Human Research Protection Program (HRPP)
Federal regulations (32 CFR 219 and DoDI 3216.02) require each institution that conducts or supports research involving human subjects must have a HRPP. Internal and external research involving human subjects must receive review and approval prior to initiating the project.
The primary mission of the U.S. Army Combat Capabilities Development Command (DEVCOM) Army Research Laboratory HRPP is to protect the safety, rights, and welfare of human subjects in research conducted under its purview. The HRPP ensures that all of DEVCOM ARL’s activities related to human subject research will be guided by the ethical principles set forth in the Belmont Report.
The ARL HRPP has a DOD assurance, #A10038, in accordance with applicable regulation. The Army Human Research Protection Office (AHRPO) provides oversight for the assurance.
Types of Reviews
Review by the DEVCOM ARL HRPP is required for all Human Subjects Research conducted by DEVCOM ARL investigators and when DEVCOM ARL provides support for research ($, facilities, equipment, CRADA, etc.).
Note for Collaborations: HRPOs are still required, even if DEVCOM ARL serves as the IRB of record. It is possible that the project is both an internal and external project.
Internal research conducted by DEVCOM ARL investigators must be reviewed by the DEVCOM ARL HRPP. Only an Exempt Determination Official from the DEVCOM ARL HRPP can determine if research is considered exempt. All non-exempt research is reviewed by the DEVCOM ARL Institutional Review Board (IRB) or a designated IRB member.
External research is any time DEVCOM ARL provides support for research (funding, facilities, equipment, CRADA, etc.) to a non-DoD institution. A Human Research Protection Official (HRPO) review is required for all external research. This includes review of exempt determinations. The HRPO review is a regulatory review only. It is not a secondary IRB review. Research may not begin until the study is approved by the HRPO.
Forms to Submit at Initial Review
- HRPO Review Submission
(version date 7/18/2019) - International Research Submission
(version date 7/18/2019) - FDA Submission
(version date 7/18/2019) - HRPO Secondary Research Involving the Use of Data/Specimens Submission
(version date 7/18/2019)
If you have further questions, contact your program manager or the DEVCOM ARL HRPP office:
usarmy.apg.devcom.mbx.arl-irb-office@army.mil
References
Guiding Principles
Department of Defense Resources
- 32CFR219 (DOD – Protection of Human Subjects)
- Protection of Human Subjects and Adherence to Ethical Standards in DoD-Supported Research Regulation Source: DoD Instruction 3216.02
- Research Integrity and Misconduct Regulation Source: DODI 3210.7
- Protection of Human Subjects “The Common Rule” Regulation Source: 45 CFR 46 (HHS Regulation)