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.
- clinical trial
- informed consent
- scientific research
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Funding The study was funded by the Regional Health Enterprise for Specialist Health Care in south-east Norway. There were no other study sponsors. The researchers are employees of Akershus University Hospital, which is an enterprise within the Regional Health Enterprise. Research papers are not subject to control by the administration.
Competing interests None.
Ethics approval The study was approved by the Regional Committee for Medical Research Ethics of south-east Norway (1.2007.356), and privacy measures were accepted by the privacy ombudsman for research in Norwegian universities (NSD approval 16423/2007).
Provenance and peer review Not commissioned; externally peer reviewed.
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