RT Journal Article
SR Electronic
T1 Post-recruitment confirmation of informed consent by SMS
JF Journal of Medical Ethics
JO J Med Ethics
FD BMJ Publishing Group Ltd and Institute of Medical Ethics
SP 126
OP 128
DO 10.1136/jme.2009.033456
VO 36
IS 2
A1 Pål Gulbrandsen
A1 Bård Fossli Jensen
YR 2010
UL http://jme.bmj.com/content/36/2/126.abstract
AB Background To allow patients to reflect about a decision to participate in a clinical trial, guidelines suggest a 24-h delay from when they are informed about the trial to when they give consent. In certain clinical settings, this is likely to hamper recruitment.Method After oral and written information about the trial has been given in person, the patient signs the declaration of consent knowing that they will be asked again after 24 h whether they confirm or regret the decision. This procedure can be done by SMS. The investigators must document the response. The procedure was tried in a study in which the doctors were randomly assigned to receive a clinical communication skills course, and encounters with patients were videotaped before and after the course.Results 553 patients were approached, 530 (95.8%) gave initial consent, eight of these later regretted their consent.Discussion The low level of regrets suggests this is an acceptable procedure for patients.Trial registration The RCT was registered before initiation – registration # ISRCTN22153332.