Clinical and Translational Science Institute Preparing Grant Proposals and Securing Research Funding Preparing For A Study Conducting A Study Completing A Study Implementing The Results

Drug or Medical Device Development

If your study will involve an investigator-sponsored test of a new drug or medical device, you must contact the University of Pittsburgh Office of Investigator-Sponsored IND and IDE Support (O3IS) and file a series of regulatory documents. O3IS is a combined service of the Office of Clinical Research–Health Sciences, the Clinical and Translational Science Institute, and the Research Conduct and Compliance Office; it assists Pitt researchers involved in the development and submission of investigator-sponsored investigational new drug (IND) applications and investigational device exemption (IDE) applications to the U.S. Food and Drug Administration (FDA) and the conduct of clinical research studies under such FDA-accepted applications and exemptions. A 54-minute video presentation by O3IS Director Dennis Swanson covers the general requirements for submitting IND and IDE applications. The O3IS Web site also includes copies of the IND and IDE application requirements as well as IND and IDE application information, templates, and submission timetables. As a reminder, any study that requires FDA approval also requires compliance with Good Clinical Practice Guidelines. In addition, industry-sponsored drug or medical device studies are subject to oversight by the UPMC Clinical Trials Office. Its Web site includes a detailed list of forms that must be filed and includes a flowchart to help investigators track the most appropriate course of action for a particular study.

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Environmental Health and Safety

If a study entails using bloodborne pathogens, working with chemicals in a laboratory, or shipping hazardous materials, the researchers involved are required to take the relevant training available through the University’s Environmental Health and Safety Office, which offers Web-based training modules and on-site training sessions regarding bloodborne pathogen safety and chemical hygiene. Dangerous goods shipping training is offered through on-site classes.

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Material Transfer Agreements (MTAs)

If your research involves the transfer of research materials to or from the University, you must complete a material transfer agreement (MTA) through the Office of Research. MTAs are defined by the Office of Research as “contractual documents used for the acquisition of various biological and research materials, and occasionally data, developed by nonprofit [organizations], government, and private industry.” The agreement specifies the use, ownership, and publication rights relating to those materials. MTAs are usually needed when there is only one source for a particular research material required for a study.

For transfers between universities, the Uniform Biological Material Transfer Agreement (UBMTA) may apply. Establishing UBMTA at an institution allows it to exchange biological materials for research purposes with other agreeing institutions without the need for individual negotiations. The UBMTA streamlines the process, reducing administrative hurdles and the time required to execute MTAs for biological materials. Universities that have signed the UBMTA retain the right to complete a customized MTA for specific material transfers, but in most cases the UBMTA will suffice.

If the source is industry, the company may want to claim ownership of any inventions that are based on the materials or restrict publication of research results, especially if the results are unfavorable. The University, on the other hand, wants to ensure that full dissemination of research results is permitted and that MTA terms do not conflict with University policies or those established by the NIH Office of Technology Transfer. Because of these conflicting views, negotiations can take some time. Note that negotiations and contract agreements must be handled by the University; individual investigators may not negotiate or sign a contract on behalf of the University.

MTAs cover either materials arriving at the University of Pittsburgh from outside sources (incoming MTAs) or being sent from the University to outside sources (outgoing MTAs).

  • Incoming MTAs—If your laboratory receives materials from an outside source, you’ll need to file the following documents with the Office of Research: a completed and signed Submission Form for the Evaluation of an Incoming MTA, any relevant regulatory compliance forms (IRB, IACUC, or IBC/rDNA), and a research description also known as the scope of work (SOW). The Office of Research prefers that all documents be submitted electronically to orcontracts@offres.pitt.edu. Be sure to copy your contracts officer on the submission. If, for any reason, you must submit paper copies of the forms, fax them to 412-624-7414. The Office of Research will contact you when the MTA has been signed.
  • Outgoing MTAs—If you’ll be sending materials from the University to an outside collaborator, you must submit the following documents to the Office of Research: a completed and signed Submission Form for the Evaluation of an Outgoing MTA, any relevant regulatory compliance forms (IRB, IACUC, or IBC/rDNA), and a research description also known as the scope of work (SOW). The Office of Research prefers that all documents be submitted electronically to orcontracts@offres.pitt.edu. Be sure to copy your contracts officer on the note. If, for any reason, you must submit paper copies of the forms, fax them to 412-624-7417.  The Office of Research will determine whether the materials transfer falls under UBMTA guidelines or whether an individual MTA is necessary. The Office of Research will contact you when the MTA has been signed. 

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Radiation Safety

If a study will involve radioactive materials or radiation-producing machines, you must work with the University of Pittsburgh Radiation Safety Office to become an authorized user. To promote the safety of individuals who use sources of ionizing radiation (X-ray machines, sealed nuclear sources, and radio-labeled chemicals in clinical work and in research), the Radiation Safety Office offers user training, monitors work places, and controls the receipt and disposal of radioactive materials and radiation-producing equipment. Depending on how radiation is to be used in your study, you may need to take one or more training modules concerning appropriate use and disposal of radiation sources and related topics. If your work requires dosimeter monitoring, you can click here for a form to apply for a badge.

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Institutional Biosafety Committee

The University’s Institutional Biosafety Committee (IBC) must review all research projects involving recombinant DNA (rDNA), including, for instance, human studies that involve transfer of a modified biologic (as in gene therapy) or a xenotransplant, to ensure compliance with NIH Guidelines (Appendix M) and the NIH’s Office of Biotechnology Activities.

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Stem Cells

The Human Stem Cell Research Oversight Committee (hSCROC) regulates the use of adult and embryonic stem cells in research at the University of Pittsburgh.  The type of review required for various scenarios is outlined by the categories of stem cell review.   In brief, is stem cells will be studied in vivo in a human, the level of review is dependent on the source from which the cells were derived.  Those derived from somatic tissue are subject to administrative review and use of cells derived from gonadal or central nervous system tissue requires full review.  You can find additional details on the policies regulated by hSCROC here.

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Payments to Research Subjects (WePay Card)

If subjects enrolled in your study will receive payment, the University of Pittsburgh and UPMC are replacing all traditional payment forms (cash, check, gift cards) with WePay cards, debit cards branded by MasterCard, through an electronic transfer system. Click here to learn more about the WePay system and how you can incorporate it into a research study.

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