The other side of the family equation can occur when the family member is eager for participation, but the patient is unsure. This is a tricky moral dilemma for those involved in running the study. The participant who is enrolled in a trial must have decided on their course freely and without coercion from anyone.
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“I have had some instances where the spouse is all for it,” says Mellynn Nuite, RN, CCRC, clinical research coordinator in the Center for Arthritis and Rheumatic Diseases at Tufts-New England Medical Center in Boston. “I always try to speak to the potential participant alone to see if this is something they really want to do. In almost all studies there is an exclusion criteria option the investigator may use to not enroll patients which can be used if there is any lingering doubt about voluntary study participation.”
However, in the end, the participants are autonomous adults and their decisions should be honored. “The real bottom line, I tell the participant, is that if nobody volunteers for Phase 1 trials, there will never be a drug approved for use in lupus,” says Dr. Buyon. “There will be no such thing as translational medicine if someone doesn’t step up to be the first.”
Kurt Ullman is a freelance writer based in Indiana.