Human subjects safety

New Rules on Classified Human Subject Research at the Dept of Energy

The Department of Energy last month issued new guidance on the conduct of classified scientific research involving human subjects.

While all human subject research is governed by federal regulations, the new DOE policy imposes several additional requirements whenever such research is to be performed on a classified basis.

For example, the proposed classified research must be reviewed and approved in advance by an Institutional Review Board, and the Board must include a non-scientist member and a member who is not a governmental employee (though he or she must hold a security clearance for this purpose). Also, the normal requirement for informed consent by the human subject cannot be waived.