A doctor who is also an investigator on a clinical trial has a patient who could benefit from the trial, but does not quite fit the eligibility criteria.
Should the doctor let the patient into the trial anyway? Or should he uphold the scientific integrity of the study and say no?
A survey published in IRB: Ethics & Human Research found that many doctors, nurses, and others who run clinical trials endorsed ignoring minor entry criteria if doing so might benefit patients who wanted to participate. Among the findings: 64 percent of respondents agreed or mostly agreed with the statement that “researchers should deviate from the protocol if doing so would improve the subject’s medical care” and 90 percent agreed or mostly agreed that “it is acceptable to disregard minor entry criteria if a patient will benefit from being in a trial.”
“The effects of such deviations are unpredictable, but given the right circumstances, they could compromise the validity of trial data,” writes Charles W. Lidz, a research professor of psychiatry at the University of Massachusetts Medical School in Worcester, and his colleagues. Among the remedies, the authors recommend better training for people who conduct clinical trials, with concrete situations that focus on the dual commitments to research and clinical care and that address how to respond to such tension.
