In order for the Clinical and Corporate Contract team to initiate its review of a new contract, a formal request by the involved principal investigator/PI's department is needed. For non-financial agreements, an electronic submission is required in MyRA. For financial agreements, a CRA submission form must be completed and submitted via email to firstname.lastname@example.org. The submissions in MyRA and the CRA submission form capture information about the requesting department, the entity with whom we are establishing the contract, the specifics of the research project and any compliance aspects. As the information contained in the submission provides the context for our negotiation of the contract, complete and accurate information in the submission is essential to ensure that the finalized contract contains the language necessary to protect the PI's interests and those of our University.
Please note that the principal investigator listed on any submission submitted to the Clinical and Corporate Contract team must be an individual holding a faculty appointment with our University.
Frequent Causes for Delay
- Incomplete submission paperwork (either electronic via MyRA or CRA submission via email)
Please ensure that all submissions are complete and accurate, and that all requests include all the relevant exhibits/attachments.
If a sponsor template is provided, please ensure that it is in an editable Word version in order to facilitate negotiation.
Appropriate compliance documents should be included in the submission. The relevant office (IRB, IACUC, IBC, etc.) will review the submission. Incorrect compliance approvals may delay the processing of an agreement.
- No contacts provided for the negotiation of the agreement
The correct name and e-mail address for the legal contact to be involved in the negotiation of the agreement must be entered on the submission. Please note that we cannot conduct University business using Gmail or other unsecure email accounts. The majority of agreements received will require at least some negotiation to bring the agreement into compliance with University standards.
- "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. Our 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 work with sponsors to find an alternative form of contract to be used in lieu of the 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 our 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 negotiate. The Office of Research will make more than one attempt to enter into a meaningful dialogue, but if the other party is unwilling to participate in those discussions, our options are quite limited.
- GLP (Good Laboratory Practices) requirements
Some agreements require compliance with the US Food and Drug Administration GLP regulations, which are very stringent, costly, and burdensome. In accordance with the Vice Chancellor for Research's November 2005 memo, our University currently has no laboratory that is compliant with those GLP requirements. We cannot accept any agreement that requires a certification of GLP compliance, and, in fact, we must expressly disclaim GLP compliance in our preclinical contracts.
- Publication restrictions
The University's policies on Openness in Research are very specific about the limitations that our University can accept on the right to publish the results of its research. Classified, secret or similarly restricted research cannot be accepted by our University.