Informed Consent Policy
An investigator may involve a human subject in research only if the investigator has obtained the legally effective and 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 investigator must provide the information to the subject or representative in a written format that uses language understandable to the subject or representative. The investigator cannot include in the consent process, either through written or oral information, any exculpatory language through which the subject or 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.