OHRP requires that sites participating in NIH Cooperative Group multicenter clinical trial protocols submit to the UAB IRB the NIH-approved sample informed consent document with the full NIH-approved protocol as a condition for review and approval of the local informed consent document. The investigator may not delete or substantively change any information concerning risks or alternatives procedures contained in the sample informed consent document. If the investigator does, it must be justified in writing and approved by the IRB. The IRB is responsible for assuring that state and local laws, professional community standards, institutional policies and the needs of differing participant or participant subpopulations are reflected in the consent document.​