HØKH, Research Centre, Akershus University Hospital, Mail drawer 95, Lørenskog 1478, Norway.
J Med Ethics. 2010 Feb;36(2):126-8. doi: 10.1136/jme.2009.033456.
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.
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.
553 patients were approached, 530 (95.8%) gave initial consent, eight of these later regretted their consent.
The low level of regrets suggests this is an acceptable procedure for patients.
The RCT was registered before initiation - registration # ISRCTN22153332.
为了让患者有时间思考是否参与临床试验，指南建议从告知患者有关试验信息到其同意参与的时间间隔为 24 小时。但在某些临床环境下，这可能会影响招募效果。
在进行口头和书面的试验信息告知后，患者会签署同意书，而他们将在 24 小时后再次被询问是否确认或后悔该决定。该程序可以通过短信完成。调查人员必须记录回复。该程序已在一项研究中进行尝试，在该研究中，医生被随机分配接受临床沟通技巧课程，并且在课程前后对患者的就诊情况进行录像。
共接触了 553 名患者，其中 530 名（95.8%）最初同意参与，其中 8 名后来后悔了他们的同意。
低后悔率表明这对患者来说是一种可接受的程序。
该 RCT 在开始前进行了注册-注册号为 ISRCTN22153332。
