Reason for submission?
* must provide value
Requesting MS Pre-Award support
Notification of large grant only (pre-award support is not being requested)
Department or Unit
* must provide value
Emergency Medicine
MS CIP
VA
MS Dept (requesting additional support)
Other
ALRT - Anesthesiology, Laboratory Medicine & Pathology, Radiology, Radiation Oncology
Duluth
Physical Therapy/Rehab Science
Ophthalmology & Visual Neurosciences
Dermatology
Neurology
Neurosurgery
Psychiatry
Center for Immunology
Rehabilitation Medicine - Npsych & PM&R
Otolaryngology
Department, Center, Institute or Program Name
* must provide value
Yes
No
Today's Date:
* must provide value
Today M-D-Y
Name of Contact PI (UMN PI if a sub-award or multi-site study):
* must provide value
last name, first name
Contact PI UMN email address:
* must provide value
Are you the PI or MPI of this submission?
* must provide value
Yes
No
Name of person completing this form
Please enter both first and last name
Email address for person completing this intent
This submission is:
* must provide value
New Revised (resubmission) Supplement Other Renewal (aka Competing Continuation)
Multi-PIs?
* must provide value
yes no
Co-Investigators?
* must provide value
yes no
Federal Identifier# assigned to the prior submission
Please indicate "n/a" if there is no award number to reference. (Note: NIH allows one resubmission).
* must provide value
eg. R01AG1024821
Is this a large-scale grant (LSG)?LSG is defined by a NIH P-, T-, U-, or other mechanism (such as ARPA-H, DoD and DARPA), at least $1m direct costs for three or more years, and a collaborative multi-investigator proposal.
* must provide value
Yes
No
Unsure
Request for Application (RFA) Number:
* must provide value
If no RFA number is available please paste the URL linked to the funding announcement or attach a PDF version in the Additional Documents section found at the bottom of the page
Solicitation # and Mechanism (i.e. R01 PA-20-185 or link to funding announcement):
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FOA/RFA/PA#/Funding program name/Website link to Funding Announcement
Project Title/Working Title:
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If unknown, enter working title or "TBD."
Project Summary/Abstract:
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Brief description (or upload document in the next field)
Upload project summary/abstract (optional)
Preferred method of contact in the four days prior to sponsor deadline:
* must provide value
List your Email, cell phone, pager, etc.
What are the major goals?
This is needed for other support. Include as much information as possible and what is known at this time.
Proposal is for:
* must provide value
Research Basic %: Applied %: Development %: Total %:______
Instruction
Other Sponsored Activity
Clinical Trial
Equipment Only
Student Support Only
$0 Master Agreement
Other
You indicated proposal is for "other." Please specify:
Sponsor Initiated PI Initiated
View equation
must equal 100
Are there subcontracts?
* must provide value
yes no
Who should the subcontract documents be sent to?
Please include as much detail as possible and what is known at this time.
List name(s) and email(s)
Alternate/Assistant contact (as applicable):
Sponsor Due Date:
* must provide value
Today M-D-Y
Expected project start date
* must provide value
Today M-D-Y
Deadlines:
* Intent to Submit Survey completed eight weeks prior to sponsor deadline.
* All proposal materials complete and delivered to pre-award contact 5 business days before sponsor due date
Goals:
*10 working days prior to sponsor due date finalize budget and route PRF
* 5 working days prior to sponsor due date finalize all documents in application
How many years of funding are being requested?
Is this a sponsor-initiated (B&I) clinical trial (company providing protocol) ?
* must provide value
Yes
No
(Business and Industry)
Is this
* must provide value
Registry
Phase I
Phase II
Phase III
Phase IV
Other
Is this sponsor initiated or PI initiated
* must provide value
Sponsor PI
In what clinic will subjects/participants be seen?
B&I Clinical Trials are handled by CTSI.
If available, please upload the finalized B&I protocol
Check all that apply
Study staff
List MPIs, Co-Is, and research team members with estimated effort.
Please include as much detail as possible and what is known at this time.
* must provide value
Include names, roles, x.500, % effort
List all building names and room numbers needed for the proposed research. This is included on the PRF. Please include as much detail as possible and what is known at this time.
* must provide value
List all sites where you are conducting your research - will be used for PRF.
Do you have a VA appointment?
* must provide value
Yes
No
What is your VA appointment?
* must provide value
1/8 2/8 3/8 4/8 5/8 6/8 7/8 8/8
Is your MOU updated?
* must provide value
Yes
No
Not sure
Who are the anticipated U of MN Research team members? Please include individuals from all departments:
Team members, their role, departments, % effort (if known at this time)
Are other institutions/entities involved?
Yes
No
For any sites outside of the USA, list them in 'International components' section.
What are the nature of your relationship with these other entities?
Describe these relationships with other institution(s):
List and describe role each will have in the research (e.g., staff, resources, spaces, analysis, etc.)
List all building names and room numbers needed for the proposed research.
List all sites where you are conducting your research.
Mark as applicable:
* must provide value
Check box to display additional information.
Radioactive Materials and/or Ionizing or Nonionizing Radiation Producing Equipment - Indicate on PRF if applicable to this proposal.
More information: https://radsafety.umn.edu/
Recombinant or synthetic nucleic acid molecules, Infectious Agents or Biologically-derived Toxins. Indicate on PRF if applicable to this proposal.
IBC review and approval is required for:
* r/sNA transfer into organisms (including human gene transfer)
* generation and/or use of infectious agents as vectors for r/sNA transfer
* generation and/or use of engineered agents/organisms.
* infectious agents (human, animal, plant, etc.)
* biologically-derived toxins with high acute toxicity (e.g., < /= 100 mcg/kg mammalian LD50), or significant potential for serious subacute or chronic toxicity (e.g., carcinogenicity)
Protocols involving human gene transfer require pre-review by the University Recombinant DNA Advisory Committee (RAC) (unless the NIH-RAC approval has been granted) and review and approval by the IBC and IRB.
For more information:
http://www.research.umn.edu/ibc
ibc@umn.edu
Purchase/Use of Custom Antibodies- Indicate on PRF if applicable to this proposal.
There is University policy in place to monitor antibodies that have been produced in animals outside of the University.
For more information contact:
iacuc@umn.edu
Human Blood, Body Fluids, or Potentially Infectious Materials - Indicate on PRF if applicable to this proposal.
All researchers working with human blood or body fluids or other pathogens must follow the University's Bloodborne Pathogen Exposure Control Plan, and complete the Bloodborne Pathogen Training.
More information at:
https://ohs.umn.edu/programs
Chemicals - Indicate on PRF if applicable to this proposal. The use of chemicals is regulated by the University in compliance with state and federal law.
More information: https://www.dehs.umn.edu
Have you completed chemical safety training?
Yes
No
Stem Cells - Indicate on PRF if applicable to this proposal.
University of Minnesota policy states that the Stem Cell Research Oversight (SCRO) Panel must review and approve:
* Research with human embryos except for the use of embryos in non-experimental clinical care provided to patients undergoing reproductive treatments.
* Research with human iPS or hPS cells for purposes of making or contributing to an embryo, germ cell (oocytes or sperm), or mixed human-animal entity.
* Research with mixed human-animal entities containing cells derived from human embryos or SCNT, or containing human iPS cells.
The SCRO Panel does not review:
* Use of non-pluripotent human stem cells in research
* Use of pluripotent human stem cells or human induced pluripotent stem cells other than contributing to an embryo, germ cell, or mixed human-animal entity.
For more information:
https://policy.umn.edu/research/embryonicstemcells
scro@umn.edu
SCRO approval for the research proposed in this application is:
Pending
Approved
Will this proposal recruit or conduct research at Saint Louis Park?
* must provide value
Yes
No
Will this proposal include Advarra (external IRB) in the budget? R01 and equivalent studies should budget $5,000-$10,000 per year per study.
* must provide value
Yes
No
PSYCHIATRY NOTICE As of January 1, 2023, Psychiatry may be able to cede to Advarra according to the guidelines in
HRP-841 on the
UMN IRB Toolkit checklist website. Previously, Pyschiatry was able to cede to Advarra for any reason.
Please direct questions to
relyirb@umn.edu .
Will this proposal include an NIH-defined clinical trial?
NIH clinical trial: A research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes.
Note that this definition may encompass mechanistic, exploratory/development, pilot/feasibility, or other interventional studies.
* Studies intended solely to refine measures are NOT considered clinical trials.
* Studies that involve secondary research with biological specimens or health information are NOT clinical trials.
NIHS recommends consulting your program officer to confirm this determination.
More information: https://grants.nih.gov/policy/clinical-trials/definition.htm
Yes
No
Did you present this proposal at Grant Getting Group (G3) in a Project Pitch session?PIs are expected to present a Project Pitch to G3 before submitting the Intent to Submit. If you have not signed up for Project Pitch yet, please sign up here .
* must provide value
Yes
No
Have you signed up for G3 review of your NIH Specific Aims?PIs are expected to bring their NIH Specific Aims to Grant Getting Group (G3) before submitting the proposal. Sign up for review .
* must provide value
Yes
No
Yes
No
Please select all categories of LOS that you would like to request.
* must provide value
IRB approval for the research proposed in this application is:
More information at:
https://research.umn.edu/units/irb/how-submit/new-study
* must provide value
Pending Approved Exempt
Today D-M-Y
Will this research involve a 'delayed onset study'?
If human subjects study information is not available at time of application, NIH may consider this a 'delayed onset study'. Justification will be required.
More information at:
https://nexus.od.nih.gov/all/2017/12/28/what-is-delayed-onset/
yes no I don't know
Multi-site awards may be required to designate a single IRB (sIRB) as the IRB of record for the study across all sites. For example, NIH requires multi-site studies to engage a single IRB (more information ).The UMN IRB does not guarantee that they will serve as the sIRB or that they will cede to another IRB as the sIRB at the time of proposal. Please review the IRB's checklists for the following:
HRP-840 - Criteria for UMN IRB Serving as sIRB HRP-841 - Criteria for Relying on an External IRB These documents can be found on the UMN IRB's Toolkit checklist website . Direct questions to relyirb@umn.edu . I have reviewed the relevant checklists and/or contacted the UMN IRB about this proposal.
* must provide value
Yes
No
N/A - Identifiable human research data will not be accessed at more than one site
VA studies: if you are ceding to Advarra, sIRB is not exempt.
The NIH Policy on the Use of a Single IRB for Multi-Site Research may apply to your research.
Have you contacted the UMN HRPP (relyirb@umn.edu) for a Letter of Intent (LOI) to include in the grant application, and/or any questions about reliance agreements.
For more information:
https://drive.google.com/file/d/1XLP08uu--76Lt2IGx3Bt4D8iprJR5rvU/view
Yes
No
Yes
No
IACUC approval for the research proposed in this application is:
More information at:
https://research.umn.edu/units/iacuc/submit-maintain-protocols/overview
* must provide value
Pending Approved
Does the proposal include research tools?In general, NIH considers research tools to be unique research resource that encompass full range of tools that scientists use in the laboratory, including: cell lines, monoclonal antibodies, reagents, animal models, growth factors, combinatorial chemistry and DNA libraries, clones and cloning tools (such as PCR), methods, laboratory equipment and machines. To determine whether a resource is a research tool in the context of the NIH Research Tools Policy, funding recipients should consider whether:
The resource is primarily a tool for discovery rather than an FDA-approved product or an integral component of such a product; The resource is a broad, enabling invention that will be useful to many other users, rather than a project or product-specific resource; and The resource is readily useable or distributable as a tool, as opposed to an instance where private sector involvement is either a necessary means or the most expedient means for developing or distributing the resource. * must provide value
Yes
No
These issues are often topics for further discussion as proposals are prepared. Even if you are not sure about their applicability, choosing one or more now is not a negative and could actually prevent your proposal from being delayed at time of submission.
* must provide value
Check box to display additional information.
Do you, or anyone else responsible for project design, conduct or reporting, or a family member:
* Have a significant financial interest, or business interest in an entity that could benefit from results of this project?
*Have a familial connection or financial or business interest with any sub-recipient or collaborator?
A current REPA must be on file for all Sr/Key personnel prior to proposal submission.
More information: https://coi.umn.edu/
* must provide value
Yes No I don't know Not sure
Have these interests been reported in a current REPA? If so, provide REPA # and approval date.
eg, REPA #1577154, approved 01/22/2022
Describe international collaborating partner or institution, and/or international travel that will be involved in this proposal:
More information on Export Controls: https://www.research.umn.edu/units/rco/export-controls/overview
bris0022@umn.edu
Type(s) of program income:
Indicate any private commercial or trade secret information in the text of the proposal. Upon award, SPA will mark the grant as 'private'.
For more information, contact the Office of Technology Commercialization: https://research.umn.edu/units/techcomm
umotc@umn.edu
Upload draft budget (if applicable)
Attach any relevant documents here.
OnCore# (if known):
For more information on use of Fairview services:
https://www.ctsi.umn.edu/researcher-resources/research-toolkit/apply-funding/develop-budget
Describe the likelihood of a patentable discovery, inventions under prior research, and/or any active patent disclosure with OTC related to this proposal.
For more information: https://research.umn.edu/units/techcomm
umotc@umn.edu
MED SCHOOL: Grant Coordinator Lead with x500
Jordan Webb - webb0023
Erin Brudvik - erinb
Kristin Hogsett - hogse005
Jamie Dillon - jjdillon
Jessica Chiovitte - jkoski
Angie Slattery - aslatter
Alex Stark - golie006
Not Applicable (transferred, not submitted, etc.)
TBD (determining who will lead)
Yorie Smart - smart006
Katie Bevins - thoma823
Alisha Cunningham - cunni729
Ann Sather - a-sath
MED SCHOOL: Internal status up to submission
Assigned to MS pre-award team member Transferred to home department In progress (not yet submitted) Submitted (to sponsor by SPA/PI) Did not submit Duplicate RPPR support provided Pending (MS pre-award support TBD) Notification of large grant only (no MS pre-award support req'd - in progress) Provided consulting services and transferred to home dept. Notification of large grant only - submitted by home dept. Submitted (pending submission to sponsor by SPA or PI) Other - provide comments Submitted LOI/other preliminary materials (e.g. ARPA-H)
SPA Submission Date:
* must provide value
Today M-D-Y Ensure internal status = Submitted to sponsor by SPA
MED SCHOOL: Post submission internal status
Awarded Not awarded Not discussed Not recommended for further consideration (NRFC) Not submitted Other
MED SCHOOL: Did MS Pre-Award submit JIT?
Yes
No
MED SCHOOL: Post Award Status incl. Set-Up (MS Pre-Award or Home Dept)
Post-award set-up by MS Pre-Award team Transferred to home department post-award team for set-up MS Pre-Award to complete RPPR Other
February 28, 2024 - DO NOT USE (JC and KH data entry only) MED SCHOOL: Post submission internal status (as of Feb 2024) Awarded Not awarded Pending external review JIT requested In progress Did not submit Withdrawn after submission Transferred to home department Consulting services provided and transferred to home dept RPPR support provided Intent form not completed Other
If awarded, grant award number
Obtain from NOGA
Obtain from NOGA
MED SCHOOL: Mechanism / Grant Type Indicate NIH mechanism, otherwise select "Other (not NIH)", if the NIH mechanism is not listed select OR if we are a sub and it's a NIH Prime indicate "Other NIH mechanism."Â
NIH - R NIH - P NIH - T NIH - U NIH - K NIH - F NIH other mechanism / NIH Prime and UMN sub AHRQ and/or PCORI ARPA DARPA DOD Foundation University / Internal / CTSI USU Other (including B&I, Clinical, State, etc,)
Indicate NIH mechanism or other
MED SCHOOL: If NIH list institute Indicate Institute if NIH, otherwise select "Other (not NIH)", if the NIH institute is unknown select "Other NIH Institute."Â
NIH (Institute unknown or not provided) Other, not NIH NCI NEI NHLBI NHGRI NIA NIAAA NIAID NIAMS NIBIB NICHD NIDCD NIDCR NIDDK NIDA NIEHS NIGMS NIMH NIMHD NINDS NINR NLM NCCIH
Indicate Institute if NIH, otherwise select "Other (not NIH)", if the NIH institute is not listed select "Other NIH Institute."Â
Is this a large-scale grant (LSG)?LSG is defined by a NIH P-, T-, U-, or other mechanism (such as ARPA-H, DoD and DARPA), at least $1m direct costs for three or more years, and a collaborative multi-investigator proposal.
* must provide value
Yes
No
Unsure
MED SCHOOL: Post submission funding distribution
Awarded Not awarded Other
MED SCHOOL: Total direct
Use PRF to obtain total direct
Use PRF to obtain
MED SCHOOL: Total indirect
Use PRF to obtain total indirect
Use PRF to obtain
MED SCHOOL: Total budget
Use PRF to obtain total budget
Use PRF to obtain
MED SCHOOL: Number of yearsÂ
Obtain from PRF
< 1 1 2 3 4 5 6 7 8 9 10 Other
Obtain from PRF
MED SCHOOL: Dept ID
Use PRF to obtain Dept ID
Use PRF to obtain Dept ID
MED SCHOOL: Enter Dept Name
Copy Dept Name EXACTLY from PRF
Copy Dept Name EXACTLY from PRF
ALRT: Grant Coordinator Lead with x500
Diane Brown - dml
Matt Wiley - wiley148
Chuck Knudsen - knud0091
Other TBN
Other TBN
Not Applicable (transferred, not submitted, etc.)
TBD
ALRT: Internal status up to submission
Assigned to ALRT pre-award team member In progress (not yet submitted) Submitted (to SPA by pre-award team member) Submitted (to sponsor by SPA/PI) Did not submit Duplicate RPPR support provided Pending (pre-award support TBD) Other - provide comments
ALRT: Post submission internal status
Awarded Not awarded Not discussed Not recommended for further consideration (NRFC) Not submitted Withdrawn Other
ALRT: Did ALRT submit JIT?
Yes
No
Post-award set-up by ALRT team Other
Use PRF to obtain
Use PRF to obtain
Use PRF to obtain
ALRT: Enter Dept Name (Anesthesiology, Laboratory Medicine & Pathology, Radiology, Radiation Oncology)
Anesthesiology Laboratory Medicine & Pathology Radiology Radiation Oncology Other
Submit
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