For an individual to give valid informed consent, three components must be present:
While Disclosure requires the researcher to supply the subject with the information necessary to make an autonomous decision, the investigators must ensure that subjects have adequate comprehension of the information provided. This latter requirement implies that the consent form be written in lay language suited for the comprehension skills of subject population, as well as assessing the level of understanding during the meeting.
Capacity pertains to the ability of the subject to both understand the information provided and form a reasonable judgment based on the potential consequences of his/her decision.
Voluntariness refers to the subject’s right to freely exercise his/her decision making without being subjected to external pressure such as coercion, manipulation, or undue influence.