The Life Cycle of a Sponsored Project

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The Life Cycle of a Sponsored
Project: An Integrated Approach
Part 1
I. Introduction
Overview of session
4/10/2015
2
II. Roles and Responsibilities of
Primary Players
Proposals
 Principal
Investigator (PI)
 Unit administrator
 Divisional review
 University approval
 Provost office
 Foundation Relations/Development
 Legal/Chief Financial Officer
4/10/2015
3
II. Roles and Responsibilities of
Primary Players
Beyond proposals
 Comptroller’s
office
 Restricted Fund accounting
 Purchasing
4/10/2015
4
II. Roles and Responsibilities of
Primary Players
Key agency personnel
 Programmatic
personnel officer
 Grants and contracts (administrative)
officials
4/10/2015
5
III. Identifying Funding
Opportunities
Resources
 URA
Web site
 URA electronic distributions
 IRIS
 Fed-X
 BSD communication tools
– ORS Web site
– Signals
– E-signals
4/10/2015
6
III. Identifying Funding
Opportunities
Resources (con’t)
 BSD
communication tools (con’t)
– Biomedical Sciences Report
– Faculty Awards Committee Bulletin
 Professional
4/10/2015
periodicals
7
III. Identifying Funding
Opportunities
Mentors/colleagues
 Service
on study section/review committees
 Current and past funding sources
Determining appropriateness
 Read
the guidelines
 Determine appropriateness for:
– The institution?
– The individual?
– The project?
4/10/2015
8
III. Identifying Funding
Opportunities
Searches
 Custom
searches
 Funding opportunity notification systems
– IRIS-Alerts
– Fed-X
– NSF Custom Search
 Ad-hoc
searches
 Agency Web pages
 URA training program - using search tools
4/10/2015
9
III. Identifying Funding
Opportunities
Agency contacts
 Technical
contact/scientific liaison
– Programmatic discussion
– Special approvals/exceptional issues appendices/late proposals
– Funding level
– Review process
4/10/2015
10
•III. Identifying Funding
Opportunities
Current Forms and Guidelines
 Check
for most current forms and
guidelines
– Web-based information
– Campus resources
– Diskettes
– Direct to PI
4/10/2015
11
•III. Identifying Funding
Opportunities
Deadlines/target dates
 Target
deadline
 Rolling deadlines
 Deadline
 No deadline
4/10/2015
12
III. Identifying Funding
Opportunities
Deadlines/target dates (con’t)
 Receipt
date
 Mailing date
 Internal deadlines
4/10/2015
13
III. Identifying Funding
Opportunities
Limited opportunities
 What
is a limited opportunity
– Coordination of selection process



Deputy Provost/Foundation Relations
Divisional
Departmental
– Nomination letters
– Assistance in proposal development
4/10/2015
14
III. Identifying Funding
Opportunities
Coordination with Foundation Relations
 Limited
opportunities
 Sensitive foundations
4/10/2015
15
III. Identifying Funding
Opportunities
Funding instruments
 Procurement
vehicles
– Contracts
 Assistance
vehicles
– Grants
– Cooperative agreements
4/10/2015
16
III. Identifying Funding
Opportunities
Funding instruments (con’t)
 Grant
– federal, state and local government,
foundations, voluntary associations,
corporations
– investigator initiated
– financial assistance
– oversight, but not direction
– federal grants subjects to OMB Circular A-110
and agency implementation
4/10/2015
17
III. Identifying Funding
Opportunities
Funding instruments (con’t)
 Grant
(con’t)
– Federal grants may be awarded under Federal
Demonstration Partnership (FDP)
– Federal grants may be awarded under
expanded authority/SNAP; some SNAP
submissions may now be handled electronically
(eSNAP)
4/10/2015
18
III. Identifying Funding
Opportunities
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
4/10/2015
19
III. Identifying Funding
Opportunities
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)
 Sponsored
research agreement
 Clinical trial agreement
4/10/2015
20
III. Identifying Funding
Opportunities
Funding instruments (con’t)
 Material
transfer agreement
– Purpose
– Incoming/outgoing
– Incoming - MTA provided by provider
– Outgoing University of Chicago types:


4/10/2015
UB MTA
UC MTA (new version to be posted soon)
21
III. Identifying Funding
Opportunities
Solicitation types
 Broad
agency announcements
 Request for proposals
(contracts/cooperative agreements)
 Request for applications (grants)
 Program announcements
(grants/cooperative agreements)
4/10/2015
22
III. Identifying Funding
Opportunities
Types of proposals
 Letters
of intent
 Pre-proposals
 Unsolicited proposals
 Solicited proposals
4/10/2015
23
IV. Proposal Preparation
Project description
 Read
the guidelines
 Agency/program specific
 Sequence/sections specified
 Use review criteria
4/10/2015
24
IV. Proposal Preparation
Project description (con’t)
 Standard
research elements
– Hypothesis
– Specific aims
– Background
– Significance
– Materials and methods
4/10/2015
25
IV. Proposal Preparation
Project description (con’t)
 Seek
advice and input
– Identify mentor
– Critique specific aims
– Critique project description
4/10/2015
26
IV. Proposal Preparation
Determination of project requirements
 Space
 Personnel
 Equipment
 Specialized
resources
 Access to expertise
4/10/2015
27
IV. Proposal Preparation
PI eligibility
 Two
parameters: sponsoring
agency/university policy
 Eligible
– Faculty tracks
– Academic non-faculty (ANF)


4/10/2015
Senior Scientists, Senior Research Associate and RA
track (Asst. Professor, Assoc. Professor, Professor)
New hires
28
IV. Proposal Preparation
PI eligibility (con’t)
 Ineligible
– Research scientist
– Lecturer
– Adjunct appointees
– Staff
– Fellows
– Students
4/10/2015
29
IV. Proposal Preparation
PI eligibility (con’t)
 Ineligible
– Part-Time (PT)
– RA
– BSD Specific


4/10/2015
Clinical Associate (CA)
RA (Instructor)
30
IV. 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


4/10/2015
Faculty Appointments - Mary Harvey
Academic Non-Faculty - Aneesah Ali
31
IV. 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
4/10/2015
32
IV. Proposal Preparation
Endorsement and support letters
 Uncompensated
collaborators
 Those supplying essential research
resources
 Mentors
 Letters of recommendation
 Mentor/department chair letter for NIH Kseries
4/10/2015
33
IV. Proposal Preparation
Acquisition of technical advice/assistance
 Collaborators
 Consultants/independent
contractors
 Subawards
4/10/2015
34
IV. Proposal Preparation
Agency and university guidelines
 Read
in detail the solicitation/program
guidelines
 Proposal checklist
 Adhere to requirements for:
– Title length
– Description length
– Margins
4/10/2015
35
IV. Proposal Preparation
Agency and university guidelines (con’t)
 Adhere
to requirements for (con’t):
– Type size/font
– Obtaining prior sponsor approval for exceptions
– Biosketch/CV
– Current and pending support
– Resources and facilities
 Use
4/10/2015
most current agency forms
36
IV. Proposal Preparation
Completing proposal forms
 University
Information
– Congressional District
– Employee Identification Number (EIN)
– DUNS Number
 Tax
exempt materials
 University annual report
 List of board of trustees
4/10/2015
37
IV. Proposal Preparation
Completing proposal forms (con’t)
 Representations
and certifications
 Board of Trustees resolution on signatory
authority
4/10/2015
38
IV. Proposal Preparation
Completing proposal forms (con’t)
 Boilerplate
– University description
– Divisional/department capabilities
– Resources and facilities
– Resources for descriptions
4/10/2015
39
IV. Proposal Preparation
Other supporting materials
 Current
and pending support
 References
 Appendices information
 Biosketch
– Format
– Page limits
– Key information
– Conflict of interest
4/10/2015
40
IV. Proposal Preparation
Just-in-Time applications/modular grants
 Abbreviated
requirements
 Special instructions:
– Just in Time (JIT):



4/10/2015
Minimal budget/detailed justification
Special biosketch requirements
No checklist required
41
IV. Proposal Preparation
Just-in-Time applications/modular grants
(con’t)
 Special
instructions (con’t)
– Modular grant:




4/10/2015
Special biosketch instructions
Minimal budget/minimal justification
No other support
Checklist page required
42
IV. Proposal Preparation
Small business plans
 Contracts
only
 Best and final
 Work with central procurement
 Small business, minority- and womenowned
 Examples available from URA
 Routing - local unit/div/URA
4/10/2015
43
IV. 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
4/10/2015
44
V. Budgeting Project Costs
Art of budget development
4/10/2015
45
V. 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
4/10/2015
46
V. Budgeting Project Costs
Budget categories -- direct costs
– confidentiality of salary data
 Graduate students – Type A; Type B
 Equipment
 Consultants
 Lab supplies
 “Sensitive” categories: office supplies,
telephone costs
 Personnel
4/10/2015
47
V. Budgeting Project Costs
Budget categories -- direct costs (con’t)
 Subcontracts
 Graduate
student tuition
 Travel – foreign; domestic
 Publication costs
4/10/2015
48
V. Budgeting Project Costs
Verification of current rates
research assistant – division
dependent
 Graduate tuition recovery – division
dependent
 Fringe benefits – choice of rate depends on
nature of employment
 Graduate
4/10/2015
49
V. Budgeting Project Costs
Verification of current rates (con’t)
centers – verify rates, e.g.
Biostatistical Lab; SSD Survey Research
Center
 Recharge
4/10/2015
50
V. Budgeting Project Costs
Verification of current rates (con’t)
service centers – excluded
from MTDC overhead
 Specialized
– Animal Facilities Charge
– PSD Central Shop
4/10/2015
51
V. Budgeting Project Costs
Verification of current rates (con’t)
 Confirm
current rate through Quick
Reference Fact Sheet
 Use resource web sites
– URA
4/10/2015
52
V. 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
4/10/2015
53
V. Budgeting Project Costs
Cost sharing/matching commitments
(con’t)
 Approvals
– Department/division
– Provost’s Office
– Concurrence of Budget Office
– Documentation of approval to URA
4/10/2015
54
V. Budgeting Project Costs
Typical budget problems
 Compensation-
employee; consultant;
subcontractor; independent contractor
 Fellows versus postdoctoral research
associates
 Salaries or stipends
 Equipment that should be supplies
(<$5,000)
4/10/2015
55
V. Budgeting Project Costs
Typical budget problems (con’t)
 Effort
on PTF matching effort in proposal
 Effort on budget does not match effort in
justification
 Translating effort to calendar/academic
months
 BSD faculty appointments are 12 month
(CY) appointments
4/10/2015
56
V. Budgeting Project Costs
Typical budget problems (con’t)
 Non-BSD
faculty appointments are 9 month
(AY) appointments
 Calculation of Animal Facilities Charge
 Justification matches budget
4/10/2015
57
V. 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
4/10/2015
58
V. 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?)
 Scope of services
4/10/2015
59
V. Budgeting Project Costs
Consultants (con’t)
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
 Rate
4/10/2015
60
V. Budgeting Project Costs
Subawards
 Organization
to organization agreement
 Use of personnel and facilities
 Approval from subrecipient institution at the
time of proposal submission
 Scope of work
 Budget, including subrecipient’s indirect
costs
4/10/2015
61
V. 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
4/10/2015
62
V. Budgeting Project Costs
NIH modular grants budgets (con’t)
 Request
the same # of modules for each
budget period of project (exceptions
permitted)
4/10/2015
63
V. 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
4/10/2015
64
V. 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
4/10/2015
65
V. Budgeting Project Costs
Modular grant – postaward notations
 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
4/10/2015
66
VI. Proposal Preparation-Compliance Issues
Regulatory compliance
 Public
trust, public perception and scientific
responsibility
 Emergence of regulations
 Consequences of non-compliance
4/10/2015
67
VI. Proposal Preparation-Compliance Issues
Protection of human subjects
 Historical
perspective
– Tuskegee experiments
– Nazi human experimentation
4/10/2015
68
VI. Proposal Preparation-Compliance Issues
Protection of human subjects (con’t)
 Development
of ethical principles
– Nuremberg code







4/10/2015
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
69
VI. Proposal Preparation-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




4/10/2015
Respect for persons
Beneficence
Justice
Boundaries between practice and research
70
VI. Proposal Preparation-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
4/10/2015
71
VI. Proposal Preparation-Compliance Issues
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,
 Includes:
– Clinical trials
– Behavioral research
– Epidemiological and survey research
– Outcomes research
4/10/2015
72
VI. Proposal Preparation-Compliance Issues
Protection of human subjects (con’t)
 Includes
(con’t):
– Anthropological research
– Educational research
– Field research
– Oral history
4/10/2015
73
VI. Proposal Preparation-Compliance Issues
Protection of human subjects (con’t)
 Any
research with human subjects must,
therefore, be reviewed and approved by a
recognized Institutional Review Board or
determined to be exempt
4/10/2015
74
VI. Proposal Preparation-Compliance Issues
Protection of human subjects (con’t)
 Institutional
Official: Associate Vice
President for Research
 Federal-Wide Assurance (FWA):
FWA00005565
 Three IRBs
– Social Science Division (03)
– Social Service Administration (02)
– Biological Sciences Division/University of
Chicago Hospitals (01)
4/10/2015
75
VI. Proposal Preparation-Compliance Issues
Protection of human subjects (con’t)
 Types
of review
– Exempt from committee review
– Expedited review
– Review by committee
4/10/2015
76
VI. Proposal Preparation-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
– Cannot initiate clinical trial without BOTH
approved protocol and approved clinical trial
agreement
– The informed consent process must be
completed before any subject can be enrolled in
a study
4/10/2015
77
VI. Proposal Preparation-Compliance Issues
Protection of human subjects (con’t)
 Points
to remember (con’t):
– Otherwise - study data is illegitimate
– Use of patient charts or radiological films or
discarded and unidentified tissues, blood etc, is
research and must have IRB approval
– Student research subject to human subjects
requirements
– Deception only allowed at discretion of IRB
4/10/2015
78
VI. Proposal Preparation-Compliance Issues
Protection of human subjects (con’t)
 Points
to remember:
– Field work subject to human subjects
requirements
– Oral history projects subject to human subjects
requirements
– IRBS are not allowed to circumvent these rules
– Protocol approval for one year or less
4/10/2015
79
VI. Proposal Preparation-Compliance Issues
Protection of human subjects (con’t)
 Points
to remember:
– Institutions are subject to review


4/10/2015
Office for the Protection from Research Risks
(OPRR):
 MPA process
 Query letters
 On-site reviews
Food & Drug Administration (FDA): periodic on-site
audits
80
VI. Proposal Preparation-Compliance Issues
Protection of human subjects (con’t)
 Human
subject challenges
– Balancing ethical principles and research needs
– Proxy consent/waiver of consent
– Changing face of research, particularly genetic
analysis
– Need to develop local policy ahead of federal
policy to keep up
4/10/2015
81
Vi. Proposal preparation-compliance issues
Protection of human subjects (con’t)
 Human
subject challenges (con’t)
– Constantly changing regulations
– Changing institutional boundaries
– International/target group field work

Sensitivity to cultural differences
– Defining research versus case studies, quality
assurance, journalism
4/10/2015
82
VI. Proposal Preparation-Compliance Issues
Protection of human subjects (con’t)
 Resources
– ORS Web-site: http://ors.bsd.uchicago.edu/
– Office of Human Research Protection
• US Food & Drug Administration
• FDA Information Sheets
4/10/2015
83
VI. Proposal Preparation-Compliance Issues
Protection of human subjects (con’t)
 Resources
(con’t)
– PRIM&R (Public Responsibility in Medicine and
Research)
– BSD/UCH IRB
4/10/2015
84
VI. Proposal Preparation-Compliance Issues
Protection of human subjects (con’t)
 Training
– BSD/UCH IRB


Videos
Annual orientation provided by UC/UCH IRB
– BSD Initiatives



4/10/2015
GCRC training
Health studies seminar series
K30 proposal
85
VI. Proposal Preparation-Compliance Issues
Protection of human subjects (con’t)
Grant-related issues
– Who can be PI on a protocol
– Verifying protocol numbers and date
– FDA requirements
– NIH requirements


4/10/2015
398 Research Plan, Section E
Inclusion of women and minorities, children
86
VI. Proposal Preparation-Compliance Issues
Protection of human subjects (con’t)
Grant-related issues (con’t)
– Notification of approval to agency
– Ban on fetal research
– FAS accounts/regulatory compliance
4/10/2015
87
VI. Proposal Preparation-Compliance Issues
Use of animals
 Ethical
principles
– US Government Principles for the Utilization
and Care of Vertebrate Animals Used in
Testing, Research and Teaching:


4/10/2015
Transportation, care and use of animals should be in
accordance with the Animal Welfare Act
Procedures involving animals should be designated
and performed with due consideration of the
relevance to human or animal health, the
advancement of knowledge, or the good of society
88
VI. Proposal Preparation-Compliance Issues
Use of animals (con’t)
 Ethical
principles (con’t)
– US Government Principles for the Utilization
and Care of Vertebrate Animals Used in
Testing, Research and Teaching (con’t):


4/10/2015
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.
89
VI. Proposal Preparation-Compliance Issues
Use of animals (con’t)
 Ethical
principles (con’t)
– US Government Principles for the Utilization
and Care of Vertebrate Animals Used in
Testing, Research and Teaching (con’t):


4/10/2015
Proper use of animals, including the avoidance or
minimization of discomfort, distress and pain
Procedures that cause more than momentary or slight
pain or distress should be performed with appropriate
sedation, analgesia, or anesthesia.
90
VI. Proposal Preparation-Compliance Issues
Use of animals (con’t)
 Ethical
principles (con’t)
– US Government Principles for the Utilization
and Care of Vertebrate Animals Used in
Testing, Research and Teaching (con’t):


4/10/2015
Animals that would suffer severe or chronic pain or
distress that cannot be relieved should be painlessly
killed at the end of the procedure
The living conditions of animals should be appropriate
for their species and contribute to their health and
comfort
91
VI. Proposal Preparation-Compliance Issues
Use of animals (con’t)
 Ethical
principles (con’t)
– US Government Principles for the Utilization
and Care of Vertebrate Animals Used in
Testing, Research and Teaching (con’t):


4/10/2015
Investigators and other personnel shall be
appropriately qualified and experienced for
conducting the specified procedures on animals
Any exceptions to these principle can be made only
by the IACUC
92
VI. Proposal Preparation-Compliance Issues
Use of animals (con’t)
 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
4/10/2015
93
VI. Proposal Preparation-Compliance Issues
Use of animals (con’t)
 Principles
– Guide for the Care and Use of Laboratory
Animals- National Research Council
4/10/2015
94
VI. Proposal Preparation-Compliance Issues
Use of animals (con’t)
 Principles
(con’t)
– Institutional Animal Care and Use Committee
(IACUC) Responsibilities




4/10/2015
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
VI. Proposal Preparation-Compliance Issues
Use of animals (con’t)
 PHS
regulations apply to all use of animals
in research, teaching, testing
 USDA regs currently apply to: non-human
primates, cats, dogs, pigs, sheep, rabbits,
hamsters, chincillas, etc.
 USDA regs do not currently apply to:
rodents, birds, fish or reptiles
4/10/2015
96
VI. Proposal Preparation-Compliance Issues
Use of animals (con’t)
 Institutional
Official: Dean of the Biological
Sciences
 Assurance: NIH-OPRR
 Single institutional animal care and use
committee
 Animal Resources Center
4/10/2015
97
VI. Proposal Preparation-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
4/10/2015
98
VI. Proposal Preparation-Compliance Issues
Use of animals (con’t)
 IACUC
Reviews (con’t)
– Field research
– Preserved specimens
4/10/2015
99
VI. Proposal Preparation-Compliance Issues
Use of animals (con’t)
 Special
considerations
– Special mandate to reduce the number of
animals used in research, to replace animals
with either lower order animals or in
vitro/computer methods and to refine methods
to reduce pain and distress
– Animals cannot give consent, so IACUC
charged with their welfare
4/10/2015
100
VI. Proposal Preparation-Compliance Issues
Use of animals (con’t)
 Special
considerations (con’t)
– Special issues






4/10/2015
Production of antibodies using the Ascites Method
Sensitivity toward animal rights
Need for security
Animal must be ordered through ARC
IACUC/ARC responsible for all animals, even if
housed outside ARC
Housing outside ARC is supposed to conform with
standards of Guide
101
VI. Proposal Preparation-Compliance Issues
Use of animals (con’t)
 Special
considerations (con’t)
– Special issues (con’t)






4/10/2015
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
102
VI. Proposal Preparation-Compliance Issues
Use of animals (con’t)
 Special
considerations (con’t)
– Special issues (con’t)

4/10/2015
Laboratory protocol
 No eating
 Standard requirements
103
VI. Proposal Preparation-Compliance Issues
Use of animals (con’t)
 Special
considerations (con’t)
– Special issues (con’t)







4/10/2015
Physical restraint
Training
Appropriate anaesthesia/analgesia
Multiple survival surgery
Food or fluid restrictions
Peer review
Transferring animals into and out of institution
104
VI. Proposal Preparation-Compliance Issues
Use of animals (con’t)
 Resources
– ORS Web-site: http://ors.bsd.uchicago.edu/
4/10/2015
105
VI. Proposal Preparation-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
4/10/2015
materials
106
VI. Proposal Preparation-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
– Grace period
– NIH requirements: research plan, Section F
– FAS accounts/regulatory compliance
– Peer review
4/10/2015
107
VI. Proposal Preparation-Compliance Issues
Use of biohazardous materials
 Infectious
agents
– Risk to laboratory personnel
– Risk to general public
 Recombinant
DNA
– Perceived risk to general public
4/10/2015
108
VI. Proposal Preparation-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
4/10/2015
109
VI. Proposal Preparation-Compliance Issues
Use of biohazardous materials (con’t)
 Institutional
official: Dean of the Biological
Sciences Division
 Single institutional biosafety committee
4/10/2015
110
VI. Proposal Preparation-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



4/10/2015
Laboratory practice and technique
Safety equipment (primary barriers)
Facility design (secondary barriers)
111
VI. Proposal Preparation-Compliance Issues
Use of biohazardous materials (con’t)
 Principles
in biosafety (con’t)
– Importation and interstate shipment of certain
biomedical materials



4/10/2015
USDA
Department of Transportation
Public Health Service Foreign Quarantine
Regulations
112
VI. Proposal Preparation-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


4/10/2015
Recombinant DNA
Vectors from viruses
113
VI. Proposal Preparation-Compliance Issues
Use of biohazardous materials (con’t)
 Biosafety
Levels I-IV (con’t)
– Biosafety Level 2: agents of moderate potential
hazard

4/10/2015
E. Coli, anthrax, chlamydia, most mycobactierim,
adenoviruses, hepatitis, retrovirus
114
VI. Proposal Preparation-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

4/10/2015
Hanta virus, hemorrhagic fever, ebola
115
VI. Proposal Preparation-Compliance Issues
Use of biohazardous materials (con’t)
 Determining
BL risk group
– American Type Culture Collection Catalogues
– Department of Labor, Occupational Safety and
Health Administration - Exposure to Bloodborne
Pathogens
– International Committee on Taxonomy of
Viruses
– Chart: 61 FR 1486
4/10/2015
116
VI. Proposal Preparation-Compliance Issues
Use of biohazardous materials (con’t)
 Noteworthy
considerations
– Identify biohazard
– Determine biosafety level/risk group
– Facilities limitations
4/10/2015
117
VI. Proposal Preparation-Compliance Issues
Use of biohazardous materials (con’t)
 Pertains
to:
– Laboratory work
– Work with animals
– Work with plants
– Greenhouses
4/10/2015
118
VI. Proposal Preparation-Compliance Issues
Use of biohazardous materials (con’t)
 Resources
– ORS Website: http://ors.uchicago.edu/l
– Institutional Biosafety Committee (IBC)
– University Safety and Environmental Affairs
– Office NIH Office of Biotechnology Activities
– Office of Recombinant DNA Activity
– USDA Biotech and Science Services
4/10/2015
119
VI. Proposal Preparation-Compliance Issues
Use of biohazardous materials (con’t)
 Training
– PI training
– Videos on biosafety or infectious agents
available in crerar library
4/10/2015
120
VI. Proposal Preparation-Compliance Issues
Use of biohazardous materials (con’t)
 Occupational
Health and Safety
– Human Resources
– Health Services
– IBC
– Coordination with other regulatory committees
4/10/2015
121
VI. Proposal Preparation-Compliance Issues
Use of radiation
 Federal/state
oversight
– FDA
– Nuclear Energy Commission
– Illinois Department of Nuclear Safety
4/10/2015
122
VI. Proposal Preparation-Compliance Issues
Use of radiation (con’t)
 Oversight
– Committee on Radiation Hazards
– Human Use of Radioisotopes and Radioactive
Drug Research Committee (RDRC)
– Office of Radiation Safety
4/10/2015
123
VI. Proposal Preparation-Compliance Issues
Use of radiation (con’t)
 Regulatory
requirements
– Purchasing restrictions
– Emission limits
– No eating
4/10/2015
124
VI. Proposal Preparation-Compliance Issues
Use of radiation (con’t)
 IDNS
regulatory licenses
– University - laboratory research
– Hospital - clinical care and clinical research
 Annual
or more frequent inspections
 Reports - citations
4/10/2015
125
VI. Proposal Preparation-Compliance Issues
Use of radiation (con’t)
 Resources
– ORS Website: http://ors.bsd.uchicago.edu
– Radiation Safety Website

http://facilities.uchicago.edu/organization/radiation/ho
me.html
 Training
– Mandatory training with periodic updates
 Newsletter
4/10/2015
– Office of Radiation Safety
126
VI. Proposal Preparation-Compliance Issues
Other Regulatory considerations
 Chemical
and laboratory safety
 OSHA
 Occupational
4/10/2015
health and safety
127
VI. Proposal Preparation-Compliance Issues
Conflict of interest
 Federal
regulations
 University policy
 Assurance Form
 Disclosure Form
 Process of review
 Approval of management plan by Office the
Provost
4/10/2015
128
VI. Proposal Preparation-Compliance Issues
Compliance with University policies
– “Whistleblower” policy [Compliance
with University Policies and Procedures]
http://hr.uchicago.edu/policy/p103.html
PI eligibility
 U103
4/10/2015
129
VI. Proposal Preparation-Compliance Issues
Compliance with University policies (con’t)
 Development-
sensitive foundations
 Cost sharing/ matching funds
4/10/2015
130
VI. Proposal Preparation-Compliance Issues
Compliance with divisional/departmental
guidelines
– faculty salary recovery
 Tuition recovery for graduate research
assistants
 BSD
4/10/2015
131
VI. Proposal Preparation-Compliance Issues
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
4/10/2015
132
VI. Proposal Preparation-Compliance Issues
Proposal review and clearance (con’t)
 Taking
exception to binding terms and
conditions
– Approval of publications
– Indemnification
– Assignment of intellectual property
 Recipient
organization: The University of
Chicago (not Medical Center; not Hospital;
not department)
4/10/2015
133
VI. Proposal Preparation-Compliance Issues
Proposal review and clearance (con’t)
management – where does the
responsibility lay?
 Deadline
4/10/2015
134
VI. Proposal Preparation-Compliance Issues
Proposal Transmittal Form – internal
control document
 Purpose
 Instructions
4/10/2015
135
VI. Proposal Preparation-Compliance Issues
Proposal Transmittal Form (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
4/10/2015
offs
136
VI. Proposal Preparation-Compliance Issues
Proposal Transmittal Form (con’t)
required for revised budgets – but
major project budgets, especially with cost
sharing, are rerouted for approval when
proposed award has significant budget
reduction
 Not
4/10/2015
137
VII. Routing and Review Process
Electronic research administration
Science Foundation – FASTLANE
 NIH Commons
 See URA page on electronic submissions
 National
4/10/2015
138
VII. Routing and Review Process
Traditional proposal and award
procedures
 Review
through channels of draft cover
page + budget +abstract + current and
pending support + senior investigator CVs
+ draft project description
 URA completes and authorizes “Reps and
Certs”
4/10/2015
139
VII. Routing and Review Process
Traditional proposal and award
procedures (con’t)
 URA
provides financial reports;
insurance/liability certifications
 Comment and sign off by URA
 Changes required by URA: “*”
requirements versus suggestions
4/10/2015
140
VII. Routing and Review Process
Traditional proposal and award
procedures (con’t)
 Submission
to agency
 Final proposal to URA, division, LBC,
department or local unit for files
4/10/2015
141
VIII. Updating Submissions and
Award Negotiations
Special considerations
 Changes
in Scope or budget
 Regulatory Approvals
 Updating Current and Pending Support
 Just in Time Updates
 Best and Final Offers
 Preaward audits
4/10/2015
142
VIII. 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
4/10/2015
143
VIII. 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
4/10/2015
144
VIII. Updating Submissions and
Award Negotiations
Preaward costs and advance accounts
 Account
create
 Limitations on advance accounts
 State and local government agreements
are increasingly problematic
 Clinical Studies – subjects may not be
enrolled until agreement is negotiated and
signed (IRB approval is not sufficient)
4/10/2015
145
VIII. Updating Submissions and
Award Negotiations
Postaward considerations
 Authorities
– Preaward
– Rebudgeting
– Project period
– No-cost extension
– Carry-forward authority
4/10/2015
146
VIII. Updating Submissions and
Award Negotiations
Postaward considerations (con’t)
 Equipment
issues
– Ownership
– Reporting
 Financial
reporting requirements
 Invoicing requirements
4/10/2015
147
VIII. Updating Submissions and
Award Negotiations
Receipt of award
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
 Email
4/10/2015
148
VIII. Updating Submissions and
Award Negotiations
Special cases
studies – routing of protocols and
proposed agreements
 Visiting scientists – corporate scientific
visitors
 Corporate-sponsored research
 Subsequent to ARCH license agreement
 Gifts and grants and contracts and which is
which is which
 Clinical
4/10/2015
149
The Life Cycle of a Sponsored
Project: An Integrated Approach
Part 2
The Life Cycle of a Sponsored
Project: An Integrated Approach
Part 2 Outline













IX
X
XI
XII
XIII
XIV
XV
XVI
XVII
XVII
XIX
XX
XXI
4/10/2015
Award evaluation & acceptance
Referenced conditions & documents
Administrative information
Award review with PI
Award accounts
Managing programmatic aspects
Managing award funding
Audits
Financial reports
Billing & collecting funds
Intellectual Property
Project Termination
Relinquishing/transferring programs or awards
151
IX. 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

4/10/2015
152
IX. Award Evaluation &
Acceptance

Administrator’s role:
Review of terms & conditions of award
 Notation of special restrictions/conditions
 Limitation on spending, prior approvals

4/10/2015
153
IX. Award Evaluation &
Acceptance

Trouble spots to look for
Cost Sharing requirements
 Unanticipated budget reductions that could
impact scope of work
 Never assume year-to-year boilerplate is
same – changes do appear

4/10/2015
154
IX. Award Evaluation &
Acceptance

Legal Office Review--URA point of
contact
Indemnification requirements
 Unusual certifications and compliance
clauses
 National Laboratory User Agreements

4/10/2015
155
IX. Award Evaluation &
Acceptance

UCTech participation in sponsored
research & MTA agreements
Unusual intellectual property rights &
requirements
 Pre-agreed upon licensing royalty rates for
research outcomes

4/10/2015
156
IX. Award Evaluation &
Acceptance

Risk Management--URA point of contact
Unusual insurance requirements
 Off campus site conditions

4/10/2015
157
IX. 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

4/10/2015
158
X. Referenced Conditions & Documents
Federal Grants
OMB Circulars
 General terms and conditions
 Specific terms and conditions
 Agency publications
 Administrative regulations
 Program regulations

4/10/2015
159
X. Referenced Conditions & Documents
Federal Grants

OMB Circulars
 A-21:
Cost Principles for Educational
Institutions
 A-110: Uniform Administrative
Requirements for Grants and
Agreements with Institutions of Higher
Education, Hospitals, and Other
Non-Profit Organizations
4/10/2015
160
X. Referenced Conditions & Documents
Federal Grants

OMB circulars (con’t)
 A-133:
Audits of States, Local
Governments, and Non-Profit
Organizations
4/10/2015
161
X. Referenced Conditions & Documents
Federal Grants

OMB Circulars (con’t)
 Referenced
through:
– General T&Cs
– Referenced agency publications
– Referenced administrative regulations
4/10/2015
162
X. Referenced Conditions & Documents
Federal Grants

General terms and conditions
 Federal
Demonstration Partnership (FDP)
terms and conditions & agency specific
terms and conditions
– Research awards from: NSF, NIH, NASA,
Energy, Air Force, Army, EPA, ONR & USDA
4/10/2015
163
X. Referenced Conditions & Documents
Federal Grants

General terms and conditions (con’t)
 NSF
– Grant General Conditions (GC-1)
– Cooperative Agreement General Conditions
(CA-1)
– Facilities Modernization Grant Conditions (FAA
GC-1)
– Fixed Amount Award General Conditions (FAA
GC-1)
4/10/2015
164
X. Referenced Conditions & Documents
Federal Grants

Award specific T&Cs
4/10/2015
165
X. Referenced Conditions & Documents
Federal Grants

Agency publications
 NSF
Grant Proposal Guide
 NIH Grants Policy Statement
 NASA Grant and Cooperative Agreement
Handbook
4/10/2015
166
X. Referenced Conditions & Documents
Federal Grants

Agency administrative regulations
agency’s implementation of A-110
 Examples
 Includes
– Agriculture: 7 CFR 3019
– DHHS: 45 CFR 74
– Education: 34 CFR 74
– Energy: 10 CFR 600
– NASA : 14 CFR 1260`
4/10/2015
167
X. Referenced Conditions & Documents
Federal Grants

Program regulations
 May
be published in
– Code of Federal Regulations
– Agency publications
4/10/2015
168
X. Referenced Conditions & Documents
Federal Grants

Program regulations (con’t)
 When
are they important?
– Research awards?

4/10/2015
No, information tends to apply to whole class of
awards
169
X. Referenced Conditions & Documents
Federal Grants

Program regulations (con’t)
 When
are they important?
– Non-research awards?



4/10/2015
Yes, information tends to be award specific
Usually available through other agency publications
Examples:
 34 FR 648: Graduate Assistance in Areas of
National need
 34 CFR 675: Federal Work-Study Program
170
X. Referenced Conditions & Documents
Federal Contracts

Consists of 4 parts
 Part
I: The “Schedule”
 Part II: Contract clauses
 Part III: List of documents, exhibits and
other attachments
 Part IV: Representations and instructions
4/10/2015
171
X. Referenced Conditions & Documents
Federal Contracts

The “Schedule”
 Section
A: Solicitation information
– May contain administrative information,
instructions
 Section
B: Description of the supplies or
services
 Section C: Specifications and statement of
work
4/10/2015
172
X. Referenced Conditions & Documents
Federal Contracts

The “Schedule” (con’t)
 Section
D: Packaging and marking
requirements
 Section E: Inspection and acceptance
requirements
 Section F: Requirements for delivery and
performance
4/10/2015
173
X. Referenced Conditions & Documents
Federal Contracts

The “Schedule” (con’t)
 Section
G: Contract administration
 Section H: Special contract requirements
– See 35.015 requirements that would be placed
here
4/10/2015
174
X. Referenced Conditions & Documents
Federal Contracts

Part II: Contract Clauses
 Many
clauses are sited
 Clauses that warrant particular attention
include
– 52.216-7

Allowable cost & payment
Reference OMB Circular A-21
– 52.232-20 Limitation of cost


4/10/2015
Applies to “fully funded” contracts
Requires notification when cost thresholds are
approached
175
X. Referenced Conditions & Documents
Federal Contracts

Part II: Contract Clauses (Con’t)
 Clauses
that warrant particular attention
include (con’t)
– 52.232-22 Limitation of funds


4/10/2015
Applies to incrementally funded contracts
Requires notification as cost thresholds on allotted
funds are approached
176
X. Referenced Conditions & Documents
Federal Contracts

Part II: Contract Clauses (Con’t)
 Clauses
that warrant particular attention
include (con’t)
– 52.244-2

Requires contracting officer approval
– 52.245-5



4/10/2015
Subcontracts
Government property
Maintenance and management requirements
Unless specifically stated in the “Schedule”, title vests
with the government
35.014 Addresses equipment title subject
177
X. Referenced Conditions & Documents
Non-Federal Grants & Contracts

Conditions & documents are referenced
in a manner similar to what is done for
federal grants and contracts
4/10/2015
178
XI. Administrative Information

Administrator needs to learn from the
award instrument information on:
 Program
and budget revisions
 Cost Principles
 Period of availability of funds
 Program (technical) reporting requirements
 Financial reporting requirements
 Record retention requirements
4/10/2015
179
XI. Administrative Information

Administrator needs to learn from the
award instrument information on (con’t):
 Cost
sharing
 Program income
 Equipment
4/10/2015
180
XI. Administrative Information:
Program and Budget Revisions

Federal agency grant prior approval
requirements
 Located
in
– For grants:



General terms & conditions
Agency publications
Agency administrative regulations that implement
Section 25 of A-110
– For contracts

4/10/2015
The “Schedule”
181
XI. Administrative Information:
Program and Budget Revisions

Federal agency prior approval is
mandatory for:
 Change
in scope
 Change in key personnel
 Program director/principal investigator’s:
– absence for more than 3 months
– 25% reduction in effort
 Need
4/10/2015
for additional funding
182
XI. Administrative Information:
Program and Budget Revisions

Federal agency prior approval is
mandatory for (con’t)
 Transfer
of training allowance funds to
other categories
 Subcontracting project scope
 Award specific restrictions
4/10/2015
183
XI. Administrative Information:
Program and Budget Revisions

Federal agency prior approvals required
unless waived:
 Transfers
between direct and indirect cost
categories
– FDP awards:

All agencies have waived
– Other awards


4/10/2015
NIH has waived
NSF has waived
184
XI. Administrative Information:
Program and Budget Revisions

Federal agency prior approvals required
unless waived (con’t):
 Transfers
between direct and indirect cost
categories (con’t)
– Other awards (con’t)



4/10/2015
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)
185
XI. Administrative Information:
Program and Budget Revisions

Federal agency prior approvals required
unless waived (con’t):
 Costs
that require prior approval because
of A-21
– Include:





4/10/2015
Intra-University consulting compensation
Insurance on federal owned equipment
Equipment
Pre-agreement (pre-award) costs
Special arrangement and alteration costs
186
XI. Administrative Information:
Program and Budget Revisions

Federal agency prior approvals required
unless waived (con’t):
 Costs
that require prior approval because
of A-21 (con’t)
– Intra-University consulting compensation

Assume no waivers
– Insurance on federal owned equipment

4/10/2015
Assume no waivers
187
XI. Administrative Information:
Program and Budget Revisions

Federal agency prior approvals required
unless waived (con’t):

Costs that require prior approval because of A-21
(con’t)
– Equipment


4/10/2015
FDP awards
 All agencies have waived
Other awards
 NIH has waived for < $25k
 NSF has waived
 Other agencies: Assume no waivers
188
XI. Administrative Information:
Program and Budget Revisions

Federal agency prior approvals required
unless waived (con’t):
 Costs
that require prior approval because
of A-21 (con’t)
– Pre-agreement (pre-award) costs


4/10/2015
FDP awards
 All agencies have waived prior approval for costs
incurred within 90 days of the award
Other awards
 Assume no waivers
189
XI. Administrative Information:
Program and Budget Revisions

Federal agency prior approvals required
unless waived (con’t):

Costs that require prior approval because of A-21
(con’t)
– Special arrangement and alteration costs


4/10/2015
FDP awards
 NSF has waived only for arrangement and alteration
cost < $10k
 Other agencies have waived
Other awards
 Assume no waivers
190
XI. Administrative Information:
Program and Budget Revisions

Federal agency prior approvals required
unless waived (con’t):

One-time no cost extensions
– FDP awards


All agencies have waived
Agency notifications required
– Other awards


4/10/2015
Research awards
 Waiver is likely
Non-research awards
 Assume no waivers
191
XI. Administrative Information:
Program and Budget Revisions

Federal agency prior approvals required
unless waived (con’t):
 Carry
forward unobligated balances to
subsequent funding periods
– FDP awards


4/10/2015
All agencies have waived
Agency notifications required
192
XI. Administrative Information:
Program and Budget Revisions

Federal agency prior approvals required
unless waived (con’t):
 Carry
forward unobligated balances to
subsequent funding periods (con’t)
– Other awards


4/10/2015
Research awards
 Waiver is likely
Non-research awards
 Assume no waivers
193
XI. Administrative Information:
Cost Principles
 Allowability
of costs is determined in
accordance with the provisions of A-21,
Cost Principles for Educational Institutions
 A-21 states that specific provisions of the
award take precedence
– Effectively allows awarding agencies to write
additional cost principles
– NIH Grants Policy Statement and NSF Grant
Policy Manual address some costs in more
detail than A-21
4/10/2015
194
XI. Administrative Information:
Cost Principles
 A-21
reference
– For grants:



General terms & conditions
Agency publications
Agency administrative regulations that implement
Section 27 of A-110
– For contracts


4/10/2015
The “Schedule”
Contract Clause 52.216-7
195
XI. Administrative Information:
Period of Availability of Funds

Grants
 Period
of availability is governed by by
Section 28 of A-110.
 Section 28 states that where funding period
is specified, only allowable costs resulting
from obligations incurred during the funding
period are allowable.
4/10/2015
196
XI. Administrative Information:
Period of Availability of Funds

Grants (con’t)
 Most
multi-year awards are incrementally
funded. Each incrementally funded period
then has its funds restricted to obligations
that arise during that period
 Section 25 of A-110, however, allows
awarding agency to give grantee authority
to carry-forward unobligated balances to
subsequent periods.
4/10/2015
197
XI. Administrative Information:
Period of Availability of Funds

Grants (con’t)
 A-110
reference
– General terms & conditions
– Agency publications
– Agency administrative regulations that
implement Section 28 & 25 of A-110
4/10/2015
198
XI. Administrative Information:
Period of Availability of Funds

Contracts
 There
is no FAR clause analogous to
Section 28 of A-110
4/10/2015
199
XI. Administrative Information:
Period of Availability of Funds

Contracts
 Unlike
grants, contracts that are
incrementally funded do not have those
funds restricted to that incremental period.
However,
– The “Schedule” may specifically restrict funds to
a period
– Funds may be used only for costs incurred
within the contract’s period of performance
4/10/2015
200
XI. Administrative Information:
Technical Reporting Requirements

Grants
 Awarding
agencies technical reporting
requirements must comply with Section 51
of A-110
– Award references



4/10/2015
General terms & conditions
Agency publications
Agency administrative regulations that implement
Section 51 of A-110
201
XI. Administrative Information:
Technical Reporting Requirements

Contracts
 There
is no FAR clause analogous to
Section 51 of A-110
 Reporting requirements will be detailed in
the “Schedule”
4/10/2015
202
XI. Administrative Information:
Financial Reporting Requirements

Grants
 Awarding
agencies financial reporting
requirements must comply with Section 52
of A-110
– Section 52 provides:



4/10/2015
Use of standard forms SF269, 269A, 270 or 272
Reports shall not be more frequently than quarterly,
or less frequently than annually
Annual reports shall be due no later than 90 days
after the grant year
203
XI. Administrative Information:
Financial Reporting Requirements

Grants (con’t)
 Awarding
agencies financial reporting
requirements must comply with Section 52
of A-110 (con’t)
– Award references



4/10/2015
General terms & conditions
Agency publications
Agency administrative regulations that implement
Section 52 of A-110
204
XI. Administrative Information:
Financial Reporting Requirements

Contracts
 There
is no FAR clause analogous to
Section 52 of A-110
 Reporting requirements will be detailed in
the “Schedule”
4/10/2015
205
XI. Administrative Information:
Record Retention Requirements

Grants
 Awarding
agencies financial reporting
requirements must comply with Section 53
of A-110
– Award references to Section 53



4/10/2015
General terms & conditions
Agency publications
Agency administrative regulations that implement
Section 53 of A-110
206
XI. Administrative Information:
Record Retention Requirements

Grants (con’t)
 Requirement
– Awards that are renewed quarterly or annually

Retain records for a period of 3 years from the date of
submission of the quarterly or annual financial report
– Awards that are renewed annually

4/10/2015
Retain records for a period of 3 years from the date of
submission of the quarterly or annual financial report
207
XI. Administrative Information:
Record Retention Requirements

Contracts
 FAR
clause 52.215-2 is analogous to
Section 53 of A-110
 Requirement
– “The contractor shall make available . . . records
until 3 years after final payment. . . .”
4/10/2015
208
XI. Administrative Information:
Cost Sharing

Cost sharing expenses are award
expenses funded by the University
 Cost
sharing not required as a condition of
the award is referred to as voluntary
 Cost sharing required as a condition of the
award is referred to as mandatory
4/10/2015
209
XI. Administrative Information:
Mandatory Cost Sharing

Grants
 Awarding
agencies cost sharing
requirements must comply with Section 23
of A-110
– Award references to Section 23



4/10/2015
General terms & conditions
Agency publications
Agency administrative regulations that implement
Section 23 of A-110
210
XI. Administrative Information:
Mandatory Cost Sharing

Grants (con’t)
 Requirements
– Allowable cost
– Documentation
– Cost sharing indirect costs requires agency
prior approval

Contracts
 Cost
sharing almost never applies to a
contract
4/10/2015
211
XI. Administrative Information:
Program Income
Program income is income that is
earned as a result of an award funded
activity
 Possible examples

 Fees
charged for award sponsored
conferences
 Equipment user charges
4/10/2015
212
XI. Administrative Information:
Program Income

Grants
 Awarding
agencies must comply with
Section 24 of A-110
– Award references to Section 24



4/10/2015
General terms & conditions
Agency publications
Agency administrative regulations that implement
Section 24 of A-110
213
XI. Administrative Information:
Program Income

Grants
 Requirement
– Agencies may exclude royalty and copyright
income
– For included income, agencies may



4/10/2015
Allow the income to be added to the award
Allow the income to be used to fund required cost
sharing
Reduce the award by the amount of income
214
XI. Administrative Information:
Program Income

Contracts
 There
is no FAR clause analogous to
Section 24 of A-110
 Reporting requirements will be detailed in
the “Schedule”
4/10/2015
215
XI. Administrative Information:
Equipment

Grants
 Awarding
agencies equipment
requirements must comply with Section 33
of A-110
– Award references to Section 33



4/10/2015
General terms & conditions
Agency publications
Agency administrative regulations that implement
Section 33 of A-110
216
XI. Administrative Information:
Equipment

Grants
 Requirement
– Title


For research awards, title may be vested with the
University
 Most, if not all, agencies have done this
For other awards, title remains with the government
– Equipment Management



4/10/2015
Prudent maintenance and safekeeping
Inventory records
Annual reporting of government owned equipment
217
XI. Administrative Information:
Equipment

Contracts
 FAR
clause 52.245-1 is analogous to
Section 53 of A-110
 Requirement
– Title belongs to the government
4/10/2015
218
XII. Award Review with the PI
Terms & Conditions
Article 1 of NSF T&Cs require that, “the
Principal Investigator or Project Director
receives a copy of the award conditions,
including the award letter, the budget, the
general terms and conditions, any special
terms and conditions, and any subsequent
changes in the award conditions.”
4/10/2015
219
XII. Award Review with the PI
Terms & Conditions
General
 FDP
T & Cs
T & Cs
Artl. 1 Recipient responsibilities and federal
requirements
Artl. 2 Allowable costs and prior approvals
– Artl. 3 Programs of related projects
– Artl. 4 Payment
Artl. 5 Significant project changes
Artl. 6 Non-competitive or continuation award
requirements
4/10/2015
220
XII. Award Review with the PI
Terms & Conditions
General

T & Cs
FDP T & Cs (con’t)
– Artl. 7
 Artl. 8
 Artl. 9
 Artl. 10
 Artl. 11
– Artl. 12
 Artl. 13
4/10/2015
Financial reports
Final report requirements
Dissemination of project results
Acknowledgement of support and disclaimer
Data collection
Site visits
Pre-award costs
221
XII. Award Review with the PI
Terms & Conditions
General
 FDP
T & Cs
T & Cs (con’t)
Artl. 14 Extensions without additional funds
– Artl. 15 Equipment and real property
– Artl. 16 Alteration and renovation
– Artl. 17 Use of U.S.-Flag air carriers
– Artl. 18 Financial management system
– Artl. 19 Procurement system
Artl. 20 Program income
4/10/2015
222
XII. Award Review with the PI
Terms & Conditions
General

T & Cs
FDP T & Cs (con’t)
 Artl. 21 Unobligated balances and limit of federal liability
 Artl. 22 Patents and inventions
 Artl. 23 Audits and records
– Artl. 24 Termination and enforcement
– Artl. 25 National security
– Artl. 26 Nondiscrimination
 Artl. 27 Animal Welfare
4/10/2015
223
XII. Award Review with the PI
Terms & Conditions
General
 FDP
T & Cs
T & Cs (con’t)
Artl. 28 Research involving recombinant DNA
Molecules
Artl. 29 Clean air and water
Artl. 30 Human subjects
– Artl. 31 Activities abroad
4/10/2015
224
XII. Award Review with the PI
Terms & Conditions
General
 FDP
T & Cs
T & Cs (con’t)
– Artl. 32
– Artl. 33
– Artl. 34
– Artl. 35
4/10/2015
Debarred or suspended parties
Closeout
Rights in data
Changes
225
XII. Award Review with the PI
Terms & Conditions
Special
terms & conditions
 What
controls are needed to ensure
compliance?
4/10/2015
226
XII. Award Review with the PI
Administrative information
Administrative
information learned from
the award instrument
 Program
and budget revisions
 Cost principles
 Period of availability of funds
 Program income requirements
4/10/2015
227
XII. Award Review with the PI
Administrative information (con’t)
Administrative
information learned from
the award instrument
 Cost
sharing requirements
 Equipment management requirements
 Program (technical) reporting requirements
 Financial reporting requirements
4/10/2015
228
XII.Award Review with the PI
Budget

Compare award budget to proposal
budget
 What
is the impact of the changes
– Are additional funds needed?
– Can work be revised without changing scope?
– Is there an impact on other awards?
4/10/2015
229
XII.Award Review with the PI
Budget

Develop a budget management strategy
 Taylor
to the specific award
 Develop reporting mechanism
– Reconcile reports back to FAS’ AM090, 91
Reports
– Establish reporting formats & schedule
4/10/2015
230
XII.Award Review with the PI
Budget

Payroll appointments
 Verify
compensation budget
– Individuals to be charged
– Charge % <= Effort %
– Other account distributions that are affected

Procurements
 Are
agency prior approvals required?
– Equipment
– Subcontracts
4/10/2015
231
XII.Award Review with the PI
Budget

Procurements (con’t)
 One-time
– When: Now or future
– How & when should procurement be initiated?
 Recurring
– Recharge center procurements
– Other misc’l supplies & expenses
4/10/2015
232
XII.Award Review with the PI
Budget

Establish communications protocol
 Identify
roles and responsibilities of:
– P.I.
– Research staff
– Administrative staff
 Review
Financial Policy No. 2101, PI
Responsibilities for Financial Oversight of
Grants and Contracts
4/10/2015
233
XIII. Award Accounts
Considerations

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?
4/10/2015
234
XIII. Award Accounts
Considerations

How many accounts are needed? (con’t)
 Additional
accounts are needed if both onand off-campus indirect cost rates are used
 Additional accounts are needed if cost
sharing is required
4/10/2015
235
XIII. Award Accounts
Considerations

How many accounts are needed? (con’t)
 Are
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
4/10/2015
236
XIII. Award Accounts
Considerations

Regulatory compliance
 Approvals
required before account can be
created/opened
– Human subjects
– Animals
– Recombinant DNA
– Biosafety
4/10/2015
237
XIII. 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
4/10/2015
238
XIII. Award Accounts
How are Regular Accounts Created

Non-LBC Account Create Process (con’t)

NIH and NSF awards
– URA e-mails the awards to




P.I.
Department
Divisional office
Restricted funds
– Restricted funds creates the account

4/10/2015
Based upon Form 70 template completed by department
239
XIII. Award Accounts
How are Regular Accounts Created

Advance accounts
 Restricted
Funds receives the award from
URA
– Changes the status from “Advance” to “Regular”
– Enters the budget based upon the award
agreement
4/10/2015
240
XIV. Managing Programmatic
Aspects

Interim technical reporting to funding
agency
Critical stewardship
 Requirement = part of terms and conditions
 On-going, incremental funding may be
dependent upon programmatic reporting
 Timing: annual or more frequent
 Differing formats

4/10/2015
241
XIV. Managing Programmatic
Aspects

NSF requirements
Annual progress report
 Submitted to cognizant program officer with
copy to URA
 Expected three months before end of
current funding period
 NSF annual reports now submitted
electronically by PI

4/10/2015
242
XIV. Managing Programmatic
Aspects

NSF requirements (con’t)

Report format requests information on:
– Summary of progress
– Summary of proposed work in next year of
support
– Proposed budget for coming year
4/10/2015
243
XIV. Managing Programmatic
Aspects

NSF requirements (con’t)

Report format requests information on
(con’t):
– Current and pending support
– Contribution to education and human resource
development
– Updated info on animal, human, biosafety, etc.
– PI certification
4/10/2015
244
XIV. Managing Programmatic
Aspects

NIH non-competing continuations under
SNAP
Administrative, financial, and programmatic
review
 Four core questions-gauge key issues

– Personnel/effort
– Spending patterns
– Budget required ?

Human subjects/animals
4/10/2015
245
XIV. Managing Programmatic
Aspects

NIH non-competing continuations
 eSNAP
submissions
 Annual progress report
 NIH prepares pre-printed 2590 face page;
see NIH Commons
 Requires administrative, financial and
programmatic review
4/10/2015
246
XIV. Managing Programmatic
Aspects

NIH non-competing continuations (con’t)

NIH Awards under SNAP ( R and K series)
– Budget not required
– Requires four questions:




4/10/2015
Significant rebudgeting
Carry forward of 25% or $250,000
Change in the effort of key personnel
Change in other support of key personnel
247
XIV. Managing Programmatic
Aspects

NIH non-competing continuations (con’t)

NIH Awards under SNAP ( R and K series)
– Requires four questions con’t):

4/10/2015
Answers of yes trigger  Justification
 Additional, updated materials, like Current and
Pending Support
 Budget
248
XIV. Managing Programmatic
Aspects

NIH non-competing continuations (con’t)

NIH Awards under SNAP ( R and K series)
– Narrative Report on Programmatic Progress
– Update on Human and Animal use
– Update on project effort for key personnel
– Updated checklist with indirect cost rate (not
calculation)
4/10/2015
249
XIV. Managing Programmatic
Aspects

NIH non-competing continuations (con’t)

If not awarded under SNAP
– Budgets required
Review by program officer
 Review triggers non-competing NGA

4/10/2015
250
XIV. Managing Programmatic Aspects
Annual Regulatory Review

Continuing review requirements
Regulatory requirement
 No less than annual
 Period determined at initial review or
previous continuing review

4/10/2015
251
XIV. Managing Programmatic Aspects
Annual Regulatory Review

Human subjects
Is study/protocol still active
 Have any changes crept in
 Have there been adverse events
 Do benefits outweigh risks

4/10/2015
252
XIV. Managing Programmatic Aspects
Annual Regulatory Review

Human subjects (con’t)
Is consent form still current and appropriate
 Must be reviewed at convened meeting
 Approval must occur before the anniversary
date
 If not renewed in time, terminated

4/10/2015
253
XIV. Managing Programmatic Aspects
Annual Regulatory Review

Animal care and use
Is study still active
 Reassess animal numbers
 Morbidity/mortality in animals
 Annual renewals maybe approved by
subcommittee
 Every three years, complete resubmission

4/10/2015
254
XIV. Managing Programmatic
Aspects

Compliance with terms and conditions of
award
Publication review
 Publication citations
 Sharing research resources

4/10/2015
255
XIV. Managing Programmatic
Aspects

Compliance with terms and conditions of
award (con’t)
Confidential materials--marking, storage,
agreement with research team
 Intellectual property--disclosure, informing
sponsor
 Record retention and storage

4/10/2015
256
XIV. 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
4/10/2015
257
XIV. 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
4/10/2015
258
XIV. Managing Programmatic
Aspects

Approval of changes to award terms
(con’t)

Requiring agency approvals--contracts
– Change in budget
– Carry forward
– Change in personnel/effort
– Etc.
4/10/2015
259
XV. Managing Award Funding
Allowable Cost Determinates

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
4/10/2015
260
XV. Managing Award Funding
Allowable Cost Determinates

A-21 Cost Principles Requirements
(Con’t)
 Treated
consistently
– Costs incurred for



4/10/2015
Same purpose
In like circumstances
Are either direct costs only or indirect costs only
261
XV. Managing Award Funding
Allowable Cost Determinates

A-21 Cost Principles Requirements
(Con’t)
 Conform
to limitations in A-21 or the
sponsored agreement
– Examples


4/10/2015
A-21 prohibits student aid charges to research
agreements
DHHS awards prohibit salary charges at a rate that
exceeds $125,900/yr..
262
XV. Managing Award Funding
Allowable Cost Determinates
A-21 Cost Principles Requirements
(Con’t)
 Practical guidelines

 Cost
must
– Benefit the project
– Be charged consistently as direct cost
– Be included in the award budget or list of
allowable costs in Section J of A-21 or an
agency publication
4/10/2015
263
XV. Managing Award Funding
Allowable Cost Determinates

Costs normally treated as indirect costs
 Administrative,
secretary, & clerical
compensation
 Telecommunications, memberships,
postage, office supplies
 University guidelines for charging appear in
Section 307B of URA’s Guidelines for
Grant and Contract Management
4/10/2015
264
XV. Managing Award Funding
Allowable Cost Determinates

Other costs that warrant attention
 Alterations
& renovations
– May require prior approval
 Alcoholic
beverages
– Generally unallowable
 Animals
– Excluded from indirect cost MTDC base
4/10/2015
265
XV. Managing Award Funding
Allowable Cost Determinates

Other costs that warrant attention (con’t)
 Books
and periodicals
– Normally treated as indirect cost
 Dependency
allowances
– Generally unallowable
4/10/2015
266
XV. Managing Award Funding
Allowable Cost Determinates

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
4/10/2015
267
XV. Managing Award Funding
Allowable Cost Determinates

Other costs that warrant attention (con’t)
 Property
insurance
– Prior approval needed for government owned
property
– University provided insurance generally
allowable
 Medical
insurance for sponsored fellows
and trainees
– Allowable because University requires proof of
coverage
4/10/2015
268
XV. Managing Award Funding
Allowable Cost Determinates

Other costs that warrant attention (con’t)
 Participant
support costs--NSF awards
– Rebudgeting prior approval required
4/10/2015
269
XV. Managing Award Funding
Allowable Cost Determinates

Other costs that warrant attention (con’t)
 Patient
care costs
– Routine and ancillary medical services
– Require prior approval
 Publications
– Costs exceeding certain amount may require
prior approval
– Acknowledgements, disclaimers required
4/10/2015
270
XV. Managing Award Funding
Allowable Cost Determinates

Other costs that warrant attention (con’t)
 Salaries
and wages
– % salaries charged must be <= % of effort
– Must conform with effort reporting procedures
– Unallowable if Annual Certification Statement is
not completed
4/10/2015
271
XV. Managing Award Funding
Allowable Cost Determinates

Other costs that warrant attention (con’t)
 Salaries
and wages (con’t)
– Salary funds may become restricted if Research
Career Development Award is received
– College Work Study Program may be used to
pay non-federal share of research project
expenses
4/10/2015
272
XV. Managing Award Funding
Allowable Cost Determinates

Other costs that warrant attention (con’t)
 Student
aid (tuition, fees and stipends)
– Unallowable charge to federal research awards
– Special terms and conditions usually apply

4/10/2015
e.g.. NRSA awards
273
XV. Managing Award Funding
Allowable Cost Determinates

Other costs that warrant attention (con’t)
 Travel
– Must comply with University travel policies
– Use of foreign flag-carriers generally prohibited
– Foreign travel may require prior approval
4/10/2015
274
XV. Managing Award Funding
Allocating Costs

Guidelines
 A-21,
Section C.4.d
 University Financial Policy No. 2109
4/10/2015
275
XV. Managing Award Funding
Allocating Costs (con’t)

If a cost benefits one project or activity,
the cost should be charged to that
project or activity.
4/10/2015
276
XV. Managing Award Funding
Allocating Costs (con’t)

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.
4/10/2015
277
XV. Managing Award Funding
Allocating Costs (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.
4/10/2015
278
XV. Managing Award Funding
Official Accounting Reports

FAS reports
Monthly Reports
 AM090: Account Statement in Whole
Dollars
 AM091: Report of Transactions

4/10/2015
279
XV. Managing Award Funding
Official Accounting Reports

Payroll reports
Reports generated for each monthly and
biweekly payroll
 Expense Summary Report
 Expense Detail Report

4/10/2015
280
XV. 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
4/10/2015
281
XV. 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

4/10/2015
282
XV. 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
4/10/2015
283
XV. Managing Award Funding
Cost Transfers

NIH and PHS Grants Policy Statement

Requires
– Timeliness

Within 90 days of original transaction
– Full explanation

4/10/2015
“To correct error” is insufficient explanation
284
XV. Managing Award Funding
Cost Transfers

University policy & procedures
Ensure conformance with regulations
 Policy

– Financial Policy No. 2111

Procedures
4/10/2015
285
XV. 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

4/10/2015
286
XV. Managing Award Funding
Effort System

Work plan
Payroll distributions reflect work plan
 Distributions to sponsored agreements

– % of salary charge <= % of effort
4/10/2015
287
XV. Managing Award Funding
Effort System

Monitoring & reporting
Payroll reports issued with pay periods
 Monthly monitoring report

– Individuals charge to sponsored agreements
– Shows all payroll % distributions
– Distributed to departmental payroll contact
person

Attachment to “closing memo”
– Shows % distribution and end date
4/10/2015
288
XV. Managing Award Funding
Effort System

Significant changes

Future
– Enter payroll distribution changes

Retroactive
– Submit cost transfers
4/10/2015
289
XV. Managing Award Funding
Effort System

Certification

Monthly employees
– Annual

Biweekly employees
– Biweekly
4/10/2015
290
XVI. Audits

Test for compliance

Federal regulations
– Award specific
– Non-award specific

Not to be feared if
UC policies and procedures are followed
 Award specific restrictions are met

4/10/2015
291
XVI. Audits

Audit requests
Comptroller Office coordinates response
 Department assists in response where
necessary

4/10/2015
292
XVI. Audits

Types
A-133
 Award closeout
 Special subjects
 Proposal

4/10/2015
293
XVI. Audits

Types

A-133
– Performed by KPMG
– Federal programs divided into 3 categories



4/10/2015
Research
Student financial assistance
Other
294
XVI. Audits

Types

A-133 (con’t)
– Emphasis on UC systems





4/10/2015
Allowable costs: Salary caps, student aid, etc.
Effort reporting
Cost transfers
Period of funding availability
Financial reporting
295
XVI. Audits

Types

A-133 (con’t)
– Emphasis on UC systems (con’t)





4/10/2015
Procurement
Recharge center pricing
Billing
Equipment inventory
Subrecipient monitoring
296
XVI. Audits

Types

A-133 (con’t)
– Tests compliance with award specific
restrictions





4/10/2015
Prior approval requirement
Cost sharing
Student assistance awards unique regulations
Training program eligibility
Etc.
297
XVI. Audits

Types (con’t)

Award interim and closeouts
– Performed by



–
–
–
–
4/10/2015
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
298
XVI. Audits

Types (con’t)

Special subjects
– Examples



4/10/2015
NSF Graduate Research Training Program
NSF travel expenses
HHS Recharge centers
299
XVI. Audits

Types (con’t)

Proposal
– Seldom done
– Usually involves contracts
– Emphasis is on


4/10/2015
Reviewing estimating techniques
Compliance with FAR solicitation provisions
300
XVII. 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

4/10/2015
301
XVII. Financial Reports
Types
Request for Advance or Reimbursement
(SF 270)
 Report of Federal Cash Transactions
(SF 272)
 Financial Status Report (SF 269, 269A)

4/10/2015
302
XVII. 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
4/10/2015
303
XVII. 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.
4/10/2015
304
XVII. Financial Reports
Financial Status Report (SF 269, 269A)

When are Closing Memos required
Required for all final FSRs
 Interim FSRs

– Required only if prior approval required for carry
forward of unobligated balance
4/10/2015
305
XVII. 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

4/10/2015
306
XVII. 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

4/10/2015
307
XVII. Financial Reports
Other Financial Reports

Report of Federal Cash Transactions
(SF 272)
Shows both expenditures and cash receipts
 Completed by Comptroller’s Office

4/10/2015
308
XVII. Financial Reports
Other Financial Reports

Non-federal reports

Similar to federal reports
4/10/2015
309
XVIII. Billing & Collecting
Funds

Billing

Federal
– 95% are letter-of-credit funded (“billed”)
– 5% are invoiced

Non-federal
– 5% are invoiced
– 95% are on a payment schedule or paid up front
4/10/2015
310
XIX. Intellectual Property

University policies
Patent Policy – Board of Trustees Statute
18
 New Information Technologies – Rights to
Intellectual Property
 Determination of who has rights to
discoveries in the course of sponsored
research/projects?

4/10/2015
311
XIX. 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?

4/10/2015
312
XIX. Intellectual Property

FOIA public right to federally-sponsored
research data
OMB in process of defining implementing
regulation
 Each agency will do agency-specific
implementation

4/10/2015
313
XIX. Intellectual Property

PI responsibility to disclose discoveries

Office of Special Projects
Guidance on Disclosure Process and forms
– Review of Disclosure to confirm sponsored
research and relevant MTAs
–

University turns over disclosure to UCTech
4/10/2015
314
XIX. Intellectual Property

PI responsibility to disclose discoveries
(con’t)
UCTech assesses commercial potential of
discovery
 UCTech has brief period to elect title to
disclosure
 If elected, UCTech must seek appropriate
protection for intellectual property (IP)

4/10/2015
315
XIX. Intellectual Property

Governing regulations for IP derived
from sponsored projects
Bayh-Dole Act for all Federally-funded IP
 Bayh-Dole spells out extensive compliance
and reporting requirements for IP elected
by UCTech
 Terms and Conditions of awards for other
sponsored projects
 MTA Terms & Conditions

4/10/2015
316
XIX. Intellectual Property

Governing regulations for IP derived
from sponsored projects (con’t)

Compliance obligations
– Royalty sharing
– Release of IP if unelected or UCTech abandons
commercialization effort
– Rights of Sponsors take precedence over rights
of PI
– March-in
4/10/2015
317
XX. Project Termination

Final technical report
FASTLANE for NSF projects
 Confirmation of receipt of FASTLANE
submission sent to URA
 Other Technical Reporting –

– Confirm submission of report to URA

4/10/2015
URA follows up on late technical reports –
Administrator, PI, Department Chair, Dean, Provost
318
XX. Project Termination

Final technical report (con’t)

Sponsor may withhold funding for
University if ANY Final Report is overdue
– Agencies that do this include NEH, Air Force
4/10/2015
319
XX. Project Termination

NIH Invention Report

Requires URA signature
4/10/2015
320
XX. 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

4/10/2015
321
XX. Project Termination

Integration of close out of records with
restricted funds (con’t)
A-110 records retention requirement
 Obligations to keep local records

4/10/2015
322
XX. 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

4/10/2015
323
XXI. Relinquishing/Transferring
Programs or Awards

Managing Faculty Arrivals/Departures
Faculty appointment/termination
 Space commissioning/decommissioning
 Equipment - transfer in and purchase/
transfer out and sell
 Other personnel
 Protocols - initiating/terminating
 Subcontracting to or from current/new
institutions

4/10/2015
324
XXI. Relinquishing/Transferring
Programs or Awards

Managing Faculty Arrivals/Departures
(con’t)
On-going responsibilities - IP, record
retention and access, sharing research
resources
 Transferring awards into or out of University
of Chicago

4/10/2015
325
XXI. Relinquishing/Transferring
Programs or Awards

Transferring property to/from U of C
Title generally resides with University
 University must approve transfers of
equipment to which it holds title
 If University does not hold title, entity with
title must provide permission

4/10/2015
326
XXI. Relinquishing/Transferring
Programs or Awards

Transferring property to/from UC (con’t)

Property inventory and tagging, as well as
local inventories = key
– Transferring property with Departing Faculty
– Agency expectations for equipment in support
of active awards
– Equipment purchased from institutional funds
– University policy and form
4/10/2015
327
XXI. Relinquishing/Transferring
Programs or Awards

Transferring property to/from UC (con’t)

Transferring property for Newly-recruited
faculty
– Decision made at prior institution
– Effect official transfer of title
– U of C property to tag and inventory
4/10/2015
328
XXI. Relinquishing/Transferring
Programs or Awards

Transfer of awards
Agency prerogative
 Agency requirements vary

4/10/2015
329
XXI. Relinquishing/Transferring
Programs or Awards

Transfer of awards

Transfer of awards from U of C
– Should U of retain award




4/10/2015
Change of PI
On-going support of personnel/students
Is award individual or institutions (e.g. RO1 versus
training grants, SCOR, etc.)
Issues:
 Estimating final balances
 Carry forward
330
XXI. Relinquishing/Transferring
Programs or Awards

Transfer of awards

Transfer of awards from U of C (con’t)
– Possibilities




4/10/2015
Leave award at U of C and name substitute PI
Leave at U of C, name substitute PI and request
permission to subcontract
Relinquish award
Relinquish award with expectation of subcontract to U
of C
331
XXI. Relinquishing/Transferring
Programs or Awards

Transfer of awards

Transferring a NIH award from UC
– Contact program officer and request institute
specific instructions
– Prepare and submit through normal sign-off
channels:




4/10/2015
Relinquishment statement
Invention and Patent statement
List of equipment purchased from that award and
proposed to be moved
A copy of the instructions received from NIH
332
XXI. Relinquishing/Transferring
Programs or Awards

Transfer of awards

Transferring a NIH award to the UC
– Contact program officer and request institute
specific instructions
– Prepare and submit through normal sign-off
channels:



4/10/2015
Face page (with IRB/IACUC info)
Proposed budget (transfer year and future years) and
justification
Workscope
333
XXI. Relinquishing/Transferring
Programs or Awards

Transfer of awards

Transferring a NIH award to the UC (con’t)
– Prepare and submit through normal sign-off
channels:






4/10/2015
Description of effects of transfer on project
Description of Facilities and Resources at U of C
Biosketch and other support, if changing
Checklist page
Copy of original NGA
Specific instructions from NIH
334
XXI. Relinquishing/Transferring
Programs or Awards

Transfer of awards

Transferring NSF award from U of C
– Contact program officer to determine course of
action
– If NSF endorses transfer, complete



4/10/2015
NSF Form 1263 - NSF Grant Transfer Request
Cover memo explaining impending move and
requesting grant be transferred
List of equipment purchased with grant funds for
transfer
335
XXI. Relinquishing/Transferring
Programs or Awards

Transfer of awards

Transferring NSF award to U of C
– Contact program officer to determine course of action
– If NSF endorses transfer, complete






4/10/2015
NSF Form 1263 - NSF Grant Transfer Request
Brief summary of progress to date
Description of work to be completed
Budget and justification
List of equipment
Ideally, copy of original grant and award letter
336
XXI. Relinquishing/Transferring
Programs or Awards

Transfer of awards

Transferring NSF award to U of C (con’t)
– Contact program officer to determine course of
action
– Contact program officer and request institute
specific instructions
– Prepare and submit through normal sign-off
channels
4/10/2015
337
Related Web Sites
FDP general and agency specific terms & conditions
NSF Grant Proposal Guide
NIH Grants Policy Statement
4/10/2015
338
Related Web Sites
NIH terms and conditions for individual and institutional National
Research Service Awards
OMB Circulars A-21, A-110, A-133
4/10/2015
339
Related Web Sites
NASA Grant and Cooperative Agreement Handbook
Code of Federal Regulations (CFR)
Agency administrative regulations that implement A-110
(Accessible through the CFR Web site)


Agriculture
Defense
4/10/2015
7 CFR 3019
32 CFR 32
340
Related Web Sites
Agency administrative regulations that implement A-110
(Accessible through the CFR Web site)
Con’t:








Education
Energy
NIH/DHHS
HUD
Interior
Justice
Labor
State
4/10/2015
34 CFR 74
10 CFR 600
45 CFR 74
24 CFR 84
43 CFR 12
28 CFR 70
29 CFR 95
22 CFR 145
341
Related Web Sites
Agency administrative regulations that implement A-110
(Accessible through the CFR Web site)
Con’t:




DOT
AID
EPA
NASA
49 CFR 19
22 CFR 226
40 CFR 30
14 CFR 1260
Federal Acquisition Regulations
4/10/2015
342
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