scope:

Purpose.

To establish policy and assign responsibility for the protection of human subjects in research conducted or supported by the Department of the Navy (DON) per Department of Defense (DoD) Instruction 3216.02, reference (a) and to implement reference (b) also known and hereinafter referred to as "the Common Rule", also subparts B through D of part 46 of Title 45, Code of Federal Regulations, reference (c) as implemented by reference (a). This instruction seeks to harmonize DON policy and procedures with those of the other Services and DoD Components. This instruction has been extensively rewritten and should be read in its entirety.

Applicability

a. This instruction applies to:

(1) All DON-conducted or -supported research involving human subjects as defined in enclosure (5) and discussed below. All such activities must include both systematic investigation designed to develop or contribute to generalizable knowledge and involve a living individual about whom an investigator conducting research obtains data through intervention or interaction with the individual or about whom identifiable private information is obtained. All activities meeting both of these conditions will hereinafter be referred t