Is it ethical for doctors to ask their own patients for research consent?
What is purpose of the integrated consent model?
The model was developed largely in an effort to simplify what some consider an unnecessarily cumbersome process that often impedes enrollment into clinical trials. With traditional informed consent, though a patient’s own doctor or nurse is usually the one to broach the idea of participating, someone other than the clinician—usually a research coordinator or assistant from the study—must do the actual enrolling. “And they’re not always handy,” says Dean Fergusson, epidemiologist at OHRI and lead scientist for its Rethinking Clinical Trials (REaCT) program, which is currently using informed consent in some 11 studies. “They’re off in different parts of the hospital, or they’re busy, or it’s after hours, or they’re on vacation, and that patient may never even meet up with the coordinator. That happens a fair amount.”
In many studies, patients are given at least 24 hours to consider the request; most never follow up, says Fergusson. Patients are frequently asked to come in for further baseline testing—a pregnancy test, for example—and these can be a challenge to schedule. Fergusson describes enrollment in cancer trials as “dismal”—less than five percent across Canada, and less than three percent for breast cancer trials. This is one of the big “knocks” against clinical trials, says Fergusson—a lack of generalizability. “If you find results in the five percent who participated, can you generalize them to the other 95 percent?”
Enrollment in REaCT trials can happen at the initial step, when the clinician first speaks to the patient. Care providers are expected to read a script explaining the purpose of the study, the process of randomization, and the fact that the patient can withdraw at any time. The patient is given an information sheet covering much of the same ground which they can take home. They can also sign up right there and then, in which case the care provider documents the patient’s consent in their clinical notes, signs off electronically in the REaCT app, and randomizes the patient to one of the two treatments—all in one visit.
The REaCT trials have been running for about three years and have enrolled about 1,700 patients—well over 80 percent of those approached. In part, this difference reflects the fact that the REaCT trials are low-risk, whereas most cancer trials are of novel therapies (for which the informed consent process typically has several more steps). Fergusson estimates that the integrated model allows a five-fold reduction in costs, due to the ease of data collection and management, and to the efficiency of enrollment.
Is the integrated consent model ethical?
When Ray Saginur, chair of the Ottawa Health Science Network Research Ethics Board, which is responsible for vetting all research at the Ottawa Hospital, first considered the integrated consent model, the hardest thing to wrap his head around was the absence of a signature. “We’re very used to having things written,” he says. “In part because we know what was said, and [in part because] we know that that the person was there.” At the same time, he welcomed the “discomfiture” caused by the departure from convention. “Because I have concerns about our conventional practice,” he says.
Saginur explains that consent documents have become increasing long, complex and jargon-ridden. “They start looking inadvertently more like contracts,” he says, speculating that they’re primarily designed to try and protect the sponsors of research from liability. “Oftentimes people who are asked to sign these forms either can’t or won’t read a whole document. They just sign them. So the consent process may be subverted.” The integrated model’s script, the information sheet provided to participants, and the fact that participants can withdraw at any time (which is true about any trial), sufficiently mitigate Saginur’s concern around the absence of written consent.
But these aspects of the model may not be enough to assuage some ethics boards when it comes to consent being obtained directly by clinicians. “How do we ensure that there’s no coercion involved?” says Sharon Freitag, director of research ethics at St. Michael’s Hospital in Toronto. “How do we ensure that the patient or participant is really understanding and not just agreeing because of the trust they put in the relationship with their physician or treating surgeon?” Freitag also wonders if some people might feel unable to decline. “If this is the person who’s going to be operating on me, who’s going to be treating me going forward, how do I say no?”