The Office of Research Services 1 Office of Research Services New Developments at Penn for Material...

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

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Office of Research Services

Material Transfer Agreement Team

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Ed PietersDon Deyo

Kerry Wilson Laurance Guido Matt Merz

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• Reagents• Chemical compounds• Biological materials such as cell

lines, plasmids, vectors, etc.• Some types of software

» http://www.upenn.edu/researchservices/

Materials

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Characteristics of Research Materials

• Necessary• Cannot be purchased• Valuable

» http://www.upenn.edu/researchservices/

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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/

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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/

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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/

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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/

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Completion of Transfer Agreements

• Presently ~ 28 days• Goal – reduce to 14 days

» http://www.upenn.edu/researchservices/

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Communication

• The ORS Penn negotiator will copy the PI in the initial negotiation email

» http://www.upenn.edu/researchservices/

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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: ORSMTA@upenn.edu

http://www.upenn.edu/researchservices/

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Resources for Material Transfer Help

»PennERA Website

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Resources for Material Transfer Help

• MTA Web Site

http://www.upenn.edu/researchservices/materialtransfer/

http://www.upenn.edu/researchservices

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Special Material Transfer Agreements

• Human tissue• Export • Stem cells

» http://www.upenn.edu/researchservices/

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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 are racing to collect them. In the past, disposable of tissue samples was routine.

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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.

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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