ALARACT 041/2025 REQUIREMENTS FOR ARMY HUMAN RESEARCH PROTECTIONS OFFICE OVERSIGHT OF HUMAN SUBJECTS RESEARCH CONDUCTED AND/OR SUPPORTED BY THE DEPARTMENT OF THE ARMY

2. (U) SITUATION: IN ACCORDANCE WITH REFERENCE 1.B., THE DEPARTMENT OF THE ARMY (DA) COMPONENT OFFICE FOR HUMAN RESEARCH PROTECTIONS (COHRP) IS THE ARMY HUMAN RESEARCH PROTECTIONS OFFICE (AHRPO). UNDER THE AUTHORITY, DIRECTION, AND CONTROL OF THE SURGEON GENERAL, AHRPO IS THE PROPONENT FOR HUMAN RESEARCH PROTECTIONS POLICY, EDUCATION, AND COMPLIANCE OVERSIGHT TO ENSURE THAT APPLICABLE DA INSTITUTIONS, ARMY COMMANDS (ACOMs), ARMY SERVICE COMPONENT COMMANDS (ASCCs), DIRECT REPORTING UNITS (DRUs), ARMY NATIONAL GUARD, U.S. ARMY RESERVE, AND EXECUTIVE AGENCIES (EAs) CONDUCTING, SUPPORTING, OR ASSISTING HUMAN SUBJECTS RESEARCH (HSR) OPERATE UNDER AN APPROVED HUMAN RESEARCH PROTECTION PROGRAM (HRPP) OR DIRECT AHRPO OVERSIGHT. SEE ATTACHMENT 1 FOR KEY DEFINITIONS APPLICABLE TO THIS MESSAGE. THIS MESSAGE DOES NOT APPLY TO THE DEPARTMENT OF DEFENSE (DOD) INSTITUTIONS OVERSEEN BY THE FOLLOWING COMPONENT OFFICES FOR HUMAN RESEARCH PROTECTIONS: 

2.A. (U) THE DEFENSE HEALTH AGENCY (DHA), OFFICE OF RESEARCH PROTECTIONS/DHA RESEARCH AND DEVELOPMENT, U.S. ARMY MEDICAL RESEARCH AND DEVELOPMENT COMMAND, OFFICE OF HUMAN AND ANIMAL RESEARCH OVERSIGHT. 

2.B. (U) THE DEPARTMENT OF THE AIR FORCE COHRP. 

2.C. (U) THE DEPARTMENT OF THE NAVY HRPP. 

2.D. (U) DEFENSE HUMAN RESOURCES ACTIVITY COHRP. 

2.E. (U) OTHER DOD COHRP.

3. (U) BACKGROUND: TO ENSURE DA COMPLIANCE WITH THE CORE ETHICAL PRINCIPLES FOR THE PROTECTION OF HUMAN SUBJECTS IN RESEARCH AND THE ADDITIONAL PROTECTIONS FOR DOD-AFFILIATED PERSONNEL WHO ARE ASKED TO PARTICIPATE IN RESEARCH, DOD IMPLEMENTS THE FEDERAL REGULATIONS FOR THE PROTECTION OF HUMAN RESEARCH SUBJECTS AT REFERENCES 1.A. AND 1.B. TO ALL RESEARCH ACTIVITIES CONDUCTED AND SUPPORTED BY THE DA. THIS INCLUDES RESEARCH, DEVELOPMENT, TESTING, AND EVALUATION ACTIVITIES THAT INVOLVE HUMANS, HUMAN DATA/INFORMATION, AND/OR BIOSPECIMENS REGARDLESS OF THE SOURCE OF FUNDING, SECURITY CLASSIFICATION OF THE RESEARCH, AGENCY OVERSEEING THE RESEARCH OR THE COMMAND STAFF, THE LOCATION OF THE RESEARCH IN THE UNITED STATES OR FOREIGN COUNTRY, OR A PROGRAM THAT INVOLVES SOME ACTIVITIES THAT DO NOT MEET THE DEFINITION OF RESEARCH. WITHOUT HRPP SUPPORT AND OVERSIGHT, DA INSTITUTIONS MAY UNKNOWINGLY INCREASE THE RISKS OF HARM TO RESEARCH SUBJECTS AND POTENTIAL FOR INSTITUTIONAL NON-COMPLIANCE WITH REFERENCE 1.B. WHEN ENGAGING IN HSR ACTIVITIES, TO INCLUDE FUNDING (FOR EXAMPLE: CONTRACTING, SPONSORING, MANAGING) AND COLLABORATION.

https://armypubs.army.mil/epubs/DR_pubs/DR_a/ARN43544-ALARACT_0412025-000-WEB-1.pdf