SLU Transmittal Form for Internal Review and Approval

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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
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