Informed consent is the legal right of all adults, with no upper age limit, to make their own decisions regarding medical, financial, and daily living matters. Gillian I. Russell, Terminology, in FUNDAMENTALS OF HEALTH LAW 1, 22 (American Health Lawyers Association 5th ed., 2011).
The doctrine of informed consent has two components: first, that the right of a person to determine what may be done to her body includes the right to consent to medical care; and second, that true consent cannot be given unless the patient is given all relevant information and has an opportunity to evaluate the available risks involved. Therefore, if a physician or other healthcare professional renders medical treatment without a patient’s consent, it is actionable as a tort.
Generally, consent may be oral or written, although some state statutes provide for statutory presumptions that appropriate informed consent was obtained if state-dictated written-consent forms are complete. The responsibility to obtain informed consent historically has rested with the physician.
The legal standard for proper informed consent is the disclosure to the patient of:
1. the patient’s condition;
2. the nature of the proposed treatment;
3. the benefits reasonably expected from a proposed treatment, together with the material risks and dangers of the proposed treatment; and
4. treatment alternatives, as well as the risks and benefits of such alternatives.
Excerpt from Susan O. Scheutzow, Patient Care, in FUNDAMENTALS OF HEALTH LAW 59, 62-63 (American Health Lawyers Association 5th ed., 2011).
Pursuant to HHS and FDA regulations, the following information must be provided to each person who agrees to participate in research (subject):
Excerpt from Teresa M. Williams et al., INSTITUTIONAL REVIEW BOARDS: A PRIMER 21-22 (2007).