A contract or research agreement is required if:
- resources or funds will be received by or provided to sources external to St. Michael’s Hospital.
- any information (i.e., data including video and audio, personal health information) or biological materials (e.g., blood, other bodily fluids, and/or tissues) will be sent to an external site.
- any research materials, including but not limited to animals and/or animal samples will be sent outside of St. Michael’s Hospital where it was collected and/or will be received by St. Michael’s Hospital.
- any researcher or external party wishes to conduct clinical trials at St. Michael’s Hospital.
The Office of Research Administration will review, negotiate, and finalize all research contracts prior to authorization and signature. The review process addresses issues such as indemnification, publication rights, patient safety, budgets, privacy, and conflicts of interest.
All information relating to potential clinical studies require a Clinical Study Agreement. Basic science research may also require a formal agreement.
What happens after I submit my contract?
- After submitting a completed application package, you will receive a specific contract identification number for your contract application from the Research Contracts Clerk within 5 business days.
- A contract is drafted and/or reviewed by a Research Contracts Analyst or Specialist and is submitted to the Principal Investigator for feedback.
- The contract is then negotiated between the parties and approved.
- Once a Research Contracts Analyst or Specialist approves a contract, the Office of Research Administration will obtain institutional signatures.
- The Principal Investigator will be notified once institutional signatures are obtained and, if applicable, when and where to pick up the contract for them to sign.
- The Research Contracts Clerk will request the Principal Investigator or their staff member to deliver the partially signed contract to the external party for signatures.
- Once the external party has signed the agreement, the Principal Investigator or their staff member shall send a fully executed agreement to firstname.lastname@example.org. This is required to complete our files and finalize the contract process.