This regulation reflects the present legal requirements pertaining to the use of human subjects participating in clinical investigations and provides guidance for the administration and funding of clinical investigation programs. Excluding situations where approval authority is limited, the authority to approve CIs using human subjects can be delegated within the military chain of command to the lowest level operating a human subjects review process. It also prescribes the annual progress report. It allows a decentralized approval option for elements that have established review committees and an internal review process.
