The IRB determines, for each protocol it reviews, which of the following elements and disclosures must be included in the informed consent process. Investigators can avoid delay in the review process ...

The U.S. Food & Drug Administration (FDA) issued final guidance (Final Guidance) regarding informed consent titled “Informed Consent: Guidance for Institutional Review Boards, Clinical Investigators, ...

Informed consent is more than just a form; it is a process that actively involves the participant. It is an "ongoing exchange of information between the investigator and [participant]" per the OHRP.

Obtaining informed consent is a basic ethical obligation and a legal requirement for researchers. This requirement is founded on the principle of respect for persons. Potential participants must be ...

Failure to obtain informed consent can result in significant consequences Exceptions to informed consent apply only in limited circumstances Elements of valid informed consent include patient capacity ...