The conduct of clinical trials involving subjects incapable of giving their consent and in the absence of a legal representative increasingly concern ethics committees. The problem has been addressed by the Council of Europe’s Convention on Human Rights and Biomedicine (1997), which has established a system of safeguards to protect uncapacitated subjects, including adult subjects without an available legal representative. On the one hand, clinical trials, including clinical trials in emergency situations, are necessary for the development of new medical procedures for those specific situations. On the other hand, clinical trials can not violate the requirement of informed consent by the patient or by his/her legal representative. However, in emergency situations it is often impossible to obtain the consent of the patient (for instance, in patients with traumatic brain injury or dementia patients) and no legal representative is available. In a context of legal uncertainty, ethics committees have developed concrete proposals that are already being used in practice. The current situation has led the Italian National Bioethics Committee to adopt a statement on this topic.
Aspectos éticos de los ensayos clinicos en situaciones de emergencia
MARRANI, DANIELA
2015-01-01
Abstract
The conduct of clinical trials involving subjects incapable of giving their consent and in the absence of a legal representative increasingly concern ethics committees. The problem has been addressed by the Council of Europe’s Convention on Human Rights and Biomedicine (1997), which has established a system of safeguards to protect uncapacitated subjects, including adult subjects without an available legal representative. On the one hand, clinical trials, including clinical trials in emergency situations, are necessary for the development of new medical procedures for those specific situations. On the other hand, clinical trials can not violate the requirement of informed consent by the patient or by his/her legal representative. However, in emergency situations it is often impossible to obtain the consent of the patient (for instance, in patients with traumatic brain injury or dementia patients) and no legal representative is available. In a context of legal uncertainty, ethics committees have developed concrete proposals that are already being used in practice. The current situation has led the Italian National Bioethics Committee to adopt a statement on this topic.I documenti in IRIS sono protetti da copyright e tutti i diritti sono riservati, salvo diversa indicazione.
