University of Pittsburgh
FINANCIAL GUIDELINE
Subject: Fee-For-Service Activities in Academic Units
12/04/19
INTERIM
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I. Guiding Principles
The University of Pittsburgh’s mission is to “advance learning through the
extension of the frontiers of knowledge and creative endeavor” and to “cooperate
with industrial and government institutions to transfer knowledge in science,
technology, and health care.”
1
The University regularly performs client-initiated
work under fee-for-service arrangements that help increase the impact of the
University’s three-fold mission of instruction, research, and public service. This
work can be provided to external for-profit as well as not-for-profit clients and
represent an extension of the University’s “core competencies” for the benefit of
the private and public sectors.
Client-initiated work at the University must adhere to the following principles
No subsidization. Fee-for-service activities should neither displace nor be
subsidized by the University’s core research and teaching missions. All
resources must be included in the analysis when determining the cost to the
University of providing the fee-for-service activity.
Fair and reasonable pricing. Fee-for-service clients cannot be charged a
price lower than the price charged to Federal awards for comparable services
performed.
No unfair competition. Inappropriate outside use of facilities could give rise
to legal risk arising from unfair pricing in relation to service providers in the
business community. Fee-for-service clients cannot be charged a price lower
than the prevailing market price for comparable services.
Prudent Risk Management. Fee-for-service activities are to be executed
within the same compliance context as that of similarly situated research or
educational activities carried out by the University Member. Particular attention
needs to be paid to conflict of interest, foreign engagements, export controls
compliance, and that consent has been obtained by clients for client-supplied
human subject data or biospecimens. Furthermore, fee-for-service activities
should not place the tax-exempt status of the University or the status of any
tax-exempt bonds at risk.
Stability. Fee-for-service activities should be highly routinized with respect to
the use of templated contracts (“build once, use many”) by the unit providing
the activity. An excessive administrative burden is placed on the University,
and the Office of Sponsored Programs in particular, if each engagement
requires contract negotiation.
1
See http://ir.pitt.edu/factbook/fbweb02/general/MISSION.PDF.
University of Pittsburgh
FINANCIAL GUIDELINE
Subject: Fee-For-Service Activities in Academic Units
12/04/19
INTERIM
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The Office of the Senior Vice Chancellor for Research is responsible for
overseeing the implementation of this Guideline and its associated procedures.
II. Definitions
Human Anatomical Material includes human cadavers, cadaveric tissue and
decedent medical records falling within the responsibility of the Committee for
Oversight of Research and Clinical Training Involving Decedents (CORID).
Human Biological Material include, but are not limited to, tissue, organs,
blood, plasma, serum, DNA, RNA, proteins, cells, urine and other body fluids.
(Note: this definition does not include immortalized cell lines).
Scope of Work document outlines a description of all services to be
provided, any acceptance criteria, all key personnel, any client-supplied
equipment or materials, the effective date of services to be performed, and the
detail of any deadline/milestone requirements. Any requirement for the
University to protect the client’s confidential information should be disclosed.
University Member refers to faculty, staff, students, fellows, trainees, and
interns employed by the University.
III. Scope of Fee-for-Service Work
The Fee-for-Service contract is appropriate where the deliverable requested by the
client is generated by University Members using practical applications of generally-
accepted procedures, established theories, well-understood methods, or standard
experiments, subject to the following limitations:
Creative Works. Fee-for-service is not appropriate for investigator-initiated
work. Neither is fee-for-service appropriate for cases where the deliverable
requested by the client requires novel, original contributions on the part of
University Members. Examples include the discovery and interpretation of
facts, revision of accepted theories in light of new facts, development of new
analytical and experimental protocols, or practical applications of such new
theories, analysis, data gathering and experiments. The pathway to discovery
and the creativity of new ideas is in the hands of a principal investigator and
other University employees and usually starts as a proposal outlining a
promising area of inquiry. Work of this type is classified as sponsored
research.
Human Anatomical Material. Fee-for-service is not appropriate for work
involving human anatomical material held in the Pitt Biorepository or obtained
by Pitt through the Humanity Gifts Registry. All such requests should be
directed to the Office for Oversight of Anatomic Specimens at
http://ooas.pitt.edu/.
University of Pittsburgh
FINANCIAL GUIDELINE
Subject: Fee-For-Service Activities in Academic Units
12/04/19
INTERIM
3
Commercialization. Fee-for-service is not appropriate for cases where the
client wants to commercialize Pitt technology, intellectual property (whether
existing or created during the fee-for-service work), or copyrighted material.
Requests to license or spin out Pitt technology should be directed to the
Innovation Institute at https://www.innovation.pitt.edu/.
Public Sector Clients. Fee-for-service is not the appropriate mechanism
contracting with the Federal government or other public sector clients.
The scope of Fee-for-Service work, which may be revised based on discussions
with University Members, is generally initiated by clients rather than the result of
responses on the part of University investigators to widely-circulated requests for
proposals. Four major categories of fee-for-service work are defined below.
Proposed work falling outside these categories will be evaluated on a case-by-
case basis.
A.) Services
University Members provide a service in response to a scope of work initiated and
defined by the external client. Examples include, but are not limited to, the
physical, chemical, molecular, or functional analysis of client-supplied samples
(laboratory services); advanced product testing, which excludes clinical trials;
printing (2D or 3D) or other fabrication of a client-supplied design; or specialized
equipment repair. In all cases, University Members do not participate in the
creation of the idea or concept on which the fee-for-service work is based.
University Members seeking approval of agreements involving the incoming
receipt of human biological materials should consult with the IRB Office for
assistance in ensuring that the client sending the samples has the
appropriate subject consents and originating-institution IRB approvals in
place to cover the draft scope of work. The IRB Office consultations may be
initiated via email (askir[email protected]) or phone (412-383-1480).
Any incoming Material Transfer Agreements (MTA), when required by the
client, must be routed to the Office of Sponsored Programs (OSP) for review
and signature. Once signed, they must be included as an attachment to the
Fee-for-Service contract.
Fee-for-service work that will rely upon Pitt-developed and Pitt-hosted
software applications may require an End User License Agreement (EULA)
as the contractual vehicle with the individual users of that application. A
copy of the EULA should be included in the fee-for-service package for work
requiring a user-facing software application.
Fee-for-service work is not appropriate for engagements that require
substantial collaboration between the client and University Members in the
University of Pittsburgh
FINANCIAL GUIDELINE
Subject: Fee-For-Service Activities in Academic Units
12/04/19
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design and performance of creative new works or discoveries. These types
of activities are sponsored research.
B.) Use of Equipment or Labs
University Members provide access to equipment, laboratory space or both to a
client who will use those assets on a non-exclusive basis, subject to the
supervision of a university employee where the University Member is not
participating in the enhancement or advancement of the client’s idea. Examples
include, but are not limited to, charging clients an hourly rate to use analytical,
experimental or fabrication equipment in a University lab or core facility.
University Members are responsible for ensuring that their external users
register with the University’s Visitor Liaison, complete a Lab Use
Addendum, and complete all applicable Employee Health and Safety
(EH&S) training.
2
The Office of Risk Management, Insurance & Workers'
Compensation requires external users who will be physically utilizing the
University’s facilities to formally acknowledge Pitt’s non-liability in case of
any accident while they are working on campus.
Fee-for-service agreements proposing use of the animal care facilities
under the control of the Division of Laboratory Animal Resources will not be
approved.
Fee-for-service agreements are not appropriate for renting or licensing use
of Pitt real estate to spin out companies or other external parties, although a
real estate license may contain an fee-for-service addendum defining
agreed upon fee-for-service arrangements.
C.) Product
University Members provide a copy of information, documents, technology,
deliverables, work product, or other materials produced through Pitt’s prior
research activity for the client’s non-commercial, non-research use.
Fee-for-service agreements must be consistent with any requirements or
limitations imposed by the agency or organization that funded the original
sponsored research activity at Pitt.
Fee-for-service agreements are not appropriate for the provision of a first-of-
a-kind or early prototype of a technology or other work product which still
involves substantial creative design work that generates intellectual property
on the part of University Members. These types of activities are sponsored
research.
Fee-for-service agreements are not appropriate for the transfer of tangible
research materials such as research reagents, cell lines, chemical
2
http://www.ehs.pitt.edu/workplace/training.html
University of Pittsburgh
FINANCIAL GUIDELINE
Subject: Fee-For-Service Activities in Academic Units
12/04/19
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compounds, physical hardware or other material to the external client when
the recipient intends to use it for their own research purposes. Outgoing
MTAs should be used with academic, government, non-profit, or industry
partners to ensure the University’s rights and any legal obligations to third
parties for the material are preserved, including rights in any progeny or
derivatives of the transferred materials.
Fee-for-service agreements are not appropriate for the outgoing transfer of
live research animals or human biological materials, regardless of the
recipient’s use case. Those transfers must use an MTA and may require
other documentation.
Fee-for-service agreements are not appropriate for use with an industry
partner seeking the right to commercialize (use, develop, market and sell)
existing Pitt technology or copyrighted materials in the marketplace. The
Innovation Institute will negotiate licensing agreements for Pitt-owned IP,
including Pitt-owned software.
D.) Evaluation, Assessment, and Training
University Members provide evaluation, assessment, training or other organized,
unit-based consulting services. Clients will receive a license to use any customized
information products derived from Pitt’s existing copyrighted materials for their
internal use. Clients may also receive a license permitting broad, non-commercial
dissemination of any such materials. All such materials should be clearly marked
with a University of Pittsburgh copyright and the sponsorship of the client
acknowledged.
Fee-for-service agreements are not appropriate for an individual faculty
member’s independent consulting engagements, unless the revenue will
accrue to the benefit of the University.
University Members within the Health Sciences Division should consult with
the Associate Vice Chancellor for Industry Relations and Continuing
Education, Health Sciences to determine whether the proposed activities
should be offered through the joint Pitt/UPMC Center for Continuing
Education in the Health Sciences (CCEHS).
Surgical training: For all surgical training activities that involve live
vertebrate animals, a signed IACUC approval letter must be furnished to
OSP prior to approval and commencement of work.
Fee-for-service surgical trainings may not involve non-human
primates or companion animals.
All visitors who enter animal research facilities must abide by the
Visitors to Animal Research Facilities Standard Operating
Procedure (ES&H 05-025):
University of Pittsburgh
FINANCIAL GUIDELINE
Subject: Fee-For-Service Activities in Academic Units
12/04/19
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https://www.ehs.pitt.edu/section-v-biosafety
IV. Governance
The Senior Vice Chancellor for Research may appoint, at his or her discretion, a
committee to conduct this review these Guidelines. Any substantive changes to
these Guidelines recommended by the committee must be presented to the Senior
Vice Chancellor for Research for approval.
V. Contact Information/Public Accessibility
These Guidelines are posted on the following website: http://www.cfo.pitt.edu
University Members are encouraged to contact OSP for assistance with
understanding their obligations related to compliance with this Guideline.
VI. Appendix Related Authorities and Policies
Outside Employment 02-06-01 (http://www.cfo.pitt.edu/policies/policy/02/02-
06-01.html).
Conflict of Interest for Designated Administrators and Staff 07-05-02
(http://www.cfo.pitt.edu/policies/policy/07/07-05-02.html).
Conflict of Interest for University of Pittsburgh Employees 07-05-03
(http://www.cfo.pitt.edu/policies/policy/07/07-05-03.html).
Responsibilities of Sponsored Research Investigators 11-01-02
(http://www.cfo.pitt.edu/policies/policy/11/11-01-02.html).
Conflict of Interest Policy for Research 11-01-03
(https://www.policy.pitt.edu/conflict-interest-policy-research-11-01-03).
Organization Conflict of Interest 11-01-08
(http://cfo.pitt.edu/policies/documents/policy11-01-08web.pdf).
Academic Visitors: For Visitors (https://visitor.pitt.edu/for-visitors/).
Industry Relationships Policy (“Policy on Conflicts of Interest and Interactions
between Representatives of Certain Industries and Faculty, Staff and
Students of the School of the Health Sciences and Personnel Employed by
UPMC at all Domestic Locations”)
(https://www.coi.pitt.edu/sites/default/files/documents/regulations-
policies/Industry-Relationships-Policy-Pitt.pdf).
Guidelines on Sponsored Projects and Gifts University’s Financial Guideline
(https://www.cfo.pitt.edu/policies/guideline/sponsored_projects_vs_gifts.pdf).
University of Pittsburgh
FINANCIAL GUIDELINE
Subject: Fee-For-Service Activities in Academic Units
12/04/19
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University of Pittsburgh Faculty Handbook (https://provost.pitt.edu/faculty-
handbook).
University of Pittsburgh Staff Handbook (http://www.hr.pitt.edu/handbook).