Post-recruitment confirmation of informed consent by SMS
- 1HØKH, Research Centre, Akershus University Hospital, Lørenskog, Norway
- 2Faculty Division Akershus University Hospital, Faculty of Medicine, University of Oslo, Norway
- Correspondence to Dr Pål Gulbrandsen, HØKH, Research Centre, Akershus University Hospital, Mail drawer 95, Lørenskog 1478, Norway; pal.gulbrandsen{at}ahus.no
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Contributors PG is the guarantor of the study. He was the lead investigator of the randomised controlled trial and wrote the paper. He approves the final version. BFJ is a PhD student who collected most of the data in the trial and all data for this paper. He revised the paper for important intellectual content and approved the final version.
- Received 17 September 2009
- Revised 27 October 2009
- Accepted 5 November 2009
- Published Online First 4 February 2010
Abstract
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.
Footnotes
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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.
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Competing interests None.
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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).
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Provenance and peer review Not commissioned; externally peer reviewed.
