Alexandra Shelley on the future of fiduciary duty in clinical trials

Alexandra Shelley has told Law Times that a recent decision made by the Court of Appeal for Ontario in a clinical trial case “gives us at least a framework going forward on how to decide if fiduciary duty exists.”

Alexandra’s comments come in an article that discusses the successful appeal of a case where clinical researchers were originally found to have been negligent and in breach of their fiduciary duties after the death of a trial participant (Stirrett v. Cheema, 2020 ONCA 288).

Alexandra and a team of Torys lawyers intervened on behalf of the Canadian Cancer Trials Group.

She told Law Times they were concerned about the chilling effect the appeal could have on the establishment of fiduciary duty in clinical trials—a budding area in the COVID-19 pandemic.

“They picked up on the intervenors argument and affirmed that establishing a fiduciary duty in a clinical trial requires that the plaintiffs show that the defendant undertook the duty…to act in the beneficiary's best interest,” Alexandra said.

“That requirement of an undertaking is consistent with the Supreme Court's precedent, and substantially raises the bar on establishing that the researcher owes a fiduciary duty to a participant in a clinical trial.”

You can read all of Alexandra’s comments in the Law Times article.

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