Research - Administration
Contracts - Process
All research contracts are centrally reviewed and signed by the Hospital. The review process addresses issues of indemnification, publication rights, patient safety, budgets and conflict of interest, among others.
The contract review process includes:
- Completing a document tracking sheet and submitting it to the Office of Research Administration (ORA).
- An initial response by the St. Michael's contract negotiators within 10 business days.
- Signing and contract pick-up.
The types of agreements that are reviewed by the office include, but are not limited to:
- Clinical study agreements
- Confidentiality agreements
- Material transfer agreements
- Consulting agreements
- Independent contractors agreements
- Grant agreements
- Animal research agreements
- Collaboration agreements
Signatures
Our investigators are parties to the agreement and sign on their own behalf. Investigator signatures do not bind the hospital. Hospital signatures are obtained through the ORA. Please see our process chart (20 KB pdf file).
Affiliation with the University of Toronto
As a fully affiliated teaching hospital of the University of Toronto, St. Michael's adheres to the University's protection for intellectual freedom and publication rights policy.
Overhead
St. Michael's applies an overhead rate of 30% of direct costs to cover the indirect costs of research, including support of St. Michael's Hospital's research infrastructure with a portion directed back to the investigator's department. The overhead must be included in all eligible study budgets. Questions related to overhead should be directed to the ORA.
Timelines
Timelines for contract review may vary depending on volume and complexity of negotiations. We strive to have our first review of a contract completed with comments to the investigator by 10 business days after receipt in the ORA. At all other points in the negotiation process, we strive for a high level of responsiveness. Please contact one of our contract reviewers as early in the process as possible.
We provide the following tips for reducing the possibility of delay:
- Please provide as much information as early as possible. The information that we typically require to review a contract can be found in the attached questionnaires:
- Contract Assessment Form: Non-human Subjects Research (75 KB Microsoft Word file)
- Contract Assessment Form: Human Subjects Research (119 KB Microsoft Word file)
- We focus on the principles in the contract first and the language second. For clinical research contracts, please review the Council of Academic Hospitals of Ontario (CAHO) document prior to negotiation and become familiar with the principles which we will need to negotiate.
- If you feel the negotiation is taking too long, please phone the contract reviewer to resolve any outstanding issues instead of relying solely on emails back and forth. We will strive to do the same.
Acknowledgements
St. Michael's thanks The Hospital for Sick Children as the source for the basic research agreement, the industry grant agreement, the privacy agreement (as adapted) and the contract assessment form (as adapted). We also thank the University of Toronto as the source for the material transfer agreement (as adapted).
CRICH Survey Research Unit
Providing high-quality and efficient research services to the health and social sciences research community.
Li Ka Shing Knowledge Institute
Bringing together leading edge research and education to shape the future of healthcare.
