Etchells E
Department of Medicine, Division of General Internal Medicine and Clinical Epidemiology, The Toronto Hospital, University of Toronto, 200 Elizabeth Street, Eng-248, Toronto, Ontario M5G 2C4, Canada.
World J Surg. 1999 Dec;23(12):1215-9. doi: 10.1007/s002689900650.
All participants must provide a valid consent to surgical clinical trials. A valid consent requires patient capacity, adequate disclosure of information, and voluntariness. Capacity is the ability to understand information relevant to making a decision and to appreciate the reasonably foreseeable consequences of a decision or lack of decision. To protect vulnerable persons, an incapable person should not be enrolled in most clinical trials. The only exception is if the study can only be conducted on incapable persons. If the willing research participant is incapable, consent must be obtained from others through a process called substitute (or proxy) consent. Disclosure refers to the provision of relevant information to the patient and its comprehension by the patient. Most surgical trials carry more than minimal risks, so the requirement for careful disclosure of these risks to potential participants is generally stringent. Voluntariness refers to the freedom of a person to make a treatment decision. In specific circumstances related to emergency research, the requirement for consent may be waived. Waiver can be justified only if the delay required to obtain consent would prevent the research from occurring and only after prior consultation with from the "community" of potential research participants.
所有参与者必须提供有效的手术临床试验同意书。有效的同意书需要患者具备行为能力、充分披露信息以及自愿性。行为能力是指理解与做决定相关信息并认识到决定或不做决定可能产生的合理可预见后果的能力。为保护弱势群体，无行为能力者通常不应纳入大多数临床试验。唯一的例外是该研究只能在无行为能力者身上进行。如果愿意参与研究的受试者无行为能力，必须通过一种称为替代（或代理）同意的程序从他人处获得同意。披露是指向患者提供相关信息并确保患者理解这些信息。大多数外科手术试验的风险超过最小风险，因此向潜在参与者仔细披露这些风险的要求通常很严格。自愿性是指个人做出治疗决定的自由。在与紧急研究相关的特定情况下，同意要求可能会被豁免。只有在获得同意所需的延迟会阻碍研究进行且事先与潜在研究参与者的“群体”进行磋商之后，豁免才是合理的。
