Informed consent (IC) is a fundamental legal and ethical tenet that requires three conditions for any valid intervention (diagnostic, therapeutic, preventive, or related to research): That the [Page 1146]participant (1) is provided with sufficient information to make an informed choice, (2) gives consent voluntarily, and (3) is competent to make a decision about involvement. Strictly speaking, requiring IC implies that no intervention or data gathering should take place until a potential participant has been informed about the purpose, nature, risks, and benefits of the intervention, and having acquired an adequate understanding of what the intervention entails has freely consented to it.

IC is predicated on the fundamental ethical principles of respect, beneficence (having the welfare of the participant as a goal), and nonmalfeasance (avoiding harm to ...