsible funding agency. The PI certifies that any false, fictitious, or fraudulent statements or claims may subject him/her to criminal, civil, or administrative penalties. By their signatures, the Chair and the Dean approve the project described in this transmittal form, including the budget, matching funds, release time, and/or other considerations identified in this proposal. By signing on a revised or supplemental proposal, the PI certifies that the information in this application still holds true. Date PI/Director: ___________________________________________ Date ________ Dean Dept. Chair: ____________________________________________ Note: Investigator must have written commitment from each person named in the proposal that they agree to be included in this application. [This is not necessary for private industry sponsored studies requiring IRB approval.] Co-PI/Co-director letter(s) of commitment attached: Yes INSTITUTIONAL SIGNATURES: Date Comparative Medicine ____________________________________ _____________ Hospital Administration____________________________________ _____________ Medical Center Finance____________________________________ _____________ Research Administrator____________________________________ _____________ SLU Institutional Official___________________________________ _____________ Office of the Provost (matching funds)________________________ 612944746 No _____________ Page 3 Created on 3/6/2014 Saint Louis University Lay Research Summary Principal Investigator (Please type) Last Name Phone: email: First Name Project Title: Funding Agency: Grant Start Date: PART 1 (SUMMARY) (To be written for understanding by the general public) Date Prepared: 612944746 Page 1 Created on 3/6/2014 Saint Louis University Lay Research Summary (Part II) This information may also be used in related Public Relations projects with your prior approval. 1. What specific problem area will your research address, and what unique questions will you try to answer, including long-range health benefits? 2a. What aspect of your work would the scientific community find most interesting? 2b. What aspect of your work would the general public find most interesting? Principal Investigator: (please type) 612944746 Page 2 Created on 3/6/2014 Date: ORSA Administrative Staff Office of Research Services Administration Medical Center Caroline Building, Room 110 3556 Caroline Street St. Louis, MO 63104 ORSA Administrative Staff Office of Research Services Administration Verhaegen Hall, Room 305 3634 Lindell Boulevard St. Louis, Missouri 63108 RE: To ORSA Administrative Staff: The purpose of this letter is to acknowledge that I agree to participate as a Co-PI or Co-Director for the project referenced above. In the event this project is funded, I am fully aware of my role in the project, that % of my salary will be recovered and I will be expending % of my effort toward the project’s completion. This letter confirms that I understand Saint Louis University policies and procedures regarding grant and contract applications as they relate to this project. I understand I am not guaranteed a position with Saint Louis University or the funding agency as a result of my inclusion in the project’s proposal. By signing this letter I further certify that I have read the University’s Conflict of Interest in Research Policy and no actual, potential, or apparent conflict of interest exists or a conflict of interest exists and the required financial disclosure(s) have been filed, and a management plan has been approved (a copy of this plan is appended) or is under review. Regards, Co-PI/Co-Director signature: Co-PI/Co-Director title: Department Chair signature*: Chair, Letter of Commitment Created on 3/6/2014