The effect of waiving consent on enrollment in a sepsis trial.
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.


METHODS
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.


METHODS
Nineteen intensive care units in France.


METHODS
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.


METHODS
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.


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.
Annane
Djillali
D
Service de Réanimation Médicale, Hôpital Raymond Poincaré AP-HP, Université de Versailles Saint-Quentin en Yvelines, 104 Boulevard Raymond Poincaré, 92380, Garches, France. djillali.annane@rpc.ap-hop-paris.fr.
Outin
Hervé
H
Service de Réanimation Médicale, Centre Hospitalier Intercommunal, 78303, Poissy, France.
Fisch
Caroline
C
Délégation Régionale à la Recherche Clinique d'Ile de France, Hôpital Saint-Louis, 75010, Paris, France.
Bellissant
Eric
E
Centre d'Investigation Clinique INSERM 0203, Hôpital de Pontchaillou, Université de Rennes 1, 35043, Rennes, France.
D032962:Consent Forms / Q000331:legislation & jurisprudence*; D005602:France; D006801:Humans; D018579:Patient Selection; D016032:Randomized Controlled Trials as Topic / Q000331:legislation & jurisprudence*; D018805:Sepsis / Q000628:therapy*