Success Rates for Notification of Enrollment in Exception from Informed Consent Clinical Trials

Abstract

Objectives

Exception from informed consent (EFIC) for research in emergency settings, requires investigators to notify enrolled subjects, family members, or legally authorized representatives about inclusion in the study. We examined the success rate of a notification strategy including mail services for subjects enrolled in EFIC trials.

Methods

We describe notification attempts for subjects in three out-of-hospital cardiac arrest clinical trials in both urban and rural areas around Pittsburgh, Pennsylvania between the years 2000 and 2014. We examined the time required to notify subjects and the success of contacting subjects or their representatives when notified in-person (if alive), by mail (if alive and unable to reach in-person) or by mail (if the subject was deceased). We characterized comments received from subjects or their representatives as positive, neutral or negative.

Results

We attempted notification on a total of 1912 subjects, 1762 by mail and 163 in person. Of these, 1,767 (92%) notification forms were successfully delivered, and 431 (24%) were signed and returned. Only 16 subjects or representatives (0.91%) requested to withdraw from the study. In-person notifications were more likely to be signed than mailed notifications (69% vs. 20%; p < .001). 3.2% of recipients contacted investigators by phone or letter in response to notifications, but only 5 recipients expressed negative attitudes towards the trial. 90% of subjects were notified within 35 days of the incident. Time to notification was shorter for in-person (median 5 days, IQR 2 – 10), than for deceased and mailed (11 days, IQR 8 – 14), or alive and mailed (20 days, IQR = 14 – 29).

Conclusions

It is possible to successfully notify recipients of enrollment in a study using EFIC over 90% of the time within 35 days, although only 24% of recipients will sign and return a form. Fewer than 1% of subjects withdraw from the study, and fewer than 5% contact investigators, usually for neutral reasons.

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