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:
“If people are informed they will do the right thing. It’s when they are not informed that they become hostages to prejudice.”
—Charlayne Hunter-Gault (b. 1942)
“Imagine that it is you yourself who are erecting the edifice of human destiny with the aim of making men happy in the end, of giving them peace and contentment at last, but that to do that it is absolutely necessary, and indeed quite inevitable, to torture to death only one tiny creature, the little girl who beat her breast with her little fist, and to found the edifice on her unavenged tears—would you consent to be the architect on those conditions?”
—Feodor Dostoyevsky (1821–1881)