RESUMEN
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.
