Sponsored Projects Administration (SPA) Training Program

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Transcript Sponsored Projects Administration (SPA) Training Program

Sponsored Projects
Administration (SPA) Training
Program
Topics: SPA Training Program
A. Research Mission of the University
B. Five University Initiatives
C. Roles and Responsibilities
D. The Life Cycle of a Sponsored Project
E. What Every P.I./Administrator Should
Know
June 15, 2000
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Five University Initiatives
Management and Internal Controls
1. Personnel Policy Guidelines, Section
U606.01: Compliance with University
Policies and Procedures
– Communicate to employees their responsibility to adhere to
University policies and procedures and report potential or
actual violations
– Affirms commitment that individuals who come forward in
good faith shall not be subject to reprisal or retaliation
June 15, 2000
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Five University Initiatives
Management and Internal Controls
(con’t)
2. Financial Policy No. 2101: Principal Investigator
Responsibilities for Financial Oversight of Grants
and Contracts
– Encourages delegation of day to day financial
management activities to departmental or Local
Business Center personnel
– Communicate P.I. responsibilities for oversight of
financial management of grants and contracts
June 15, 2000
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Five University Initiatives
Management and Internal Controls
(con’t)
3.Principal Investigator Certification:
Project Proposals
– Proposal Transmittal Form (PTF) requires
the P.I. to certify his/her:
• Compliance with University Conflict of Interest policies
and procedures
• Acceptance of financial oversight responsibilities for the
sponsored project
June 15, 2000
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Five University Initiatives
Management and Internal Controls (con’t)
4. Increased Internal Audit Focus to Supplement Annual
OMB Circular A-133 Audit
– Reinforce importance of compliance with federal
regulations and University policy
– Enhance internal control by identifying problems
or potential problems
• Summary of findings and corrective actions submitted to
University Officers
• Material adverse findings reported to Department of
Health and Human Services
June 15, 2000
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Five University Initiatives
Management and Internal Controls
(con’t)
5. Mandatory Training Program
– For all University administrative and
clerical employees who work in any area of
Sponsored Project Management
June 15, 2000
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Roles and Responsibilities
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Who are the Players?
What are their Roles and
Responsibilities?
June 15, 2000
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Roles and Responsibilities
The Players
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Principal Investigator
Unit Administrator
Department Chair
Dean
Central Offices
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Office of the Provost
University Research Administration
Comptroller/Restricted Funds
Others
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Roles and Responsibilities
Principal Investigator
The primary person in charge of a research grant,
cooperative agreement, training or service project,
clinical study, contract, other sponsored project or
material transfer agreement. Usually a faculty
member holding a regular appointment, although
other employees may be approved to serve as P.I.s.
In some sponsored projects, the P.I. may be referred
to as the project or program director.
June 15, 2000
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Roles and Responsibilities
Principal Investigator (Con’t)
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Responsible for the design and implementation of all
aspects of the project
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Prepares, seeks approval and responsible for
Oversight Committee Approvals
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Develops Research Plan and Technical Proposal
Seeks out funding opportunities
Prepares technical reports, noncompeting
continuations, interim and final reports
June 15, 2000
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Roles and Responsibilities
Principal Investigator (Con’t)
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Determines the budgetary needs of the project
Adheres to relevant agency, institutional, divisional
and departmental guidelines
Reviews and signs Proposal Transmittal Form (PTF)
Discloses Inventions
Manages all Project Personnel
Reviews and adheres to all terms and conditions of
award
June 15, 2000
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Roles and Responsibilities
Principal Investigator (Con’t)
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Oversees workscope and authorizes payments to
consultants and subcontractors
Authorizes all expenditures, cost transfers,
rebudgeting
Updates Assurance and prepares Disclosure Form if
significant financial conflict of interest develops
Provides information on closing reports
Retains project data and materials as required
June 15, 2000
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Roles and Responsibilities
Unit Administrator
An employee responsible for providing administrative
support to one or more sponsored projects. This position may
include a wide variety of roles and position titles including
faculty service representative, account manager, grants &
contracts administrator, administrative assistant, pre-award
administrator, post-award administrator, account assistant,
project assistant, secretary, etc.
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Roles and Responsibilities
Unit Administrator (Con’t)
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Obtains and reviews proposal
guidelines/forms
Coordinates and communicates with P.I. to
understand relationship between project
goals and resources
Prepares (assists with) proposal budget &
other administrative documents
Prepares Proposal Transmittal Form (PTF)
June 15, 2000
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Roles and Responsibilities
Unit Administrator (Con’t)
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Assures institutional review and approval of
proposal
Assures submission of proposal to sponsor
Assists with regulatory compliance (human
subjects, animals, biohazards, etc.)
Assists with sponsor inquiries & negotiation of
award
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Roles and Responsibilities
Unit Administrator (Con’t)
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Assists in establishing account
Assists with recruitment, appointment and
effort assignment for personnel
Reconciles monthly ledgers of expenditures
Expedites documentation for purchases,
subcontracts, consulting agreements
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Roles and Responsibilities
Department Head
A University official with managerial and fiscal
responsibilities for a designated area, such as
department chair, center director, institute director.
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Roles and Responsibilities
Department Head (Con’t)
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Reviews and approves Proposal Transmittal Form
Reviews and endorses requests for P.I. eligibility
Approves cost sharing and matching from
departmental funds
Expedites request for indirect cost waiver
Approves pre-award arrangements and authorizes a
guarantee account from which expenditures may be
paid if award is not received
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Roles and Responsibilities
Department Head (Con’t)
Provides local oversight for the following:
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Compliance with regulatory research requirements, as
necessary
Rebudgeting, cost transfers, and carry forwards
Compliance with effort reporting, reporting of program income,
and all other award terms and conditions
Records retention and data ownership
Availability of administrative support, facilities and resources
June 15, 2000
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Roles and Responsibilities
Dean
A University official with managerial and
fiscal responsibilities. Each school, division,
or college is administered by a dean under the
supervision of the Provost of the University.
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Roles and Responsibilities
Dean (Con’t)
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Approves divisional commitments for cost
sharing/matching
Reviews and approves Proposal Transmittal Form
Approves requests to Office of the Provost for P.I.
Eligibility
Provides divisional/unit oversight for compliance with
regulatory research requirements, such as human &
animal subjects, radiation safety, etc.
June 15, 2000
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Roles and Responsibilities
Dean (Con’t)
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Provides divisional/unit concurrence in negotiation
and acceptance of awards
Interacts with Comptroller’s office and URA in all
areas of compliance with proposal and award terms
and conditions, as necessary
Assists with compliance with technical and financial
reporting, as necessary
June 15, 2000
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Roles and Responsibilities
BSD/Office of Research Services
(BSD/ORS)
Office designated by the Dean of the Division of
Biological Sciences to review and provide divisional approval
for all proposals to Federal and other external sponsors
(excluding gifts) assuring compliance with divisional policies.
Office oversees regulatory compliance for institutional animal
care and use committee, BSD-institutional review board,
human use of radioisotopes and radioactive drug research
committee, institutional biosafety committee. Director of
ORS has been delegated signature authority for University
approval of certain NIH and several nonfederal proposals. 24
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Roles and Responsibilities
BSD/ORS (Con’t)
Five Sections:
1. Clinical Trial Office
– Encourages the growth of Clinical Trial Activity, Management
and Conduct of Trials
2. Research Funding
– Distributes funding opportunity information to BSD faculty
and researchers
– Manages Internal BSD Funding Opportunities
– Selects Candidates for Limited BSD Program Submissions
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Roles and Responsibilities
BSD/ORS (Con’t)
3. Regulatory Compliance
Manages and oversees administrative support for
four divisional regulatory research committees
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BSD/UCH Institutional Review Boards (IRB)
Institutional Biosafety Committee (IBC)
Institutional Animal Care and Use Committee (IACUC)
UC/UHC Combined committee for Use of Radioisotopes
in Humans (RDRC)
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Roles and Responsibilities
BSD/ORS (Con’t)
4. Grant and Contract Management
– Reviews all BSD proposals with special attention to
oversight committee information and approvals, abstracts
and lay summaries, budget and justification, divisional and
institutional guidelines and policies
– Reviews for divisional approval material transfer agreements
and clinical trials
– Approves requests for financial accounts and any postaward
modifications for the BSD
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Roles and Responsibilities
BSD/ORS (Con’t)
5. Director
– Facilitates Review and Recommendations regarding
disclosed conflicts of interest by Dean
– Approves Cost sharing and matching Funds Commitments,
and BSD PI status
– Designated Signatory Authority on Certain Applications.
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Roles and Responsibilities
PROVOST
The chief academic and administrative officer for all
academic units, including the college, the divisions,
schools and centers. The Provost oversees the
University’s compliance with all academic research
policies.
DEPUTY PROVOST
The chief academic official designated by the Provost
as the person responsible for the direction and guidance
of the University’s research mission.
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Roles and Responsibilities
Office of the Provost (Con’t)
Oversees the formulation and implementation
of academic research policies governing all
units of the University
 Approves indirect cost waivers and PI
eligibility
 In cooperation with the Budget Office,
authorizes and approves all University budget
cost sharing/matching commitments greater
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Junethan
15, 2000 $100,000 (except BSD)
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Roles and Responsibilities
Office of the Provost (Con’t)
Provides institutional oversight for:
– handling of academic fraud allegations
and compliance with other regulatory
research policies
– resolution of potential conflict of interest
situations
– interactions with ARCH regarding research
and technology transfer
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Roles and Responsibilities
University Research Administration (URA)
Office designated by the University with the
responsibility to review and provide institutional
endorsement for all proposals to Federal and other external
sponsors (excluding gifts), assuring compliance with
University policies and sponsor terms and conditions. URA
is the institutional authority for the negotiation and
acceptance of financial support or other contractuallybinding obligations in the form of a contract, grant, or
agreement, including material transfer agreements and
clinical trials. URA is the authorized institutional official
for post-award actions necessitating agency approvals:
change in P.I., rebudgeting, no-cost extension, etc.
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Roles and Responsibilities
URA (Con’t)
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Approves and authorizes submission of proposals
and award acceptance on behalf of institution
Expedites processing and approval of subcontract
and consulting agreements
Reviews, negotiates and approves Material
Transfer Agreements and Clinical Trials
Disseminates notification of award and reviews
terms and conditions of award
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Roles and Responsibilities
URA (Con’t)
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Provides institutional oversight for cost
sharing/matching commitments
Maintains database of University-wide proposal
and award activity, including the development of
TRACS, coming in Summer 2000
Informs Office of Special Projects and ARCH of
sponsor intellectual property and invention
reporting requirements
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Roles and Responsibilities
URA (Con’t)
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Coordinates Legal Counsel and Risk Management
reviews and approvals, as necessary
Coordinates with ARCH on negotiation and
acceptance of intellectual property provisions on
sponsored research agreements and MTAs
involving patents, licensing and commercialization
of University-developed inventions
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Roles and Responsibilities
URA (Con’t)
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Disseminates funding opportunity information to
university community
Provides leadership for electronic research
administration planning and implementation
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Roles and Responsibilities
URA (Con’t)
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Confirms that proposals to “sensitive” foundations
are cleared through development office for
submission
Reviews proposals for compliance with university
policies and sponsor proposal guidelines and
potential award terms and conditions
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Roles and Responsibilities
Comptroller/Restricted Funds
OFFICE OF THE COMPTROLLER
The Comptroller, at the direction of the Board of Trustees has
supervision over the financial records and accounts of the University. The
Comptroller is responsible for keeping proper books of accounts
adequately setting forth the financial condition and transactions of the
University and shall devise proper methods of accounting and internal
controls for all departments of the University.
RESTRICTED FUNDS
The unit of the Comptroller’s Office that is responsible for the
financial accounting, reporting and collecting of funds for federal and
other sponsored project awards. Also, this unit is responsible for
preparing the Indirect Cost Proposal and negotiating an Indirect Cost Rate
Agreement with the Federal Government.
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Roles and Responsibilities
Comptroller/Restricted Funds (Con’t)
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Establishes and maintains sponsored project accounts in FAS
Enforces University financial policies and federal grant and contract
financial regulations
Coordinates the preparation and submission of financial reports to the
sponsoring agency
Manages project account receivables
Monitors overdrafts to ensure their timely resolution
Ensures that project accounts are closed in FAS
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Roles and Responsibilities
Comptroller/Restricted Funds (Con’t)
Establishes procedures to comply with the sponsor’s financial
terms and conditions for:
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Allowable cost
Cost transfers
Direct costs allocations
Cost sharing expenses/matching funds
Effort reporting
Equipment management and reporting
Subrecipient A-133 Audit monitoring
June 15, 2000
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Roles and Responsibilities
Comptroller/Restricted Funds (Con’t)
Establishes procedures to comply with the sponsor’s financial
terms and conditions for (Con't):
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Time restrictions on award funds
Program income
Invoicing/letter-of-credit drawdowns
Cash management
Cash receipt/expenditure reporting
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Roles and Responsibilities
Other Players
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Office of the Comptroller
– Payroll
– Independent Contractor/Travel Reimbursement
– Property Management
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Central Procurement Services
HRM
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Roles and Responsibilities
Other Players (Con’t)
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Facilities Services
– Radiation Safety
– Safety and Environmental Affairs
– Renovations
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Development / Medical Center Development
ARCH
Dean of Student Offices (Training Awards, Research
Assistant Appts.)
University News Office
June 15, 2000
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Roles and Responsibilities
Other Players (Con’t)
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Legal Counsel / Medical Legal
Risk Management
Hospital Safety
Medical Legal
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The Life Cycle of a Sponsored
Project
Part I.
Part II.
Part III.
Part IV.
Part V.
Proposal preparation
Budgeting Project Costs
Compliance Issues
Routing and Review Process
Updating Submissions and Award
Negotiations
Part VI. Award Evaluation and Acceptance
Part VII. Administration Information
Part VIII. Award Accounts
Part IX. Managing Programmatic Aspects
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The Life Cycle of a Sponsored
Project (Con’t)
Part X.
Part XI.
Part XII.
Part XIII.
Part XIV.
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Managing Award Funding
Audits
Financial Reports
Intellectual Property
Project Termination
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Part I. Proposal Preparation
Current Forms and Guidelines
Web-based information
• Campus resources
• Diskettes
• Direct to PI
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I. Proposal Preparation
Deadlines/target dates
– Target deadline
– Rolling deadlines
– Deadline
– No deadline
– Receipt date
– Mailing date
– Internal deadlines
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I. Proposal Preparation
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Limited opportunities
– Coordination of selection process
• Deputy Provost/Foundation Relations
• Divisional
• Departmental
– Nomination letters
– Assistance in proposal development
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Coordination with Foundation Relations
– Limited opportunities
– Sensitive foundations
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I. Proposal Preparation
Funding Instruments
– Procurement vehicles
• Contracts
– Assistance vehicles
• Grants
• Cooperative agreements
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I. Proposal Preparation
Major Federal Regulations
– Office of Management and Budget Circulars (OMB)
– Federal Acquisition Regulations (FAR)
– Code of Federal Regulations (CFR)
Boilerplate Federal Demonstration Partnership
(FDP)Terms and Conditions
– General
– Agency Specific
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I. Proposal Preparation
Funding Instruments (con’t)
Grant
• Federal, state and local government,
foundations, voluntary associations,
corporations
• Oversight, but not direction
• P.I. initiated
• Federal grants subjects to OMB Circular A-110
and agency implementation, may be awarded
under Federal Demonstration Partnership
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(FDP).
I. Proposal Preparation
Funding Instruments (con’t)
Cooperative agreement (federal)
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Agency initiated
Financial assistance
Oversight and some direction; partnership
Federal cooperative agreements subject to
OMB Circular A-110
• Generally not awarded under Federal
Demonstration Partnership
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I. Proposal Preparation
Funding Instruments (con’t)
Federal contract
• Federal, state or local government,
corporations
• Procurement of services (research)
• Sponsor initiated - targeted project
– Oversight
– Federal contracts subject to Federal Acquisitions
Regulations (FARs)
June 15, 2000
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I. Proposal Preparation
Funding Instruments (con’t)
– Material transfer agreement
• Incoming/outgoing
• Incoming - MTA provided by provider
• Outgoing University of Chicago types:
– UBMTA
– UC MTA
– Sponsored research agreement
– Clinical trial agreement
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I. Proposal Preparation
Solicitation Types
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Broad agency announcements
Request for proposals (contracts/cooperative
agreements)
Request for applications (grants)
Program announcements (grants/cooperative
agreements)
June 15, 2000
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I. Proposal Preparation
Types of Proposals
– Letters of intent
– Pre-proposals
– Unsolicited proposals
– Solicited proposals
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I. Proposal Preparation
Project Description
– READ THE GUIDELINES!!!
– Agency/program specific
– Sequence/sections specified
– Use review criteria
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I. Proposal Preparation
PI Eligibility
– Two parameters: sponsoring
agency/university policy
– Eligible
• Faculty tracks
• Academic non-faculty (ANF)
– Senior Scientists, Senior Research Associate and RA
track (Asst. Professor, Assoc. Professor, Professor)
– New Hires, not yet in PI eligible positions
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I. Proposal Preparation
PI Eligibility (con’t)
Ineligible
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Research scientist
Fellows
Lecturer
Part-Time (PT)
Students
BSD Specific
– Clinical Associate (CA)
– RA (Instructor)
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I. Proposal Preparation
PI Eligibility (con’t)
Requesting special permission
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Sectional, departmental support and oversight
Written request with detailed justification
Curriculum Vitae
Approval by Dean or designee
Approval of URA
Final approval by Provost Office
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I. Proposal Preparation
PI Eligibility (con’t)
Appropriate Reasons
• Fellowship but agency requires fellow to serve
as PI
• In advance of final approval of appointment
• Exceptional circumstances on a case by case
basis
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I. Proposal Preparation
Freedom of Information Act (FOIA)
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When to mark proposal
Proposal subject to FOIA when awarded
Protection of proprietary/confidential information
To be protected, each proposal page must be
marked
– Post award – access to data now required by law
in certain circumstances
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Part II. Budgeting Project Costs
Budgets
– Reflect the scope of work of the proposal
– Compliant with sponsor guidelines
– Necessary to perform the proposed work and are
not precluded by specific program guidelines or
applicable cost principles
– Compliant with departmental, divisional, and
University policies and guidelines
– Narrative justification
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II. Budgeting Project Costs
Direct Costs
– Personnel – confidentiality of salary data
– Graduate students – Type A; Type B
– Equipment
– Consultants
– Lab supplies
– “Sensitive” categories: office supplies,
telephone costs
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II. Budgeting Project Costs
Direct costs (con’t)
– Subcontracts
– Graduate student tuition
– Travel – foreign; domestic
– Publication costs
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II. Budgeting Project Costs
Verification of current rates
– Graduate research assistant – division
dependent
– Graduate tuition recovery – division
dependent
– Fringe benefits – choice of rate depends
on nature of employment and source of
funding
– Recharge centers
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II. Budgeting Project Costs
Verification of current rates (con’t)
– Confirm current rate through Guidelines for Grant
& Contract Management
– Specialized service centers – excluded from
MTDC overhead
• Animal Facilities Charge
• PSD Central Shop
– Use resource web sites
• http://www.uchicago.edu/adm/ura/
• http://ors.bsd.uchicago.edu
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II. Budgeting Project Costs
Cost sharing/matching commitments
– Definitions
• .Required cost sharing or matching is a
programmatic requirement – often expressed
as a percent of budget request or by
requirement of faculty effort without
compensation. Required cost sharing should
generally not exceed amount required
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II. Budgeting Project Costs
Cost sharing/matching commitments
– Definitions (con’t)
• .Voluntary cost sharing is not required, but is
sometimes offered to enhance a proposal’s
competitiveness. Voluntary cost sharing,
including effort without salary recovery, must be
prudently allocated.
• .Implicit cost sharing occurs when an agency
places a cap or limit on budget items; e.g. NIH
salary cap
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II. Budgeting Project Costs
Cost sharing/matching commitments
– University policy
• Only when required by sponsor
• Avoid commitments requiring detailed
supporting documentation
• Designation of source of cost sharing/matching
• $100,000 threshold requires additional
approvals
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II. Budgeting Project Costs
Consultants
– Individual expert in the field of the technical
project
– Use Sponsored Research Consultant
Agreement
– Meet IRS test for independent contractor
(should person be a casual employee?
Should a subcontract be utilized?)
– Scope of services
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II. Budgeting Project Costs
Consultants (con’t)
– Rate of compensation – test for
reasonableness
– Rate may be capped by sponsor (e.g.
NSF)
– Former UC employee is special case
– Use SRC Invoice
– PI confirmation of satisfactory performance
of service - OK for payment
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II. Budgeting Project Costs
Subcontracts
– Organization to organization agreement
– Use of personnel and facilities
– Approval from subcontracting institution at
the time of proposal submission
– Scope of work
– Budget, including subcontractor’s indirect
costs
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II. Budgeting Project Costs
NIH training Grants
– Special budget restrictions
– Stipends are set by NIH
– Limited post-award flexibility
– Health benefits
– Tuition: budget full amount/awarded by NIH
formula
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II. Budgeting Project Costs
NIH modular grants budgets
– Designed to focus efforts of investigators
and reviewers on science and away from
detailed budget
– No detailed categorical budgets
– Direct cost budgets in modules of $25K up
to ceiling of $250K/year
– Request the same # of modules for each
budget period of project (exceptions
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permitted)
II. Budgeting Project Costs
NIH modular grants budgets (con’t)
– No detailed or summary budget pages in
application
– No annual escalation – PLAN AHEAD
when estimating modules
– Modular budget evaluated on basis of
general, expert estimate of total effort and
resources required to carry out the
proposed research
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II. Budgeting Project Costs
NIH modular grants budgets (con’t)
– Additional budget information will be requested
only under special circumstances
– Departmental/divisional guidelines may require
supporting budget detail
– Modular awards are issued without direct cost
categorical breakdowns – significant rebudgeting
provision does not apply.
– Allocate and account for costs related to award by
category within FAS system
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Break and Budget Exercise
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Part III. Compliance Issues
Regulatory compliance
– Subject Safety, public trust, public
perception and scientific responsibility
– Emergence of regulations
– Consequences of non-compliance
– Historical perspective
• Tuskegee experiments
• Nazi human experimentation
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III. Compliance Issues
Protection of human subjects (con’t)
Development of ethical principles
• Nuremberg code
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June 15, 2000
Voluntary consent to participate
Capacity to consent
Freedom from coercion
Appropriate research design
Minimization of risks
Appropriate risk/benefit ratio
Freedom to withdraw at any time
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III. Compliance Issues
Protection of human subjects (con’t)
Development of ethical principles (con’t)
• Declaration of Helsinki
• Policies for the Protection of Human Subjects
(NIH)
• Belmont Report
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June 15, 2000
Respect for persons
Beneficence
Justice
Boundaries between practice and research
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III. Compliance Issues
Protection of human subjects (con’t)
– Federal regulations
• DHHS: 45 CFR 46
• Federal Common Rule: 1991 - 16 federal
agencies
• FDA: 21 CFR 50 and 56
– International Harmonization of Good
Clinical Practice
– Recent HHS Announcement
• Emerging Requirements for Investigator
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III. Compliance Issue
Protection of human subjects (con’t)
– Applies to:
• Any research with human subjects or their information,
whether linked or not linked by identifiers to individuals
and therefore, must be reviewed and approved by a
recognized Institutional Review Board or determined to
be exempt
– Includes:
• Clinical trials
• Behavioral research
• Epidemiological and survey research
• Outcomes research
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III. Compliance Issues
Protection of human subjects (con’t)
Includes (con’t):
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Anthropological research
Educational research
Field research
Oral history
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III. Compliance Issues
Protection of human subjects (con’t)
– Institutional Official: Associate Vice
President for Research
– Multiple Project Assurance (MPA): M1264
– Three IRBs
• Social Science Division and Social Service
Administration, Combined in Summer 2000
• Biological Sciences Division/University of
Chicago Hospitals (01A and 01B)
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III. Compliance Issues
Protection of human subjects (con’t)
Types of review:
• Exempt from committee review
• Expedited review
• Review by committee
June 15, 2000
87
III. Compliance Issues
Protection of human subjects (con’t)
Points to remember:
• Protocols must be approved by the IRB in full
prior to the initiation of any research
• The informed consent process must be
completed before any subject can be enrolled
in a study
• Use of patient charts or radiological films or
discarded and unidentified tissues, blood etc, is
research and must have IRB approval
• IRBS are not allowed to circumvent these rules88
June 15, 2000
III. Compliance Issues
Protection of human subjects (con’t)
Institutions are subject to review
– Office for the Protection from Research
Risks (OPRR):
» MPA process
» Query letters
» On-site reviews
– Food & Drug Administration (FDA): periodic
on-site audits
June 15, 2000
89
III. Compliance Issues
Protection of human subjects (con’t)
Resources
• ORS Web-site: http://ors.bsd.uchicago.edu/HS/
• OPRR:
http://www.nih.gov/grants/oprr/library_human.ht
m
• BSD/UCH IRB Policy and Procedure Manual
• BSD/UCH IRB Member’s Handbook
• FDA: http://www.fda.gov
• FDA Information Sheets
90
June 15, 2000
– http://www.fda.gov/oc/oha/IRB/toc.htm
III. Compliance Issues
Use of animals
Ethical principles: US Government Principles for the
Utilization and Care of Vertebrate Animals Used in
Testing, Research and Teaching:
– Transportation, care and use of animals should be in
accordance with the Animal Welfare Act
– Investigators and other personnel shall be
appropriately qualified and experienced for
conducting the specified procedures on animals
– The living conditions of animals should be
appropriate for their species and contribute to their
health and comfort
June 15, 2000
91
III. Compliance Issues
Use of animals (con’t)
US Government Principles for the Utilization and
Care of Vertebrate Animals Used in Testing,
Research and Teaching (con’t):
June 15, 2000
– Animals selected for a procedure should be of an
appropriate species and quality and the minimum
number required to obtain valid results
– Alternatives to use of animals models, such as
mathematical models, computer simulation, and in
vitro biological systems should be considered.
– Procedures that cause more than momentary or
slight pain or distress should be performed with
appropriate sedation, analgesia, or anesthesia.
92
III. Compliance Issues
Use of animals (con’t)
– Principles
• Guide for the Care and Use of Laboratory
Animals- National Research Council
– Federal regulations
• Public Health Service Policy on Humane Care
and Use of Laboratory Animals
• Animal Welfare Act of 1966 (1970, 1976, 1985,
1990) - USDA
• Endangered Species Act
93
June 15, 2000
III. Compliance Issues
Use of animals (con’t)
Institutional Animal Care and Use
Committee (IACUC) Responsibilities
June 15, 2000
– Approve all use of animals for research,
teaching or testing purposes
– Review protocols on an on-going basis
– Provide oversight of the Animal Resources
Center
– Semi-annual program review, includes ARC
and inspection of all labs where animals are
94
housed more than 12 hours
III. Compliance Issues
Use of animals (con’t)
– Institutional Official: Dean of the Biological
Sciences
– Assurance: (A3523-01)
– New: OLAW-Office of the Laboratory of Animal
Welfare
– Single institutional animal care and use committee
– Animal Resources Center
June 15, 2000
95
III. Compliance Issues
Use of animals (con’t)
IACUC Reviews
• Use of live animals
• Use of tissue, including tissue from
slaughterhouse and/or routine tissue harvest
• Production of antibodies in live animals,
whether on-campus or from vendor
• Use of animal parts from dead animals
• Breeding of colonies
June 15, 2000
96
III. Compliance Issues
Use of animals (con’t)
Special considerations
• Partnership between Institutional Official (Dean
Steele), IACUC, ARC and users
• Occupational health and safety
• Coordination with other committees
• Periodic review
• Good Laboratory Practice
• AAALAC Accreditation
June 15, 2000
97
III. Compliance Issues
Use of animals (con’t)
Resources
• ORS Web-site: http://ors.bsd.uchicago.edu/
• OPRR:
http://www.nih.gov/grants/oprr/library_animal.ht
m
• USDA: http://www.aphis.usda.gov/ac/
• AAALAS: http://www.aalas.org
• ARC Web-site: http://arc.bsd.uchicago.edu/
• ARENA
98
June 15, 2000
III. Compliance Issues
Use of animals (con’t)
– Training
• Introduction
– Monthly
– Required for all with access to ARC facilities
• Monthly seminars
• Mandatory training for biohazards, primates
– Printed materials
June 15, 2000
99
III. Compliance Issues
Use of animals (con’t)
Special grant related issues
•
•
•
•
•
•
June 15, 2000
Who can be PI on a protocol
Verifying protocol numbers and date
Agency notification
NIH requirements: research plan, Section F
FAS accounts/regulatory compliance
Peer review
100
III. Compliance Issues
Use of biohazardous materials
– Infectious agents
• Risk to laboratory personnel
• Risk to general public
– Recombinant DNA
• Perceived risk to general public
– Institutional official: Dean of the Biological
Sciences Division
– Single institutional biosafety committee
June 15, 2000
101
III. Compliance Issues
Use of biohazardous materials (con’t)
Federal oversight and regulations
• Centers for Disease Control - Biosafety in
Microbiological and Biomedical Laboratories
(BMBL)
• NIH Guidelines for Research Involving
Recombinant DNA
• Classification of Etiologic Agents on the Basis
of Hazards
• OSHA Blood Borne Pathogen Standard
June 15, 2000
102
III. Compliance Issues
Use of biohazardous materials (con’t)
Principles in biosafety
• Biosafety in the laboratory: Prudent practices
for the handling and disposal of infectious
materials (National Research Council)
• Four biosafety levels
• Containment
– Laboratory practice and technique
– Safety equipment (primary barriers)
– Facility design (secondary barriers)
June 15, 2000
103
III. Compliance Issues
Use of biohazardous materials (con’t)
Principles in biosafety (con’t)
• Importation and interstate shipment of
certain biomedical materials
– USDA
– Department of Transportation
– Public Health Service Foreign Quarantine
Regulations
June 15, 2000
104
III. Compliance Issues
Use of biohazardous materials (con’t)
Biosafety Levels I-IV
• Biosafety Level 1: well characterized agents
not known to cause disease in healthy adults
and of minimal potential hazard to lab
personnel and the environment
– Recombinant DNA
– Vectors from viruses
• Biosafety Level 2: agents of moderate potential
hazard
June 15, 2000
– E. Coli, anthrax, chlamydia, most mycobactierim,
adenoviruses, hepatitis, retrovirus
105
III. Compliance Issues
Use of biohazardous materials (con’t)
Biosafety Levels I-IV (con’t)
• Biosafety Level 3: applicable to clinical,
diagnostic, teaching, research or production
facilities in which work is done with indigenous
or exotic agents which may cause serious or
potentially lethal infections
– Mycobacterium tuberculosus, encephalitis
• Biosafety Level 4: dangerous exotic agents
– Hanta virus, hemorrhagic fever, ebola
June 15, 2000
106
III. Compliance Issues
Use of biohazardous materials (con’t)
Resources
• ORS Website:
http://ors.uchicago.edu/IBC/index.html
• CDC:
http://www.cdc.gov/od/ohs/biosfty/bmbl/b
mbl-1.htm
• NIH: http://www.nih.gov/od/orda/
June 15, 2000
107
III. Compliance Issues
Use of biohazardous materials (con’t)
Occupational Health and Safety
• Human Resources
• Health Services
• IBC
• Coordination with other regulatory
committees
June 15, 2000
108
III. Compliance Issues
Use of radiation
– Federal/state oversight
• FDA
• Nuclear Energy Commission
• Illinois Department of Nuclear Safety
– Oversight
• Committee on Radiation Hazards
• Radioactive Drugs and Radioactivity Committee (RDRC)
• Office of Radiation Safety
June 15, 2000
109
III. Compliance Issues
Use of radiation (con’t)
– Regulatory requirements
• Purchasing restrictions
• Emission limits
• No eating
– IDNS regulatory licenses
• University - laboratory research
• Hospital - clinical care and clinical research
– Annual or more frequent inspections
– Reports - citations
June 15, 2000
110
III. Compliance Issues
Use of radiation (con’t)
– Resources
• ORS Website: http://ors.bsd.uchicago.edu
• Radiation Safety Website
– http://adminet.uchicago.edu/adminfac/frameset/facfra
me.html
– Training
• Mandatory training with periodic updates
– Newsletter – Office of Radiation Safety
June 15, 2000
111
III. Compliance Issues
Conflict of interest
– Federal regulations
– University policy
– Assurance Form
– Disclosure Form
– Process of review
– Approval of management plan by Office the
Provost
June 15, 2000
112
Part IV. Routing and Review
Process
Proposal review and clearance
– Forms and agency guidelines
– Project personnel
– Evaluation of scope and nature of work to
be performed
– Representations and certifications
– University audit and financial reports
June 15, 2000
113
IV. Routing and Review Process
Proposal review and clearance
– Taking exception to binding terms and conditions
– UC Policy does not accept
• Approval of publications
• Indemnification
• Assignment of intellectual property
– Recipient organization: The University of Chicago
(not Medical Center; not Hospital; not department)
June 15, 2000
114
IV. Routing and Review Process
Proposal Transmittal Form (PTF)
– Internal control document
(http://www2.uchicago.edu/adm-ura/ura/PTF.pdf)
• Purpose
• Instructions
– Purpose
• Summarizes Information
• Mechanism to obtain PI Certification
• Ensures endorsement of Department and Division
June 15, 2000
115
IV. Routing and Review Process
PTF (con’t)
– Trouble spots
• Incomplete data
• PTF data does not match proposal data
• Salary and effort of PI and senior investigators
does not match up
• Cost sharing/.matching information incomplete
• Illegible handwriting
– Sign offs
June 15, 2000
116
IV. Routing and Review Process
Electronic Research Administration
(ERA)
– National Science Foundation – FASTLANE
– URA FASTLANE proposal policies updated
February 1999
– NIH Commons – coming to your proposal
soon
– Many Non Federal Awards and Proposals
(AHA, Cystic Fibrosis Foundation, ACS)
117
June 15, 2000
with more to come
IV. Routing and Review Process
Traditional proposal and award
procedures
– URA completes and authorizes “Reps and Certs”
– Comment and sign off by URA
– Changes required by URA: “*” requirements
versus suggestions
– Submission to agency dy department
– Final proposal to URA, BSD/ORS, Division, LBC,
department or local unit for files
June 15, 2000
118
Part V. Updating Submissions
and Award Negotiations
Special considerations
– Changes in Scope or budget
– Regulatory Approvals
• “Just in Time” updates based on priority score
assigned by NIH
– Updating Current and Pending Support
• “Just in Time” updates based on priority score
assigned by NIH
– Best and Final Offers
June 15, 2000
119
V. Updating Submissions and
Award Negotiations
Special considerations (con’t)
Site visits
•
•
•
•
•
June 15, 2000
Inform departmental/divisional/URA offices
Office of Special Projects expertise
Critical importance of run-through
Involve senior academic administrators
Assure administrative and financial systems
support
120
V. Updating Submissions and
Award Negotiations
Negotiation of award terms and
conditions
– PI key point of contact for technical
negotiations
– URA point of contact for business and
budget negotiations
– Review and approval of negotiated
technical and budget changes
June 15, 2000
121
V. Updating Submissions and
Award Negotiations
Preaward costs and advance accounts
• Account create
• Limitations on advance accounts
Postaward considerations
Authorities
•
•
•
•
•
June 15, 2000
Preaward Costs
Rebudgeting
Project period
No-cost extension
Carry-forward authority
122
V. Updating Submissions and
Award Negotiations
Postaward considerations (con’t)
– Equipment issues
• Ownership
• Reporting
– Financial reporting requirements
– Invoicing requirements
June 15, 2000
123
V. Updating Submissions and
Award Negotiations
Receipt of award
– Email notifications – NSF, NIH
– Award letters – unilateral or bilateral
– Distribution of award information
– Acceptance by “institutional or authorized”
official – this means URA!
– Exceptional agreements – PI leaving or left
University
June 15, 2000
124
V. Updating Submissions and
Award Negotiations
Special cases
– Clinical studies – routing of protocols and
proposed agreements
– Visiting scientists – corporate scientific
visitors
– Corporate-sponsored research
– Gifts and grants and contracts and which is
which is which
June 15, 2000
125
Part VI. Award Evaluation &
Acceptance
Notification of award
– For most Federal grants: Expenditure of
funds constitutes acceptance of award,
e.g. NIH, NSF
– Formal acceptance by “Authorized
Institutional Official” - NOT the PI
June 15, 2000
126
VI. Award Evaluation &
Acceptance
Trouble spots to look for
– Cost Sharing requirements
– NSF – budget line M
– Unanticipated budget reductions that could
impact scope of work
– Never assume year-to-year boilerplate is
same – changes do appear
June 15, 2000
127
VI. Award Evaluation &
Acceptance
Legal Office Review-URA point of
contact
– Indemnification requirements
– Unusual certifications and compliance
clauses
– National Laboratory User Agreements
June 15, 2000
128
VI. Award Evaluation &
Acceptance


ARCH participation in sponsored research
& MTA agreements
– Unusual intellectual property rights &
requirements
– Pre-agreed upon licensing royalty rates for
research outcomes
Risk Management--URA point of contact
– Unusual insurance requirements
– Off campus site conditions
June 15, 2000
129
VI. Award Evaluation &
Acceptance
Notification to URA of
PI/departmental/divisional approval
to accept:
– File Documentation – PI Approval (not
administrator signing for PI)
– Acceptance of unusual terms and
conditions by department/division
– Distribution of signed agreement
June 15, 2000
130
Part VII. Administrative
Information
Program and Budget Revisions

Federal agency prior approval
requirements
– Located in
• For grants:
– General terms & conditions
– Agency publications
– Agency administrative regulations that implement
Section 25 of A-110
• For contracts
– The “Schedule”
June 15, 2000
131
VII. Administrative Information
Program and Budget Revisions

Federal agency prior approval is
mandatory for:
– Change in scope
– Change in key personnel
– Program director/principal investigator’s:
• absence for more than 3 months
• 25% reduction in effort
– Need for additional funding
June 15, 2000
132
VII. Administrative Information
Program and Budget Revisions

Federal agency prior approval is
mandatory for (con’t)
– Transfer of training allowance funds to
other categories
– Subcontracting project scope
– Award specific restrictions
June 15, 2000
133
VII. Administrative Information
Program and Budget Revisions

Federal agency prior approvals required
unless waived:
– Transfers between direct and indirect cost
categories
• FDP awards:
– All agencies have waived
• Other awards
– NIH has waived
– NSF has waived
June 15, 2000
134
VII. Administrative Information
Program and Budget Revisions

Federal agency prior approvals required
unless waived (con’t):
– Transfers between direct and indirect cost
categories (con’t)
• Other awards (con’t)
– NASA reserves the right not to waive
– DOE has waived unless prohibited by program
regulations
– Others: Check agency publications & regulations
that implement A-110 §__.25(c)(5)
June 15, 2000
135
VII. Administrative Information
Program and Budget Revisions

Federal agency prior approvals required
unless waived (con’t):
– Costs that require prior approval because of A-21
• Include:
–
–
–
–
–
June 15, 2000
Intra-University Consulting compensation
Insurance on federally-owned equipment
Equipment
Pre-agreement (pre-award) costs
Special arrangement and alteration costs
136
VII. Administrative Information
Program and Budget Revisions

Federal agency prior approvals required
unless waived (con’t):
– Costs that require prior approval because of A-21
(con’t)
• Intra-University consulting compensation
– Assume no waivers
• Insurance on federal owned equipment
– Assume no waivers
June 15, 2000
137
VII. Administrative Information
Program and Budget Revisions

Federal agency prior approvals required
unless waived (con’t):
– Costs that require prior approval because of A-21
(con’t)
• Equipment
June 15, 2000
– FDP awards
» All agencies have waived
– Other awards
» NIH has waived for < $25k
» NSF has waived
» Other agencies: Assume no waivers
138
VII. Administrative Information
Program and Budget Revisions

Federal agency prior approvals required
unless waived (con’t):
– Costs that require prior approval because of A-21
(con’t)
• Pre-agreement (pre-award) costs
– FDP awards
» All agencies have waived prior approval for
costs incurred within 90 days of the award
– Other awards
» Assume no waivers
June 15, 2000
139
VII. Administrative Information
Program and Budget Revisions

Federal agency prior approvals required
unless waived (con’t):
– Costs that require prior approval because of A-21
(con’t)
• Special arrangement and alteration costs
June 15, 2000
– FDP awards
» NSF has waived only for arrangement and
alteration cost < $10k
» Other agencies have waived
– Other awards
» Assume no waivers
140
VII. Administrative Information
Program and Budget Revisions

Federal agency prior approvals required
unless waived (con’t):
– One-time no cost extensions
• FDP awards
– All agencies have waived
– Agency notifications required
• Other awards
June 15, 2000
– Research awards
» Waiver is likely
– Non-research awards
» Assume no waivers
141
VII. Administrative Information
Program and Budget Revisions

Federal agency prior approvals required
unless waived (con’t):
– Carry forward unobligated balances to
subsequent funding periods
• FDP awards
– All agencies have waived
– Agency notifications required
June 15, 2000
142
VII. Administrative Information
Program and Budget Revisions

Federal agency prior approvals required
unless waived (con’t):
– Carry forward unobligated balances to
subsequent funding periods (con’t)
• Other awards
– Research awards
» Waiver is likely
– Non-research awards
» Assume no waivers
June 15, 2000
143
VII. Administrative Information
Cost Principles
– Allowability of costs is determined in
accordance with the provisions of A-21,
Cost Principles for Educational Institutions
– A-21 states that specific provisions of the
award take precedence
• Effectively allows awarding agencies to write
additional cost principles
• NIH Grants Policy Statement and NSF Grant
Policy Manual address some costs in more
detail than A-21
June 15, 2000
144
VII. Administrative Information
Cost Principles
– A-21 reference
• For grants:
– General terms & conditions
– Agency publications
– Agency administrative regulations that implement
Section 27 of A-110
• For contracts
– The “Schedule”
– Contract Clause 52.216-7
June 15, 2000
145
VII. Administrative Information
Period of Availability of Funds

Grants
– Period of availability is governed by by Section 28
of A-110.
– Section 28 states that where funding period is
specified, only allowable costs resulting from
obligations incurred during the funding period are
allowable.
– Section 25 of A-110, however, allows awarding
agency to give grantee authority to carry-forward
unobligated balances to subsequent periods.
June 15, 2000
146
VII. Administrative Information
Period of Availability of Funds

Contracts
– Unlike grants, contracts that are
incrementally funded do not have those
funds restricted to that incremental period.
However,
• The “Schedule” may specifically restrict funds
to a period
• Funds may be used only for costs incurred
within the contract’s period of performance
June 15, 2000
147
VII. Administrative Information
Technical Reporting Requirements

Grants
– Awarding agencies technical reporting
requirements must comply with Section 52 of A110
• Section 51 provides among other things that:
– Reports shall not be more frequently than quarterly,
or less frequently than annually
– Annual reports (Technical and Financial

Contracts
– Reporting requirements will be detailed in the
“Schedule”
June 15, 2000
148
VII. Administrative Information
Financial Reporting Requirements

Grants
– Awarding agencies financial reporting
requirements must comply with Section 52
of A-110
• Section 52 provides:
– Use of standard forms SF269, 269A, 270 or 272
– Reports shall not be more frequently than quarterly,
or less frequently than annually
– Annual reports (Technical and Financial) shall be due
no later than 90 days after the grant year
June 15, 2000
149
VII. Administrative Information
Financial Reporting Requirements

Contracts
– Reporting requirements will be detailed in the
“Schedule”
June 15, 2000
150
VII. Administrative Information
Record Retention Requirements

Requirement
– Retain records for a period of 3 years from
the date of submission of the annual or
final financial report
June 15, 2000
151
Part VIII. Award Accounts
How many accounts are needed?
– Every award needs at least one master
account
– Are new accounts needed for each budget
year?
• Only if carry forward needs agency approval
– Are additional accounts need to show
compliance with T&Cs
• Are funds restricted by multiple purposes?
June 15, 2000
152
VIII. Award Accounts
How many accounts are needed? (con’t)
– Additional accounts are needed if both on- and offcampus indirect cost rates are used
– Additional accounts are needed if cost sharing is
required
– Additional accounts needed for University
management purposes
• Research may be subdivided into multiple subprojects
with their own budgets
• University requires multiple accounts when award is for
student aid that crosses divisional/school lines
June 15, 2000
153
VIII. Award Accounts
Regulatory compliance
Approvals required before account can be
created/opened
•
•
•
•
June 15, 2000
Human subjects
Animals
Recombinant DNA
Biosafety
154
VIII. Award Accounts
How are Regular Accounts Created?


LBC-Account Create Process
Non-LBC Account Create Process
(Awards other than NIH and NSF)
• Department completes Form 70, “Request for Restricted
Funds Account - Ledgers 5 and 6”
• Divisional office reviews and approves
• URA reviews and approves
• Restricted Funds creates the account
June 15, 2000
155
VIII. Award Accounts
Non-LBC Account Create Process (con’t)
– NIH and NSF, AHA and some DOD awards
• URA e-mails the awards to
–
–
–
–
P.I.
Department
Divisional office
Restricted funds
• Restricted funds creates the account
– Based upon Form 70 template completed by
department
June 15, 2000
156
VIII. Award Accounts
Advance accounts
Restricted Funds receives the award from
URA
• Changes the status from “Advance” to
“Regular”
• Enters the budget based upon the award
agreement
June 15, 2000
157
Part IX. Managing Programmatic
Aspects
Compliance with terms and conditions
of award
– Publication review
– Publication citations
– Sharing research resources
June 15, 2000
158
IX. Managing Programmatic
Aspects
Compliance with terms and conditions
of award (con’t)
– Confidential materials--marking and
storage
– Intellectual property--disclosure, informing
sponsor
– Record retention and storage
June 15, 2000
159
IX. Managing Programmatic
Aspects
Approval of changes to award terms
– Expanded authority/FDP
• OMB A-110, plus agency implementation
• No cost extensions
• Carry-forward
– Requiring agency approvals--grants
• Significant change in PI effort
• Change in PI
• Change in institution
June 15, 2000
160
IX. Managing Programmatic
Aspects
Approval of changes to award terms
(con’t)
– Requiring agency approvals--grants (con’t)
•
•
•
•
•
•
June 15, 2000
Significant changes of effort
Significant change in scope of work
Subcontacting
Requests for additional funding
Foreign travel
Use of non-USA airline
161
Part X. Managing Award Funding
A-21 Cost Principles Requirements
– Reasonable
• Reflects action of a prudent person
–
–
–
–
Generally recognized as necessary
Arm’s-length bargaining
Circumstances at the transaction time
Institutional policies and practices
– Allocable
• Cost can be assigned to a sponsored agreement on the
basis of the relative benefits received or some other
equitable basis
June 15, 2000
162
Part X. Managing Award Funding
A-21 Cost Principles Requirements
(con’t)
– Treated consistently
• Costs incurred for
– Same purpose
– In like circumstances
– Are either direct costs only or indirect costs only
– Cost must
• Benefit the project and be charged consistently as direct
cost
163
June 15, 2000
• Be included in the award budget or list of allowable costs
X. Managing Award Funding
Allowable Cost Determinates
Costs normally treated as indirect costs
– Administrative, secretary, & clerical compensation
– Telecommunications, memberships, postage,
office supplies
– University guidelines for charging appear in
Section 307B of URA’s Guidelines for Grant and
Contract Management
June 15, 2000
164
X. Managing Award Funding
Other costs that warrant attention
– Alterations & renovations
• May require prior approval
– Alcoholic beverages
• Generally unallowable
– Animals
• Excluded from indirect cost MTDC base
– Books and periodicals
• Normally treated as indirect cost
– Dependency allowances
• Generally
June 15, 2000
unallowable
165
X. Managing Award Funding
Other costs that warrant attention (con’t)
– Consultants
• May require prior approval if substantive work is involved
• Compensation caps may exist
• Sponsored Consulting Agreement required
– Drugs
– Entertainment costs-Unallowable
– Property insurance
• Prior approval needed for government owned property
• University provided insurance generally allowable
June 15, 2000
166
X. Managing Award Funding
Other costs that warrant attention
(con’t)
– Medical insurance for sponsored fellows and
trainees
• Allowable because University requires proof of coverage
– Participant support costs--NSF awards
• Rebudgeting prior approval required
– Patient care costs
• Routine and ancillary medical services
– Publications
June 15, 2000
• Acknowledgements,
disclaimers required
167
X. Managing Award Funding
Other costs that warrant attention
(con’t)
– Student aid (tuition, fees and stipends)
• Unallowable charge to federal research awards
– Salaries and wages
• % salaries charged must be <= % of effort
• Unallowable if Annual Certification Statement is not
completed
– Travel
• Must comply with University travel policies
• Use of foreign flag-carriers generally prohibited
June 15, 2000
• Foreign travel may require prior approval
168
X. Managing Award Funding
Allocating Costs
 Guidelines
– A-21, Section C.4.d & University Financial
Policy No. 2109
• If a cost benefits one project or activity, the cost should
be charged to that project or activity.
• If a cost benefits two or more projects or activities in
proportions that can be determined without undue effort
or cost, the cost should be allocated to the projects
based on the proportional benefit.
June 15, 2000
169
X. Managing Award Funding
Allocating Costs (con’t)
– A-21, Section C.4.d & University Financial
Policy No. 2109 (Con’t)
• If a cost benefits two or more projects or activities in
proportions that cannot be determined because of the
interrelationship of the work involved, then the cost may
be allocated to benefited projects on any reasonable
basis.
June 15, 2000
170
X. Managing Award Funding
Official Accounting Reports

FAS reports
– Monthly Reports
– AM090: Account Statement in Whole Dollars
– AM091: Report of Transactions

Payroll reports
– Reports generated for each monthly and biweekly payroll
– Expense Summary Report
– Expense Detail Report
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X. Managing Award Funding
Official Accounting Reports
 Reconcile to “shadow” reports
 Act to correct errors
 Update cost projections
– Consider commitments not shown on FAS

Reports cease when Acct Admin names
are removed
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X. Managing Award Funding
Cost Sharing Procedures





Accounting documents cost sharing
compliance
Recorded in separate associate account
“Funding” account is designated
FAS cost sharing entry moves expense to
funding account
See Financial Policy No. 2110
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X. Managing Award Funding
Cost Transfers
 A-21
– Costs allocable to an award may not be
transferred to another award:
• To meet deficiencies caused by overruns
• To avoid restrictions imposed by the terms of
an agreement
• Or for other reasons of convenience
– Must comply with any agency specific
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policies
174
X. Managing Award Funding
Cost Transfers
 NIH and PHS Grants Policy Statement
– Requires
• Timeliness
– Within 90 days of original transaction
• Full explanation
– “To correct error” is insufficient explanation
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X. Managing Award Funding
Cost Transfers
 University policy & procedures
– Ensure conformance with regulations
– Policy
• Financial Policy No. 2111
– Procedures
• http://adminet.uchicago.edu/admincompt/costtr
an/contents.html
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X. Managing Award Funding
Effort System

Required by A-21
– Non-compliance results in disallowance of
salaries, wages and benefit expense

System characteristics
–
–
–
–
Work plan
Monitoring & reporting
Significant changes
Certification
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Part XI. Audits

Test for compliance
– Federal regulations
• Award specific
• Non-award specific

Not to be feared if
– UC policies and procedures were followed
– Award specific restrictions were met
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XI. Audits
Types of Audit
– A-133
– Award closeout
– Special subjects
– Proposal
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XI. Audits
A-133
• Performed by KPMG
• Federal programs divided into 3 categories
– Research
– Student financial assistance
– Other
• Emphasis on UC systems
– Allowable costs: Salary caps, student aid, etc.
– Effort reporting
– Cost transfers
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XI. Audits
A-133 (con’t)
• Emphasis on UC systems (con’t)
–
–
–
–
–
–
–
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Period of funding availability
Financial reporting
Procurement
Recharge center pricing
Billing
Equipment inventory
Subrecipient monitoring
181
XI. Audits
A-133 (con’t)
• Tests compliance with award specific
restrictions
–
–
–
–
–
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Prior approval requirement
Cost sharing
Student assistance awards unique regulations
Training program eligibility
Etc.
182
XI. Audits
Award interim and closeouts
• Performed by
– DHHS
– Prime contractor
– Non-federal awarding agency
•
•
•
•
June 15, 2000
Usually federal direct contracts or subcontract
Desk audit vs.. on-site audit
Tests for allowable costs
Tests for compliance with award specific
restrictions
183
Part XII. Financial Reports
Deadlines



A-110 requires agencies to impose filing date
deadlines
Most are due 90 days after end of reporting period
Non-compliance is reported as an audit finding
Types



Request for Advance or Reimbursement (SF 270)
Report of Federal Cash Transactions (SF 272)
Financial Status Report (SF 269, 269A)
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XII. Financial Reports
Closing Memo
– The Closing Memo is a workpaper used to complete FSR
(i.e., Financial Status Report SF 269 or 269A)
– Closing Memo is issued to Account Administrator #1 one
month prior to budget or award end date
– Closing Memo is returned to Comptroller’s Office no later
than 15 days prior to the FSR due date
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XII. Financial Reports
When are Closing Memos required?
– Required for all final FSRs
– Interim FSRs
• Required only if prior approval required for carry forward
of unobligated balance
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XII. Financial Reports
Closing Memo (Con’t)
Steps to complete:
1. Post the Budget Balance from AM090
2. Add encumbrance balance from AM090
3. Add trailing credit transactions
4. Subtract trailing charge transactions
5. Equal unobligated balance to report
6. Certify the charges are appropriate (allowable)
to the award.
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XII. Financial Reports
Financial Status Report (SF 269, 269A)
Steps to complete
– Step 1: Closing Memo issued to Account
Administrator
– Step 2: Closing Memo returned to Comptroller’s
Office
– Step 3: Closing Memo audited by Comptroller’s
Office
– Step 4: FSR completed and submitted by
Comptroller’s Office
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XII. Financial Reports
Other Financial Reports

Request for Advance or Reimbursement (SF 270)
– Completed for awards not funded by a letter of credit
agreement
– May require Closing Memo
– Completed by Comptroller’s Office

Report of Federal Cash Transactions (SF 272)
– Shows both expenditures and cash receipts
– Completed by Comptroller’s Office

Non-federal reports
– Similar to federal reports
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Part XIII. Intellectual Property
University policies
– Patent Policy – Board of Trustees Statute
18
• http://apwww.uchicago.edu/UCPOL/UCPOLidx.html
– New Information Technologies – Rights to
Intellectual Property
– Determination of who has rights to
discoveries in the course of sponsored
190
research/projects?
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XIII. Intellectual Property
Data Rights
– Who has access rights?
– What are PI responsibilities for retention of data?
– Do employees who have worked in a sponsored project
have the right to remove data, materials from The University
when they leave?
FOIA public right to federally-sponsored
research data
– OMB issued prescribed implementing regulation
– Each agency has agency-specific implementation191191
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191
XIII. Intellectual Property
PI responsibility to disclose discoveries
– Office of Special Projects
http://www.uchicago.edu/adm/spec-proj/
• Guidance on Disclosure Process and forms
• Review of Disclosure to confirm sponsored research and
relevant MTAs
–
–
–
–
University turns over disclosure to ARCH
ARCH assesses commercial potential of discovery
ARCH has brief period to elect title to disclosure
If elected, ARCH seeks appropriate protection for
IP
192
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XIII. Intellectual Property
Governing regulations for IP derived
from sponsored projects
– Bayh-Dole spells out extensive compliance and
reporting requirements for IP elected by ARCH
– Terms and Conditions of awards for other
sponsored projects
– Compliance obligations
• Royalty sharing
• Release of IP if unelected or ARCH abandons
commercialization effort
• Rights of Sponsors take precedence over rights of PI
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XIV. Project Termination
Final technical report
– Sponsor may withhold funding for
University if ANY Final Report is overdue
Agencies that do this include NEH, Air
Force
– Confirm submission of report to URA
– URA follows up on late technical reports –
Administrator, PI, Department Chair, Dean, Provost
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XIV. Project Termination
Integration of close out of records with
restricted funds
– Confirmation of Compliance with Technical
Reporting requirements
– Confirmation that Restricted Funds has closed
financial report
– All URA Terminated Project Files archived for at
least 3 years after closing of project
– A-110 records retention requirement
– Obligations to keep local records
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XIV. Project Termination
Delete project accounts from FAS
– Before accounts can be delete
• Budget balance must be reduced to zero
• Voucher payable balance and other balance
sheet account controls must be zero
– AM090 and 91 reports stop only after
accounts have been deleted
– Accounting is not completed until accounts
are deleted
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What Every PI and Administrator
Should Know

Indicators of problems
–
–
–
–
–
Unauthorized or inappropriate charges
Unallowable costs
Improper cost allocations
Overdrafts
Assignments of costs based on fund availability or project
expiration
– Frequent delinquent cost transfers
– Equipment purchases near end of project
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What Every PI and Administrator
Should Know (Con’t)
See handout for information on the following
topics:
–
–
–
–
–
–
–
–
–
General rules
Major federal regulations
Performance periods
Unallowable costs
Cost sharing/matching
Salary/effort commitments and reporting
Travel and business expenses
Equipment purchases
Indirect costs
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What Every PI and Administrator
Should Know (Con’t)
–
–
–
–
–
–
–
Budgeting/rebudgeting
Cost transfers
Program income
Monthly account/financial reviews
Agency reporting
Invoicing
recharge centers
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What Every PI and Administrator
Should Know (Con’t)
–
–
–
–
Regulatory compliance
Other research related policies
Knowing your resources
Consultants/subcontractors
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200
Acknowledgements










Judith K. Argon, Director of Research Services, BSD
Arnold Aronoff, Director of Training, HRM
Sandra Bateman, Director of Employee Relations, HRM
William J. Hogan, Jr., Comptroller
Thomas P. Jurczak, Manager, PSD Local Business Center
Lauren McGrath, Grants and Contracts Manager, URA
Casey J. Murray, Associate Comptroller for Restricted Funds
Mary Ellen Sheridan, Associate Vice President for Research,
URA
Robert Smentek, Associate Comptroller for Disbursements
Lynda Wolter, Associate Director of Research Services, BSD
Robert Zimmer, Deputy Provost for Research

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