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Elements of Informed Consent Described in Federal Regulations

The eight basic required elements of informed consent can be found in the HHS regulations (45 CFR 46.116)

These elements include:

• A statement that the study involves research, an explanation of the purposes of the research and the expected duration of the subject's participation, a description of the procedures to be followed, and identification of any procedures which are experimental.
• A description of any reasonably foreseeable risks or discomforts to the subject.
• A description of any benefits to the subject or to others which may reasonably be expected from the research.
• A disclosure of appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the subject.
• A statement describing the extent, if any, to which confidentiality of records identifying the subject will be maintained.
• For research involving more than minimal risk, an explanation as to whether any compensation or any medical treatments are available if injury occurs and, if so, what they consist of, or where further information may be obtained.
• An explanation of whom to contact for answers to pertinent questions about the research and research subjects' rights, and whom to contact in the event of a research-related injury to the subject.
• 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.

The regulations (45 CFR 46.116) also suggest inclusion of the following elements where appropriate:

• 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.
• Anticipated circumstances under which the subject's participation may be terminated by the investigator without regard to the subject's consent.
• Any additional costs to the subject that may result from participation in the research.
• The consequences of a subject's decision to withdraw from the research and procedures for orderly termination of participation by the subject.
• A statement that significant new findings developed during the course of the research which may relate to the subject's willingness to continue participation will be provided to the subject.
• The approximate number of subjects involved in the study.

Study investigators are not limited to including the 14 elements listed above. Any information that might be useful for the individual as he or she decides whether or not to take part in the study should be included. Furthermore, an institution's Institutional Review Board (IRB) may require additional elements that are not specifically listed in the regulations to ensure that adequate information is presented in accordance with institutional policy and law.

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Last Updated: May 19, 2012