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Sponsored Projects Administration SPA Training Program

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Assists with sponsor inquiries & negotiation of award. June 15, 2000. 17 ... Invoicing/letter-of-credit drawdowns. Cash management. Cash receipt/expenditure reporting ... – PowerPoint PPT presentation

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Title: Sponsored Projects Administration SPA Training Program


1
Sponsored Projects Administration (SPA) Training
Program
2
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

3
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

4
Five University Initiatives
  • Management and Internal Controls (cont)
  • 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

5
Five University Initiatives
  • Management and Internal Controls (cont)
  • 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

6
Five University Initiatives
  • Management and Internal Controls (cont)
  • 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

7
Five University Initiatives
  • Management and Internal Controls (cont)
  • 5. Mandatory Training Program
  • For all University administrative and clerical
    employees who work in any area of Sponsored
    Project Management

8
Roles and Responsibilities
  • Who are the Players?
  • What are their Roles and Responsibilities?

9
Roles and Responsibilities
  • The Players
  • Principal Investigator
  • Unit Administrator
  • Department Chair
  • Dean
  • Central Offices
  • Office of the Provost
  • University Research Administration
  • Comptroller/Restricted Funds
  • Others

10
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.

11
Roles and Responsibilities
  • Principal Investigator (Cont)
  • Responsible for the design and implementation of
    all aspects of the project
  • Prepares, seeks approval and responsible for
    Oversight Committee Approvals
  • Develops Research Plan and Technical Proposal
  • Seeks out funding opportunities
  • Prepares technical reports, noncompeting
    continuations, interim and final reports

12
Roles and Responsibilities
  • Principal Investigator (Cont)
  • 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

13
Roles and Responsibilities
  • Principal Investigator (Cont)
  • 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

14
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.

15
Roles and Responsibilities
  • Unit Administrator (Cont)
  • 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)

16
Roles and Responsibilities
  • Unit Administrator (Cont)
  • 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

17
Roles and Responsibilities
  • Unit Administrator (Cont)
  • 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

18
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.

19
Roles and Responsibilities
  • Department Head (Cont)
  • 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

20
Roles and Responsibilities
  • Department Head (Cont)
  • Provides local oversight for the following
  • 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

21
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.

22
Roles and Responsibilities
  • Dean (Cont)
  • 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.

23
Roles and Responsibilities
  • Dean (Cont)
  • Provides divisional/unit concurrence in
    negotiation and acceptance of awards
  • Interacts with Comptrollers 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

24
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.

25
Roles and Responsibilities
  • BSD/ORS (Cont)
  • 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

26
Roles and Responsibilities
  • BSD/ORS (Cont)
  • 3. Regulatory Compliance
  • Manages and oversees administrative support for
    four divisional regulatory research committees
  • 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)

27
Roles and Responsibilities
  • BSD/ORS (Cont)
  • 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

28
Roles and Responsibilities
  • BSD/ORS (Cont)
  • 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.

29
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 Universitys 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 Universitys
    research mission.

30
Roles and Responsibilities
  • Office of the Provost (Cont)
  • 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 than
    100,000 (except BSD)

31
Roles and Responsibilities
  • Office of the Provost (Cont)
  • 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

32
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 contractually-binding 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.

33
Roles and Responsibilities
  • URA (Cont)
  • 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

34
Roles and Responsibilities
  • URA (Cont)
  • 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

35
Roles and Responsibilities
  • URA (Cont)
  • 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

36
Roles and Responsibilities
  • URA (Cont)
  • Disseminates funding opportunity information to
    university community
  • Provides leadership for electronic research
    administration planning and implementation

37
Roles and Responsibilities
  • URA (Cont)
  • 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

38
Roles and ResponsibilitiesComptroller/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 Comptrollers 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.

39
Roles and Responsibilities
  • Comptroller/Restricted Funds (Cont)
  • 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

40
Roles and Responsibilities
  • Comptroller/Restricted Funds (Cont)
  • Establishes procedures to comply with the
    sponsors financial terms and conditions for
  • Allowable cost
  • Cost transfers
  • Direct costs allocations
  • Cost sharing expenses/matching funds
  • Effort reporting
  • Equipment management and reporting
  • Subrecipient A-133 Audit monitoring

41
Roles and Responsibilities
  • Comptroller/Restricted Funds (Cont)
  • Establishes procedures to comply with the
    sponsors financial terms and conditions for
    (Con't)
  • Time restrictions on award funds
  • Program income
  • Invoicing/letter-of-credit drawdowns
  • Cash management
  • Cash receipt/expenditure reporting

42
Roles and Responsibilities
  • Other Players
  • Office of the Comptroller
  • Payroll
  • Independent Contractor/Travel Reimbursement
  • Property Management
  • Central Procurement Services
  • HRM

43
Roles and Responsibilities
  • Other Players (Cont)
  • Facilities Services
  • Radiation Safety
  • Safety and Environmental Affairs
  • Renovations
  • Development / Medical Center Development
  • ARCH
  • Dean of Student Offices (Training Awards,
    Research Assistant Appts.)
  • University News Office

44
Roles and Responsibilities
  • Other Players (Cont)
  • Legal Counsel / Medical Legal
  • Risk Management
  • Hospital Safety
  • Medical Legal

45
The Life Cycle of a Sponsored Project
  • Part I. Proposal preparation
  • Part II. Budgeting Project Costs
  • Part III. Compliance Issues
  • Part IV. Routing and Review Process
  • Part V. Updating Submissions and Award
    Negotiations
  • Part VI. Award Evaluation and Acceptance
  • Part VII. Administration Information
  • Part VIII. Award Accounts
  • Part IX. Managing Programmatic Aspects

46
The Life Cycle of a Sponsored Project (Cont)
  • Part X. Managing Award Funding
  • Part XI. Audits
  • Part XII. Financial Reports
  • Part XIII. Intellectual Property
  • Part XIV. Project Termination

47
Part I. Proposal Preparation
  • Current Forms and Guidelines
  • Web-based information
  • Campus resources
  • Diskettes
  • Direct to PI

48
I. Proposal Preparation
  • Deadlines/target dates
  • Target deadline
  • Rolling deadlines
  • Deadline
  • No deadline
  • Receipt date
  • Mailing date
  • Internal deadlines

49
I. Proposal Preparation
  • Limited opportunities
  • Coordination of selection process
  • Deputy Provost/Foundation Relations
  • Divisional
  • Departmental
  • Nomination letters
  • Assistance in proposal development
  • Coordination with Foundation Relations
  • Limited opportunities
  • Sensitive foundations

50
I. Proposal Preparation
  • Funding Instruments
  • Procurement vehicles
  • Contracts
  • Assistance vehicles
  • Grants
  • Cooperative agreements

51
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

52
I. Proposal Preparation
  • Funding Instruments (cont)
  • 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 (FDP).

53
I. Proposal Preparation
  • Funding Instruments (cont)
  • Cooperative agreement (federal)
  • 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

54
I. Proposal Preparation
  • Funding Instruments (cont)
  • 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)

55
I. Proposal Preparation
  • Funding Instruments (cont)
  • Material transfer agreement
  • Incoming/outgoing
  • Incoming - MTA provided by provider
  • Outgoing University of Chicago types
  • UBMTA
  • UC MTA
  • Sponsored research agreement
  • Clinical trial agreement

56
I. Proposal Preparation
  • Solicitation Types
  • Broad agency announcements
  • Request for proposals (contracts/cooperative
    agreements)
  • Request for applications (grants)
  • Program announcements (grants/cooperative
    agreements)

57
I. Proposal Preparation
  • Types of Proposals
  • Letters of intent
  • Pre-proposals
  • Unsolicited proposals
  • Solicited proposals

58
I. Proposal Preparation
  • Project Description
  • READ THE GUIDELINES!!!
  • Agency/program specific
  • Sequence/sections specified
  • Use review criteria

59
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

60
I. Proposal Preparation
  • PI Eligibility (cont)
  • Ineligible
  • Research scientist
  • Fellows
  • Lecturer
  • Part-Time (PT)
  • Students
  • BSD Specific
  • Clinical Associate (CA)
  • RA (Instructor)

61
I. Proposal Preparation
  • PI Eligibility (cont)
  • Requesting special permission
  • 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

62
I. Proposal Preparation
  • PI Eligibility (cont)
  • 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

63
I. Proposal Preparation
  • Freedom of Information Act (FOIA)
  • 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

64
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

65
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

66
II. Budgeting Project Costs
  • Direct costs (cont)
  • Subcontracts
  • Graduate student tuition
  • Travel foreign domestic
  • Publication costs

67
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

68
II. Budgeting Project Costs
  • Verification of current rates (cont)
  • 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

69
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

70
II. Budgeting Project Costs
  • Cost sharing/matching commitments
  • Definitions (cont)
  • .Voluntary cost sharing is not required, but is
    sometimes offered to enhance a proposals
    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

71
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

72
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

73
II. Budgeting Project Costs
  • Consultants (cont)
  • 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

74
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 subcontractors indirect costs

75
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

76
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 permitted)

77
II. Budgeting Project Costs
  • NIH modular grants budgets (cont)
  • 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

78
II. Budgeting Project Costs
  • NIH modular grants budgets (cont)
  • 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

79
Break and Budget Exercise
80
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

81
III. Compliance Issues
  • Protection of human subjects (cont)
  • Development of ethical principles
  • Nuremberg code
  • 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

82
III. Compliance Issues
  • Protection of human subjects (cont)
  • Development of ethical principles (cont)
  • Declaration of Helsinki
  • Policies for the Protection of Human Subjects
    (NIH)
  • Belmont Report
  • Respect for persons
  • Beneficence
  • Justice
  • Boundaries between practice and research

83
III. Compliance Issues
  • Protection of human subjects (cont)
  • 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 Training

84
III. Compliance Issue
  • Protection of human subjects (cont)
  • 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

85
III. Compliance Issues
  • Protection of human subjects (cont)
  • Includes (cont)
  • Anthropological research
  • Educational research
  • Field research
  • Oral history

86
III. Compliance Issues
  • Protection of human subjects (cont)
  • 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)

87
III. Compliance Issues
  • Protection of human subjects (cont)
  • Types of review
  • Exempt from committee review
  • Expedited review
  • Review by committee

88
III. Compliance Issues
  • Protection of human subjects (cont)
  • 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 rules

89
III. Compliance Issues
  • Protection of human subjects (cont)
  • 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

90
III. Compliance Issues
  • Protection of human subjects (cont)
  • Resources
  • ORS Web-site http//ors.bsd.uchicago.edu/HS/
  • OPRR http//www.nih.gov/grants/oprr/library_human
    .htm
  • BSD/UCH IRB Policy and Procedure Manual
  • BSD/UCH IRB Members Handbook
  • FDA http//www.fda.gov
  • FDA Information Sheets
  • http//www.fda.gov/oc/oha/IRB/toc.htm

91
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

92
III. Compliance Issues
  • Use of animals (cont)
  • US Government Principles for the Utilization and
    Care of Vertebrate Animals Used in Testing,
    Research and Teaching (cont)
  • 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.

93
III. Compliance Issues
  • Use of animals (cont)
  • 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

94
III. Compliance Issues
  • Use of animals (cont)
  • Institutional Animal Care and Use Committee
    (IACUC) Responsibilities
  • 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 housed
    more than 12 hours

95
III. Compliance Issues
  • Use of animals (cont)
  • 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

96
III. Compliance Issues
  • Use of animals (cont)
  • 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

97
III. Compliance Issues
  • Use of animals (cont)
  • 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

98
III. Compliance Issues
  • Use of animals (cont)
  • Resources
  • ORS Web-site http//ors.bsd.uchicago.edu/
  • OPRR http//www.nih.gov/grants/oprr/library_anima
    l.htm
  • USDA http//www.aphis.usda.gov/ac/
  • AAALAS http//www.aalas.org
  • ARC Web-site http//arc.bsd.uchicago.edu/
  • ARENA

99
III. Compliance Issues
  • Use of animals (cont)
  • Training
  • Introduction
  • Monthly
  • Required for all with access to ARC facilities
  • Monthly seminars
  • Mandatory training for biohazards, primates
  • Printed materials

100
III. Compliance Issues
  • Use of animals (cont)
  • Special grant related issues
  • 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

101
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

102
III. Compliance Issues
  • Use of biohazardous materials (cont)
  • 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

103
III. Compliance Issues
  • Use of biohazardous materials (cont)
  • 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)

104
III. Compliance Issues
  • Use of biohazardous materials (cont)
  • Principles in biosafety (cont)
  • Importation and interstate shipment of certain
    biomedical materials
  • USDA
  • Department of Transportation
  • Public Health Service Foreign Quarantine
    Regulations

105
III. Compliance Issues
  • Use of biohazardous materials (cont)
  • 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
  • E. Coli, anthrax, chlamydia, most mycobactierim,
    adenoviruses, hepatitis, retrovirus

106
III. Compliance Issues
  • Use of biohazardous materials (cont)
  • Biosafety Levels I-IV (cont)
  • 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

107
III. Compliance Issues
  • Use of biohazardous materials (cont)
  • Resources
  • ORS Website http//ors.uchicago.edu/IBC/index.htm
    l
  • CDC http//www.cdc.gov/od/ohs/biosfty/bmbl/bmbl-1
    .htm
  • NIH http//www.nih.gov/od/orda/

108
III. Compliance Issues
  • Use of biohazardous materials (cont)
  • Occupational Health and Safety
  • Human Resources
  • Health Services
  • IBC
  • Coordination with other regulatory committees

109
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

110
III. Compliance Issues
  • Use of radiation (cont)
  • 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

111
III. Compliance Issues
  • Use of radiation (cont)
  • Resources
  • ORS Website http//ors.bsd.uchicago.edu
  • Radiation Safety Website
  • http//adminet.uchicago.edu/adminfac/frameset/facf
    rame.html
  • Training
  • Mandatory training with periodic updates
  • Newsletter Office of Radiation Safety

112
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

113
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

114
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)

115
IV. Routing and Review Process
  • Proposal Transmittal Form (PTF)
  • Internal control document (http//www2.uchicago.ed
    u/adm-ura/ura/PTF.pdf)
  • Purpose
  • Instructions
  • Purpose
  • Summarizes Information
  • Mechanism to obtain PI Certification
  • Ensures endorsement of Department and Division

116
IV. Routing and Review Process
  • PTF (cont)
  • 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

117
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) with more to come

118
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

119
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

120
V. Updating Submissions and Award Negotiations
  • Special considerations (cont)
  • Site visits
  • 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

121
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

122
V. Updating Submissions and Award Negotiations
  • Preaward costs and advance accounts
  • Account create
  • Limitations on advance accounts
  • Postaward considerations
  • Authorities
  • Preaward Costs
  • Rebudgeting
  • Project period
  • No-cost extension
  • Carry-forward authority

123
V. Updating Submissions and Award Negotiations
  • Postaward considerations (cont)
  • Equipment issues
  • Ownership
  • Reporting
  • Financial reporting requirements
  • Invoicing requirements

124
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

125
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

126
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

127
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

128
VI. Award Evaluation Acceptance
  • Legal Office Review-URA point of contact
  • Indemnification requirements
  • Unusual certifications and compliance clauses
  • National Laboratory User Agreements

129
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

130
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

131
Part VII. Administrative InformationProgram 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

132
VII. Administrative InformationProgram and
Budget Revisions
  • Federal agency prior approval is mandatory for
  • Change in scope
  • Change in key personnel
  • Program director/principal investigators
  • absence for more than 3 months
  • 25 reduction in effort
  • Need for additional funding

133
VII. Administrative InformationProgram and
Budget Revisions
  • Federal agency prior approval is mandatory for
    (cont)
  • Transfer of training allowance funds to other
    categories
  • Subcontracting project scope
  • Award specific restrictions

134
VII. Administrative InformationProgram 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

135
VII. Administrative InformationProgram and
Budget Revisions
  • Federal agency prior approvals required unless
    waived (cont)
  • Transfers between direct and indirect cost
    categories (cont)
  • Other awards (cont)
  • 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)

136
VII. Administrative InformationProgram and
Budget Revisions
  • Federal agency prior approvals required unless
    waived (cont)
  • Costs that require prior approval because of A-21
  • Include
  • Intra-University Consulting compensation
  • Insurance on federally-owned equipment
  • Equipment
  • Pre-agreement (pre-award) costs
  • Special arrangement and alteration costs

137
VII. Administrative InformationProgram and
Budget Revisions
  • Federal agency prior approvals required unless
    waived (cont)
  • Costs that require prior approval because of A-21
    (cont)
  • Intra-University consulting compensation
  • Assume no waivers
  • Insurance on federal owned equipment
  • Assume no waivers

138
VII. Administrative InformationProgram and
Budget Revisions
  • Federal agency prior approvals required unless
    waived (cont)
  • Costs that require prior approval because of A-21
    (cont)
  • Equipment
  • FDP awards
  • All agencies have waived
  • Other awards
  • NIH has waived for lt 25k
  • NSF h
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