IRB Policy: #10 Informed Consent Options, Processes, and Documentation

The IRB requires investigators to conduct an effective informed consent process with each and every potential human research participant or his or her legally authorized representative before the participant may be enrolled in a research study. The exceptions to this requirement are limited and must be approved by the IRB before the commencement of the study. Informed consent reflects the basic principle of respect for persons elaborated in the Belmont Report by ensuring that prospective participants understand the nature of the research in order to decide knowledgeably and voluntarily whether to participate. The elements required to be included in the informed consent process are enumerated in the consent form, which documents the informed consent process. While there are a few circumstances in which the IRB may grant a waiver or provide for an alternative to the informed consent process, the principle of obtaining legally effective informed consent is the standard for all research with human participants.