Informed consent in surgical trials

All participants must provide a valid consent to surgical clinical trials. A valid consent requires patient capacity, adequate disclosure of informati on, and voluntariness. Capacity is the ability to understand information re levant to making a decision and to appreciate the reasonably foreseeable co nsequences of a decision or lack of decision. To protect vulnerable persons , an incapable person should not be enrolled in most clinical trials. The o nly exception is if the study can only be conducted on incapable persons. I f the willing research participant is incapable, consent must be obtained f rom others through a process called substitute (or proxy) consent. Disclosu re refers to the provision of relevant information to the patient and its c omprehension by the patient. Most surgical trials carry more than minimal r isks, so the requirement for careful disclosure of these risks to potential participants is generally stringent. Voluntariness refers to the freedom o f a person to make a treatment decision. In specific circumstances related to emergency research, the requirement for consent may be waived. Waiver ca n be justified only if the delay required to obtain consent would prevent t he research from occurring and only after prior consultation with from the "community" of potential research participants.