General Requirements for Informed Consent

Except as provided elsewhere in this policy, no investigator may involve a human being as a subject in research covered by these regulations unless the investigator has obtained the legally effective informed consent of the subject or the subject's legally authorized representative. An investigator shall seek such consent only under circumstances that provide the prospective subject or the representative sufficient opportunity to consider whether or not to participate and that minimize the possibility of coercion or undue influence. The information that is given to the subject or the representative shall be in language understandable to the subject or the representative. No informed consent, whether oral or written, may include any exculpatory language through which the subject or the representative is made to waive or appear to waive any of the subject's legal rights, or releases or appears to release the investigator, the sponsor, the institution or its agents from liability for negligence. (sec. 45 CFR 46.116)

Except as ... [modified by the IRB], in seeking informed consent the following information shall be provided to each subject:

(1)

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;

(2)

A description of any reasonably foreseeable risks or discomforts to the subject;

(3)

A description of any benefits to the subject or to others which may reasonably be expected from the research;

(4)

A disclosure of appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the subject;

(5)

A statement describing the extent, if any, to which confidentiality of records identifying the subject will be maintained;

(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 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; and

(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.

• Additional Elements of Informed Consent
• Research
• Documentation of Informed Consent

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