Proposal Planning & Submission Process
Proposal Planning &
Submission Process
Proposal Submission & Review
https://www.nursing.arizona.edu/resources/research
Complete Intent to Submit Form (ITS) and submit to
CON-
ORS@email.arizona.edu
and
preaward@email.arizona.edu
(6-8 weeks prior to submission deadline*)
*Exceptions for funding opportunities with tight turnaround
from original posting)
Proposal is submitted to ORS and is sent to the
proposal review panel.
(4 weeks prior to submission deadline)
Proposal review panel is selected and contacted.
(6 weeks prior to submission deadline)
Review panel returns proposal submission with
comments and revision suggestions.
(2 weeks turnaround time required)
PI has approximately 1-2 weeks to implement any
changes and send final documents to Preaward for
final formatting before submission deadline.
Planning to submit an extramural
grant proposal?
ǂ
Office of Research &
Scholarship (ORS)
UAHS Administration
(Preaward)
Submits to Sponsored Projects
(3 days prior to submission deadline)
Formats and prepares final application
(1 week prior to deadline)
Routes budget through UAccess Research
(1-2 weeks prior to submission deadline)
Works with PI to create budget, coordinates
subawards, if applicable.
(4 weeks prior to submission deadline)
Sends proposal checklist and timeline to PI.
(4-6 weeks prior to submission deadline)
Coordinates collection and formatting of biosketches
and letters of support, provides standard sections for
PI editing (e.g., facilities and resources)
(2-4 weeks prior to submission deadline)
Consult with ORS staff on resources, proposal
planning, assistance needed with application
(6-8 weeks prior to submission deadline*)
ǂIntramural submissions can benefit from this process, too.
Intent to Submit (ITS) Form
(6 – 8 Weeks Prior to Deadline)
ORS
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Help with Grant Application
•
Arrange for Pre-Review
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Advocate for CON Faculty
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CON Approval (Division and College)
UAHS ADMINISTRATION (PREAWARD)
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Plan for Submission
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Generate Proposal Checklist
ITS PURPOSE
Proposal Planning
(6 – 8 Weeks Prior to Deadline)
ORS
•
Funding Opportunities
•
Study Design & Methods
•
Collaborators
•
Statistical Consulting
DEPARTMENT CHAIRS
•
Study Design & Methods
•
Collaborators
PREAWARD
•
Budget Preparation
•
Coordinate Subawards
ASSISTANCE AVAILABLE
Pre-Review
(4 – 6 Weeks Prior to Deadline)
•
More Competitive Application
•
Feedback from Experts
•
Content Specialists
•
Experienced Reviewers
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Ensure adequate resources
•
Select and Contact Reviewers (6 weeks prior to deadline)
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Send to Reviewers (4 weeks prior to deadline)
•
Return Reviews (2 weeks prior to deadline)
PURPOSE OF PRE-REVIEW
TIMELINE FOR PRE-REVIEW
Preaward
(1 – 6 Weeks Prior to Deadline)
•
Creates Budget
•
Coordinates Subawards
•
Coordinates & Formats
•
Biosketches
•
Letters of Support
•
Standard Sections (e.g., Facilities & Resources)
•
Routes Budget through UAccess Research (UAR)
•
Formats and Prepares Final Application
•
PI Reviews Final Application
•
Submits Application to Office of Sponsored Projects
PREAWARD PROCESS
Sponsored Projects
(3 Days Prior to Deadline)
•
Submits Final Application
•
Sends Confirmation
•
For Federal Grants, PI Logs In and Reviews Final
Application
•
If good, proposal is submitted
•
If errors, recall, revise and resubmit
SUBMISSION PROCESS
Proposal Review
•
Federal Applications
•
Assigned to Study Section
•
Reviewed 3-6 Months after Submission
•
Results 3-30 Days after Review
•
Feedback Provided
•
Funding Based on Review and Institute Priorities (1-3
Months after Review)
•
Let ORS Know of Result
•
Foundations
•
Varies Dependent on Foundation
•
Usually Quicker Turnaround
•
Feedback Not Always Provided
PROCESS VARIES
Proposal Resubmission
•
Send Results/Summary Statement
•
Collaborators
•
ORS
•
Decide Whether to:
•
Revise and Resubmit
•
Submit as New
•
Try Something Else
•
Persistence Pays Off!
ORS & PREAWARD
Questions
?
https://www.nursing.arizona.edu/ors
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Assistant Director
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Assistant Director
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Associate Director
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Senior Research Administrator
University of Arizona Health Sciences
Research Administration
What is a Sponsored Project?
Agreement for funds from a federal, state, or private
organization provided on a contractual or grant basis and
used for a specific purpose.
1.
Requires separate accounting procedures and reports or
other deliverables
2.
Involves programmatic decision making, effort, analysis or
interpretation to carry out objectives
3.
Negotiated between University and sponsor and requires
signature of official UA signatory
Grants
and Clinical Trials
G
R
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N
T
S
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An award of financial
assistance for research,
instruction, or other sponsored
activity
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Awarded on a competitive basis
to recipients responding to a
sponsor's program
announcement
•
Specific period of performance
•
Cost reimbursement
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A type of clinical research that
follows a pre-defined plan or
protocol involving controlled,
clinical testing in humans
•
May be conducted under
industry-developed or
investigator-initiated trial
protocol
•
Open until recruitment goals
met
•
Fee-for-service (milestone)
NIH-Funded Clinical Trials
On January 25
th
, 2018, NIH released FORMS-E and put in
place new policies regarding Clinical Trials reporting and
Human Subjects studies. This was a major change to NIH
funding and required a complete overhaul of active Program
Announcements and RFAs.
Clinical Trials may only be proposed on PAs/RFAs/PARs that
specifically allow them.
https://grants.nih.gov/policy/clinical-trials/new-human-subject-clinical-trial-info-form.htm
Applying for Funding
Fit with area of interest
Sponsor requirements
Review the program announcement
Submission format/process
Internal requirements/approvals
Deadlines
Proposal Development
A proposal (application) consists of:
The narrative of proposed work
Budget and budget justification
Credentials/qualifications of the people involved
Letters of support
Forms/formats required by the funding party
Successful Applications
Are the result of:
Planning – weeks & months,
not
hours & days
Following instructions
Demonstrating:
PI/Team is qualified to perform the proposed aims
PI is current in the field (literature, recent developments, etc.)
The proposed aims are in line with the sponsor’s area of interest/public
need
The scale of the proposal is appropriate to the time/resources being
requested
PreAward Services
Review of eligibility & sponsor requirements
Provision of Timeline & Checklist
Budget and budget justification development
Internal routing through UAccess Research
Acquisition of Letters of Support
Provision of templates for Facilities & Resources, and others
Awareness of Sponsor-specific Forms
Application completion via ASSIST, Proposal Central, FastLane, etc…
Submission through SPCS and/or sponsor portal
Post-submission materials (Just-in-Time, rebudget, etc.)
BUDGETS
We are here to help!!
Anatomy of a Budget
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Personnel
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Equipment
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Services
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Subcontracts/sub-sites
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Supplies & Materials
directly
related to the project
•
Travel
•
Publication costs
•
Other Expenses – Relevant,
Related, Justified
I
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Also called: IDC, F&A, Negotiated
Costs, Administrative Costs
These costs are non-negotiable and
are a cost of doing business. Rates
vary based on the type of project,
location of work, and sponsor
allowability.
Personnel: people to do the work
–
Principal Investigator
–
Co-investigators, collaborators
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Consultants, mentors
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Research associates, specialists, technicians,
–
Nurses, Clinical coordinators
–
Post-docs
–
Graduate students
Special Rule: NIH Salary Cap
Persons earning more than federal government
Executive Level II, set each year
Currently: $192,300 @ 12.0 calendar months effort*
This is the base salary maximum that NIH will allow:
i.e. the salary cap
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Budget Justification
All budgets require a written narrative explaining how the funds will be
spent, known as the
Budget Justification.
Describe Personnel and their roles & committed effort, types and costs of
supplies, Travel (inc. mandatory by the sponsor), equipment, core and
professional service fees, consortiums and subaward expenses (inc.
their detailed budget).
Note: NIH modular budgets require Personnel, Consortium, and Additional
Narrative (MTDC Exclusions, differing number of modules requested)
justifications only
This commits the University and PI to spend funds in manner described.
Some sponsors are more flexible than others allowing changes after an
award is made, so be sure to become familiar with the policies
governing each award. Our office can help you.
Where to find funding opportunities
U
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http://research.uahs.arizona.edu/
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http://rgw.arizona.edu/
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https://grants.nih.gov/grants/guide/listserv_dev.htm
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P
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https://rgw.arizona.edu/development/funding-
opportunities/search-databases-and-useful-funding-sources/cos-
pivot
Funding Opportunity Announcement
(FOA)
•
Investigator - Initiated
•
Parent R01 (Clinical Trial NOT Allowed): PA-19-056
•
Parent R01 (Clinical Trial Required): PA-19-055
•
Parent R21 (Clinical Trial NOT Allowed: PA-19-053
•
Parent R21 (Clinical Trial Required): PA-19-054
•
K Awards: K Kiosk (K for “C”areer)
•
RFA – Request for Funding Announcement
•
PA – Program Announcement – NIH topic interest
•
PAR – Program Announcement – special receipt dates
•
RFP – Request for Proposal – single receipt date
Career Development Awards
•
Can be Mentored or Independent, or a hybrid
•
Have very specific eligibility requirements
•
Generally require a significant commitment of protected
research time: 50% to 75% of total effort
•
Generally support salary for PI up to a cap; no salary support
for mentor/other faculty-level collaborators
•
Provide a small amount of funding to support project costs
•
Usually require an institutional commitment of support
(additional funding, space, access to resources)
•
Last 2 to 5 years
•
Intended to lead to independent investigator-initiated funded
research (R21, R01)
NIH NINR - Specific
Post-Submission
•
What happens next?
–
Hurry up & wait – it will be months before you receive feedback
–
Most awards start 6-9 months after a deadline date, or more
•
Peer review comments
•
If your proposal is in a fundable range:
–
Additional information may be required
–
Budget numbers are settled
–
Submit protocols to IRB EARLY; missing approvals will delay your
award. If you wait for the Just-in-Time request you will be LATE
•
Award documents are sent to Sponsored Projects
–
You can begin spending on the project as of the start date
Grant Award
•
Grants are awarded to the applicant institution, not the
individual PI
•
Not official until Notice of Grant Award (NOA) is received
or contract/subcontract is fully executed
•
Read NOA carefully for restrictions; must be in
compliance
throughout the life of the grant.
This includes
reporting on Key Personnel, prior approval for effort
changes, etc.
During the Award
•
Sponsored Projects
–
Prepares financial reports / invoices
–
Monitors account / deposits cash
–
Assists PI and department with cost allowability questions*
–
Assists PI and department with sponsor regulation questions*
•
The PI
–
Oversees the proposed work
–
Prepares technical/progress reports*
–
Monitors expenditures
•
The PI’s department
–
Works with SPCS on expenditure allowability
–
Prepares requisition documents to make purchases
–
Prepares interim cost reports for the PI
Award Management
•
Spending someone else’s money = high level of
organization & responsibility
•
Effort Tracking
•
Expenditure Allowability
•
Progress Reporting
•
Compliance issues
•
All while getting the research done (and searching for the next
opportunity(ies)!)
•
Sponsored research is a coordinated effort
•
Become familiar with the different offices
•
Find out the rules of your
department/college/institution/company (ITS Forms!)
UAHS Regulatory Services
•
Support UAHS Faculty with preparing, finalizing, and submitting
completed applications and authorizations to both local and
commercial IRBs
•
New projects/deferrals, human research determinations, retrospective chart reviews;
•
Modifications, consent form revisions;
•
Partial HIPAA waivers;
•
Continuing review;
•
Safety/AE and protocol deviations
•
Assistance with the UAHS Research Intake Application (RIA) for
Banner feasibility review and budget preparation
•
Assistance with processing regulatory start up documents (1572,
financial disclosures, protocol signature page, site contact form, etc.),
obtaining signatures and returning completed documents to Sponsor.
•
Protocol and Informed Consent development, support, review, and
expertise for investigator-initiated studies.
•
Maintenance of electronic files and hard copy regulatory
binders for assigned studies.
•
ClinicalTrials.gov
submissions including closeout and
posting of results for concluded studies.
•
Human Research training requirements and CITI dates
•
Just-In-Time Requests from Sponsors requiring proof of
IRB approval
•
Study start-up support for Industry Sponsored protocols
UAHS Regulatory Services
Research Intake Application (RIA)
All submissions involving patients, facilities,
services, health records, or resources of a
clinical provider (e.g., Banner Health,
Dignity Health) must be submitted via email
(
ResearchApp@email.arizona.edu
) prior to
submission to the University of Arizona
Institutional Review Board (IRB).
Research Intake Application (RIA)
https://research.uahs.arizona.edu/clinical-trials/research-intake-form
For any UAHS agreements not related to clinical trials
including:
•
Confidentiality Disclosure Agreements (CDA)
•
Data Use Agreements (DUA)
•
Material Transfer Agreements (MTA)
•
Research Collaboration Agreements
•
Sub-federal Agreements
•
Education/Affiliation Agreements
UAHS Contracts
Contract Submission
Cover Sheet
https://research.uahs
.arizona.edu/content/
contracts
Navigation of the Process
•
We are here to guide PI’s and study teams through the
Clinical Trial Process
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Grants
Grants
•
Budget development
•
Prepare grant
administrative sections
•
Provide institutional
support letters
•
Secure institutional
Endorsements
•
Route for internal
approvals
•
Submit grant to external
sponsor
•
Progress reports
•
Sponsor prior approval &
carryforward requests
•
Public Access Compliance
•
Consulting agreements,
subawards
•
Grant close-outs &
no-cost extensions
•
Data reports and metrics
•
Departing PI transitions
Proposal
Proposal
Development
Development
•
Find grant opportunities
•
Coordinate internal grant
competitions
•
Maintain description of
core facilities services
•
Develop and maintain
trainee tracking database
(T32s)
Contracts
Contracts
•
Receipt of award
•
Interpret terms and
conditions as well as
sponsor requirements
•
Offer consultations with
faculty seeking external
funding and explain
university requirements
relative to funding
•
Negotiate terms and
conditions with sponsors
•
Sign the negotiated
agreement
Clinical Trials
Clinical Trials
•
Research Intake Form
Management
•
Coverage Analysis
development
•
Budget development,
negotiation
•
Secure institutional
endorsement for CTAs,
CDAs, MTAs, amendments
•
Monthly Newsletter for
Research Community
•
Visit earning
reconciliation, invoicing
•
Cash collection, deposits
Regulatory
Regulatory
•
IRB application
preparation and
submission
•
Sponsor start-up
documents
•
Protocol & informed
consent development
and review
•
Regulatory file
maintenance
•
Clinicaltrials.gov
•
Research intake form
(RIF) system navigation
& guidance
Website
:
http://research.uahs.arizona.edu/
Additional Contact Information:
For Clinical Trials:
CRC@email.arizona.edu
Coverage analysis, budget development
and negotiation support. Research Intake
Form (RIF) questions.
For Contracting Support:
UAHSContracts@email.arizona.edu
UAHS Contracting questions and
assistance including: clinical trials,
material transfer agreements,
confidentiality agreements, data use
agreements, research collaborations, new
student/resident service rotation contract
requests, and more.
For New Grants: Pre-Award
Preaward@email.arizona.edu
Grant pre-award questions including new
submissions, searching for grant funding,
advice on submission strategy, and
letters of support
For Existing Grants: Post-Award
Postaward@email.arizona.edu
Grant post-award questions including
post-award management services
(progress reporting and closeout),
guidance on expenditure allowability,
interpreting sponsor and institutional
policies, and regulations.
For
C
linical
R
esearch
O
perations
Support:
VPHS-CRO@email.arizona.edu
Clinical research questions, open clinical
trial listings, study coordinator services,
study preparation, and management
questions.
For Regulatory Support:
Regulatory@email.arizona.edu
Regulatory submission assistance,
Research Intake Form (RIF) navigation
and questions, ClinicalTrials.gov, and
general questions.
For Clinical Trial Post-Award:
CTFinance@email.arizona.edu
Clinical Trial account reconciliation,
sponsor payments, budget forecasting,
and accounts payable functions.
For Research Intake Applications:
ResearchApp@email.arizona.edu
Research application submission for
new projects, amended projects, and
retrospective chart reviews.
QUESTIONS?
"This detailed process outlines the steps involved in planning, submitting, and reviewing a proposal for extramural grant funding at the University of Arizona's College of Nursing. From completing the Intent to Submit Form to final submission to Sponsored Projects, each stage is meticulously organized to facilitate a smooth and efficient process. Collaborate with the Office of Research & Scholarship for assistance, resources, and guidance throughout the proposal development journey."
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Presentation Transcript
Proposal Planning & Submission Process
Proposal Submission & Review https://www.nursing.arizona.edu/resources/research Planning to submit an extramural grant proposal? Complete Intent to Submit Form (ITS) and submit to CON- ORS@email.arizona.edu and preaward@email.arizona.edu (6-8 weeks prior to submission deadline*) *Exceptions for funding opportunities with tight turnaround from original posting) UAHS Administration (Preaward) Office of Research & Scholarship (ORS) Consult with ORS staff on resources, proposal planning, assistance needed with application (6-8 weeks prior to submission deadline*) Sends proposal checklist and timeline to PI. (4-6 weeks prior to submission deadline) Works with PI to create budget, coordinates subawards, if applicable. (4 weeks prior to submission deadline) Proposal review panel is selected and contacted. (6 weeks prior to submission deadline) Coordinates collection and formatting of biosketches and letters of support, provides standard sections for PI editing (e.g., facilities and resources) (2-4 weeks prior to submission deadline) Proposal is submitted to ORS and is sent to the proposal review panel. (4 weeks prior to submission deadline) Review panel returns proposal submission with comments and revision suggestions. (2 weeks turnaround time required) Routes budget through UAccess Research (1-2 weeks prior to submission deadline) Formats and prepares final application (1 week prior to deadline) PI has approximately 1-2 weeks to implement any changes and send final documents to Preaward for final formatting before submission deadline. Submits to Sponsored Projects (3 days prior to submission deadline) Intramural submissions can benefit from this process, too.
Intent to Submit (ITS) Form (6 8 Weeks Prior to Deadline) ITS PURPOSE ORS Help with Grant Application Arrange for Pre-Review Advocate for CON Faculty CON Approval (Division and College) UAHS ADMINISTRATION (PREAWARD) Plan for Submission Generate Proposal Checklist
Proposal Planning (6 8 Weeks Prior to Deadline) ASSISTANCE AVAILABLE ORS Funding Opportunities Study Design & Methods Collaborators Statistical Consulting DEPARTMENT CHAIRS Study Design & Methods Collaborators PREAWARD Budget Preparation Coordinate Subawards
Pre-Review (4 6 Weeks Prior to Deadline) PURPOSE OF PRE-REVIEW More Competitive Application Feedback from Experts Content Specialists Experienced Reviewers Ensure adequate resources TIMELINE FOR PRE-REVIEW Select and Contact Reviewers (6 weeks prior to deadline) Send to Reviewers (4 weeks prior to deadline) Return Reviews (2 weeks prior to deadline)
Preaward (1 6 Weeks Prior to Deadline) PREAWARD PROCESS Creates Budget Coordinates Subawards Coordinates & Formats Biosketches Letters of Support Standard Sections (e.g., Facilities & Resources) Routes Budget through UAccess Research (UAR) Formats and Prepares Final Application PI Reviews Final Application Submits Application to Office of Sponsored Projects
Sponsored Projects (3 Days Prior to Deadline) SUBMISSION PROCESS Submits Final Application Sends Confirmation For Federal Grants, PI Logs In and Reviews Final Application If good, proposal is submitted If errors, recall, revise and resubmit
Proposal Review PROCESS VARIES Federal Applications Assigned to Study Section Reviewed 3-6 Months after Submission Results 3-30 Days after Review Feedback Provided Funding Based on Review and Institute Priorities (1-3 Months after Review) Let ORS Know of Result Foundations Varies Dependent on Foundation Usually Quicker Turnaround Feedback Not Always Provided
Proposal Resubmission ORS & PREAWARD Send Results/Summary Statement Collaborators ORS Decide Whether to: Revise and Resubmit Submit as New Try Something Else Persistence Pays Off!
Questions ? https://www.nursing.arizona.edu/ors
An Overview of Research Funding & UAHS Services Sponsored Projects, Budgets, RFAs Shannon Carver Assistant Director Elisha Johnson Assistant Director Christine Gaul Associate Director Sarah Clarke Senior Research Administrator University of Arizona Health Sciences Research Administration
What is a Sponsored Project? Agreement for funds from a federal, state, or private organization provided on a contractual or grant basis and used for a specific purpose. 1. Requires separate accounting procedures and reports or other deliverables 2. Involves programmatic decision making, effort, analysis or interpretation to carry out objectives 3. Negotiated between University and sponsor and requires signature of official UA signatory
Grants and Clinical Trials GRANTS An award of financial assistance for research, instruction, or other sponsored activity Awarded on a competitive basis to recipients responding to a sponsor's program announcement Specific period of performance Cost reimbursement CLINICAL TRIALS A type of clinical research that follows a pre-defined plan or protocol involving controlled, clinical testing in humans May be conducted under industry-developed or investigator-initiated trial protocol Open until recruitment goals met Fee-for-service (milestone)
NIH-Funded Clinical Trials On January 25th, 2018, NIH released FORMS-E and put in place new policies regarding Clinical Trials reporting and Human Subjects studies. This was a major change to NIH funding and required a complete overhaul of active Program Announcements and RFAs. Clinical Trials may only be proposed on PAs/RFAs/PARs that specifically allow them. https://grants.nih.gov/policy/clinical-trials/new-human-subject-clinical-trial-info-form.htm
Applying for Funding Fit with area of interest Sponsor requirements Review the program announcement Submission format/process Internal requirements/approvals Deadlines
Proposal Development A proposal (application) consists of: The narrative of proposed work Budget and budget justification Credentials/qualifications of the people involved Letters of support Forms/formats required by the funding party
Successful Applications Are the result of: Planning weeks & months, not hours & days Following instructions Demonstrating: PI/Team is qualified to perform the proposed aims PI is current in the field (literature, recent developments, etc.) The proposed aims are in line with the sponsor s area of interest/public need The scale of the proposal is appropriate to the time/resources being requested
PreAward Services Review of eligibility & sponsor requirements Provision of Timeline & Checklist Budget and budget justification development Internal routing through UAccess Research Acquisition of Letters of Support Provision of templates for Facilities & Resources, and others Awareness of Sponsor-specific Forms Application completion via ASSIST, Proposal Central, FastLane, etc Submission through SPCS and/or sponsor portal Post-submission materials (Just-in-Time, rebudget, etc.)
BUDGETS We are here to help!!
Anatomy of a Budget Direct Costs Indirect Costs Also called: IDC, F&A, Negotiated Costs, Administrative Costs Personnel Equipment Services Subcontracts/sub-sites Supplies & Materials directly related to the project Travel Publication costs Other Expenses Relevant, Related, Justified These costs are non-negotiable and are a cost of doing business. Rates vary based on the type of project, location of work, and sponsor allowability.
Personnel: people to do the work Principal Investigator Co-investigators, collaborators Consultants, mentors Research associates, specialists, technicians, Nurses, Clinical coordinators Post-docs Graduate students
Special Rule: NIH Salary Cap Persons earning more than federal government Executive Level II, set each year Currently: $192,300 @ 12.0 calendar months effort* This is the base salary maximum that NIH will allow: i.e. the salary cap Cost share: The difference between the actual university base salary and this cap is covered by the university sharing the cost of the research project
Budget Justification All budgets require a written narrative explaining how the funds will be spent, known as the Budget Justification. Describe Personnel and their roles & committed effort, types and costs of supplies, Travel (inc. mandatory by the sponsor), equipment, core and professional service fees, consortiums and subaward expenses (inc. their detailed budget). Note: NIH modular budgets require Personnel, Consortium, and Additional Narrative (MTDC Exclusions, differing number of modules requested) justifications only This commits the University and PI to spend funds in manner described. Some sponsors are more flexible than others allowing changes after an award is made, so be sure to become familiar with the policies governing each award. Our office can help you.
Where to find funding opportunities UAHS Research Administration Website http://research.uahs.arizona.edu/ UA Research Gateway http://rgw.arizona.edu/ NIH Weekly Table Of Contents (TOC) https://grants.nih.gov/grants/guide/listserv_dev.htm Grants.gov: Manage Subscriptions (home page; top right) http://www.grants.gov/web/grants/manage-subscriptions.html Community of Science (CoS) PIVOT https://rgw.arizona.edu/development/funding- opportunities/search-databases-and-useful-funding-sources/cos- pivot
Funding Opportunity Announcement (FOA) Investigator - Initiated Parent R01 (Clinical Trial NOT Allowed): PA-19-056 Parent R01 (Clinical Trial Required): PA-19-055 Parent R21 (Clinical Trial NOT Allowed: PA-19-053 Parent R21 (Clinical Trial Required): PA-19-054 K Awards: K Kiosk (K for C areer) RFA Request for Funding Announcement PA Program Announcement NIH topic interest PAR Program Announcement special receipt dates RFP Request for Proposal single receipt date
Career Development Awards Can be Mentored or Independent, or a hybrid Have very specific eligibility requirements Generally require a significant commitment of protected research time: 50% to 75% of total effort Generally support salary for PI up to a cap; no salary support for mentor/other faculty-level collaborators Provide a small amount of funding to support project costs Usually require an institutional commitment of support (additional funding, space, access to resources) Last 2 to 5 years Intended to lead to independent investigator-initiated funded research (R21, R01)
Post-Submission What happens next? Hurry up & wait it will be months before you receive feedback Most awards start 6-9 months after a deadline date, or more Peer review comments If your proposal is in a fundable range: Additional information may be required Budget numbers are settled Submit protocols to IRB EARLY; missing approvals will delay your award. If you wait for the Just-in-Time request you will be LATE Award documents are sent to Sponsored Projects You can begin spending on the project as of the start date
Grant Award Grants are awarded to the applicant institution, not the individual PI Not official until Notice of Grant Award (NOA) is received or contract/subcontract is fully executed Read NOA carefully for restrictions; must be in compliance throughout the life of the grant. This includes reporting on Key Personnel, prior approval for effort changes, etc.
During the Award Sponsored Projects Prepares financial reports / invoices Monitors account / deposits cash Assists PI and department with cost allowability questions* Assists PI and department with sponsor regulation questions* The PI Oversees the proposed work Prepares technical/progress reports* Monitors expenditures The PI s department Works with SPCS on expenditure allowability Prepares requisition documents to make purchases Prepares interim cost reports for the PI
Award Management Spending someone else s money = high level of organization & responsibility Effort Tracking Expenditure Allowability Progress Reporting Compliance issues All while getting the research done (and searching for the next opportunity(ies)!) Sponsored research is a coordinated effort Become familiar with the different offices Find out the rules of your department/college/institution/company (ITS Forms!)
UAHS Regulatory Services Support UAHS Faculty with preparing, finalizing, and submitting completed applications and authorizations to both local and commercial IRBs New projects/deferrals, human research determinations, retrospective chart reviews; Modifications, consent form revisions; Partial HIPAA waivers; Continuing review; Safety/AE and protocol deviations Assistance with the UAHS Research Intake Application (RIA) for Banner feasibility review and budget preparation Assistance with processing regulatory start up documents (1572, financial disclosures, protocol signature page, site contact form, etc.), obtaining signatures and returning completed documents to Sponsor. Protocol and Informed Consent development, support, review, and expertise for investigator-initiated studies.
UAHS Regulatory Services Maintenance of electronic files and hard copy regulatory binders for assigned studies. ClinicalTrials.gov submissions including closeout and posting of results for concluded studies. Human Research training requirements and CITI dates Just-In-Time Requests from Sponsors requiring proof of IRB approval Study start-up support for Industry Sponsored protocols
Research Intake Application (RIA) All submissions involving patients, facilities, services, health records, or resources of a clinical provider (e.g., Banner Health, Dignity Health) must be submitted via email (ResearchApp@email.arizona.edu) prior to submission to the University of Arizona Institutional Review Board (IRB).
Research Intake Application (RIA) https://research.uahs.arizona.edu/clinical-trials/research-intake-form
UAHS Contracts For any UAHS agreements not related to clinical trials including: Confidentiality Disclosure Agreements (CDA) Data Use Agreements (DUA) Material Transfer Agreements (MTA) Research Collaboration Agreements Sub-federal Agreements Education/Affiliation Agreements
Contract Submission Cover Sheet https://research.uahs .arizona.edu/content/ contracts
Navigation of the Process We are here to guide PI s and study teams through the Clinical Trial Process
Research Administration Services Proposal Development Grants Regulatory Contracts Receipt of award Interpret terms and conditions as well as sponsor requirements Offer consultations with faculty seeking external funding and explain university requirements relative to funding Negotiate terms and conditions with sponsors Sign the negotiated agreement Clinical Trials Budget development Prepare grant administrative sections Provide institutional support letters Secure institutional Endorsements Route for internal approvals Submit grant to external sponsor Progress reports Sponsor prior approval & carryforward requests Public Access Compliance Consulting agreements, subawards Grant close-outs & no-cost extensions Data reports and metrics Departing PI transitions IRB application preparation and submission Sponsor start-up documents Protocol & informed consent development and review Regulatory file maintenance Clinicaltrials.gov Research intake form (RIF) system navigation & guidance Research Intake Form Management Coverage Analysis development Budget development, negotiation Secure institutional endorsement for CTAs, CDAs, MTAs, amendments Monthly Newsletter for Research Community Visit earning reconciliation, invoicing Cash collection, deposits Find grant opportunities Coordinate internal grant competitions Maintain description of core facilities services Develop and maintain trainee tracking database (T32s)
Website: http://research.uahs.arizona.edu/ Additional Contact Information: For New Grants: Pre-Award Preaward@email.arizona.edu Grant pre-award questions including new submissions, searching for grant funding, advice on submission strategy, and letters of support For Clinical Trials: CRC@email.arizona.edu Coverage analysis, budget development and negotiation support. Research Intake Form (RIF) questions. For Existing Grants: Post-Award Postaward@email.arizona.edu Grant post-award questions including post-award management (progress reporting guidance on expenditure allowability, interpreting sponsor and institutional policies, and regulations. For Clinical Trial Post-Award: CTFinance@email.arizona.edu Clinical Trial account sponsor payments, budget forecasting, and accounts payable functions. For Research Intake Applications: ResearchApp@email.arizona.edu Research application submission for new projects, amended projects, and retrospective chart reviews. reconciliation, services closeout), and For Contracting Support: UAHSContracts@email.arizona.edu UAHS Contracting assistance including: material transfer confidentiality agreements, data use agreements, research collaborations, new student/resident service rotation contract requests, and more. For Regulatory Support: Regulatory@email.arizona.edu Regulatory submission assistance, Research Intake Form (RIF) navigation and questions, ClinicalTrials.gov, and general questions. For Clinical Research Operations Support: VPHS-CRO@email.arizona.edu Clinical research questions, open clinical trial listings, study coordinator services, study preparation, and management questions. questions clinical agreements, and trials,
