The Belmont Report, identifies that the ethical principle of respect for a research participant begins with the informed consent process. The IIRB, Inc. review process includes assessment of the site’s informed consent procedures so as to verify compliance with this ethical principle.

Sites are required to have policies and procedures that guide the Informed Consent Process. The IIRB, Inc. has developed an outline of the privacy and confidentiality elements that are necessary for inclusion in the informed consent process.

Click here to view these elements in the Investigator’s Guidebook.