What is an alteration of an authorization?

An alteration allows an investigator to have any of the 6 specific core elements or 3 required statements removed from the requirement of HIPAA authorization. For example, a study has been approved with a waiver of documentation of consent. In order for participants to not have to sign an authorization, the investigator or sponsor will need to request an alteration in order to remove the HIPAA requirement to obtain the signature of the individual and date.