Fundamentals: Proposal Preparation

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FundamentalsProposal Preparation
HMS ASPIRE

• March 17, 2006
• TMEC 250

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Presenters

• HMS Sponsored Programs Administration
• Jill Mortali, Director
• Deborah Good, Assisstant Director
• Tiffany Blackman, SSRA
• Kelly Evans, SSRA
• Kim Hesse, SSRA

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Proposal PreparationCourse Outline

• Overview of Funding and Research Administration
  at HMS

ROLES RULES TOOLS
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HMSs Biggest Sponsorthe NIH

• Office of the Director
• 27 Institutes Centers
• Budget for FY05 ???

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Award Cycle
Receipt of Award Setup of Account Notify
Faculty Negotiation
Pre-Award Proposal Preparation Project Budget
Post-Award Billing/Reimbursements Receivables/Coll
ection Financial Reporting
Audit Compliance with terms and
conditions Federal Regulation
Project Closeout Terminate Account Submit Final
Reports
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ROLES
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So who is involved in this whole deal?
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The Players(people you meet in the Gordon Hall
elevator)

• Principal Investigator (PI)
• Department Administrator
• Sponsored Programs Administration (SPA)
• Office for Research Subject Protection (ORSP)
• Office of Technology and Licensing (OTL)
• Office of Sponsored Programs (OSP
• Financial Operations and Analysis (FOA)
• Faculty Affairs

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ORSPOffice of Research Subject Protection

• ROLE
• Handles all protocols
• Animal
• Human
• Microbiological
• Certain agreements with affiliate IRBs IACUCs
• Director Carolyn Connelly, PhD
• Gordon Hall 4th floor
• 2-3192
• www.hms.harvard.edu/orsp

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OTLOffice of Technology and Licensing

• ROLE
• Facilitiates transfers of inventions made by HMS
  researchers
• Provides advice on technology agreements
• Gordon Hall 4th floor
• 2-0920

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OSPOffice for Sponsored Programs

• ROLE
• The post-award office
• Awards Management Financial Services
• HMS Manager Min Xiao
• Gordon Hall 3rd floor
• vpf-web.harvard.edu/osr

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FOAFinancial Operations and Analysis

• ROLE
• Negotiate FA (IDC) rate
• Effort and Space Reporting
• Train for financial systems
• Gifts and unrestricted designated funds
• Equipment Management
• Dean for Finance Cynthia Walker
• Gordon Hall 4th floor
• 2-3119
• www.hms.harvard.edu/foa

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FA ORIFaculty Affairs Office for Resarch
Integrity

• ROLE
• Management of Faculty Appointments (Purple Book
• Faculty Support (Red Book)
• Conflict of Interest Policy
• Assoc. Dean Margaret Dale
• Gordon Hall 1st floor
• 2-1540
• www.hms.harvard.edu/fa

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Role and Responsiblities
Dept Admin
PI
SPA
To answer this.... We refer to the matrix.
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Roles and ResponsibilitiesWhat is the Matrix you
say?
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Who can be a Principal Investigator at HMS?

• Faculty Member at HMS
• Usually an employee affiliation agreements are
  closely scrutinized by SPA
• Usually only one PI (sometimes called the Project
  Director)

THE GOLDEN TRIANGLE
Location of Research
Employer (payroll)
Faculty Appointment
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What is the role of the Department?

• Facilitates administrative aspects of grant
  application
• Assists in development of budget
• Chair reviews and approves proposal before
  sending to SPA
• Partners with SPA and OSP at award stage
• Evaluates cost reasonableness and manages
  accounts
• Support management of award and compliance with
  terms and conditions

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Mission of SPA

• To support the research mission of Harvard
  Medical School (HMS) by providing
• Specified research support services to HMS
  departments, HSDM and NEPRC
• Compliance oversight of sponsored research
  activities related to these research support
  services and
• Expert advice to the faculty and departments
  related to these research support services.

TO SERVE PROTECT...YOUR GRANTS.
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RULES
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Where do all these rules come from?
Office of Management Budget
OMB
NIH
Harvard
HMS
SPA
PI Dept
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OMB CircularsRules, Terms, and Conditions

• OMB Circulars
• A-21 Cost Principles for Education Institutions
• A-110 Administrative Requirements for Grants to
  Educational Institutions, Hospitals, and
  Non-Profits
• A-133 Audit Requirements
• http//whitehouse.gov/omb/circulars
• Federal Acquisition Regulation
• (FAR clauses) are applicable to contracts
• http//www.arnet.gov/far

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OMB Circular A-21
Purpose Establishes principles for determining
costs applicable to grants, contracts, and other
agreements with education institutions.
?
?

• Sets forth allowability principles for the
  reimbursement of costs associated with federally
  sponsored agreements
• Costs must be reasonable
• Costs must be allocable to sponsored agreements
  under the principles and methods provided
• Prudent person rule

• Defines direct versus FA (indirect) costs
• Direct lab supplies, PI salary, fringe
• FA office supplies, rent

?

• Defines the costs that can be included in the FA
  rate
• Depreciation, operating expenses, library
  expenses, administrative expenses

?

• Prescribes methods to distribute FA costs to
  various functions of the university

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OMB Circular A-110Uniform Administrative
Requirements for Grants and Agreements
Purpose Establish uniform administrative
requirements

• Subpart A General
• Definitions of key terms
• Requirements to pass down to subrecipients
• Subpart B Pre Award Requirements
• Subpart C Post-Award Requirements
• Cost-sharing matching
• Program Income
• Budget Revisions
• Subpart D After Award Requirements
• Establish procedures for closeout
• All reports submitted within 90 days
• Appendix A Contract Provisions

• Also
• Financial Systems
• Property Systems
• Procurement Standards
• Project Administration

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OMB Circular A-133

• OMB Circular that delineates the requirements for
  an annual external audit of non-profits receiving
  federal funds for sponsored programs in excess of
  500,000.
• Applies to state and local governments and
  non-profit organizations
• The circular provides information to the auditors
  and the auditees
• Audits include
• Testing of internal controls
• Testing of specific transactions
• Testing of compliance functions (effort
  reporting)
• Defines standards for the audits

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NIH Grants Policy Statement

• last revised 12/2003
• available at www.nih.gov
• (full address http//grants2.nih.gov/grants/polic
  y/nihgps_2003/nihgps_2003.pdf)
• OMB A-110 provides the framework for NIH terms
  and conditions
• Incorporates cost principles and public policy
  requirements

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Harvard and HMSResearch Policies

• Conflict of Interest
• Research Misconduct
• Statement on Outside Activities
• HMS Statement on Industry Sponsored Research
• Use of Harvard name
• Cost Sharing Policy
• Expenditure Policy

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HMS Sponsored Project Expenditure Policy

• Guide to assessing appropriateness of budgeting
  and charging certain costs to HMS awards
• Relates to A21 cost principles

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SPA Proposal Requirements
1. Internal Documentation

• Proposal Routing Form
• Internal document required for all applications
  for external funding
• Must be completed and signed prior to submission
  to Sponsore
• Provides a mechanism for collecting information
  about the application
• Addresses several important compliance areas
• Conflict of Interest Disclosure Forms (now
  required for ALL applications)
• Part 1 - Summary - required at time of proposal
  for all key personnel, indicates yes or no on
  financial interest
• Part 2 - Detail - required if yes on part 1,
  should be sent directly to Faculty Administration
  (not SPA) at time of application or when
  financial interest arises
• Agency Guidelines

The SPA 5 Day Rule
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SPA Proposal Requirements

• Application Face Page
• Research Abstract
• Budget
• Budget Justification
• or an internal budget for modular grants
• Biographical Sketches
• Resources Page
• Draft Research Plan
• Checklist form

2. Application Materials
The SPA 5 Day Rule
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TOOLS
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HMSRAML

• sends email notifications of funding
  opportunities, policy trainings, and important
  events
• to sign up visit www.hms.harvard.edu

Harvard Medical School Research Administration Mai
ling List
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SPA website
www.hms.harvard.edu/spa

• Funding Opportunities
• Institutional Information
• SPA Policies
• News and notices
• Post-Doc resources
• Training Opportunities
• Grants.gov transition info
• Forms

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The NIH Website
http//grants.nih.gov/grants/oer.htm

• Request for Applications
• Program Announcements
• Notices of policy changes
• NIH Grants Policy Statement
• Forms and Applications

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The NIH Commons
https//commons.era.nih.gov/commons

• Prepare and submit SNAP progress reports
• Check status of proposals
• Submit Just-In-Time information
• PI views summary reports (pink sheets)

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THE NIH APPLICATION

• SUBMISSION PROCESS
• AND
• COMPLETING THE APPLICATION

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NIH Types of Applications

• (1) New Application A request for an award not
  currently receiving support
• (5) Noncompeting Continuation A request for the
  subsequent budget period within an approved
  project period
• (-A1/-A2) Revised Application Unfunded
  application that has been resubmitted for
  consideration. (max of 2 times.)
• (3) Competing Supplement request to increase
  support for current period
• (2) Competing Continuation request for funding
  to renew a project for an additional project
  period
• (7) Change of Grantee Institution

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NIH Deadlines

• February 1
• June 1
• October 1

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NIH Receipt Referral Timeline
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NIH Award Mechanisms
R21
F32 or T32
T32 mentor
T32 trainee
P01
U01
F31
K22
K02
F33
R37
R01
Graduate Student
Independent PI
Faculty Position
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Things to Think About

• Check deadline dates - is a letter of intent also
  due?
• Check eligibility of the institution and PI
• Check page limits, font requirements, and special
  requirements (e.g. sealed letters of support)
• As you read through, make a checklist of the
  things you will need to submit a proposal
• Check the SPA website for forms that you will
  need to submit for our review (routing form,
  conflict of interest forms, cost-sharing form,
  etc.

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Things to Think About

• Find out from your PIs what proposals they are
  thinking of submitting
• Ask your PIs about renewals of IACUCs or IRB or
  biosafety approvals
• Ask your PIs about potential collaborations
  outside of HMS
• Work with your PIs on the budget particulars, the
  players, their effort, and their expenses
• Keep track of required Progress Report dates for
  awarded grants and remind your PIs (often)

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major components of theAdministrative Pages

• Face Page summarizes the package - Title, PI,
  performance site, budget requests, and contacts
• Abstract Page
• the abstract page should be as perfect as
  possible it will be used to make reviewing
  assignments and it may be the only thing that
  most people at the NIH will read.
• Key Personnel important to remember that they
  all must show measurable effort
• Budget Budget Justification
• Biosketches summarizes the career of the
  researcher and should demonstrate their ability
  to complete the research they are proposing.
• Resources the PI and his or her colleagues
  should have all the space and equipment they need
  to complete the research they are proposing
• Checklist Page for the NIH deals with overhead
  (FA) rates, type of submission, institutional
  assurances, program income/inventions. For non
  NIH the checklist page may be a list of item to
  include.

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NIH Peer Review Process

• Center for Scientific Review (CSR) at NIH is the
  central receipt point for all applications
• CSR refers applications to a Scientific Review
  Group (SRG) based on content and assigns to peer
  review study section
• Assigns to an NIH Institute or Center who will
  conduct the secondary review

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Applications Pathway at the NIH
NIH Center for Scientific Review (CSR)
Scientific Review Group (CSR)
assigns
Peer Review Study Session
NIH Institute/Center (2nd review/funding)
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Peer Review Timeline
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Grant Application Identification Number
see IMPAC guide http//grants2.nih.gov/grants/fund
ing/ac.pdf
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The 398!
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Face Page
Human protocol approvals
Animal protocol approvals
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Face Page
Budget information
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Checklist PageFAFacilities Administration
The current HMS FA Rate is 69.5 Date 2/22/06

• What is a FA rate?
• For every one dollar that a PI receives to
  perform the research of an award, HMS receives
  69.5 cents to support the research activities
• What does that 69.5 cents pay for?
• Cost of lab space (heat, light, power, cleaning,
  depreciation)
• Library
• SPA FOA
• Department administrator
• All indirect cost of HMS

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Budget Development

• Be realistic. Reviewers pick up on excessive
  padding or under-budgeting
• Always obtain and read the guidelines every
  sponsor has different requirement and policies
• Many budgets carry the same items for all years
  of the grant however, some dont and the budget
  should follow the phases of the project
• Include cost-of living escalation across all
  categories except non-recurring expense
  categories such as equipment. The NIH recommends
  an escalation of 3

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PHS398 Form Page 4
Personnel
Fringe
Effort
Salary
Consultants
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Consultants

• Non-HMS personnel only (generally not allowable
  to budget HMS faculty or staff in this category)
• Generally, not appropriate arrangement if using
  the facility of their home institution
• Use for services too urgent, temporary,
  specialized or technical to be provided by HMS
  personnel
• Will be paid directly as an individual
• Consultant vs. Subcontractor
• Generally, use subcontract category if
  collaboration involves
• Use of institutions space
• Use of other staff beyond PI
• Money is to run through institution
• Work is not outside regular duties

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PHS398 Form Page 4
Supplies Equipment
Travel
Patient Care Costs
Other Direct Costs
Consortium/Subcontracts Costs
Total Initial Budget Period
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Consortium/Contractual

• Required Documentation for Two potential
  scenarios
• HMS is prime grantee with a collaborating
  institution serving as a subcontractor
• Document Subcontractors agreement to participate
  by including one of the following
• For PHS application - fully signed face page
• For NSF application - fully signed Proposal Cover
  Sheet
• Institutions signed Statement of Intent
• Total costs of subcontract become part of HMS
  direct costs
• Subcontractor needs to prepare and approve their
  own individual budget (year one and project
  period) and budget justification
• Subcontract budget documentation is inserted in
  proposal
• Statement of Work  
• Biographical sketches and other support (if
  required by sponsor)
• HMS is the subcontractor and another institution
  is the primary grantee/applicant
• Proposal Routing Sheet 
• Conflict of Interest
• HMSs statement of intent is included in the HMS
  Subcontract Cover Letter
• Budget (year one and project period) and budget
  justification
• Statement of Work  
• Biographical sketches and other support (if
  required by sponsor)

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Part-of-Accounts

• HMS Part-of-Accounts only require
• An approved Proposal Routing Sheet (to serve as
  dept. institutional endorsement)
• Part-of-Accounts from other tubs within Harvard
  require
• Institutional approval from the appropriate
  pre-award office (either a letter or their
  Assurance of Compliance)
• A budget with the appropriate fringe and FA
  rates

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Entire Budget Period
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Budget Justification

• Most budget cuts occur when a justification in
  inadequate
• Provide a detailed justification. Format of the
  justification cost categories as individualized
  sections to allow reviewers to locate information
  easily
• List the percentage of annual increases
• No page limits for justifications

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Modular Grants

• Effective 6/1/99
• Applies to certain award mechanisms (R01, R03,
  R21, SBIR)
• Annual budgets not to exceed 250,000
• Request budgets in increments of 25,000
• Budget narrative describes all personnel, role,
  of effort
• Estimate number of modules to request be
  preparing internal budget and rounding to nearest
  module
• Adhere to NIH salary cap when estimating request

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NIH Noncompeting ApplicationsSNAP
https//commons.era.nih.gov/commons

• Simplified Process for the submission of the PHS
  2590 progress report
• NGA will state This grant is subject to
  Streamlined Noncompeting Application Procedures
  (SNAP)
• There are notable differences between a full 2590
  submission and a SNAP submission.