Informed Consent
The IRB must approve the informed consent prior to study initiation and often the CRC is liaison between the IRB and the sponsor. The sponsor will have set requirements of the informed consent as does the IRB. Each local IRB is responsible for the review and approval of the informed consent, but the CRC is responsible for the communication between the IRB and the sponsor. ยง46.116 of the Code of Federal Regulations outlines the elements of informed consent as:
Read more about this topic: Clinical Research Coordinator, Responsibilities
Famous quotes containing the words informed and/or consent:
“Where people wish to attach, they should always be ignorant. To come with a well- informed mind, is to come with an inability of administering to the vanity of others, which a sensible person would always wish to avoid. A woman especially, if she have the misfortune of knowing any thing, should conceal it as well as she can.”
—Jane Austen (1775–1817)
“It is but too easy to establish another durable and harmonious routine. Immediately all parts of nature consent to it. Only make something to take the place of something, and men will behave as if it was the very thing they wanted.”
—Henry David Thoreau (1817–1862)