Wager E, Tooley P J, Emanuel M B, Wood S F
Department of General Practice, University of Glasgow, Woodside Health Centre.
BMJ. 1995 Sep 16;311(7007):734-7. doi: 10.1136/bmj.311.7007.734.
Gaining patients' consent to enter clinical trials is essential, but not easy. Giving careful thought to the design of the study itself, information which patients receive, and the use of a signed consent form may all help. To be properly informed, patients need to know something about their condition, the proposed study, and alternative options. The type and amount of information will vary and investigators need to judge the level appropriate for each person. Patients should understand that taking part in a clinical trial is voluntary and that their decision will not affect the quality of care they receive. The process of obtaining consent requires time and good communication. Working with young, elderly, or mentally impaired patients, or those particularly vulnerable to coercion, requires special sensitivity to the potential dangers.
获得患者参与临床试验的同意至关重要，但并非易事。仔细考虑研究本身的设计、患者所获得的信息以及签署同意书的使用可能都会有所帮助。为了得到充分的信息，患者需要了解自己的病情、拟进行的研究以及其他选择。信息的类型和数量会有所不同，研究人员需要判断适合每个人的信息水平。患者应该明白参与临床试验是自愿的，而且他们的决定不会影响所接受治疗的质量。获得同意的过程需要时间和良好的沟通。与年轻、年老或有精神障碍的患者，或那些特别容易受到胁迫的患者合作时，需要对潜在风险格外敏感。
