Incompetent Adults

It is important to recognize when a prospective subject is of questionable capacity to consent. If an investigator or designee either knows or suspects that a subject falls into this category, the researcher should determine whether the individual is competent to provide informed consent.

If the subject is not able to provide informed consent, then the investigator must determine whether there is either (1) a legally authorized representative for the subject and/or (2) a family member who is involved in decisions about his/her health and other important matters. Further guidance involving individuals with questionable capacity to consent is provided in the Research Manual.