Sponsored Programs at Penn
Introduction to Sponsored
Projects Administration
Revised May 18, 2015
The Office of Research Services
The Office of Research Support Services
1
Welcome to
Sponsored Programs at Penn
• Modules
– Day 1 – Introduction to Sponsored Projects
Administration at Penn
– Day 2 – Proposal Budget Preparation,
Budgeting Using PennERA, Routing &
Approval and Award Setup and AIS
– Day 3 – Project Management, Reporting
Tools & Closeouts and Audits
Revised May 18, 2015
The Office of Research Services
The Office of Research Support Services
2
Anticipated Benefits of Program
• Introduction of resources and tools
available to Research Administrators at
Penn
• Overview of general terms
• Overview of federal and sponsor rules and
regulations related to sponsored projects
• Clarification of responsibilities
• Building strong, informed Penn Research
Administrators
Revised May 18, 2015
The Office of Research Services
The Office of Research Support Services
3
What is a Sponsored Project?
• Any project, which meets any of the following criteria, is
considered to be a "sponsored project" and will be
administered accordingly:
– The project commits the University to a specific line of scholarly or
scientific inquiry, typically documented by a statement of work;
– A specific commitment is made regarding the level of personnel effort,
deliverables, or milestones;
– Project activities are budgeted, and the award includes conditions for
specific formal fiscal reports, and/or invoicing;
– The project requires that unexpended funds be returned to the sponsor
at the end of the project period;
– The agreement provides for the disposition of either tangible property
(e.g., equipment, records, technical reports, theses or dissertations) or
intangible property (e.g., inventions, copyrights or rights in data) which
may result from the project;
– The sponsor identifies a period of performance as a term and condition.
2101 Administration of Sponsored Projects
Revised May 18, 2015
The Office of Research Services
The Office of Research Support Services
4
Grant vs. Contract
Project
conceived
by:
Agency
function:
Control:
Agency
oversight:
Revised May 18, 2015
Grant
Investigator
Contract
Agency
Supports or
assists
Performer
defines details
and retains
scientific
freedom
Maintains
cognizance
Procures
service
Agency
exercises
direction or
control
Closely
monitors
The Office of Research Services
The Office of Research Support Services
5
Cooperative Agreement
Grant
Cooperative Agreement
Contract
In Between
Revised May 18, 2015
The Office of Research Services
The Office of Research Support Services
6
A Special Case: Fee for Service
• Third party use of Penn facilities
• Penn personnel performing service for
third party with
– No expectation of publication
– No expectation of new intellectual property
– “Work for Hire”
Revised May 18, 2015
The Office of Research Services
The Office of Research Support Services
7
Roles and Responsibilities
ORS
PI/Department/School
Proposal
Preparation
•
•
•
•
•
Award
Acceptance
•
prepare technical proposal
prepare budget
ID and address any space
requirements
ID sources of required cost
sharing
create, prepare and submit
proposal through PennERA
•
if award is received by PI,
Department or School, send
immediately to ORS
•
•
•
•
•
Revised May 18, 2015
provide assistance in
completing administrative
information
Review proposal for
conformance with
sponsor and Penn policies
and requirements
provide Penn approval
and signature as required
and submit the proposal
review award for
acceptable terms and
conditions
negotiate terms as
required
obtain Penn Signature if
required and return to
Sponsor
The Office of Research Services
The Office of Research Support Services
8
Where to Find
Laws & Rules of Grants
Administration
• Read the Notice of Award
– Know terms and conditions
• Federal awards under the agency policy statements
– Read the references
• Non federal awards
• Federal contracts (Federal Acquisition Regulations)
• Refer to Sponsor’s website
• Don’t assume you know the rules
– Rules change!
Revised May 18, 2015
The Office of Research Services
The Office of Research Support Services
9
Office Of
Management & Budget (OMB) Guidance
• OMB is responsible for overseeing the activities of other federal
agencies, providing guidance for grants and agreements and
agency implementation regulations. Effective 12/26/14, the
Uniform Guidance (UG) replaced OMB circulars A21, A110, and
A133.
– Uniform Guidance-2 CFR 200- Cost Principles for Educational
Institutions
• Direct costs, F&A, unallowable costs, service centers, etc.
– Uniform Guidance 2 CFR 200- Administrative Requirements for
Institutions of Higher Education, Hospitals, and Other Non-Profit
Organizations
• Reporting and closeout requirements, program income, etc.
– Uniform Guidance 2 CFR 200- Audit Requirements for States, Local
Governments and Non-Profit Institutions
• Requirements for annual audit
All found at www.whitehouse.gov/omb/grants/
Revised May 18, 2015
The Office of Research Services 10
The Office of Research Support Services
UG Subparts
• Acronyms & Definitions-Subpart A
• General Provisions-Subpart B
• Pre-Federal Award RequirementsSubpart C
• Post Award Requirements-Part D
• Cost Principles-Subpart E
• Audit Requirements-Subpart F
Revised May 18, 2015
The Office of Research Services 11
The Office of Research Support Services
UG Subpart C
Pre-Award Requirements
•Pre-award Costs
•Forms for Federal Assistance
•Debarment and Suspension
•Special Award Conditions
•Certifications and Representations
Revised May 18, 2015
The Office of Research Services 12
The Office of Research Support Services
OMB UG Administrative
Requirements
• Provides general guidelines for the administration of
grants to federal agencies
• Agencies will have their own implementations of the
guidance which communicate their specific requirements
– Contained in the Code of Federal Regulations
www.access.gpo.gov/nara/cfr/cfr-table-search.html
– or on ORS’ home page
www.upenn.edu/researchservices/omb%20announcement.ht
ml
Revised May 18, 2015
The Office of Research Services 13
The Office of Research Support Services
Subpart D:
Post-Award Requirements
• Revision of Budget & • Cost Sharing
Program
• Program Income
• Extensions
• Progress
• Carryover
Reporting
• Property &
• Financial
Procurement
Reporting
Standards
• Closeout
• Subrecipient
• Record Retention
Monitoring
Revised May 18, 2015
The Office of Research Services 14
The Office of Research Support Services
UG Subpart D
Revision of Budget & Program
Change in Effort of Key Personnel
• Key Personnel = Principal Investigator
– As well as other individuals responsible for the design,
conduct and reporting of project results
• Disengagement of PI (for NIH: or key personnel as
named in the Notice of Grant Award) PI can be
absent from campus but still engaged
• Agencies retain approval authority for significant
reductions (>25%) in PI effort
– (NIH: includes named key personnel)
– Check NOA
Revised May 18, 2015
The Office of Research Services 15
The Office of Research Support Services
OMB Uniform Guidance
Cost Principles (Subpart E)
• General objectives of allowable
costs
– Government-wide policies on cost
reimbursement
• Standards for cost allowability
– Reasonable
– Allocable
– Consistently treated
• Standards for cost allocation
• Also applies to costs used for cost sharing
See SPP #2110 Direct Cost Expenditures
Revised May 18, 2015
The Office of Research Services 16
The Office of Research Support Services
OMB UG Cost Principles
Reasonable and Necessary
• Prudent person rule for reasonableness
• Is cost necessary for overall operation of the
institution or the performance of the sponsored
project?
• Are costs incurred consistent with University
policies and procedures?
Revised May 18, 2015
The Office of Research Services 17
The Office of Research Support Services
OMB UG Cost Principles
Allocable
• Cost is incurred for the benefit of only
one project or can be readily assigned
to multiple projects which directly
benefit from the cost
– Relative benefits received
– Approximated through use of reasonable
methods
Revised May 18, 2015
The Office of Research Services 18
The Office of Research Support Services
OMB UG Cost Principles
Consistently Treated
• Requires costs incurred for the same
purpose, in like circumstances, to be
handled the same way
• As Direct or F&A Costs
– According to University Policies
Revised May 18, 2015
The Office of Research Services 19
The Office of Research Support Services
OMB UG Cost Principles
Direct vs. F&A Costs
• Direct Costs
– Specifically identifiable with a specific sponsored
project, an instructional activity or any other
institutional activity that can be easily assigned
with a high degree of accuracy
• Facilities and Administrative Costs
referred to as Indirect Costs or Overhead)
(formerly
– Expenses that are incurred for common or joint
objectives and, therefore, cannot be identified
readily and specifically with a particular
sponsored project, an instructional activity, or
any other institutional activity
Revised May 18, 2015
The Office of Research Services 20
The Office of Research Support Services
Direct Costs at Penn
• Generally should be charged as proposed
• Department is responsible for maintaining
documentation for necessity and appropriateness
of direct charges and cost transfers
• PI is responsible for reviewing and approving all
expenditures
• Authority provided under federal terms and
conditions permit rebudgeting of allowable costs
(subject to agency’s terms and conditions)
Revised May 18, 2015
The Office of Research Services 21
The Office of Research Support Services
UG Allowable Cost Considerations
• Materials and Supplies
– Computing devices allowable as direct cost
– Must be essential and allocable
– Not solely dedicated to performance of award
• Clerical and Administrative Salaries if
–
–
–
–
Integral to the project
Individuals can be specifically identified with project
Cost explicitly included in budget or prior written approval
Cost not also recovered as indirects
• Temporary Dependent Care Costs
– Above and beyond normal care resulting from travel to conferences
on federal award
– Temporary during travel period
– Consistent with Entity’s travel policy (if applicable)
• Value Added Tax
– Non exempt foreign taxes charged for purchase of goods or services
legally required to pay
Revised May 18, 2015
The Office of Research Services 22
The Office of Research Support Services
F&A Costs
The following should generally be treated as
F&A costs except for non-federal awards
– Administrative and clerical salaries
– Shop personnel
– General supplies and materials
Federal award considerations
– Complex programs
– Significant data collection
– Unlike circumstances
See SPP #2138 Direct Cost Expenditures for Non-Government
Organizations
Revised May 18, 2015
The Office of Research Services 23
The Office of Research Support Services
F&A Rates
• F&A costs are claimed based on rates
• Rates are developed by Penn in a periodic F&A
Cost Rates Proposal
– Currently on four year cycle
• Proposal is submitted to our cognizant agency,
Dept. of Health and Human Services (DHHS), for
review, negotiation, and approval
• Must honor Subrecipients’ negotiated rate or De
minimus rate of 10%
Revised May 18, 2015
The Office of Research Services 24
The Office of Research Support Services
F&A Rates
• F&A Rates are applied to the “Base” of the approved award
– For federal awards, this base is generally Modified Total
Direct Costs (MTDC)
• Modified Total Direct Cost Base (MTDC)
TDC less:
Revised May 18, 2015
Equipment
18XX
Tuition
(4180-4190)
Subcontracts > $25K
5333
Patient Care
5334
Rental Costs
525X
The Office of Research Services 25
The Office of Research Support Services
Direct or Indirect?
Salaries of
Technical Staff
Computer
Federal Express
Charges
Office Supplies
Bad Debts
Animal & Care Costs
Postage (stamps)
Local Phone
Charges
Salaries of Clerical or
Administrative Staff*
Long Distance
Charges
Laboratory Supplies
Service/Recharge
Centers
Entertainment
Routine Maintenance
of Plant/Equipment
Library Support
Revised May 18, 2015
The Office of Research Services 26
The Office of Research Support Services
End Game
Direct
Revised May 18, 2015
The Office of Research Services 27
The Office of Research Support Services
Indirect
Revised May 18, 2015
The Office of Research Services 28
The Office of Research Support Services
Indirect
(with exceptions)
Revised May 18, 2015
The Office of Research Services 29
The Office of Research Support Services
Neither!
These costs unallowable!
Revised May 18, 2015
The Office of Research Services 30
The Office of Research Support Services
Neither!
These costs unallowable!
Revised May 18, 2015
The Office of Research Services 31
The Office of Research Support Services
Consistent Treatment of Costs
Direct Cost
Indirect (F&A) Cost
Salaries of Technical
Staff
Laboratory Supplies
Travel
Salaries of Clerical or
Administrative Staff
Office Supplies
Local Phone Chgs
Equipment
Postage (stamps)
Animal & Care Costs
Library Support
Applicable Employee
Benefits
Service/Recharge Ctrs
Routine Maintenance
of Plant/Equipment
Insurance
Revised May 18, 2015
The Office of Research Services 32
The Office of Research Support Services
Consistent Treatment of
Costs
Unallowable
Entertainment & Alcoholic
Beverages
Bad Debts
Fines and Penalties
Honoraria (lecture fee allowed)
Lobbying or Fundraising Costs
Contingency Costs
Revised May 18, 2015
The Office of Research Services 33
The Office of Research Support Services
Direct Costs
Non-Federal Sponsors
• Different guidelines for Non-Federal Sponsors
alters Penn’s Policies
• Dependent Care Tuition
• Cost of Space allocated to schools as part of
“allocated costs”
• Cost of University Services
• Cost of Space Used by the Project (and not captured
as part of 5295)
• School and Departmental Administrative Costs
Revised May 18, 2015
The Office of Research Services 34
The Office of Research Support Services
Indirect (F&A) Costs
Non-Federal Sponsors
• Not Subject to F&A
• Cost of Space allocated to schools as part of
“allocated costs”
• Cost of University Services
• Cost of Space Used by the Project (and not
captured as part of 5295)
• Subject to F&A
• Dependent Care Tuition
• School and Departmental Administrative Costs
Revised May 18, 2015
The Office of Research Services 35
The Office of Research Support Services
OMB UG Administrative Requirements
Cost Sharing
• Contributions, including cash & third party inkind, shall be accepted as part of recipient's cost
sharing or matching when such contributions
meet all the following criteria
– Are verifiable from the recipient's records
– Are not included as contributions for any other
federally-assisted project or program
– Are necessary and reasonable for proper and efficient
accomplishment of project or program objectives
SPP #2119 Cost Sharing/Matching Requirements
SPP #2120 Accounting for Matching Gifts
Revised May 18, 2015
The Office of Research Services 36
The Office of Research Support Services
OMB UG Administrative Requirements
Cost Sharing (cont.)
– Are allowable under the applicable cost principles
– Are not paid by the Federal Government under
another award, except where authorized by Federal
statute to be used for cost sharing or matching
– Are provided for in the approved budget when
required by the Federal awarding agency
– Conform to other provisions of the UG, as applicable
– Foregone F&A reimbursements are not allowable as
cost sharing unless specifically approved by the
agency, except for awards under the Federal terms
and conditions
Revised May 18, 2015
The Office of Research Services 37
The Office of Research Support Services
OMB UG Administrative Requirements
Program Income
• Program income earned during the project
period
– Shall be retained and be used in one or more of the ways listed
in the following as defined by the agency (see specific agency’s
guidelines)
• Additive - Added to funds committed to the project by the Federal
awarding agency and recipient and used to further eligible project or
program objectives (applicable to awards under FDP T&C)
• Cost Share - Used to finance the non-Federal share of the project or
program
• Deductive - Deducted from the total project or program allowable
cost in determining the net allowable costs on which the Federal
share of costs is based
SPP #2121 Accounting for Program Income
Revised May 18, 2015
The Office of Research Services 38
The Office of Research Support Services
Federal Demonstration Partnership
• Applies to federal grants ONLY
• Provided more liberal interpretation of Uniform
Guidance
– includes expanded authority to approve certain
actions previously reserved to awarding agency
• Reference is made in Notice of Grant award that the
University of Pennsylvania is a signatory to the FDP Phase
agreement
Revised May 18, 2015
The Office of Research Services 39
The Office of Research Support Services
Federal Terms and Conditions
The Federal Terms and Conditions (RTC’s) grew
out of an initiative by the Federal Demonstration
Partnership (FDP), which is a non-profit
association of federal agencies, academic
research institutions (administrative, faculty and
technical), and research policy organizations that
works to streamline the administration of
federally sponsored research.
(Formerly the Federal Demonstration Partnership Special
Conditions)*
REVISED May, 2015
The Office of Research Services
The Office of Research Support Services
40
Federal Terms and Conditions
• Basic Provisions
• Supplemental Set of Federal Agency T&C
• If Federal Terms & Conditions apply( with
some agency exceptions)
– Rebudgeting between most direct cost categories
and between direct and indirect costs;
– Carry-forward of unexpended balances to
subsequent non-competitive funding periods;
– Pre-Award costs for up to 90 days prior to the
effective date of the award
– Time extensions (one-time only), without additional
funds, for up to twelve months;
REVISED May, 2015
The Office of Research Services
The Office of Research Support Services
41
RTC’s-Order of Precedence
• When there is a question about whether a
federal rule applies to an award, the following
order of precedence should be followed:
– Award-specific terms and conditions
– Federal Agency’s program-specific terms and
conditions
– Federal Agency’s general terms and conditions
– Uniform Administrative Requirements, Cost
Principles, and Audit Requirements for Federal
Awards (2 CFR 200)
REVISED May, 2015
The Office of Research Services
The Office of Research Support Services
42
General Considerations
• Penn Administrative Requirements
• Regulatory Requirements
– Humans subjects in research
– Use of animals in research
– Conflict of Interest
– Export Controls
• Reporting Non-compliance
Revised May 18, 2015
The Office of Research Services 43
The Office of Research Support Services
Administrative Requirements
• Open Identification of Sponsors
• Unrestricted dissemination of all findings
• Resources or data sources on which research
is wholly dependent must be free of control by
sponsor
• No conditions which would jeopardize the
University’s commitment to non-discrimination
• Sponsor shall not ordinarily participate in the
selection of person to work on a project
• Contracts must not allow the use of the
University’s name for commercial purposes
unless specifically approved by President
Revised May 18, 2015
The Office of Research Services 44
The Office of Research Support Services
Administrative Policy Considerations
• Ownership of Intellectual Property is governed
by University Patent policy and terms of the
sponsored research agreement
• University does not warrant results
• University does not normally indemnify
sponsors
• University does not accept agreements which
require access to classified data
Revised May 18, 2015
The Office of Research Services 45
The Office of Research Support Services
Office of Regulatory Affairs
• Administers
– Institutional Review
Board (IRB)
– Institutional Animal
Care and Use
Committee (IACUC)
• Provides Research
Services with approval
status for all protocols
Revised May 18, 2015
The Office of Research Services 46
The Office of Research Support Services
Federal Oversight
• Public health Service (PHS) provides oversight of the
use of animals and Health and Human Services (HHS)
over human subjects in federally sponsored research.
Institutions applying for and receiving federal funds file
assurances that the work will be conducted with
appropriate oversight and in compliance with regulatory
requirements.
– Animal research is overseen by the
Office of Laboratory Animal Welfare
(OLAW)
– Human research is overseen by the
Office of Human Research Protections
(OHRP)
Revised May 18, 2015
The Office of Research Services 47
The Office of Research Support Services
Assurances
• OLAW Animal Welfare Assurance
A3079-01 expiration July 31, 2018
• OHRP Federalwide Assurance
– FWA 00004028 expiration March 13,
2019
Revised May 18, 2015
The Office of Research Services 48
The Office of Research Support Services
Institutional Review Board
• Protects the rights and welfare
of human research subjects
• Authorized to approve, require
modifications in, or disapprove
all research activities involving
human subjects
At Penn, human subjects research
protocols are submitted
through HS-ERA
Revised May 18, 2015
The Office of Research Services 49
The Office of Research Support Services
Human Subjects
Approval Requirements & Timelines
• Approval of a human subject protocol for a new
application is not required at time of submission
– Unless mandated by sponsor
– Approval can be “Just-in-Time” for NIH
• Human subject protocol approval and
appropriate education certification
– Required to be in place prior to the awarding
of a new project
Revised May 18, 2015
The Office of Research Services 50
The Office of Research Support Services
Human Subjects
Approval Requirements & Timelines (cont.)
• For non-competing continuations the
approval date must not be earlier than
one year before the start date for which
the progress report is submitted
– If the protocol approval date does not meet
this criteria the non-competing application
will be delayed
Revised May 18, 2015
The Office of Research Services 51
The Office of Research Support Services
Institutional Animal Care and
Use Committee (IACUC)
• Reviews and approves the use of animals
in research
• Reviews the animal care program (every
six months as required by the Health
Research Extension Act))
• Reports to the Institutional Official the
status of the animal care program,
deficiencies and non-compliance
At Penn, animal use protocols are
submitted through ARIES
Revised May 18, 2015
The Office of Research Services 52
The Office of Research Support Services
Use of Animals
Approval Requirements & Timelines
• Approval of an animal subject protocol for a
new application is not required at time of
submission
– Unless mandated by sponsor
– Approval can be granted “Just-in-Time” for
NIH
• Non-competing continuation applications must
have a valid approval date at the time of
submission
* Protocols should be submitted to IACUC if
funding is likely (approval times at least 60
days)
Revised May 18, 2015
The Office of Research Services 53
The Office of Research Support Services
NIH Requirements for Vertebrate Animal Use at
Subrecipient Institutions
• Prime awardee remains responsible for the animal use:
Prime submission needs to indicate animal use
• All subrecipients that will house or perform experiments
using live animals must have a valid Assurance
• Animal protocol must be approved by the IACUC at the
Prime awardee or that IACUC must delegate/ approve
the review at the subrecipient institution
• For foreign subrecipients, the Prime awardee IACUC
must review and approve the animal use protocol.
Revised May 18, 2015
The Office of Research Services 54
The Office of Research Support Services
Export Controls – What They Are and What
You Should Know
• U.S. laws and regulations that restrict, limit, curtail, or prevent the
distribution of strategically important products, services, and information to
foreign nationals and foreign countries for reason of foreign policy and
national security.
– Export Administration Regulations (EAR) Department of Commerce,
Bureau of Industry and Security (BIS)
– International Traffic in Arms Regulations (ITAR)
Department of State, Directorate of Defense Trade Control (DDTC)
– Office of Foreign Asset Controls (OFAC) Department of Treasury
– Other Departments and Agencies –NRC, DEA, EPA, FDA, etc.
Revised May 18, 2015
The Office of Research Services 55
The Office of Research Support Services
Export Controls – So What?
•Export Control Laws prohibit the unlicensed “export” of certain
controlled technologies for reasons related to national security,
treaty compliance, and trade agreement. If Penn research involves
these controlled technologies, Penn may be required to get U.S.
government approvals (licenses) before allowing:
•
Foreign researchers and students in the U.S. (including at Penn!) or anyone
outside the U.S. to participate in such research
•
The sharing of research materials or results with persons who are not U.S.
citizens or permanent residents
•
“Export” is defined very broadly as any oral, written, electronic or visual
disclosure, shipment, transfer or transmission of a commodity, technology or
software/codes. Note: Server access could be an export!
Revised May 18, 2015
The Office of Research Services 56
The Office of Research Support Services
Export Control Laws and
Research at Penn
General Rule: Penn, its faculty, and employees may not export to some
foreign entities certain materials and information without a license
from the U.S. Government, unless an exception applies
ORS and OGC will determine whether an exception applies.
Researchers are the first line of defense and need to make ORS aware
of any potential Export Control issues with a particular study or
agreement.
So, what do you need to look out for?
Revised May 18, 2015
The Office of Research Services 57
The Office of Research Support Services
Export Control Laws and
Research at Penn
What to look for in your study/agreement:
International Component
•
Are there foreign entities, researchers, or students involved?
•
Will information be shared with persons who are not U.S. citizens or permanent residents?
•
Is there international travel or field research where Penn-owned equipment may be shipped
outside the U.S.?
Agreement terms
•
References to U.S. export regulations
•
Restrictions or approvals of who may participate
•
Receipt of and/or restricted use of proprietary information
•
Restrictions on the dissemination of research results
Purchase of Equipment that is Controlled
•
Non-export certifications
Any study/agreement that has an international component may be subject to Export
Control Laws and should be reviewed by ORS to ensure compliance.
Revised May 18, 2015
The Office of Research Services 58
The Office of Research Support Services
Export Control Laws and
Research at Penn
Important: Most research studies will pass Export Control review without any
further action (90%+) because of the Fundamental Research Exclusion.
Fundamental Research: basic and applied research in science and engineering, the
results of which are ordinarily published and shared broadly within the
scientific community, as distinguished from proprietary research and from
industrial development, design, production, and product utilization, the
results of which ordinarily are restricted for proprietary or national security
reasons.
Consequences of Non-Compliance:
1) Loss of exporting privileges of the University
2) Place Federal funding at risk for both University and individual PIs
3) Criminal and Civil penalties for both the University and individuals
Any questions? Please contact ORS at anytime.
Revised May 18, 2015
The Office of Research Services 59
The Office of Research Support Services
Reporting Non-Compliance
• Responsible Offices
– ORS
– IRB
– IACUC
• Office of General Counsel
• 215-P-Comply
Revised May 18, 2015
The Office of Research Services 60
The Office of Research Support Services
RESEARCH INVENTORY SYSTEM
(RIS)
RIS is an electronic system for requesting and managing material transfer and other nonmonetary agreements at Penn.
Non-monetary agreements are research agreements that do not bring funding into Penn.
Examples of non-monetary research agreements:
Material Transfer Agreements
Data Use Agreements
Purchased Service Agreements
Confidentiality Agreements
Equipment Loan Agreements
Collaboration Agreements
Revised May 18, 2015
The Office of Research Services 61
The Office of Research Support Services
Creating a Request
Log-in for RIS:
https://medley.isc-seo.upenn.edu/researchInventory/jsp/fast2.do
Enter PennKey/Password
Revised May 18, 2015
The Office of Research Services 62
The Office of Research Support Services
•CHOOSE FROM 6 DIFFERENT TYPES OF AGREEMENTS
•AGREEMENTS MAY HAVE MORE THAN ONE COMPONENT
•RIS WILL PROMPT YOU FOR INFORMATION IN EACH OF THE
TABBED CATEGORIES CIRCLED BELOW
Revised May 18, 2015
The Office of Research Services 63
The Office of Research Support Services
Filters and Searches
Revised May 18, 2015
The Office of Research Services 64
The Office of Research Support Services
NEED ASSISTANCE?
ri_mta_help@lists.upenn.edu
Revised May 18, 2015
The Office of Research Services 65
The Office of Research Support Services
International Considerations in
Sponsored Research Programs
• Operational Issues
• Rules and the Legal Landscape
• Where to Go for Help
Revised May 18, 2015
The Office of Research Services 66
The Office of Research Support Services
Operational Issues
• Risk assessment and due diligence with respect to
partners
• Export and import controls
• Cash needs, transfer ability, and monetary controls
• Permanent establishment “PE” in foreign jurisdiction
• Personnel needs locally
• Required insurances
• Lease or purchase of space or equipment
Revised May 18, 2015
The Office of Research Services 67
The Office of Research Support Services
What are the Rules? Who’s
Rules Apply?
• Foreign Corrupt Practices Act
• Review by local ethics committee
• In country sponsor or researcher
responsibilities may differ
Our rules, their rules, international rules
and guidance – All Apply!!
Revised May 18, 2015
The Office of Research Services 68
The Office of Research Support Services
Getting Help at Penn
Each program, country, or situation is different
• Global Support Services
– Artemis Koch, Executive Director avkoch@upenn.edu
– Kathryn Homa, Associate Director khoma@upenn.edu
• Key International Contacts in University Offices
–
–
–
–
–
–
OGC
Risk and Insurance
Finance
Tax and International Operations
Technology and Privacy
Office of Research Services
Revised May 18, 2015
The Office of Research Services 69
The Office of Research Support Services
Financial Conflicts of
Interest in Research
Sponsored Projects at Penn
Joanne Rosenthal, BSN, JD
Research Integrity Office
December 2, 2014
•71
Outline
• Conflict of Interest Defined
• The Special Nature of COIs Related to Research (FCOI)
• PHS Regulations and Penn FCOI Policy 8/24/12
• Investigator Disclosure Requirements
• Disclosure Review and FCOI Determination
• Training
• BA Responsibilities
•72
Conflict of Interest Defined
May exist when financial or other personal considerations have
potential to compromise or bias professional judgment or objectivity
Researcher’s primary interests
• Producing generalizable knowledge
• Disseminating research results
• Ensuring the safety of research subjects
Secondary or other interests
• Tangible:
 Personal financial gain
 Funding for research
• Intangible
 Publications
 Promotion
 Prestige
A professional’s judgment does not necessarily have to be biased in
order to trigger concerns regarding COI — even the appearance of bias
in judgment is ethically worrisome.
•73
Conflict of Interest Defined
Institutional FCOI
Conflicts of interest may involve:
• Individuals and / or
• Institutions
 Institution has a financial interest in the research
• Equity, royalties etc.

•74
Member of leadership has a financial interest in the
research
• Dean, Department Chair, Trustee
• IRB members
The Special Nature of
FCOIs Related to Research
COIs are intrinsic to the researcher's enterprise
Problem is not just the FCOI but the potential for BIAS
Recipe for a FCOI
• Researcher must have:
 A role in the design, conduct, or reporting of research
results
AND
 A personal financial interest / relationship related to the
research
 Consult for research sponsor
o Have stock in company that manufactures
experimental product
o Receive royalties related to IP being tested in the
research
•75
FCOI Concerns
Personal financial ties with industry might distort researcher’s
judgment:
•
Validity of study design
•
Subject enrollment
•
Data Collection
•
Data Analysis
•
Data Reporting
•
Publication
 Secrecy
 Subject safety
Researchers don’t think their conflicts affect their research, but that
conflicts do affect other people’s decisions. Eric Campbell
•76
PHS Regulations and Penn FCOI Policy
PHS regulations effective 8/24/12 - Promoting Objectivity in
Research, 42 CFR 50, Subpart F and Responsible Prospective
Contractors, 45 CFR 94
University of Pennsylvania Policy on Conflicts of Interest related to
Research (the FCOI Policy) posted on 8/24/12
http://www.upenn.edu/almanac/volumes/v59/n02/pdf_n02/09041
2-Supplement-ConflictsInterest.pdf
• Applicable to all research being conducted under Penn’s
auspices, regardless of funding source
 Implementation being done in stages
 Initial emphasis is to first assure compliance with the PHS
regulations (transition period)
•77
Disclosure Thresholds
What to disclose – SFIs
Investigators must disclose SFIs for any research.
If PHS-funded research, Investigator must disclose SFIs to his / her
School in PHS-FITS
• For a public Outside organization: remuneration for the 12 months
plus the value of current equity that when aggregated exceeds
$5,000
• For a non-publicly traded Outside organization: any equity or
remuneration for the 12 months exceeding $5,000
• Income from intellectual property rights not assigned to Penn
• Any Clinical trial intellectual property, whether or not assigned to
Penn
• Any Fiduciary Role for an Outside organization
PHS Investigators must also disclose travel reimbursed or paid on the
Investigator’s behalf within the most recent 12 months, other than by
certain entities (Excluded Payers).
•78
Disclosure Requirements - Scope of Disclosure
For PHS-funded research
• Each Investigator must disclose SFIs (and those of his/her Family members) in a
PHS-Financial Interests and Travel Statement (PHS-FITS) that reasonably
appear to be related to the Investigator’s Institutional responsibilities
(regardless of whether related to the research).
•
•
An SFI is related to an Investigator’s institutional responsibilities if it arises from
extramural activities that derive from the Investigator’s professional standing or
are within that Investigator’s expertise in his or her professional field(s) of
discipline
Equity in, or serving in a fiduciary role for, an Outside organization that, to the
best of the Investigator’s knowledge, conducts or seeks to conduct business
related to the Investigator’s field of discipline, is related to the Investigator’s
Institutional responsibilities.
Applicable for non-PHS research
• Investigators disclosed SFIs (and those of their Family members), based on their
own self-assessment, if such interests could affect or be affected by the
research and / or such interests were in / with one or more Outside
Organizations whose interests could affect / be affected by the research
•79
FCOI Screening Questions PD – PI Certification
This project, if awarded, will be funded either directly or indirectly, by the Public Health
Service (PHS) or one of its agencies (e.g. NIH)
If Yes
Research to be funded by the Public Health Service - Financial Conflict of Interest
(FCOI) Disclosure and Training Requirements for Investigators.
At the time of proposal submission, all Investigators (senior/key personnel and any other
individuals responsible for the design, conduct and reporting of PHS-funded research)
must submit a "PHS Financial Interests and Travel Statement" (PHS-FITS) at
https://medley.isc-seo.upenn.edu/phsFits/jsp/fast2.do?fastStart=investigator .
Investigators must also complete FCOI training prior to participating in PHS-funded
research and then every 4 years in KnowledgeLink.
I understand that I am responsible for identifying all Investigators (as defined in the
paragraph above) on this proposal and advising them of their obligation to complete all
FCOI disclosures and training requirements as more fully set forth in the University of
Pennsylvania Policy on Conflicts of Interest Related to Research,
http://www.upenn.edu/research/pdf/policy_on_conflicts_of_interest_related_to_research.
pdf
Yes
•80
No
FCOI Screening Questions PD - PI Certification Cont.
This project, if awarded, will be funded either directly or indirectly, by the Public Health
Service (PHS) or one of its agencies (e.g. NIH)
If No
Does any person who is responsible for the design, conduct, or reporting of the proposed
research (or his/her spouse or dependent children) have a Significant Financial Interest*
that may affect or be affected by this research, including Significant Financial Interests
related to any entity whose interests may affect or be affected by this research?
If YES to the above, any person identified with such Significant Financial Interests
must submit a financial disclosure via Penn's Financial Interest Disclosure
Electronic System (FIDES). FIDES may be accessed at https://fides.iscseo.upenn.edu
•81
Investigator Decision Tree: The Who, What, Where, and When
for Disclosure Requirements at Penn
When do I complete a Grant Relatedness Assessment in PHS-FITS?
• For new proposals
• At Just-in-Time (but no later than at the time the NOA is issued)
• For awarded grants
• When NOA is received (if I have not submitted a Relatedness
Assessment at Just-in-Time)
• When I report a new SFI in PHS-FITS (but not a change in a
previously reported SFI)
• If there is a change in the relatedness of a previously reported SFI
to a specific grant
A separate Grant Relatedness Assessment must be submitted for
EACH grant
•82
Assessment of PHS-FITS Disclosures
• School COI Office / Officer reviews SFI disclosures and the
Investigator’s input on their relatedness to determine which (if any)
SFIs are related to specific PHS research.
• If the School determines that any SFIs are related to the research,
the School shall direct the Investigator to submit a more detailed
disclosure to the OVPR (presently, in the Financial Interest
Disclosure Electronic System or FIDES).
•83
FCOI Determination
CISC advisory to VPR
• Makes recommendations regarding whether a related SFI = an
FCOI (SFI could directly and significantly affect the design,
conduct and reporting of the research) and its management
• CISC will generally review SFIs involving:
 Any equity in a private company or equity > $50,000 in a public
company
 Payments > $25,000
 Fiduciary roles
 IP Interests and Clinical Trial IP related to the research
Other types of SFIs may be handled administratively
VPR makes final determination regarding FCOI and management
•84
Management of FCOIs
Factors considered for management include:
• Nature and design of the research
• Magnitude and nature of the SFI
• Other
For Clinical Trials
• No presumption against participation based on having an
FCOI
• FCOIs still may not be amenable to management
• Must consider degree of risk to human subjects, the
Investigator role, study’s design, degree of the
Investigator’s influence upon the recruitment/ enrollment of
subjects and/or the results of the study, and other factors
•85
Mandatory Investigator Training
• Investigators must receive FCOI training in KnowledgeLink prior to
participating in PHS-funded research and every 4 years
• Investigators are prompted in PHS-FITS to take training
• Investigators can print and save Certificate of Completion
•86
Other Policy Elements
•
•
•
•
•87
Public Accessibility

Must respond within 5 business days to written requests for
information regarding FCOIs of Senior/key personnel
Reporting

RIO must report details of FCOI and management prior to
expenditure of funds, within 60 days of identifying a new FCOI,
and at least annually
Response to Noncompliance
Subawards
BA Responsibilities related to Triggering Events
Triggering events are:
• New and competing awards - at JIT or other indication of funding but no
later than NOA
• Noncompeting Continuations - when submitting progress reports for
NCCs
• For subawards – prior to execution
BA for the proposal responsible org must:
 Confirm Investigators for that award with the PI.
 In the PHS-FITS Investigator Maintenance module
o Add any Investigators who were not previously listed.
– Make sure each Investigator is assigned a role.
– For any Non-Penn Investigator not on a subaward /
subcontract, select “Other” and then in the text box add
“Consultant No Subaward”
o End any Investigators who are no longer participating.
o Certify the list of Investigators.
•88
BA Responsibilities related to Triggering Events
• Run the Financial/Travel Report and confirm that each Penn
Investigator has completed his/her SFIs and Travel after 7/1/14.
• Run the Grant Relatedness Status Report and confirm that each Penn
Investigator has a Relatedness Assessment for that award with a final
status of “FIDES required; school concurs" or "FIDES not required;
school concurs" (regardless of the date submitted).
• Confirm that each Penn Investigator has completed FCOI Training.
• Confirm that each Non-Penn Investigator not covered under a
subaward has a Relatedness Status of “Non PHS-FITS Disclosure
Received.” If this status is blank, please contact the RIO.
• When all the above steps are complete, email ORS advising that the
proposal is ready for review / account set-up.
•89
Investigator Maintenance and Reports
Investigator Maintenance Module in PHS-FITS:
•
•
Populates initially from PD
Enables BA to add / remove Investigators for life of award, including non-Penn
Investigators
• Requires certification as to accuracy
• FCOI training completion data is available in this portal
Reports:
•
The following reports are available in PHS-FITS:
 Investigators who submitted SFIs and Travel
 Investigators who submitted Grant Relatedness Assessments
 Grant Relatedness Overdue (3rd report) should not be used
Other:
• Investigators are required to certify SFIs and Travel every July
 For remainder of this FY, SFIs must have been submitted on or after 7/1/14
• Investigators are required to complete Relatedness Assessments for new or competing
awards
• Investigators must update existing Relatedness Assessments when adding new SFIs
or if a previously reported SFI that was unrelated becomes related
• Investigators do not need to update Relatedness for each noncompeting
segment
•90
PHS-funded Subawards
Subaward agreement must state whether Penn’s or the subrecipient’s FCOI policy will
apply to the subrecipient’s Investigators
•
•
•
If Penn’s FCOI policy applies, Penn must obtain disclosures from subrecipient’s
Investigators and determine if any FCOIs exist
As a rule, Penn will require subrecipients to have their own FCOI policies or adopt FDP
model policy
Only in exceptional circumstances will Penn assume primary responsibility for
obtaining and reviewing subrecipient personnel disclosures
 Foreign subawards
 Community Investigators
Investigators must disclose SFIs that are directly related to the subrecipient’s work for
Penn on Financial Interests Disclosure Form for Investigators Not Affiliated with the
University of Pennsylvania and complete Penn’s FCOI Training
o Penn will require Investigator to eliminate any FCOIs
Detailed process has been developed to handle these situations
o BAs responsible for adding Investigators in PHS-FITS once RIO receives list
o BAs also responsible for interfacing with subrecipient if issues arise
•91
Consulting on PHS Awards
Other institution engages Penn personnel as independent contractors to consult on
grant
• No subaward or other agreement with Penn
• School and University will not be responsible for FCOI compliance obligations
related to an individual’s private, extramural consulting activities
• Disclosure requests from other institutions should be routed to ORS
Penn engages non-Penn personnel as independent contractors to consult on Penn
award (and no subaward with other institution)
If consultant with an academic affiliation qualifies as an Investigator:
o Home institution with compliant FCOI compliant policy may accept FCOI
compliance responsibilities for the Investigator (e.g., obtain disclosure, report
FCOIs to Penn)
o Otherwise, Penn will assume primary responsibility for obtaining and reviewing
disclosures
o Investigator must complete Financial Interests Disclosure Form for
Investigators Not Affiliated with the University of Pennsylvania and Penn’s
FCOI Training
o Consultants affiliated with industry or startup
– Work should be done under subaward / subcontract
•92
Useful Links
• PHS-FITS Investigator Disclosure Link:
https://phsfits.apps.upenn.edu/phsFits/jsp/fast2.do?fastStart=
investigator
• PHS-FITS Administrator Disclosure Link:
https://phsfits.apps.upenn.edu/
• Access the FCOI training in KnowledgeLink at:
https://upenn.plateau.com/learning/user/deeplink_redirect.jsp
?linkId=ITEM_DETAILS&componentID=UP.91028.ITEM.FC
OI&componentTypeID=COURSE&revisionDate=1349737260
000
•93
Coming Soon
Taskforce convened in October to make
recommendations regarding a web-based
disclosure application
Will combine into one system
• School-based annual extramural reporting
• Research disclosures
• Including non-Penn Investigators
Final recommendations being presented to VPR
this month
•94
Questions???
Revised May 18, 2015
The Office of Research Services 95
The Office of Research Support Services