When protocol changes, updated consent needed
September 1, 2002
Informed consent should be ongoing and timely
Informed consent can be a significant source of legal action. Though the court in the case cited in this month’s Compliance Spotlight ruled in favor of the physicians on a matter involving informed consent, a federal district court judge in Seattle ruled just the opposite. In a summary judgment issued last month, the judge said that The Fred Hutchinson Cancer Research Center and others named in the complaint failed to gain study a study volunteer’s informed consent and therefore the case against them could move forward.
The patient was Kathryn Hamilton — her experience was featured in last year’s Seattle Times series of articles titled "Uninformed Consent: What Patients at The Hutch’ Weren’t Told About the Experiments in which They Died."
Hamilton enrolled in a clinical trial in January 1993, after having been diagnosed with breast cancer for a third time. She was given one to two years to live with conventional therapy.
The study, referred to as Protocol 681, sought to treat cancer patients with high-dose chemotherapy, the effects of which were to be offset by pentoxifylline (PTX). Hamilton was told that PTX could be administered intravenously, important because Hamilton had in the past been unable to keep down drugs administered orally. The previous fall, however, one of the principal investigators decided to stop using the IV form of PTX in the study.
Though the IRB overseeing the study was notified of the change and the reference to intravenous PTX was deleted from the consent form before Hamilton’s treatments began, the suit alleges that Hamilton was not told of the change. Her family says that had she known, she would not have participated. She died 44 days after entering the study.
The lawyers for Hamilton’s family allege that the Center and the investigators associated with the study failed to tell Hamilton that the method of drug administration named in the informed consent document was no longer available. In doing so, the lawsuit points out, the Center and investigators failed to obtain Hamilton’s informed consent.
In the summary judgment, the judge decided that "The Hutch’s own documents show that its Division of Clinical Research believed the lack of intravenous PTX to be a material fact of which potential study participants should be apprised." The judge went on to write: "The court finds as a matter of law that defendant Fred Hutchinson Cancer Research Center’s failure to disclose the unavailability of intravenous PTX invalidated Hamilton’s consent to participate in Protocol 681."
This legal matter is between the institution, the principal investigators, and the volunteer’s family, but it could easily have spilled over to the IRB. There are several lessons here for IRBs, says Mark Waxman, general counsel for CareGroup Healthcare System of Boston and IRB Advisor editorial board member.
One, the IRB must prioritize the informed consent process. "The IRB must continue to emphasize the informed consent process as a key element of its review. This means that the elements of informed consent must be clearly communicated to the researchers. The fact that patients who may be in a particular trial have no perceived alternative to the trial if they have any hope of improving does not mean that there can be any loosening of the efforts required to obtain truly informed consent," he says.
Two, IRBs should develop a system for obtaining updated consent. "IRBs will be challenged to develop appropriate procedures to determine on a continuing review basis whether the consents which were in effect at the inception of the trial should remain in that original form over the course of a trial."
And three, Waxman says, "When a drug is being tested, it will be deemed material to the consent process to make disclosures with respect to the potential availability of the drug in the future."
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