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Regulatory Compliance and Human Subjects Protection Branch (RCHSPB)

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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.

Last Updated February 07, 2008