Bending the Rules of Clinical Trials for the Patient’s Sake

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In the current issue of the bioethics journal IRB: Ethics & Human Research, investigators from four different institutions surveyed over 700 clinicians involved in clinical trials and found that 90 percent believed that ignoring certain entry criteria was acceptable if a patient could, in their estimation, benefit from the trial. In addition, over 60 percent of those surveyed also believed that researchers should deviate from study rules if doing so might improve a patient’s care.

While bioethicists and researchers have long suspected that doctors and other clinicians might be committing an occasional protocol infraction, few if any studies have looked at the extent to which such violations occur and how they might compromise research results.” (NYTimes)

I am not a researcher but purely a clinician. I’ve never been in a position to discover whether I would compromise a research protocol to benefit a patient, but I suspect the temptation would be strong (and would limit my ability to deliver good research findings).