Vulnerable subject

Vulnerable subjects, such as minors, incapacitated adults or people in a dependent position, need extra protection in consent and in ethics committee review.

individuals who are unable to fully understand all aspects of the investigation that are relevant to the decision to participate, or who could be manipulated or unduly influenced as a result of a compromised position, expectation of benefits or fear of retaliatory response

ISO 14155:2020, clause 3.55