Introduction:
Relatively minimal data exist regarding perspectives of patients (or surrogate decision-makers) after enrollment in clinical trials using the exception from informed consent (EFIC) for emergency research, a regulation essential for resuscitation research. Prior studies have shown that attitudes are generally positive but have enrolled a small proportion of participants and may have been subject to selection bias.
Methods:
As part of the study protocol, a 10-item paper-and-pencil survey was integrated into the protocol for all sites of the Established Status Epilepticus Treatment Trial (ESETT) trial, a randomized trial of three treatments for benzodiazepine-refractory status epilepticus in pediatric and adult patients. All patients (or surrogate) were given the survey after being asked for consent to continue in ESETT. Primary domains included acceptance of trial enrollment, acceptance of EFIC, and views on which population to include in community consultation. Response items primarily used a 5-point Likert scale. Simple descriptive statistics were tabulated.
Results:
In total, 317 of 443 patients/surrogates completed the survey (71.6% response). Only 7.3% (23/317) disagreed with the statement “I am glad that my family member/I was included in the ESETT research study,” and 24.9% (79/317) disagreed with being included under EFIC. When asked whom researchers should consult during community consultation, 81.1% (257/317) said patients who have had seizures, 64.7% (205/317) said their family members, and individuals at particular risk for seizures (50.8%) (161/317) were most frequently chosen. Only 26.5% (84/317) felt that members of the general public should be consulted.
Conclusions:
This is the largest study to date of participants’ perspectives on being enrolled in an EFIC trial. Rates of enrollment acceptance were relatively high; acceptance of EFIC specifically was slightly lower. There is much greater support for consulting individuals with connections to the disease under study than the general public or other groups. These findings further suggest that targeted community consultation may be appropriate and the importance of clear communication with participants after enrollment regarding reasons for EFIC use.
Exception from Informed Consent: Viewpoint of Institutional Review Boards-Balancing Risks to Subjects, Community Consultation, and Future Directions