Exceptions to the rule of informed consent for research with an intervention.
BACKGROUND Resuscitation research has been allowed to proceed using waiver of consent when compliance with guidelines is assured. In these circumstances, institutional review boards (IRBs) may request notification of enrolled patients. OBJECTIVES To describe the notification process developed with IRB feedback and implemented in two out-of-hospital randomized controlled trials (RCTs) in a large urban setting. METHODS This was a descriptive review of two RCTs recruiting a total of 620 patients: the Out-of-hospital Cardiac Arrest Rectilinear Biphasic to Monophasic Damped Sine Defibrillation Waveforms with Advanced Life Support Intervention Trial (ORBIT), which compared rectilinear biphasic and monophasic damped sine waveform for out-of-hospital cardiac arrest, and the Prehospital Pacing versus Conventional Treatment Effectiveness Trial (PrePACE), which compared dopamine and transcutaneous pacing for unstable bradycardia. RESULTS The ORBIT study enrolled 538 patients. In 44 (8%) patients, contact information could not be obtained. Notification was attempted for 494 (92%) patients; 48 (10%) letters were returned to sender. Researchers were contacted by telephone regarding 37 (8%) subjects: 16 (43%) requested information, 14 (38%) responded positively, and one (3%) did not return follow-up calls. Overall, two (0.4%) were withdrawn from the study. The PrePACE study enrolled 82 subjects. Contact information was unavailable for one (1%). For the remaining 81 patients, four (5%) letters were returned to sender. Researchers were contacted regarding ten (13%) subjects: seven (70%) requested information, two (20%) responded positively, and one (10%) did not return follow-up calls. No patient was withdrawn from the study. CONCLUSIONS Contact information may be difficult to obtain for up to 20% of out-of-hospital critical patients. In 8% to 13% of cases, patients or designates contacted researchers; most feedback was positive. Frequently, non-study-related information was requested, consuming significant resources. Using this method, fewer than 1% of patients were withdrawn from the studies.