Anonymous - Comment

Wow - Did anyone with background in IRBs and the protection of human subjects review the proposed language that is to be included in consent forms under the proposed rule? It is absolutely unintelligible! At a time when FDA, OHRP, and many others have been promoting improving readability and understandability of consent forms, this proposed rule seems completely counter-productive. The final rule should provide a description of what the element should include; allow investigators and IRBs to craft specific language appropriate to the expected subject population that addresses the new element, as is done with all of the other required elements of informed consent.