Research Clinical Trials Contract Review
Research Clinical Trial Contracts
Agreements for research conducted at any of the Hamilton Health Sciences sites (including Hamilton General Hospital, McMaster University Medical Centre, McMaster Children's Hospital, Chedoke Hospital, the Juravinksi Hospital and Cancer Centre and St. Peter's Hospital) are logged centrally by the Office of Integrated Research Services (OIRS) before sign-off by Hamilton Health Sciences.
Since a research contract is a legally binding agreement, research contracts under HHS must be reviewed by a Contract Reviewer assigned through the Office of Integrated Research Services (OIRS), and can only be executed by a designated signing authority, as per the "Research Agreements Entered into with Third Parties" policy.
We welcome your submissions and look forward to helping you negotiate a fair and reasonable agreement. To submit a research contract for review, please e-mail a soft copy to OIRS at email@example.com.
Once received, it will be assigned to a Contracts Specialist that same day. The research contract will be reviewed and returned to the Sponsor within 9 business days. We endeavour to negotiate agreements in a timely way, while ensuring the agreement complies with HHS policies, as well as the CAHO Statement of Principles, Version 2.0.
CAHO Harmonization of Clinical Study Agreements Initiative
In an effort to reduce timelines and promote transparency in contract negotiation, our institution has adopted the document developed through an initiative of Council of Academic Hospitals of Ontario (CAHO) and entitled "Statement of Principles to be Considered when Negotiating a Clinical Studies Agreement" which can be accessed on the CAHO website, www.caho-hospitals.com, or via the link above. Our institution encourages companies to review and incorporate these principles into their clinical study agreement templates prior to entering into negotiations with us. If any of the items in the principles document are issues of concern, please do not hesitate to contact us to discuss them.
Contract Review Process at HHS
To view an overview on the clinical trials contract review process, please click here.
Indirect Costs Associated with Clinical Trials
Clinical trial agreements with Industry Sponsors are subject to an overhead rate of 30% of the research budget. This charge covers the infrastructure and support costs associated with health research conducted within the academic health science centre. We negotiate this overhead rate with the Sponsor in addition to the research budget to ensure there are sufficient funds to carry out the research after the 30 percent overhead is deducted.
Some more complex clinical trials are subject to a charge in excess of 30% applied on a case-by-case basis. This should be discussed directly with your Contract Reviewer.
293 Wellington St. N - Suite 103
Hamilton, ON L8L 8E7
Phone: 905-521-2100 ext. 47041