A brief educational intervention may increase public acceptance of emergency research without consent

Abstract

Objectives: We hypothesized that knowing the regulations regarding emergency research without consent would increase public support for this type of research.

Methods: Randomized controlled trial. Consecutive patients presenting during eight 24-h periods received one of two interviews; the intervention interview included an educational paragraph.

Results: There were 473 (74% of eligible) patients who participated: 51% (95% confidence interval [CI] 46-55) were willing to be enrolled in a study using exception to informed consent; 84% (95% CI 80-87) believed that current therapy for cardiac arrest offers ≥ 50% chance of full recovery, and these patients were less willing to enroll (odds ratio [OR] 0.5, 95% CI 0.3-0.9). The educational intervention increased willingness to enroll (OR 1.3, 95% CI 1.0-1.6, p = 0.03).

Conclusions: A brief educational intervention had only a modest effect on willingness to participate in emergency research without consent. It may be more important to educate patients on the shortcomings of current therapy than on the ethical and regulatory justifications for such research.