The effect of waiving consent on enrollment in a sepsis trial

Abstract

Objective: Illustration of the difficulties in approaching critically ill patients for informed consent for inclusion into a randomized controlled trial and the impact of a waiver of consent from the patient's next of kin in the conduction of such studies.

Design: Descriptive survey of the inclusion rates into the Ger-Inf-05 study before and after a waiver of consent from the patient's next of kin.

Setting: Nineteen intensive care units in France.

Patients: Septic shock patients (n=300) included in a placebo-controlled randomized double-blind study on the efficacy and safety of a 7-day treatment with 50 mg hydrocortisone every 6 h intravenously and 50 microg fludrocortisone every 24 h orally.

Intervention: Introduction, 10 months after the beginning of the study, of a waiver of consent from the patient's next of kin if it was not present at the time of the patient's inclusion.

Measurements and results: The mean inclusion rate was four patients per month before the introduction of the waiver of consent and increased to 10 patients per month after the study amendment including the waiver of consent. Informed consent was obtained from the patient himself or herself in 10 patients (3%) and from next of kin in 70 patients (23%). For the 220 other patients (74%), the investigators could not contact the responsible relative within the inclusion period.

Conclusions: Recruitment rate in the Ger-Inf-05 study was clearly improved after the waiver of consent from the patient's next of kin. This probably contributed to the successful completion of the study.