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Waiver from the Additional Requirements for Classified HSR

In certain cases, when classified projects can be fully reviewed in an unclassified form (e.g., because the protocol and consent form are unclassified), the IRB may submit, for consideration by the appropriate HSP Program Manager (and for intelligence-related HSR, also in consultation with the DOE Office of Intelligence and Counterintelligence), a request for a project-specific waiver from some or all of the additional requirements for classified HSR specified in Section 4.a.(14) of this Order. Such a waiver might be approved, for example, if only the sponsor or the ultimate use of a particular technology were classified, but everything else about the study were not. Note that even if a waiver from the additional requirements of classified HSR is approved for a particular project, all other Federal and DOE-specific HSR requirements must still be met.

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