Researchers using humans as research subjects must obtain the legally effective informed consent of the subject or the subject's legally authorized representative. The investigator must seek such consent only under circumstances that provide the prospective subject sufficient opportunity to consider whether or not to participate and that minimize the possibility of coercion. The information shall be conveyed in language understandable to the subject. No informed consent may include any language which appears to make the subject waive or appear to waive any legal rights, or releases or appears to release the investigator or the institution from liability for negligence.
Basic elements of informed consent:

(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 statement describing the extent, if any, to which confidentiality and/or anonymity of records identifying the subject will be maintained.

(5) 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;

(6) An explanation of whom to contact for answers to pertinent questions about the research and research subjects' rights. This should include both the lead investigator and the chair of HARRC.

(7) 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.