R 171610Z SEP 08
MARADMIN 522/08
MSGID/GENADMIN/CMC WASHINGTON DC CDI//
SUBJ/COMPLIANCE WITH THE DEPARTMENT OF THE NAVY HUMAN RESEARCH PROTECTION PROGRAM (DON HRPP)//
REF/A/MSGID:SECNAVINST 3900.39D/-/-//
NARR/REF A IS SECNAVINST 3900.39D, HUMAN RESEARCH PROTECTION PROGRAM.//
GENTEXT/REMARKS/1. REF A ESTABLISHES POLICY AND ASSIGNS RESPONSIBILITY FOR THE PROTECTION OF HUMAN SUBJECTS IN RESEARCH CONDUCTED BY, WITHIN, OR FOR THE DEPARTMENT OF THE NAVY. THE INTENT OF THIS PROGRAM IS TO ASSURE, BOTH IN ADVANCE AND BY PERIODIC REVIEW, THAT APPROPRIATE STEPS ARE TAKEN TO PROTECT THE RIGHTS AND WELFARE OF HUMAN SUBJECTS PARTICIPATING IN A RESEARCH STUDY.  THIS MARADMIN IMPLEMENTS REF A WITHIN THE MARINE CORPS AND PROVIDES AMPLIFYING INFORMATION. FOR PURPOSES OF THE DON HRPP, RESEARCH IS DEFINED AS A SYSTEMATIC INVESTIGATION, INCLUDING RESEARCH, DEVELOPMENT, TESTING AND EVALUATION, DESIGNED TO DEVELOP OR CONTRIBUTE TO GENERALIZABLE KNOWLEDGE. THE INTENT OF THE PROGRAM IS TO ENSURE THAT ANY RESEARCH INVOLVING HUMAN SUBJECTS IS CONDUCTED WITH SPECIFIC CONSIDERATION OF THE SUBJECTS'
SAFETY AND WELFARE.  THIS INCLUDES THE RESPONSIBLE DISPOSITION OF PERSONALLY IDENTIFIABLE INFORMATION (PII) AND THE HANDLING OF ANY DATA ABOUT AN INDIVIDUAL'S BEHAVIOR THAT OCCURS IN A CONTEXT IN WHICH AN INDIVIDUAL CAN REASONABLY EXPECT THAT NO OBSERVATION OR RECORDING IS TAKING PLACE.  HUMAN SUBJECT RESEARCH ALSO INCLUDES THE USE OF INFORMATION WHICH HAS BEEN PROVIDED FOR SPECIFIC PURPOSES BY AN INDIVIDUAL AND WHICH THE INDIVIDUAL CAN REASONABLY EXPECT WILL NOT BE MADE PUBLIC.
2.  RESEARCH CONDUCTED OR SUPPORTED BY MARINE CORPS ACTIVITIES OR PERSONNEL MUST COMPLY WITH REF A.  THIS INCLUDES RESEARCH CONDUCTED AT MARINE CORPS FACILITIES OR RESEARCH CONDUCTED AT OTHER SITES INVOLVING MARINE CORPS OR OTHER DOD SUBJECTS.  RESEARCH CONDUCTED ON BEHALF OF THE MARINE CORPS (E.G., UNDER CONTRACT) IS NOT AN EXCEPTION TO THIS RULE.  ALL RESEARCH INVOLVING HUMAN SUBJECTS CONDUCTED BY MARINE CORPS ACTIVITIES OR MARINE CORPS PERSONNEL OR SUPPORTED BY MARINE CORPS ACTIVITIES BY ANY MEANS, INCLUDING GRANTS, CONTRACTS, COOPERATIVE AGREEMENTS, OR OTHER AGREEMENTS MUST COMPLY WITH REF A.
3.  THE PROGRAM APPLIES SPECIFICALLY TO THE FOLLOWING:
A.  ALL BIOMEDICAL AND PHYSIOLOGICAL RESEARCH.
B.  SOCIAL-BEHAVIORAL-EDUCATIONAL RESEARCH, INCLUDING SURVEYS.
EXCEPTIONS GENERALLY INCLUDE CUSTOMER SATISFACTION SURVEYS, QUALITY ASSURANCE, PROCESS IMPROVEMENT, STUDENT END-OF-COURSE CRITIQUES, AND LESSONS LEARNED.
C.  HUMAN RESEARCH CONDUCTED IN THE DEVELOPMENT, TESTING OR EVALUATION OF ANY ITEM, SYSTEM, VEHICLE, WATERCRAFT, AIRCRAFT, PIECE OF EQUIPMENT, OR OTHER MATERIEL, EVEN IF A PERSON IS NOT THE DIRECT OBJECT OF THE RESEARCH. 
D.  RESEARCH INVOLVING HUMAN SUBJECTS THAT ARE NOT US CITIZENS OR DOD PERSONNEL.  MARINE CORPS RESEARCH CONDUCTED OR SUPPORTED OUTSIDE THE UNITED STATES REQUIRES COMPLIANCE WITH REF A. 
4.  THE REQUIREMENTS OF THE DON HRPP ARE NOT SUSPENDED OR WAIVED DUE TO OPERATIONAL CONTINGENCY OR DURING TIMES OF NATIONAL EMERGENCY, EXCEPT BY EXPLICIT ACTION OF THE SECNAV. 
5.  THE HRPP DOES NOT REPLACE OR RELIEVE COMMANDERS FROM COMPLIANCE WITH HEALTH AND SAFETY DIRECTIVES AND REQUIREMENTS, SUCH AS OPERATIONAL RISK MANAGEMENT (ORM) ASSESSMENTS.
6.  COMMANDERS, COMMANDING OFFICERS, AND OFFICERS-IN-CHARGE ARE RESPONSIBLE FOR ENSURING THAT THE PROVISIONS OF REF A ARE IMPLEMENTED WITHIN THEIR COMMANDS.  AS DESCRIBED IN REF A, COMMANDERS OF ACTIVITIES THAT CONDUCT OR SPONSOR RESEARCH INVOLVING HUMAN SUBJECTS MUST APPLY TO THE NAVY SURGEON GENERAL (SG) FOR AN ORGANIZATIONAL ASSURANCE. AN ASSURANCE IS SIMILAR TO A LICENSE TO CONDUCT OR SPONSOR HUMAN SUBJECT RESEARCH AND A COMMANDERS CERTIFICATION TO COMPLY WITH REF A. 
7.  REF A PROVIDES FOR THE COMMAND-LEVEL ESTABLISHMENT OF INSTITUTIONAL REVIEW BOARDS (IRB) FOR SYSTEMATIC REVIEW OF RESEARCH PROTOCOLS.  AN IRB IS A COMMITTEE APPOINTED BY THE COMMANDER TO CONDUCT PROTOCOL REVIEW AND PROVIDE RECOMMENDATIONS TO THE COMMANDER.  COMMANDERS ALSO MAY UTILIZE ANY SG-APPROVED IRB FOR THIS PURPOSE. 
8.  COMMANDERS WILL ENSURE 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. 
9.  THE SG IS THE SINGLE POINT OF ACCOUNTABILITY FOR THE DEPARTMENT OF THE NAVY AND THE CHIEF OF NAVAL RESEARCH PROVIDES PROGRAM SUPPORT, INCLUDING ADVICE ON PROGRAM IMPLEMENTATION.  REFERENCE MATERIAL ON THE PROGRAM IS AVAILABLE AT WWW.ONR.NAVY.MIL/SCI_TECH/34/34C/.  QUESTIONS CONCERNING THE PROGRAM MAY BE REFERRED TO THE DON HRPP MARINE CORPS LIAISON, DR ANDY JONES, ANDY.JONES@NAVY.MIL 703-588-0612 OR DIRECTOR, RESEARCH PROTECTION DIVISION, OFFICE OF NAVAL RESEARCH, DR TIMOTHY SINGER, TIM.SINGER@NAVY.MIL 703-696-4038.  IN ADDITION, THEY ARE AVAILABLE FOR TRAINING, ADVICE, AND ON-SITE ASSISTANCE IN ESTABLISHING ORGANIZATIONAL ASSURANCES AND COMMAND-LEVEL IRBS. 
10.  RELEASED AUTHORIZED BY LTGEN GEORGE J. FLYNN, DEPUTY COMMANDANT FOR COMBAT DEVELOPMENT AND INTEGRATION.//