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What determines whether patients are willing to participate in resuscitation studies requiring exception from informed consent?


Objectives: 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 (χ2 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.

  • CPA, cardiopulmonary arrest
  • FDA, Food and Drug Administration
  • RCT, randomised controlled trial

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