Transcript Post Award Project Management

Office of Research Services
Update on Material
Transfer Agreements
The Office of Research Services 1
Office of Research Services
Introduction
The Office of Research Services 2
Office of Research Services
Material Transfer
Agreement Team
The Office of Research Services 3
Matt Merz
Laurance Guido
Ed Pieters
Katya Wickersham
Kerry Wilson
Alice Cao
The Office of Research Services 4
Characteristics of
Research Materials
• Necessary
• Cannot be purchased
• Valuable
• Cannot be used in humans
»
The Office of Research Services 5
Materials
• Reagents
The Office of Research Services 6
Materials
• Chemical compounds
The Office of Research Services 7
Materials
• Biological materials such as cell
lines, plasmids, vectors, etc.
The Office of Research Services 8
Penn Policy for Material
Transfer Agreements
• To protect researchers and Penn,
whenever research materials are
transferred into or out of Penn, a
MTA must be completed
The Office of Research Services 9
Material Transfer
Agreement
• Contractual document used for the
acquisition of various biological and
research materials, and
occasionally data that are not
available via retail channels
• Typically, there is no payment for
materials other than costs
• Does not involve funding
The Office of Research Services 10
»
/
Approval of Material
Transfer Agreements
• The Office of Research Services
reviews MTAs to ensure that researchers
and Penn are protected
• Signatures
– Authorized ORS signature
– Principal Investigator
The Office of Research Services 11
Issues with Research
Materials
• Intellectual property rights to
modifications, new uses or
inventions related to the material
• Use restrictions
• Publication of results
• Indemnification
• Governing law
The Office of Research Services 12
Special Considerations
• Human tissue
• Export
• Stem cells
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Human Tissue?
• Hospitals, medical schools, drug companies
hold millions of samples of human blood,
tumors, skin, hearts, kidneys, livers,
placenta, embryos, etc.
• Samples might come from potentially
cancerous tumors, organs removed during
surgery, or even hair and nail clippings.
• Samples in Tissue Banks
• Hospitals, medical schools and
pharmaceutical houses interested in
collecting samples. In the past, disposal of
tissue samples was routine.
The Office of Research Services 14
Human Tissue =
Human Subject Research
• Transfer and use of Human Tissues
is research involving human
subjects and may be subject to the
IRB common rule.
• HIPAA: the privacy of individually
identifiable health information is
protected for the establishment of
conditions of its use and
disclosure.
The Office of Research Services 15
MTAs and Export Controls
• Any MTA that has an international
component may be subject to Export
Control Laws
• “International Component” is defined as
research that involves foreign entities,
researchers or students and/or research
that involves sharing of information
with persons who are not US citizens or
permanent residents
• MTAs are reviewed for this, particularly
for materials going outside the US
The Office of Research Services 16
Stem Cells
• All requests to conduct research or
to possess human embryonic stem
cells (NIH and/or non-NIH
approved lines) on Penn’s campus
must be evaluated and approved
by the Office of the Vice Provost
for Research and the OGC. The
process is coordinated and
ultimately processed by ORS as a
MTA.
The Office of Research Services 17
Communication
• Notify PI that the request was
received and the review process
started and provide the name of
the assigned negotiator
• The ORS Penn negotiator will copy
the PI on communications with the
outside party so that the PI may
understand the negotiation status
The Office of Research Services 18
Completion of Transfer
Agreements
200
180
160
140
120
100
80
60
40
20
0
2008 Neg. MTA
0-30
2008 Non Neg. MTA
31-60
61-90
91-120
2009 Neg. MTA
121-180
181-360
2009 Non Neg. MTA
Over 1 Year
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Looking Ahead
• Master Agreements
• Non-negotiable Agreements
• Web-based MTA requests
• Electronic execution
The Office of Research Services 20
Resources for Material
Transfer Help
• Before negotiator is assigned, contact
Matthew Merz, MTA Administrator
University of Pennsylvania
Office of Research Services
Franklin Building, Room P221
3451 Walnut Street
Philadelphia, PA 19104-6205
Phone: (215) 573-4505
Fax: (215) 898-9707
Email: [email protected]
• After negotiator is assigned, contact
assigned negotiator
The Office of Research Services 21
Resources for Material
Transfer Help
• MTA Web Site
http://www.upenn.edu/researchservices/materialtransfer/
The Office of Research Services 22