Sponsored Programs at Penn
Introduction to Sponsored
Projects Administration
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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
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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
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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
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Grant vs. Contract
Project
conceived
by:
Agency
function:
Control:
Agency
oversight:
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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
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Cooperative Agreement
Grant
Cooperative Agreement
Contract
In Between
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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!
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Office Of
Management & Budget (OMB) Circulars
• OMB is responsible for overseeing the activities of
other federal agencies. Their guidance documents
are published as circulars.
– A-21 Cost Principles for Educational Institutions
• Direct costs, F&A, unallowable costs, service centers, etc.
– A-110 Administrative Requirements for Institutions of Higher
Education, Hospitals, and Other Non-Profit Organizations
• Reporting and closeout requirements, program income, etc.
– A-133 Audit Requirements for States, Local Governments and NonProfit Institutions
• Requirements for annual audit
All found at www.whitehouse.gov/omb/grants/
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OMB Circular A-21
• General objectives of A-21
– 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
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OMB Circular A-21
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?
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OMB Circular A-21
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
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OMB Circular A-21
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
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OMB Circular A-21
Direct vs. F&A Costs
• Direct Costs
– Specifically identifiable with a specific sponsored
project, an instructional activity or any other
institutional activity
• 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
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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 expanded authorities
permits rebudgeting of allowable costs (subject
to agency’s terms and conditions)
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F&A Costs
The following should generally be treated as
F&A costs except for non-federal awards
–
–
–
–
Secretarial and clerical support costs
Administrative assistants
Shop personnel
General supplies and materials
Federal exceptions (A-21, Exhibit C)
– Complex programs
– Significant data collection
– Unlike circumstances
See SPP #2138 Direct Cost Expenditures for Non-Government
Organizations
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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
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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:
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Equipment
18XX
Tuition
(4180-4190)
Subcontracts > $25K
5333
Patient Care
5334
Rental Costs
525X
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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
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End Game
Direct
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Indirect
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Indirect
(with exceptions)
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Neither!
These costs unallowable!
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Neither!
These costs unallowable!
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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
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Consistent Treatment of
Costs
Unallowable
Entertainment & Alcoholic
Beverages
Bad Debts
Fines and Penalties
Honoraria (lecture fee allowed)
Lobbying or Fundraising Costs
Contingency Costs
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OMB Circular A-110
• Uniform administrative requirements
for grants and other agreements with
– Institutions of Higher Education
– Hospitals
– Other Nonprofit Organizations
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OMB Circular A-110 (cont.)
• A-110 Provides general guidelines for the
administration of grants to federal agencies
• Agencies have their own implementations of
A-110 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/links.html
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Subpart A:
General
• Definitions
• Subawards
– Flow down of circular provisions
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Subpart B:
Pre-Award Requirements
•Pre-award Policies
•Forms for Federal Assistance
•Debarment and Suspension
•Special Award Conditions
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Subpart C:
Post-Award Requirements
• Revision of Budget
& Program
• Pre-Award Costs
• Extensions
• Carryover
• Property &
Procurement
Standards
• Cost Sharing
• Program Income
• Progress
Reporting
• Financial
Reporting
• Record Retention
It is within Subpart C that the OMB allows for many of the privileges that are
associated with grants under the Federal Demonstration Partnership (FDP).
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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
• Absence of PI (for NIH: or key personnel as named
in the Notice of Grant Award) for more than 3
months requires sponsor approval
• Agencies retain approval authority for significant
reductions (>25%) in PI effort
– (NIH: includes named key personnel)
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OMB Circular A-110
Cost Sharing
• All 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
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OMB Circular A-110
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 Circular A-110, as
applicable
– Foregone F&A reimbursements are not allowable as
cost sharing unless specifically approved by the
agency, except for awards under the Federal
Demonstration Partnership terms and conditions
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OMB Circular A-110
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
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Subpart D:
After-the-Award
Requirements
• Submit Reports
• Liquidate
obligations
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Accounting Procedures of NonFederal 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
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Accounting Procedures of NonFederal 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
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Federal Demonstration Partnership
• Applies to federal grants ONLY
• Provided more liberal interpretation of OMB Circular A110
– 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
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Federal Wide Standard Terms and Conditions
• Effective July 1, 2008, FDP Federal agencies implemented
use of Federal-wide Standard Terms and Conditions for
Research Grants. These new Federal-wide research terms
were a direct result of the years of cooperative work
between Federal agencies and institutions participating in
the FDP. The FDP Terms of Award were the foundation for
these Federal-wide research terms; however they now span
beyond the FDP participating agencies and apply to all
Federal agencies that support research. All research
agencies now utilize this standard core set of administrative
terms and conditions on awards subject to OMB Circular A110 (2 CFR Part 215), to the extent practicable. Supporting
documentation, including Agency-specific Terms and
Conditions, can be found at:
http://www.nsf.gov/awards/managing/rtc.jsp.
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General Considerations
• Administrative Requirements
• Regulatory Requirements
– Humans subjects in research
– Use of animals in research
– Conflict of Interest
– Export Controls
• Reporting Non-compliance
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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
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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
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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
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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)
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Assurances
• OLAW Animal Welfare Assurance
A3079-01 expiration July 31, 2014
• OHRP Federalwide Assurance
– FWA 00004028 expiration April 27,
2014
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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
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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
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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
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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
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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)
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•Financial Conflicts of
Interest in Research
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Outline
• Conflict of Interest Defined
• The Special Nature of COIs Related to Research (FCOI)
• New PHS Regulations and Penn FCOI Policy 8/24/12
• Investigator Disclosure Requirements
• Disclosure Review and FCOI Determination
• Training
• BA Responsibilities
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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.
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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.
– Member of leadership has a financial interest in the
research
• Dean, Department Chair, Trustee
• IRB members
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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
• Consulting
• Equity
• Inventor’s right to / receipt of
•
royalties
Service as officer , or in any
fiduciary role for company
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• With research sponsor
• With company that manufactures
product being tested, evaluated or
developed in the research
(including competitive products)
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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
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Major Regulatory and Penn FCOI Policy Changes
New 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_n02/090412-Supplement-ConflictsInterest.pdf
• Applicable to all research being conducted under Penn’s
auspices, regardless of funding source
– Implementation will be in stages
– Initial emphasis will be to first assure compliance
with the PHS regulations (transition period)
– For Investigators – biggest change is in the
disclosure process
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New 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 and
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).
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Prior and New
Disclosure Requirements - Scope of Disclosure
Past (and still 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
Now for PHS 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, such as consulting or serving on a scientific advisory board
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. 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.
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New 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 senior / key personnel and other individuals
responsible for the design, conduct and reporting of PHS-funded research
(Investigators) must submit a PHS Financial Interest and Travel Statement (PHSFITS). Investigators must also complete FCOI training prior to participating in PHS
funded research and then every 4 years. Please contact the Office of the Vice
Provost for Research at 215-898-3603 or email coi@exchange.upenn.edu regarding
how to submit a PHS-FITS and how to comply with FCOI training requirements.
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 disclosure 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_res
earch.pdf
Yes
No
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New 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.isc-seo.upenn.edu
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Investigator Decision Tree: The Who, What, Where, and
When for Disclosure Requirements at Penn
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Assessment of PHS-FITS Disclosures
• School COI Office / Officer will review 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).
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FCOI Determination
CISC advisory to SVPR
• 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
SVPR makes final determination regarding FCOI and
management
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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
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Mandatory Investigator Training
• Investigators must receive FCOI training in KnowledgeLink
prior to participating in PHS-funded research and every 4
years
•
• Commenced training this summer in Blackboard.
• Training records have been migrated to
KnowledgeLink.
• Investigators are prompted in PHS-FITS to take training
• Investigators should print and save Certificate of
Completion
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Other Policy Elements
•
•
•
•
Public Accessibility
– Must respond within 5 business days to written
requests for information regarding FCOIs of
Senior/key personnel
Reporting
– Must report details of FCOI and management prior
to expenditure of funds, within 60 days of
identifying a new FCOI, and at least annually
– OVPR will handle for if NOA after 8/24/12
Response to Noncompliance
Management of subawards
– Subaward agreement must specify the applicable
FCOI policy and timeframes for reporting to Penn
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BA Responsibilities
At JIT or other indication of funding for a new or competing
award, and when submitting progress reports for NCCs
(“Triggering Events”)
• Confirm with the PI a complete list of Investigators
• Confirm in PHS-FITS Administrative Module that all Penn
Investigators have a complete PHS-FITS (SFIs, Travel and
Relatedness Assessment) and that their final FCOI status
is either:
 a) FIDES not required, school concurs;
 b) FIDES required by system, school concurs; or
 c) School requested additional disclosure in FIDES
• Confirm that all Penn Investigators have completed FCOI
training in KnowledgeLink (may obtain through Data
Warehouse report)
• Complete the PHS-FITS Confirmation Form and submit to
ORS
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PHS-FITS Confirmation Form
PHS-FITS Confirmation Form
Date:
Award Title:
Institution Number:
Award Number:
Investigators participating in this research
I have confirmed with the Principal Investigator that the below is a complete list of Investigators (individuals responsible for the
design, conduct or reporting of this research), including but not limited to key personnel, consultants and collaborators (you may
enter multiple names in each text box below.):
Penn Investigators:
Non-Penn Subaward Investigators:
Other Non-Penn Investigators (e.g., consultants and collaborators):
O
I confirm that all Penn Investigators have submitted a current PHS-FITS, including a Relatedness Assessment for this research.
O
I confirm that all Penn Investigators have completed the Financial Conflicts of Interest in Research Investigator Training
Course – OVPR.
Business Administrator Certification
I certify that the above information is complete and accurate to the best of my knowledge.
Type Name
Business Administrator
Signature:
School:
Department:
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Useful Links
• PHS-FITS Investigator Disclosure Link:
https://medley.iscseo.upenn.edu/phsFits/jsp/fast2.do?fastStart=investigat
or
• PHS-FITS Administrator Disclosure Link:
https://medley.isc-seo.upenn.edu/phsFits/jsp/fast2.do
• Access the FCOI training in KnowledgeLink at:
https://upenn.plateau.com/learning/user/deeplink_redir
ect.jsp?linkId=ITEM_DETAILS&componentID=UP.91028.
ITEM.FCOI&componentTypeID=COURSE&revisionDate=
1349737260000
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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.
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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!
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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?
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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.
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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.
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Reporting Non-Compliance
• Responsible Offices
– ORS
– IRB
– IACUC
• Office of General Counsel
• 215-P-Comply
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Questions???
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