Abstract 10: The Feasibility and Methods of an Exception from Informed Consent Pilot Study of Estrogen in Trauma Patients in the Emergency Department
Introduction:Despite significant supporting evidence to conduct clinical trials of estrogens as an acute trauma therapy, there are none to date. This is in part due to the need for rapid drug administration for optimal effect, causing logistical and consent issues. We recently completed the first-ever pilot trauma study of estrogen for acute injury, RESCUE Shock.
Methods: 50 patients were enrolled in RESCUE Shock (SBP<90) at 2 Level I trauma centers. Preclinical data led to ED drug dosing within 2 hours of injury. The mental status of severely injured patients and absence of an early Legally Authorized Representative (LAR) left informed consent generally unfeasible, so an exception from informed consent FDA IND was required.
Results: To date, several important findings have emerged: 1) Investigator-initiated exception from informed consent studies are feasible, with our FDA IND approval obtained in 31 days, IRB 1 approval in 25 days, and IRB 2 approval in 24 days. 2) Community consultation/notification was successfully accomplished, with no one opting out. 3) 47/50 enrolled patients (or LARs) were notified of participation (one died unidentified, and 2 died with no LAR or contact information). One LAR was able to be consented in the ED prior to enrollment, and nine LARS received letters after the patient’s death. The average number of days to verbal notification of the remaining patients was 6.55 days (range 0-51 days), as the study team began notification only after the patient or family was able to reasonably understand information about the study. No one decided against continued follow-up. Overall, patients and their families were very enthusiastic about participation. 4) The DSMB has no safety concerns after reviewing study data twice to date.
Conclusion: Exception from informed consent for novel, time-sensitive ED trauma studies is crucial, feasible, and well accepted by patients and communities. Delayed notice of participation is justified for many reasons.
- © 2012 by American Heart Association, Inc.