Informed consent

Informed consent means the knowing consent of an individual or his legally authorized representative, so situated as to be able to exercise free power of choice without undue inducement or any element of force, fraud, deceit, duress, or other form of constraint or coercion. The basic elements of information necessary to such consent include:
(1) A fair explanation of the procedures to be followed, and their purposes, including identification of any procedures which are experimental;
(2) A description of any attendant discomforts and risks reasonably to be expected;
(3) A description of any benefits reasonably to be expected;
(4) A disclosure of any appropriate alternative procedures that might be advantageous for the subject;
(5) An offer to answer any inquiries concerning the procedures; and
(6) An instruction that the person is free to withdraw his consent and to discontinue participation in the investigation any time without prejudice to the subject.

Source

42 CFR § 85a.2

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Scoping language

Any term defined in the Occupational Safety and Health Act of 1970 or the Federal Mine Safety and Health Act of 1977 and not defined below shall have the meaning given it in the Acts. As used in this part:

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