NIAID Regulatory Review for Intramural Protocol and Informed Consent or Assent Documents

As outlined in the National Institute of Allergy and Infectious Disease (NIAID) SOP on informed consent/assent documents, before an investigator submits an initial intramural protocol (investigational new drug [IND] and non-IND studies) and informed consent/assent documents to the NIAID Institutional Review Board (IRB), he or she must submit the protocol documents to the RCHSPP staff for a regulatory review. In addition, amendments to IND protocols must be submitted for regulatory review before they are submitted to the NIAID IRB office.