Human subjects safety

DoD INSTRUCTION: Protection of Human Subjects and Adherence to Ethical Standards inDoD-Supported Research

 ... Research involving human subjects covered under this Instruction shall also comply with applicable Federal and State laws and regulations. When the research is conducted outside of the United States, it must also comply with applicable requirements of the foreign country and its national laws and requirements. In the event of an unresolved conflict between this Instruction, including its references, and other applicable laws and requirements such that compliance with both is impossible, the requirements most protective of the human subjects shall be followed. When there is an unresolved conflict, DoD Components shall consult with legal counsel and seek guidance from the Assistant Secretary of Defense for Research and Engineering (ASD(R&E)).

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.