Clinical Research & Trials

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Proposal Development
April 2014
Proposal Development
After this session you will:
• Understand the award lifecycle
• Have a timeline to follow when planning to
submit a proposal
• Know about different types of programs you can
apply for
• Know where to find and what to look for in
sponsor guidelines and instructions
• Understand the typical elements of a proposal
• Know the basic elements of budgets
2
Life Cycle of Award
More Money!
Proposal
Development
Locate Funding &
Complete Proposal
Package
Institutional
Review
Proposal
Submission
and/or
Signature
Approval
Close-outs
and
Sponsor
Reports
Award Lifecycle
Just-in-Time
submission
Progress Report
review &
Submission
Tracking and
Accounting
Account set up
Incurring Costs
and Purchasing
Negotiate & Execute
incoming &
outgoing
Subcontract &
Contract
agreements
Prior
Approval
Requests
3
Proposal Timelines
2 – 3 Months Prior to Deadline
Review Sponsor’s proposal
Requirements
Start writing – 2 to 3
months prior to deadline
Confer with Colleagues
Review RFA Review
Criteria
Talk to Federal Program
Officers
1 Month Prior to Deadline
Collect all Biosketches,
etc..; Develop Budget &
Justification; Obtain
Subcontractor Documents
(LOI, Budget, Scope of
Work, etc.)
5 Days prior to Deadline (At
least)
Submit all internal
paperwork, including COI
forms, and preliminary
proposal to BMC Grants
Administration for initial
review
Submit completed
proposal to BMC Grants
Administration for final
review-(Minimum 48 hours
to ensure success)
4
Federal Program Types
K01: Research Career Programs - Research Scientist Development Award
For support of a scientist, committed to research, in need of both advanced research
training and additional experience.
K08: Research Career Programs - Clinical Investigator Award (CIA)
To provide the opportunity for promising medical scientists with demonstrated aptitude to
develop into independent investigators, or for faculty members to pursue research
aspects of categorical areas applicable to the awarding unit, and aid in filling the
academic faculty gap in these shortage areas within health profession's institutions of
the country.
R01: Research Projects
To support a discrete, specified, circumscribed project to be performed by the named
investigator(s) in an area representing his or her specific interest and competencies.
R03: Research Projects - Small Research Grants
To provide research support specifically limited in time and amount for studies in categorical
program areas. Small grants provide flexibility for initiating studies which are generally
for preliminary short-term projects and are non-renewable.
http://grants.nih.gov/grants/funding/ac_search_results.htm
5
Proposal Development – General
Sponsor Instructions
• Read the Program Announcement / Instructions thoroughly
 Sponsor’s policies and procedures – often additional links
 Review Criteria
• NIH SF424 RR Guidelines and Forms
http://grants.nih.gov/grants/funding/424/index.htm
BMC Grants Administration Websites
• Contains links to sponsor guidelines, internal forms, sponsor forms and
instructions
• BMC Grants Administration:
http://internal.bmc.org/grants/pre_award.html
6
Sponsor Requirements
The Sponsor’s Program Announcement (PA) or Research Funding
Announcement (RFA), etc contain the following information:
• Paper or Electronic? When due?
• Required NIH Forms
Biosketch
Other Support
(http://grants.nih.gov/grants/funding/424/index.htm)
• Page Limitations
• Budget
Total Cost Cap?
Direct Cost Cap
• Review Criteria
7
“Typical” Proposal Elements
•
Cover page - PI contact info, title of proposal, funds requested, project duration,
and signature lines
•
Abstract - brief description of proposed project (usually 1 page)
•
Narrative - detailed description of proposed project
•
Personnel - CVs, biosketches, or paragraph-size descriptions
•
Budget - annual costs of the project, using standard categories
•
Budget justification - narrative explanation of how amounts were calculated and
how funds will be used
•
Supporting documents - letters of support and other items showing strength of
partnerships, university commitments, etc.
•
Other - management, diversity, outreach, and/or evaluation plans
8
Institutional Requirements - Forms
• Proposal Summary Form
• Financial Conflict of Interest Form(s)
• Letters of Intent (Subcontractors)
• Rate Agreements
http://internal.bmc.org/grants/pre_forms.html
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BUDGETS
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Criteria of a Good Budget
• Translates resource needs to dollars
• Conforms to agency guidelines
• Estimates are realistic
• Supports the program
• Explains itself
• Plans ahead
• Identifies organizational concerns/issues
11
Direct Costs
Direct costs are those costs that can be
easily identified specifically with a
particular sponsored project, institutional
activity, or that can be assigned to such
activities relatively easily with a high
degree of accuracy. Identification with the
sponsored work rather than the nature of
the goods and services involved is the
determining factor in distinguishing direct
costs from indirect costs.
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Direct Costs – Salary
• 75 – 80% of Budget is Salary and Fringe Benefits
• Salary Cap: Legislatively mandated limitation of direct
salary charges to an NIH grant, currently $181,500
(http://grants.nih.gov/grants/guide/notice-files/NOT-OD-14043.html)
• Calculation of Salary Cost:
Institutional Base Salary × Percent Effort
or
Institutional Base Salary
Academic Appointment i. e. 12 or 9 × Person Months of Effort
13
Direct Costs - Fringe Benefits
BMC FB Rates
FB Rates - Federal
Non-Federal FB
Rates
BU FB Rates*
10/01/12 31.2% BMC 27.6% Professional
Staff
24.9% Support Staff
N/A Consultant
9.5% Graduate
Students
10/01/12 31.2% BMC 29.2% Professional
Staff
26.5% Support Staff
N/A Consultant
9.5% Graduate
Students
* BU FB Rates as of 07/01/2014; these are renegotiated each year
14
Direct Cost Budget Categories
Consultants
•
BU and BMC employees can not be classified as “consultants” on a BMC grant
proposal – if BU employee, they can either be part of a subcontract (primarily working in
BU space), or they can be listed in the Salary/FB budget category (primarily working in
BMC space).
Capital Equipment
•
•
Greater than $5,000 in acquisition cost (capitalization threshold)
Sponsor often requires quote from equipment vendor
Travel
•
Information about per diem costs for travel (car mileage on a federal grant can be found
at:http://www.gsa.gov/portal/content/100715; and
http://internal.bmc.org/grants/policies_post/BMC-grants_travel.doc
Animal
•
Per diem costs for animals, and purchasing costs for different species can be found
at:http://www.bu.edu/animalcare/services/per-diem-rates/ and
http://www.bu.edu/animalcare/services/animal-ordering/
Patient Care Costs
•
Pharmacy (Investigational Drug Service or IDS) and Inpatient/Outpatient Service
chargeshttp://internal.bmc.org/grants/ClinicalTrials.html
15
Direct Cost – Subcontractors
Subcontractors vs. Consultants
• Subcontractor – A third-party organization that conducts a significant part of
the research, assists in making programmatic decisions, and has
deliverables to the final product.
• Consultant* – An individual who lends specific technical expertise and
whose relationship with the project is of limited duration and scope.
* BMC employees can never be budgeted as consultants
Budget Considerations
• On subcontracts, only the first $25,000 is subject to the institution’s F&A
Recovery (Indirect Costs).
• Consultants, Vendors and Purchase Orders are subject to full F&A
Recovery (Indirect Costs).
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Direct Cost - Subcontractors
Documents required:
• Letter of Intent
• Scope of Work
• Budget & Budget Justification
• Biosketch(es) (if sponsor requires)
• Other Support (if sponsor requires)
• DUNS number
For NIH Grants:
If direct cost budget is “capped”, the Indirect Costs for the
subcontractor does not count toward the “direct cost cap”
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Direct Cost – Unallowable
•
•
•
•
•
•
•
•
•
•
•
•
Business Meals (non-travel)
Alcohol
Computer Supplies (paper, toner)
Copier Charges
Entertainment
Fixed Phone Charges
Maintenance of General Purpose Equipment
Membership and Dues
Office Supplies
Postage
Software (General Purpose)
Subscriptions
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Modular Grants
http://grants.nih.gov/grants/funding/modular/modular.htm
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BMC Indirect Costs
Indirect Costs or IDC = Facility and Administrative Costs (F&A) = Overhead
Federal Indirect Cost Rates
Research: 10/1/12
10/1/13
10/1/14
10/1/12
69.% on site
71% on site
74% on site
17.8% off-site
Clinical/Service/Edu./Other: 28% clinical/service/education
Training: 8% training
BMC calculates IDC using a “Modified Total Direct Cost” or MTDC
method:
Direct Costs minus subcontract costs, equipment costs,
patient care costs, tuition and fees costs = MTDC
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Modified Total Direct Costs (MTDC)
Modified total direct costs (MTDC), consisting of all salaries and wages,
fringe benefits, materials, supplies, services, travel and sub-grants and
subcontracts up to the first $25,000 of each sub-grant or subcontract
(regardless of the period covered by the sub-grant or subcontract).
Modified total direct costs shall exclude equipment, capital expenditures,
charges for patient care, tuition remission, rental costs of off-site facilities,
as well as the portion of each sub-grant and subcontract in excess of
$25,000.
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Indirect Costs Overview
Grants and Contracts
Administration
Research Finance
Administration
Finance
Costs that can not
be directly
assigned to any
one program
Purchasing
Accounts Payable
Human Resources
Utilities (lights, heat, etc)
House Keeping
Building and Equipment
Depreciation
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Facility and Administration Allocations (F & A)
F & A Allocations
FACILITY COST POOLS
 Building Depreciation
 Land/Building
Improvements
 Equipment Depreciation
 Operations and
Maintenance
 Utilities
ADMINISTRATIVE COST
POOLS



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General Administration
Hospital Services
Grants Administration
IACUC, IBC, IRB costs
Compliance Costs
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Questions?
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