Regulations

AHRPO maintains regulatory oversight of human subjects research within the Army, in accordance with several statutory and regulatory guidelines. Key provisions are indexed below.

Federal Regulations:

Title 21, Parts 50, 56, 312, 314, 600, 812 and 814 Food & Drug Administration (FDA) 

Title 32, Part 219 Protection of Human Subjects also known as the Common Rule (2018)                         

Title 48, Part 252.235-7004 and Part 207.172 Defense Federal Acquisition Regulations

Title 45, Part 46, Subpart B Additional Protections for Pregnant Women, Human Fetuses, and Neonates Involved in Research (2001) 

Title 45, Part 46, Subpart C Additional Protections Pertaining to Biomedical and Behavioral Research Involving Prisoners as Subjects (1978) 

Title 45, Part 46, Subpart D Additional Protections for Children Involved as Subjects in Research (1983) 

Title 45, Part 46, Subpart E Registration of Institutional Review Boards (2009) 

United States Code Section 980 of Title 10 Limitation on Use of Humans as Experimental Subjects (2001) 

Department of Defense Regulations:

DoD Instruction 3216.02, Protection of Human Subjects and Adherence to Ethical Standards in DoD-Conducted and –Supported Research (2020)

Army Regulations:

AR 70-25 Use of Volunteers as Subjects of Research (In Revision)