Kompanje E J O, Maas A I R, Hilhorst M T, Slieker F J A, Teasdale G M
Department of Neurosurgery, Erasmus MC University Medical Center Rotterdam, The Netherlands.
Acta Neurochir (Wien). 2005 Jun;147(6):633-9; discussion 639-40. doi: 10.1007/s00701-005-0525-3. Epub 2005 Apr 7.
Therapeutic trials in TBI are subject to principles of Good Clinical Practice (GCP), to national legislation, and to international and European ethical concepts and regulations [e.g. 13]. The guiding principles underlying these investigations of treatment are respect for autonomy of research subjects, protection against discomfort, risk, harm and exploitation and the prospect of some benefit. Patients with significant TBI are mentally incapacitated, thus prohibiting obtaining consent directly from the subject. Various approaches to consent procedures are used as surrogate to subject consent: proxy consent, consent by an independent physician and waiver of consent. These approaches are reviewed. A questionnaire soliciting opinions was mailed to 148 EBIC (European Brain Injury Consortium) associated neuro-trauma centers in 19 European countries. 48% respondents believe that relatives were not able to make a balanced decision, 72% believed that consent procedures are a significant factor causing decrease in enrollment rate and 83% stated that consent procedures delay initiation of study treatment, resulting in possible harm if the agent has shown to be effective. 64% of the respondents considered TBI an emergency situation in which clinical research could be initiated under the emergency exception for consent. In new European legislation, emergency research under waiver of consent is not permitted. Nevertheless, we consider that randomising patients with TBI into carefully evaluated trial protocols without prior consent may be considered ethically justified.
创伤性脑损伤（TBI）的治疗试验需遵循《药物临床试验质量管理规范》（GCP）原则、国家法律以及国际和欧洲的伦理观念与法规[如文献13]。这些治疗研究的指导原则包括尊重研究对象的自主权、保护其免受不适、风险、伤害和剥削以及有望获得某种益处。重度TBI患者精神上无行为能力，因此禁止直接从患者本人获取同意。同意程序采用了各种替代患者同意的方法：代理同意、独立医生同意和同意豁免。对这些方法进行了综述。向19个欧洲国家的148个与欧洲脑损伤协会（EBIC）相关的神经创伤中心邮寄了一份征求意见问卷。48%的受访者认为亲属无法做出权衡决策，72%的受访者认为同意程序是导致入组率下降的一个重要因素，83%的受访者表示同意程序会延迟研究治疗的启动，如果药物已证明有效则可能造成伤害。64%的受访者认为TBI是一种紧急情况，可根据同意的紧急例外情况启动临床研究。在新的欧洲立法中，不允许在豁免同意的情况下进行紧急研究。然而，我们认为，在未经事先同意的情况下将TBI患者随机纳入经过仔细评估的试验方案在伦理上可能是合理的。
