IDE Informed Consent

No clinical investigator may involve a human being as a subject in research unless the investigator has obtained the legally effective informed consent from the subject. Informed Consent is a written notification to human subjects involved in clinical investigations that provides them with sufficient opportunity to consider whether or not to participate in the study.

The informed consent document must include all the basic elements of informed consent or it may be a short form written consent document stating that the elements of informed consent have been presented orally. If the short form method is used, there must be a witness to the oral presentation.

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.

Criteria for exception from informed consent

There are special cases under emergency care research in which the human subject is in a life-threatening situation and it is not feasible to obtain informed consent. In order to allow such research to proceed, there are special provisions for exception from informed consent requirements.