UNCLASSIFIED//
R 232007Z JAN 08
FM SECNAV WASHINGTON DC
TO ALNAV
BT
UNCLAS
ALNAV 004/08
MSGID/GENADMIN/SECNAV WASHINGTON DC/-/JAN// 
REF/A/SECNAVINST 3900.39D// 
AMPN/REF A IS THE HUMAN RESEARCH PROTECTION PROGRAM// 
SUBJ/COMPLIANCE WITH THE DEPARTMENT OF THE NAVY HUMAN RESEARCH 
PROTECTION PROGRAM (DON HRPP)// 
RMKS/1.  HUMAN SUBJECT RESEARCH IS CRITICAL TO SUPPORT THE WARFIGHTER 
AND NAVY AND MARINE CORPS OPERATIONAL CAPABILITY. OPERATIONAL UNITS, 
TRAINING, MEDICAL, MANPOWER AND PERSONNEL, AND RESEARCH, DEVELOPMENT, 
TEST AND EVALUATION (RDT&E) ACTIVITIES CONDUCT HUMAN SUBJECT RESEARCH 
TO ENHANCE MISSION EFFECTIVENESS.
2.  HUMAN SUBJECT RESEARCH MAY BE INVOLVED IN THE DEVELOPMENT, TESTING, 
OR EVALUATION OF ANY ITEM, SYSTEM, VEHICLE, AIRCRAFT, PIECE OF 
EQUIPMENT OR OTHER MATERIAL, EVEN IF A PERSON IS NOT THE DIRECT OBJECT 
OF THE RESEARCH.  TRAINING EXERCISES ASSOCIATED WITH TESTING PERSONAL 
PROTECTIVE EQUIPMENT WORN BY PERSONNEL AND STUDIES OF THE BIOEFFECTS OF 
WEAPON SYSTEMS ALSO ARE EXAMPLES OF RESEARCH WITH HUMAN SUBJECTS.
3.  IN RESPONSE TO A DOD-WIDE INITIATIVE TO RAISE AWARENESS OF AND 
IMPROVE COMPLIANCE WITH HUMAN RESEARCH PROTECTIONS, THIS OFFICE ISSUED 
REVISED GUIDANCE (REF A) REGARDING RESEARCH INVOLVING HUMAN SUBJECTS.  
THE SURGEON GENERAL (SG) OF THE NAVY IS THE SINGLE POINT OF 
ACCOUNTABILITY FOR THE DON HRPP, AND THE CHIEF OF NAVAL RESEARCH 
PROVIDES SUPPORT AND EXPERTISE TO THE SG FOR MONITORING AND OVERSIGHT 
OF NON-MEDICAL RDT&E ACTIVITIES, NAVY AND MARINE CORPS SYSTEMS COMMANDS, 
OPERATIONAL FORCES, TRAINING COMMANDS, AND NAVY-SUPPORTED EXTRAMURAL 
INSTITUTIONS.
4.  ALL RESEARCH INVOLVING HUMAN SUBJECTS CONDUCTED BY NAVAL ACTIVITIES 
OR NAVAL PERSONNEL OR SUPPORTED BY NAVAL ACTIVITIES BY ANY MEANS, 
INCLUDING GRANTS, CONTRACTS, COOPERATIVE AGREEMENTS, OR OTHER 
ARRANGEMENTS MUST COMPLY WITH REF A.  NO RESEARCH WITH HUMAN SUBJECTS 
MAY BE CONDUCTED UNLESS IT MEETS THE REQUIREMENTS OF THIS INSTRUCTION.
5.  COMMANDERS, COMMANDING OFFICERS, AND OFFICERS-IN-CHARGE ARE 
RESPONSIBLE FOR ENSURING THAT ALL PERSONNEL WHO MAY BE INVOLVED IN THE 
REVIEW, APPROVAL, SUPPORT, OVERSIGHT, OR CONDUCT OF RESEARCH WITH HUMAN 
SUBJECTS ARE FAMILIAR WITH AND COMPLY WITH REF A.
6.  COMMANDERS, COMMANDING OFFICERS, AND OFFICERS-IN-CHARGE OF ALL 
COMMANDS AND ACTIVITIES ARE DIRECTED TO REPORT TO FLEET AND ECHELON II 
ACTIVITIES WHETHER THEY ARE OR MAY BE CONDUCTING RESEARCH WITH HUMAN 
SUBJECTS.  WHEN IN DOUBT ASSUME REF A APPLIES.
7.  FLEET AND ECHELON II ACTIVITIES SHALL COORDINATE AND CONSOLIDATE 
INDIVIDUAL COMMAND RESPONSES FROM THEIR SUBORDINATE COMMANDS.  
CONSOLIDATED RESPONSES CONSISTING OF A LIST OF COMMANDS/ACTIVITIES 
CONDUCTING HUMAN SUBJECT RESEARCH AND COMMAND POINTS OF CONTACT SHALL 
BE SENT VIA EMAIL WITHIN 45 DAYS TO DONHRPP.INFO-AT-NAVY.MIL.  
ADDITIONAL INFORMATION ABOUT THE DON HRPP CAN BE FOUND AT THE DON HRPP 
AND OFFICE OF NAVAL RESEARCH (ONR) WEBSITES 
HTTP://NAVYMEDICINE.MED.NAVY.MIL/HUMANRESEARCH/ OR 
HTTP://WWW.ONR.NAVY.MIL/SCI_TECH/34/343/.
8.  THE DEPARTMENT OF THE NAVY IS COMMITTED TO THE ETHICAL AND 
RESPONSIBLE CONDUCT OF HUMAN SUBJECT RESEARCH.  I AM CONFIDENT THAT 
THROUGH COMMAND LEADERSHIP WE WILL SUCCEED IN ENSURING THE SAFETY AND 
WELFARE OF ALL PERSONS INVOLVED IN NAVAL RESEARCH.
9.  RELEASED BY THE HONORABLE DONALD C. WINTER, SECRETARY OF THE 
NAVY.//

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