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Informed Consent

Overview

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).

Policy

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).

Authority

Pursuant to HHS and FDA regulations, the following information must be provided to each person who agrees to participate in research (subject):

1. A statement that the clinical study involves research, an explanation of the purposes of the Research and the expected duration of the human subject’s participation, a description of the procedures to be followed, and identification of any procedures that are experimental;

2. A description of any reasonably foreseeable risks and discomforts to the human subject;

3. A description of any benefits to the human subject or others to be reasonably expected from the research;

4. A disclosure of any appropriate alternative procedures or courses of treatment that might be advantageous for the human subject;

5. A statement describing the extent to which confidentiality of records identifying the human subject will be maintained, and noting the possibility that the FDA may inspect the records;

6. For research involving more than minimal risk, an explanation as to whether any compensation, and an explanation as to whether any medical treatments are available, if injury occurs and, if so, what they consist of, or where further information may be obtained.

7. An explanation as to whom to contact for answers to pertinent questions about the research and the human subject’s rights, and whom to contact in the event of a research related injury to the subject;

8. A statement that participation is voluntary, refusal to participate will involve no penalty or loss of benefits to which the subject is otherwise entitled, and the subject may discontinue participation at any time without penalty or loss of benefits, to which the subject is otherwise entitled; and

9. When appropriate, one or more of the following elements of information shall be provided to each subject: a. A statement that the particular treatment or procedure may involve risks to the subject (or to the embryo or fetus, if the subject is or may become pregnant) which are currently unforeseeable. b. Anticipated circumstances under which the human subject’s participation may be terminated by the investigator without regard to the subject’s consent. c. Additional costs to the subject that may result from participation in the research. d. The consequences of a subject’s decision to withdraw from the research and procedures for orderly termination of participation by the subject. e. A statement that significant new findings developed during the course of the research which may relate to the subject’s willingness to continue participation f. The approximate number of human subjects involved in the study

Excerpt from Teresa M. Williams et al., INSTITUTIONAL REVIEW BOARDS: A PRIMER 21-22 (2007).