What determines whether patients are willing to participate in resuscitation studies requiring exception from informed consent?
OBJECTIVE
To examine the willingness of patients to participate in a resuscitation study that requires exception from informed consent and to determine if willingness to participate is associated with demographic and other characteristics.


METHODS
Adult patients in an emergency department and in a geriatric outpatient clinic were surveyed. Patients were asked to imagine that they presented to an emergency department with cardiac arrest and asked about their willingness to (1) receive a new drug outside of a study, (2) receive a new drug as part of a study and (3) participate in a randomised controlled trial (RCT) for a new drug. Patients were also asked about participation in studies of invasive procedures.


RESULTS
213 patients from a geriatric clinic and 207 from an emergency department were surveyed. Two thirds of patients from the geriatric clinic and 83% from the emergency department were willing to receive an experimental drug outside of a study. Patients were less willing to participate in a study of the new drug and even less likely to participate in an RCT for the new drug (chi(2) test for trend, p<0.001 for both settings). Patients were less likely to participate in a study of thoracotomy than in a study that required placement of a femoral catheter (p = 0.008 for the geriatric clinic, p = 0.01 for the emergency department). Willingness to participate was not associated with trust in the doctors.


CONCLUSIONS
Study design and invasiveness of the intervention were associated with the willingness of patients to participate in resuscitation studies that require exception from informed consent.
Abboud
P-A
PA
Division of Emergency Medicine, University of Colorado School of Medicine, The Denver Health Residency in Emergency Medicine, 4200 E 9th Ave B215, Denver, CO 80262, USA.
Heard
K
K
Al-Marshad
A A
AA
Lowenstein
S R
SR
D000328:Adult; D000367:Age Factors; D000368:Aged; D004630:Emergencies; D005260:Female; D006323:Heart Arrest / Q000188:drug therapy; D006801:Humans; D007258:Informed Consent / Q000523:psychology*; D008297:Male; D010358:Patient Participation / Q000523:psychology*; D016032:Randomized Controlled Trials as Topic; D012107:Research Design; D012151:Resuscitation / Q000523:psychology*; D012737:Sex Factors; D012959:Socioeconomic Factors