What does the Clinical and Corporate Contract area need from me and when?
Involve us as early as possible. Communications are key. Try to provide University of Pittsburgh forms of agreement to your PIs and sponsors as starting points for discussions. If using the sponsor's form, give us electronic or editable drafts of agreements to review/negotiate from. Make sure all compliance approvals are in order and sent to us. Make sure that all compliance trainings have been completed. Above all, be patient! This takes time. Who can sign a research contract?
The University of Pittsburgh's Office of Research is designated as the office to enter into research contracts on behalf of the University. This includes MTAs and other non financial agreements which relate to research. When a researcher attempts to sign such an agreement on behalf of the University of Pittsburgh, the researcher could be subjected to personal legal and financial risks. Even MTAs, while usually not conveying funding, are still binding documents with possible legal penalties for violations of the terms. Should a PI or department staff member negotiate their own contract?
Never. The Office of Research is the only official office authorized to accept binding terms in research contracts on behalf of the University. The PI and department are certainly permitted (and are encouraged) to discuss the scope of work and the budget with a sponsor, but the rest of the contract terms are the purview of the Office of Research. Only those terms reflected in the final, executed contract are binding on the parties. Communications between the PI or department in the sponsor may lead to confusion over the contract terms.
It is important for the researcher to read the terms of all research agreements before transmitting it for University signature. The Office of Research assumes that a researcher who transmits a contract has read and agrees to conform to those terms (http://www.pitt.edu/HOME/PP/policies/11/11-01-02.html).
Note: The Office of Research will confer with General Counsel and the Office of Technology Management, or any necessary compliance office as required in the review and negotiation of any research contracts. What is the role of the UPMC OSPARS and how do we work together?
The UPMC OSPARS handles a subset of corporate clinical trials under a formal agreement between the University of Pittsburgh and the UPMC for the purpose of facilitating the implementation of industry-initiated and sponsored clinical trials being conducted by Physician Services Division (PSD) or UPMC investigators within the UPMC environment.
The purview of the UPMC OSPARS with respect to corporate clinical trials is limited to industry-initiated and sponsored clinical trial of drugs and devices conducted within a UPMC or University of Pittsburgh Physicians (UPP) facility or conducted under the direction of a UPMC or UPP staff member in connection with his/her UPMC and/or UPP responsibilities, appointments and clinical privileges, as appropriate. Checklist of Applicability for Corporate Clinical Trial Submission to UPMC OSPARS
Was any University of Pittsburgh faculty or staff member involved substantially in the development of the clinical trial protocol?
Does any University of Pittsburgh faculty or staff member serve as the investigator-sponsor of an investigational New Drug (IND) application or Investigational Device Exemption (IDE) for the experimental drug or device being evaluated in this clinical trial?
Is the conduct of this clinical trial being financially supported by any entity other than the industry sponsor and, possibly, the clinical department or division to whom the principal investigator reports?
Will the clinical trial procedures be performed exclusively within a University facility without any use of UPMC patients, records, or facilities (i.e., this does not apply to University-owned buildings leased by UPMC)?
Does the experimental drug or device being evaluated in the clinical trial 1) emit ionizing radiation; 2) involve a gene transfer intervention; or 3) involve a transgenic xenotransplant?
If the answer to ALL of the above questions is "NO", the clinical trial will be routed to UPMC OSPARS (412) 647-4666. What about compliance?
All contractual documents for research are held to the same levels of compliance review (http://www.rcco.pitt.edu/), whether non-financial, or a proposal for funding, or a grant, or a contract.
Submission of Incomplete agreements and forms to the University of Pittsburgh's Office of Research
If an agreement is to be submitted in duplicate, we will need two signed original copies. Researchers must sign prior to the Office of Research sign-off.
If the agreement requires a research scope or budget to be attached, please attach it before submission.
If the agreement is an MTA, and it requires the list of materials to be filled in, please do so. The Office of Research cannot process incomplete agreements.
Failure to submit a required Submission Form.
No Contacts provided for negotiation
If you have the name and e-mail address of a contact person for the other party, please provide this information on the submission form to expedite the process of negotiation. If you have the contract in draft electronic form, please provide it to us as early in the process as possible.
"Work for Hire" or Consulting agreements
Work-for-Hire contracts reflect a commercial type of purchasing agreement. Key identifying factors are that the sponsor outright owns all the data, reports, drawings, and materials and inventions developed under the agreement. Publication is often prohibited. The work is often warrantied. The University does not provide commercial services and cannot sign these types of agreements without substantial modification designed to reflect the fact that we conduct academic research. The Office of Research is happy to try to work with sponsors to find an
appropriate form of agreement to replace a work-for-hire contract.
Other party's unwillingness to negotiate
Some contracts are presented as containing non-negotiable language in areas of key concern to the University. While the Office of Research is frequently successful in negotiating appropriate language with sponsors, we cannot negotiate with a party who is unwilling to do so. The Office of Research will make more than one attempt to enter into a meaningful dialog, but if the other party is unwilling to participate our options are quite limited.
GLP (Good Laboratory Practices) requirement
Some contracts require compliance with Food and Drug Administration GLP regulations which are very stringent, costly, and burdensome. According to the Research Conduct and Compliance Office, there is currently no laboratory at the University that is compliant with thos requirements. We cannot accept any agreement that requires a certification of GLP and in fact, we must expressly disclaim GLP in preclinical contracts.
The University's Policy on Openness in Research (http://www.pitt.edu/~offres/policies/OpennessinResearch2.pdf) is very specific about the limitations that the University can accept on the right to publish the results of its research. Classified, secret or similarly restricted research cannot be accepted by the University.