This MAPP describes: (1) when an informed consent document (ICD) submitted under an investigational new drug application (IND) should be reviewed; (2) when the Center for Drug Evaluation and Research (CDER) should request that an ICD be submitted to an IND; and (3) procedures for reviewing an ICD.
This MAPP does not address consent for treatment INDs or exception from informed consent. The review of ICDs for those two regulatory scenarios is covered by procedures described in MAPP 6030.6 INDs: Processing Treatment INDs and Treatment Protocols and MAPP 6030.8 INDs: Exception From Informed Consent Requirements for Emergency Research.