Do all the individuals listed on the electronic IRQ have to be listed on the consent form?
No. It is not an IRB requirement to list the entire study staff on the consent form. At minimum, the PI must be listed on the consent form. Beyond that, we suggest no more than 5 of the people the subject is most likely to encounter during the conduct of the study. The IRB will accept as many names as you choose to put on the consent, or as many as your sponsor requires. Some industry sponsors prefer that only investigators who have filed the FDA Form 1572 be listed on the consent form. This is acceptable.
