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The Office of Research Services 1
Office of Research Services
New Developments at Penn for Material
Transfer Agreements
The Office of Research Services 2
Office of Research Services
Introduction
The Office of Research Services 3
Office of Research Services
Material Transfer Agreement Team
The Office of Research Services 4
Ed PietersDon Deyo
Kerry Wilson Laurance Guido Matt Merz
The Office of Research Services 5
• Reagents• Chemical compounds• Biological materials such as cell
lines, plasmids, vectors, etc.• Some types of software
» http://www.upenn.edu/researchservices/
Materials
The Office of Research Services 6
Characteristics of Research Materials
• Necessary• Cannot be purchased• Valuable
» http://www.upenn.edu/researchservices/
The Office of Research Services 7
Issues with Research Materials
• Intellectual property rights to modifications, new uses or inventions related to the material
• Restrictions• Publication of results• Indemnification
»http://www.upenn.edu/researchservices/
The Office of Research Services 8
Material Transfer Agreement
• Material Transfer Agreements (MTAs) are contractual documents used for the acquisition of various biological and research materials, and occasionally data, developed by non-profit, government and for-profit organizations.
» http://www.upenn.edu/researchservices/
The Office of Research Services 9
Penn Policy for Material Transfer Agreements
• Whenever research materials are transferred into or out of Penn, a “Material Transfer Agreement” (MTA) must be completed and signed by an authorized ORS Penn representative, as well as the Penn researcher
» http://www.upenn.edu/researchservices/
The Office of Research Services 10
Approval of Material Transfer Agreements
• The Office of Research Services cannot sign a MTA without review
• Signatures– Authorized ORS signature– Principal Investigator
» http://www.upenn.edu/researchservices/
The Office of Research Services 11
Completion of Transfer Agreements
• Presently ~ 28 days• Goal – reduce to 14 days
» http://www.upenn.edu/researchservices/
The Office of Research Services 12
Communication
• The ORS Penn negotiator will copy the PI in the initial negotiation email
» http://www.upenn.edu/researchservices/
The Office of Research Services 13
Resources for Material Transfer Help
• Matthew Merz, MTA AdministratorUniversity of PennsylvaniaOffice of Research ServicesFranklin Building, Room P2213451 Walnut StreetPhiladelphia, PA 19104-6205Phone: (215) 573-4505Fax: (215) 898-9707Email: [email protected]
http://www.upenn.edu/researchservices/
The Office of Research Services 14
Resources for Material Transfer Help
»PennERA Website
The Office of Research Services 15
Resources for Material Transfer Help
• MTA Web Site
http://www.upenn.edu/researchservices/materialtransfer/
http://www.upenn.edu/researchservices
The Office of Research Services 16
Special Material Transfer Agreements
• Human tissue• Export • Stem cells
» http://www.upenn.edu/researchservices/
The Office of Research Services 17
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 are racing to collect them. In the past, disposable of tissue samples was routine.
The Office of Research Services 18
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 19
MTAs and Export Controls
• Export Control Regulations may apply to some materials covered by MTA
• Examples: materials usable in biological / chemical weapons (pathogens and toxins)
• MTAs are reviewed for this, particularly for materials going outside the US
