Summary:
A recent decision from the Ontario Superior Court of Justice examines when a researcher-participant relationship in the context of human studies will give rise to fiduciary obligations. In Stirrett v Cheema et al, 2018 ONSC 2595, a plaintiff successfully recovered damages from a defendant physician on the basis that the doctor breached his fiduciary duty to the plaintiff’s deceased spouse who was a participant in the doctor’s study.
Facts:
The deceased spouse of the plaintiff, David Stirrett, underwent an angiogram on June 7, 2004, which revealed a 90 per cent blockage of one of Mr. Stirrett’s arteries. Four days later, Mr. Stirrett attended St. Michael’s Hospital to undergo angioplasty on an urgent basis. Shortly before the procedure, Mr. Stirrett was recruited for the STREAM Study (the “Study”) by Anne Fry, a registered nurse at St. Michael’s Hospital, on behalf of the principal investigator (and one of the defendants), Dr. Strauss.
The Study sought to determine whether strict control of insulin levels in non-insulin dependant diabetics could reduce restenosis in patients treated for life threatening blockages by the placement of stents within their arteries. Participants were assigned to two groups – the first group was required to self-administer insulin while the second group was educated on and encouraged to follow exercise and dietary recommendations. All participants were required to undergo a follow-up angiogram six months later. It was explained to the participants, including Mr. Strirrett, that the angiogram, which carried an inherent risk of 1 in 1000 of a serious complication such as heart attack, stroke, or death, was not to be done as part of regular clinical practice but only for medical research purposes.
Prior to enrolling in the Study, Mr. Stirrett signed a consent form, which stated that the Study was being funded by the Heart and Stroke Foundation and involved the participation of 240 patients. The consent form also clearly stated that the participants would be informed of any “new information about the study that might develop during the course of this research and might influence your willingness to participate.”[20] However, unbeknownst to Mr. Stirrett, the Study had been undergoing some difficulties and, as of September 2003, the Heart and Stoke Foundation had declined to fund the Study. The total number of participants had also been reduced to 100. Mr. Stirrett was never informed of these changes.
On February 10, 2005, Mr. Stirrett underwent a follow-up angiogram. During the procedure, conducted by Drs. Sheth and Cheema, the inner and middle layers of the artery walls separated, blocking the blood flow in Mr. Stirrett’s heart. He died a few days later.
Analysis:
- Breach of Fiduciary Duty
Drawing on the principles of fiduciary duty outlined in the seminal Supreme Court decision, Norberg v Wynrib, the court held that Dr. Strauss owed a fiduciary duty to Mr. Stirrett. The court noted that in a medical study on humans, the patient-to-doctor relationship becomes a participant-to-researcher relationship. However, the obligations of a researcher to a participant in such studies were stricter than the obligation of a doctor to a patient and gave rise to a fiduciary duty.
The researcher’s obligation under such duty was to comply with the terms of the consent form that Dr. Strauss had set out and that Mr. Stirrett had agreed to. The court found that, per the terms of the consent form, Dr. Strauss was required to advise Mr. Stirrett of the changes in the Study.
The court also noted that that although the changes may not have been significant or changed the risk of harm to Mr. Stirrett, it was not up to Dr. Strauss to decide that. His obligations were to relay the changes to the participants and allow them to decide whether to continue to participate or withdraw their consent .
- Negligence
The jury also found Dr. Strauss to be negligent, on the basis that:
- The sample size should have been changed in the protocol from 240 to 100 patients;
- The Data Safety Monitoring Board was never set up as set out in the protocol;
- The consent form was never updated with the new sample size from 240 patient to 100; and,
- No protocol deviations were submitted to the Research Ethics Board based on the above information.
However, the jury concluded that the negligence of Dr. Strauss did not cause Mr. Stirrett to undergo the follow-up angiogram that resulted in his death.
Takeaways:
The decision is important for lawyers working with researchers and healthcare institutions as it underscores the importance of obtaining informed consent from participants in research studies, and provides further guidance on what constitutes “informed” consent in the context of studies on humans. Specially, practitioners should take note of the researcher’s obligations to relay any information that has the potential to impact a patient’s decision to participate in a study, regardless of how minor the new information may be.
The case also shines light on when a researcher-participant relationship may give rise to fiduciary duty. The court recognized that “not all aspects of the participant to researcher relationship, where it involves research on humans, will rise to the level of a fiduciary duty.” [46]. However, given that participants generally do not stand to directly benefit from research studies on humans, their involvement is premised on voluntary and informed consent. The participant stands to be in a vulnerable position and trusts that the “person who has assumed superior power and responsibility will exercise that power for his or her good” [47]. Accordingly, the aspect of obtaining informed and voluntary consent from participants will give rise to fiduciary obligations on the part of the researcher.
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