Since 1996, federal regulations 21 CFR 50.24 have been available that allow enrollment of critically ill or injured patients into clinical trials using Exception from Informed Consent (EFIC). These regulations are applicable only under narrow clinical circumstances when prospective informed consent is not possible. Examples would include a patient–subject whose critical condition makes it impossible for the patient to give meaningful prospective consent, and it also not feasible to obtain meaningful prospective consent from the patient’s Legally Authorized Representative (LAR).
Michelle Biros, MD, MS, Department Head and Professor of Emergency Medicine, is a national expert on issues concerning consent within clinical trials, and specifically is considered an expert on exception from informed consent within emergency medicine.
Innovative patient safeguards are built into the EFIC regulations, including pre-study community consultation and public notification. For our department's EFIC trials - including ProTECT, RAMPART, ESETT, and ACCESS - we did extensive consultation with thousands of members of the general public and a more targeted group at risk of the diseases under study (brain injuries, status seizures). Our results suggest a general support of emergency research with and without consent, and an appreciation that the investigators were seeking the community’s opinion.
It is also necessary, when conducting EFIC trials, for investigators to develop an informed consent process in the event that prospective informed consent may somehow be possible for an individual case. In such severe critical circumstances as those for which EFIC was developed, any prospective informed consent, if possible at all, would likely come from the patient’s LAR. In many EFIC circumstances, prospective consent is not feasible from the LAR because the LAR is not present within the intervention’s time window, the subject (and hence the LAR) is not identifiable, or it is felt that the LAR is too distraught or otherwise incapacitated to render an informed prospective decision regarding the participation of the patient-subject in the trial.
Learn more about EFIC in the Articles section.
RECEIVE AN OPT OUT BRACELET
The Department of Emergency Medicine also provides an "OPT OUT" bracelet for individuals who do not want to participate in the study in order that they would not be enrolled.
To receive an OPT OUT bracelet, please email or phone the department at 612-624-7426 or at firstname.lastname@example.org.