sponsored projects administration (spa) training program

201
Sponsored Projects Administration (SPA) Training Program

Post on 20-Dec-2015

224 views

Category:

Documents


1 download

TRANSCRIPT

Sponsored Projects Administration (SPA) Training Program

June 15, 2000 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

June 15, 2000 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

June 15, 2000 4

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 5

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 6

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 7

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 8

Roles and Responsibilities

Who are the Players? What are their Roles and

Responsibilities?

June 15, 2000 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

June 15, 2000 10

Roles and Responsibilities

Principal InvestigatorThe 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 11

Roles and Responsibilities

Principal Investigator (Con’t) 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

June 15, 2000 12

Roles and Responsibilities

Principal Investigator (Con’t) 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 13

Roles and Responsibilities

Principal Investigator (Con’t) 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 14

Roles and Responsibilities

Unit AdministratorAn 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.

June 15, 2000 15

Roles and Responsibilities

Unit Administrator (Con’t) 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 16

Roles and Responsibilities

Unit Administrator (Con’t) 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

June 15, 2000 17

Roles and Responsibilities

Unit Administrator (Con’t) 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

June 15, 2000 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.

June 15, 2000 19

Roles and Responsibilities

Department Head (Con’t) 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

June 15, 2000 20

Roles and Responsibilities

Department Head (Con’t)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

June 15, 2000 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.

June 15, 2000 22

Roles and Responsibilities

Dean (Con’t) 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 23

Roles and Responsibilities

Dean (Con’t) 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 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.

June 15, 2000 25

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

June 15, 2000 26

Roles and Responsibilities

BSD/ORS (Con’t)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)

June 15, 2000 27

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

June 15, 2000 28

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.

June 15, 2000 29

Roles and Responsibilities

PROVOSTThe 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 PROVOSTThe chief academic official designated by the Provost

as the person responsible for the direction and guidance of the University’s research mission.

June 15, 2000 30

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 than $100,000 (except BSD)

June 15, 2000 31

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

June 15, 2000 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.

June 15, 2000 33

Roles and Responsibilities

URA (Con’t) 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

June 15, 2000 34

Roles and Responsibilities

URA (Con’t) 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

June 15, 2000 35

Roles and Responsibilities

URA (Con’t) 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

June 15, 2000 36

Roles and Responsibilities

URA (Con’t) Disseminates funding opportunity information to

university community Provides leadership for electronic research

administration planning and implementation

June 15, 2000 37

Roles and Responsibilities

URA (Con’t) 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

June 15, 2000 38

Roles and ResponsibilitiesComptroller/Restricted Funds

OFFICE OF THE COMPTROLLERThe 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 FUNDSThe 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.

June 15, 2000 39

Roles and Responsibilities

Comptroller/Restricted Funds (Con’t) 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

June 15, 2000 40

Roles and Responsibilities

Comptroller/Restricted Funds (Con’t)Establishes procedures to comply with the sponsor’s 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

June 15, 2000 41

Roles and Responsibilities

Comptroller/Restricted Funds (Con’t)Establishes procedures to comply with the sponsor’s 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

June 15, 2000 42

Roles and Responsibilities

Other Players Office of the Comptroller

– Payroll– Independent Contractor/Travel Reimbursement– Property Management

Central Procurement Services HRM

June 15, 2000 43

Roles and Responsibilities

Other Players (Con’t) 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

June 15, 2000 44

Roles and Responsibilities

Other Players (Con’t) Legal Counsel / Medical Legal Risk Management Hospital Safety Medical Legal

June 15, 2000 45

The Life Cycle of a Sponsored ProjectPart 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

June 15, 2000 46

The Life Cycle of a Sponsored Project (Con’t)Part X. Managing Award Funding

Part XI. Audits

Part XII. Financial Reports

Part XIII. Intellectual Property

Part XIV. Project Termination

June 15, 2000 47

Part I. Proposal Preparation

Current Forms and GuidelinesWeb-based information

• Campus resources• Diskettes• Direct to PI

June 15, 2000 48

I. Proposal Preparation

Deadlines/target dates– Target deadline– Rolling deadlines– Deadline– No deadline– Receipt date– Mailing date– Internal deadlines

June 15, 2000 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

June 15, 2000 50

I. Proposal Preparation

Funding Instruments – Procurement vehicles

• Contracts

– Assistance vehicles• Grants• Cooperative agreements

June 15, 2000 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

June 15, 2000 52

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 (FDP).

June 15, 2000 53

I. Proposal Preparation

Funding Instruments (con’t)

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

June 15, 2000 54

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 55

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

June 15, 2000 56

I. Proposal Preparation

Solicitation Types Broad agency announcements Request for proposals (contracts/cooperative

agreements) Request for applications (grants) Program announcements (grants/cooperative

agreements)

June 15, 2000 57

I. Proposal Preparation

Types of Proposals

– Letters of intent

– Pre-proposals

– Unsolicited proposals

– Solicited proposals

June 15, 2000 58

I. Proposal Preparation

Project Description

– READ THE GUIDELINES!!!

– Agency/program specific

– Sequence/sections specified

– Use review criteria

June 15, 2000 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

June 15, 2000 60

I. Proposal Preparation

PI Eligibility (con’t)Ineligible

• Research scientist• Fellows• Lecturer• Part-Time (PT)• Students• BSD Specific

– Clinical Associate (CA)

– RA (Instructor)

June 15, 2000 61

I. Proposal Preparation

PI Eligibility (con’t)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

June 15, 2000 62

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

June 15, 2000 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

June 15, 2000 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

June 15, 2000 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

June 15, 2000 66

II. Budgeting Project Costs

Direct costs (con’t)– Subcontracts– Graduate student tuition– Travel – foreign; domestic– Publication costs

June 15, 2000 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

June 15, 2000 68

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

June 15, 2000 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

June 15, 2000 70

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

June 15, 2000 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

June 15, 2000 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

June 15, 2000 73

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

June 15, 2000 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 subcontractor’s indirect

costs

June 15, 2000 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

June 15, 2000 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)

June 15, 2000 77

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

June 15, 2000 78

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

June 15, 2000 79

Break and Budget Exercise

June 15, 2000 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

June 15, 2000 81

III. Compliance Issues

Protection of human subjects (con’t)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

June 15, 2000 82

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

– Respect for persons– Beneficence– Justice– Boundaries between practice and research

June 15, 2000 83

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 Training

June 15, 2000 84

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

June 15, 2000 85

III. Compliance Issues

Protection of human subjects (con’t)Includes (con’t):

• Anthropological research• Educational research• Field research• Oral history

June 15, 2000 86

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)

June 15, 2000 87

III. Compliance Issues

Protection of human subjects (con’t)Types of review:

• Exempt from committee review• Expedited review• Review by committee

June 15, 2000 88

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 rules

June 15, 2000 89

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 90

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.htm• BSD/UCH IRB Policy and Procedure Manual• BSD/UCH IRB Member’s Handbook• FDA: http://www.fda.gov• FDA Information Sheets

– http://www.fda.gov/oc/oha/IRB/toc.htm

June 15, 2000 91

III. Compliance Issues

Use of animalsEthical 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 92

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):

– 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.

June 15, 2000 93

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

June 15, 2000 94

III. Compliance Issues

Use of animals (con’t)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

June 15, 2000 95

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 96

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 97

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 98

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.htm• USDA: http://www.aphis.usda.gov/ac/• AAALAS: http://www.aalas.org• ARC Web-site: http://arc.bsd.uchicago.edu/• ARENA

June 15, 2000 99

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 100

III. Compliance Issues

Use of animals (con’t)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

June 15, 2000 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

June 15, 2000 102

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 103

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 104

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 105

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– E. Coli, anthrax, chlamydia, most mycobactierim,

adenoviruses, hepatitis, retrovirus

June 15, 2000 106

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 107

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/bmbl-1.htm

• NIH: http://www.nih.gov/od/orda/

June 15, 2000 108

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 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

June 15, 2000 110

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 111

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/facframe.html

– Training• Mandatory training with periodic updates

– Newsletter – Office of Radiation Safety

June 15, 2000 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

June 15, 2000 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

June 15, 2000 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)

June 15, 2000 115

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 116

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 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

June 15, 2000 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

June 15, 2000 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

June 15, 2000 120

V. Updating Submissions and Award Negotiations

Special considerations (con’t)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

June 15, 2000 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

June 15, 2000 122

V. Updating Submissions and Award Negotiations

Preaward costs and advance accounts• Account create• Limitations on advance accounts

Postaward considerationsAuthorities

• Preaward Costs• Rebudgeting• Project period• No-cost extension• Carry-forward authority

June 15, 2000 123

V. Updating Submissions and Award Negotiations

Postaward considerations (con’t)– Equipment issues

• Ownership• Reporting

– Financial reporting requirements– Invoicing requirements

June 15, 2000 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

June 15, 2000 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

June 15, 2000 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

June 15, 2000 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

June 15, 2000 128

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 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

June 15, 2000 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

June 15, 2000 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”

June 15, 2000 132

VII. Administrative InformationProgram 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 133

VII. Administrative InformationProgram 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 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

June 15, 2000 135

VII. Administrative InformationProgram 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 136

VII. Administrative InformationProgram and Budget Revisions

Federal agency prior approvals required unless waived (con’t):– 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

June 15, 2000 137

VII. Administrative InformationProgram 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 138

VII. Administrative InformationProgram and Budget Revisions

Federal agency prior approvals required unless waived (con’t):– Costs that require prior approval because of A-21

(con’t)• Equipment

– FDP awards» All agencies have waived

– Other awards» NIH has waived for < $25k» NSF has waived» Other agencies: Assume no waivers

June 15, 2000 139

VII. Administrative InformationProgram 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 140

VII. Administrative InformationProgram 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

– FDP awards» NSF has waived only for arrangement and alteration

cost < $10k» Other agencies have waived

– Other awards» Assume no waivers

June 15, 2000 141

VII. Administrative InformationProgram 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– Research awards

» Waiver is likely

– Non-research awards

» Assume no waivers

June 15, 2000 142

VII. Administrative InformationProgram 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 143

VII. Administrative InformationProgram 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 144

VII. Administrative InformationCost 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 145

VII. Administrative InformationCost 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 146

VII. Administrative InformationPeriod 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 147

VII. Administrative InformationPeriod 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 148

VII. Administrative InformationTechnical Reporting Requirements

Grants– Awarding agencies technical reporting requirements

must comply with Section 52 of A-110• 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 149

VII. Administrative InformationFinancial 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 150

VII. Administrative InformationFinancial Reporting Requirements

Contracts– Reporting requirements will be detailed in the

“Schedule”

June 15, 2000 151

VII. Administrative InformationRecord 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 152

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 153

VIII. Award Accounts

How many accounts are needed? (con’t)– Additional accounts are needed if both on- and off-

campus 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 154

VIII. Award Accounts

Regulatory complianceApprovals required before account can be

created/opened• Human subjects• Animals• Recombinant DNA• Biosafety

June 15, 2000 155

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 156

VIII. Award AccountsNon-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 157

VIII. Award AccountsAdvance 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 158

Part IX. Managing Programmatic Aspects

Compliance with terms and conditions of award– Publication review– Publication citations– Sharing research resources

June 15, 2000 159

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 160

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 161

IX. Managing Programmatic Aspects

Approval of changes to award terms (con’t)– Requiring agency approvals--grants (con’t)

• Significant changes of effort• Significant change in scope of work• Subcontacting• Requests for additional funding• Foreign travel• Use of non-USA airline

June 15, 2000 162

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 163

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• Be included in the award budget or list of allowable costs

June 15, 2000 164

X. Managing Award Funding

Allowable Cost DeterminatesCosts 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 165

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 unallowable

June 15, 2000 166

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 167

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• Acknowledgements, disclaimers required

June 15, 2000 168

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• Foreign travel may require prior approval

June 15, 2000 169

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 170

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 171

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

June 15, 2000 172

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

June 15, 2000 173

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

June 15, 2000 174

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 policies

June 15, 2000 175

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

June 15, 2000 176

X. Managing Award Funding

Cost Transfers University policy & procedures

– Ensure conformance with regulations– Policy

• Financial Policy No. 2111

– Procedures• http://adminet.uchicago.edu/admincompt/

costtran/contents.html

June 15, 2000 177

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

June 15, 2000 178

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

June 15, 2000 179

XI. Audits

Types of Audit– A-133– Award closeout– Special subjects– Proposal

June 15, 2000 180

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

June 15, 2000 181

XI. Audits

A-133 (con’t)• Emphasis on UC systems (con’t)

– Period of funding availability– Financial reporting– Procurement– Recharge center pricing– Billing– Equipment inventory– Subrecipient monitoring

June 15, 2000 182

XI. Audits

A-133 (con’t)• Tests compliance with award specific

restrictions– Prior approval requirement– Cost sharing– Student assistance awards unique regulations– Training program eligibility– Etc.

June 15, 2000 183

XI. Audits

Award interim and closeouts• Performed by

– DHHS – Prime contractor– Non-federal awarding agency

• Usually federal direct contracts or subcontract• Desk audit vs.. on-site audit• Tests for allowable costs• Tests for compliance with award specific

restrictions

June 15, 2000 184

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)

June 15, 2000 185

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

June 15, 2000 186

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

June 15, 2000 187

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.

June 15, 2000 188

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

June 15, 2000 189

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

June 15, 2000 190

Part XIII. Intellectual Property

University policies– Patent Policy – Board of Trustees Statute 18

• http://ap-www.uchicago.edu/UCPOL/UCPOLidx.html

– New Information Technologies – Rights to Intellectual Property

– Determination of who has rights to discoveries in the course of sponsored research/projects?

June 15, 2000 191

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

June 15, 2000 192

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

June 15, 2000 193

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

June 15, 2000 194

XIV. Project Termination

Final technical report – Sponsor may withhold funding for

University if ANY Final Report is overdueAgencies 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

June 15, 2000 195

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

June 15, 2000 196

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

June 15, 2000 197

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

June 15, 2000 198

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

June 15, 2000 199

What Every PI and Administrator Should Know (Con’t)– Budgeting/rebudgeting– Cost transfers– Program income– Monthly account/financial reviews– Agency reporting– Invoicing– recharge centers

June 15, 2000 200

What Every PI and Administrator Should Know (Con’t)– Regulatory compliance– Other research related policies– Knowing your resources– Consultants/subcontractors

June 15, 2000 201

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