Human Research Protection Program (HRPP)

Research is usually conducted to answer a question or to determine if one method is better than another. While the research is under way, the answer to the question of which method is better is not known.

Research conducted by DEVCOM ARL employees and contractors ensures that methods, technologies and systems are fully capable of operating during all the tactics, techniques and procedures (TTPs) for which they will be used.

The Human Research Protection Program (HRPP) provides oversight for all research activities involving human subjects at DEVCOM ARL. Before a research study can start, scientists and engineers develop a plan for their research. The plan (protocol and test plan) is first reviewed by the Human Research Protection Program to determine if the research involves human participants, directly or indirectly. If there is human participation, a review is then conducted by the DEVCOM ARL Institutional Review Board (IRB).

The purpose of the DEVCOM ARL Institutional Review Board (IRB) is to ensure the safe and ethical treatment of humans as subjects in research. In accordance with federal and DEVCOM ARL regulations, it is required that the IRB review all research involving human subjects prior to the initiation of the protocol.

The purpose of the DEVCOM ARL IRB is to ensure the safe and ethical treatment of humans as subjects in research. In accordance with federal and DEVCOM ARL regulations, it is required that the IRB review all research involving human subjects prior to the initiation of the protocol.

The IRB is made up of scientists, engineers, medical professionals and non-scientists. Its duty is to ensure the protection of people enrolled in research studies. If the IRB does not approve a study, a study cannot start. All studies involving human participants conducted by ARL employees must be reviewed and approved by the DEVCOM ARL IRB.

The Principal Investigator (researcher) is required to return to the IRB any time there is a change and report the progress of the study at least annually. The consent form is reviewed by the IRB to ensure that it contains complete information and that it is written so that it can be understood by people unfamiliar with research terms.

The DoD funds external research and receiving approval to conduct research from your local organization (such as universities or labs) is required. There is an ADDITIONAL HRPO review that is required after receiving local IRB approval that must be completed prior to the start of spending DoD funds.

To satisfy the regulations in the DODI all DoD supported research must be reviewed by DEVCOM ARL. This includes research conducted by non-DoD organizations that are receiving financial, equipment, facilities or DoD personnel support. All documents submitted to the non-DoD organization’s IRB for review must also be sent to DEVCOM ARL for review after the PI has received approval from the non-DoD IRB. Research cannot begin until both reviews have been completed. Submit these documents and DEVCOM ARL’s HRPO Form 401 to: usarmy.apg.devcom.mbx.arl-irb-office@army.mil

All documents submitted to your non-DoD organization’s IRB in order to receive approval should also be submitted to the ARL HRPP office. In addition, complete the DEVCOM ARL HRPO Form 401. At minimum, submit the following documents for studies under IRB oversight:

It is an agreement between engaged institutions for the single IRB review for a research study. The agreement is made between the institutions for one or more institutions to cede review to another institution that is not organizationally or legally part of the institution. DOD calls these agreements Institutional Agreement for Institutional Review Board (IRB) Review (IAIR).

Documentation of Scientific Review means the project must be reviewed for scientific merit by independent subject matter expert(s).

Three possible ways this can be done are:

Once you have all the required documents and the completed DEVCOM ARL HRPP FM 401, please contact the HRPP email with these documents attached: usarmy.apg.devcom.mbx.arl-irb-office@army.mil. Due to email file size limitations, you may be required to submit via a DoD SAFE site.

Please give the HRPP office two business days to respond to your submission. Upon response you will receive an ARL tracking number. This number will be used for the lifespan of your project at the ARL HRPP level. If you do not receive an email response with this tracking number and additional information after two business days, please contact the office again for confirmation that your email was received.

Yes. All changes to the study must be submitted to the IRB prior to their implementation. For projects conducted by DoD personnel, submit an amendment and all revised documents (both Tracked and Clean versions) to the ARL HRPP Office for review. For projects support by the DoD, submit the amendment to your IRB of record. Once you receive local IRB approval submit the revised documents and the IRB approval to the ARL HRPP Office for review.