The Monitor's Consent

You a research fellow in the Department of Psychiatry. A nurse on the inpatient schizophrenia research unit complains to you that two patients who agreed to participate in a challenge study are now quite symptomatic. The nurse is concerned that the patients were "too impaired" when they gave consent to participate. Dr. B's patient, Mr. Young, has become very symptomatic. He did not sign an advance directive, but his father is his monitor. The father had assisted in the informed consent process (Mr. Young was quite impaired at that time) and was seeing him daily and talking with Dr. B about his symptoms. Both the patient's father and Dr. B, the Director of the unit and principle investigator of the study, agree that Mr. Young should stay on the committee. The father tells Dr. B that "it's worth it because studies like this will help people like my son in the future."

• What are the strengths and weaknesses of using monitors in general and in this case in particular?
• What limits, if any, should be placed on monitors' discretion to enroll patients in studies or remove patients from them?
• What should be done when a compromised patient and her monitor disagree about the course of action?
• What should be done when the principle investigator and the monitor disagree?
• Can you suggest any methods for resolution of disagreements between and among monitors, patients, psychiatrists, and research fellows?