Thinking of bringing an international academic trial to OHRI? Read this first

Are you interested in making OHRI a site for an international, academic trial? If so, then this article is for you.

OHRI Investigators often contact the OHRI Contracts office because they want to join an international trial (the “trial”) led by an academic institution in another country (“International Academic Sponsor”). When trials are regulated by Health Canada (including phase IV trials), OHRI has strict contractual terms that the International Academic Sponsor must agree to in writing (called the “trial agreement”). Sometimes the trial agreements are delayed while OHRI and the International Academic Sponsor try to agree on the terms.

To help explain our requirements for trial agreements—and why we have them—we made this list. Below are our requirements for trial agreements that are led by International Academic Sponsors and that are regulated by Health Canada.

Health Canada Regulated Trial Contract Requirements

Every time OHRI acts as a site for a Health Canada regulated trial, the trial agreement must include specific minimum rules. These requirements apply no matter if the trial is led by a Canadian academic sponsor, an International Academic Sponsor, or a company sponsor (industry sponsor).

At a minimum, OHRI requires these three terms:

• Ontario Law: The sponsor must agree that Ontario law and courts will have exclusive jurisdiction for any dispute from the trial or the trial agreement.
• Insurance: The sponsor must state they have insurance of at least $5 million CAD per occurrence and $5 million CAD in the aggregate, and that their insurance covers legal claims made in Ontario.
• Indemnification (or sufficiently robust liability terms): The sponsor must promise to indemnify OHRI and the OHRI Principal Investigator (“OHRI PI”) in accordance with OHRI’s requirements.

These rules often surprise International Academic Sponsors, especially the insurance requirement. Because of this, we encourage OHRI PIs to share this blog post with any potential international collaborators as early as possible. 

OHRI requires these contractual terms to adequately balance the safety risks of doing Health Canada regulated research.

OHRI Acting as the Health Canada Sponsor

Sometimes, the International Academic Sponsor asks OHRI to take on the official role of “sponsor” under Health Canada’s regulations. OHRI is open to this idea, but we must check every trial on a case-by-case. The OHRI administrative team, the study team, and the OHRI PI must all agree they can handle this extra responsibility.

If OHRI agrees to be the sponsor, we have to add terms to the trial agreement, including:

• Clear Roles: The trial agreement must clearly state which sponsorship duties belong to OHRI and which belong to the International Academic Sponsor.
• Canadian Subsites: If other sites in Canada are planning to join the trial, OHRI must be responsible for the contracts with each Canadian sites. 
• Flow-down terms: All legal protections and warranty promises given by the International Academic Sponsor to OHRI must equally protect all of the Canadian subsites.

Wow, this is a lot. Is there an alternative to these requirements?

Sometimes, the International Academic Sponsor may be unwilling to accept the OHRI's requirements. When this happens, OHRI looks at another potential arrangement for conducting the trial. In this case, OHRI could run a separate but connected Canadian sister-study to the trial. This is different from being a regular “site” of the International Academic Sponsor because OHRI would need to have complete control over the protocol and all decision-making arising from the sister-study. It would be, for all intents and purposes, an OHRI-led trial where we are collaborating with an international partner. This is a very different arrangement than being provided the protocol from an International Academic Sponsor who is making all decisions and is handling all issues. 

In this sister-study arrangement, the agreement with the International Academic Sponsor would give OHRI:

1. Full control over the study plan (protocol) in Canada.
2. The right to publish Canadian data independently from the International Academic Sponsor.
3. Ownership of all intellectual property (IP) created during the Canadian study.

With a sister-study, OHRI will still ask for Ontario law, insurance, and legal protection. However, we can be much more flexible with the final wording to match the shared costs and benefits.

The sister-study model requires the International Academic Sponsor to give up a lot of control, and it requires OHRI to take on that control. Because of this, a sister-study is not right for every project. However, for some trials, it is the perfect way to get past difficult contract debates and move the trial forward.

In Summary

OHRI is happy to join trials run by International Academic Sponsors, but we must have the right contractual terms. Our office is happy to work with your study team to find the best path forward.
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Do you have any questions about this blog post? Do you want to learn more about international academic trials? Do you have a blog topic you would love us to write about? Let us know by reaching out to the OHRI Research Contracts Office at contracts@ohri.ca or the author of this article at jencox@ohri.ca.