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 Pieters Don 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 » Materials

The Office of Research Services 6 Characteristics of Research Materials Necessary Cannot be purchased Valuable »

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 »

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. »

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 »

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 » / /

The Office of Research Services 11 Completion of Transfer Agreements Presently ~ 28 days Goal – reduce to 14 days »

The Office of Research Services 12 Communication The ORS Penn negotiator will copy the PI in the initial negotiation »

The Office of Research Services 13 Resources for Material Transfer Help Matthew Merz, MTA Administrator University of Pennsylvania Office of Research Services Franklin Building, Room P Walnut Street Philadelphia, PA Phone: (215) Fax: (215) /

The Office of Research Services 14 Resources for Material Transfer Help »PennERA WebsitePennERA Website

The Office of Research Services 15 Resources for Material Transfer Help MTA Web Site

The Office of Research Services 16 Special Material Transfer Agreements Human tissue Export Stem cells »

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