scope:

This instruction applies to the use of human subjects:

In all research conducted by naval activities or personnel, or supported by naval activities through any agreement (e.g., contract, grant, cooperative agreement, or other arrangement), regardless of the source of funding or site of performance.

In the development, testing or evaluation of any item, system, vehicle, aircraft, piece of equipment or other materiel, even if a person is not the direct object of the research. Examples include training exercises associated with the testing of personal protective equipment when worn by a person and the study of a new clinical laboratory test requiring freshly drawn blood.

This instruction does not apply to:

Efforts determined to be exempt per Section 101(b) of reference (a). For determination of exempt research, see paragraph 7g(1) of this instruction.

Purpose. To prescribe policy and assign responsibility concerning the use and protection of human subjects and assurance of their personal privacy rights in studies conducted by, within, or for the Department of the Navy (DON) per references (a) through (h).