J. M. Podbielski1, L. E. Vincent1, E. E. Fox1, C. E. Wade1, B. A. Cotton1, J. B. Holcomb1 1McGovern Medical School at UTHealth,Surgery/McGovern Medical School,Houston, TX, USA
Introduction: As clinical studies advance into an emergent setting, the use of exception from informed consent (EFIC) is increasing. EFIC requires researchers to inform the patient or their legally authorized representative (LAR) and obtain informed consent (IC) as soon as possible after the study intervention has begun. Due to the critical nature of the study population, research staff may be unable to obtain IC in a timely fashion if at all. Notification and consent may be difficult due to LARs who may be too distraught to make decisions or unavailable to make decisions. This study describes the timing of notification and consent at one site in a large EFIC trial.
Methods: Our center enrolled 145 subjects in a recently completed randomized trial of transfusion ratios. During enrollment the research staff screened, enrolled and followed the patients through the first 24 hours. Attempts were made at least every 4 hours during the first 24 hours to inform the LAR/family/subject about the study and to obtain IC with attempts at least daily until hospital discharge. The Institutional Review Board approved a wavier for those patients who died prior to obtaining consent and for those subjects who were consent was unable to be obtained.
Results:Randomization occurred at a median of 26 minutes after hospital arrival. IC was obtained for 96 (66%) subjects, including 41 from the LAR, 31 from the patient, and 24 from both. Consent was waived for 37 (26%) subjects due to death or patient’s inability to consent. 12 (8%) refused to continue with the study. Median time to first notification of the LAR/subject was 22.4 hours from hospital arrival (Range: 4.8 hours–24 days). Median times to LAR and subject notification were 20.9 and 88.5 hours, respectively. 41% of the LARs/subjects provided IC at time of first notification. Median time to obtaining IC from LAR or subject was 20 minutes from time of notification, with a range of 0 to 14.8 days. The overall median injury severity score (ISS) score was 29 (IQR 21-41) and significant differences existed in ISS (p<0.001) among patients for whom IC was obtained (Median=35; IQR=25-52), patients who refused (Median=33; IQR=23-45) and patients in whom IC was waived (Median=43; IQR=24-63). There were no significant differences detected among patients who consented, refused or received a waiver by age, gender, race, Hispanic ethnicity or treatment group.
Conclusion:We have shown that notification and consent can be obtained in 92% of subjects (of these 72% actual, 28% waived) in an EFIC trial through diligent efforts of the research staff to contact patient and/or LAR. When planning an EFIC trial, research teams should be aware that substantial personnel effort are required throughout the study in conducting the IC process.