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 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 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 at DEVCOM ARL 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.

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:

1. Scientific review is incorporated into the IRB process and documented in IRB approval letter
2. SOP from the reviewing institution detailing the scientific review process
3. Completion of the DEVCOM ARL scientific review form by an independent subject matter expert

Sometimes sponsors pay volunteers for their time, information and samples needed for the research. Not all studies pay for participation.

You will not directly benefit from research conducted by DEVCOM ARL.

Military personnel must inform the Principal Investigator (PI) of their status. Special precautions will be taken so you can be recruited outside of the chain of command.

After you are asked to join and listen to all of the information about the study, you decide whether or not you wish to participate. You are under no obligation to participate in any study.

You must give voluntary permission in order to participate in a research study. You will not be a participant in a study without your knowledge and consent. You are under no obligation to participate in any research study. Your decision will not affect any potential benefits you may receive at DEVCOM ARL or from the U.S. Army.

A consent form is long because it is important for you to have all the information needed to make an informed decision. There will be time to answer your questions. You will receive a copy of the consent form after you sign it so that you may refer to it when needed.

The consent process will contain the following:

• An invitation to be part of the research and who will sponsor the study.
• An explanation of why the study is being done and a description of the study procedures.
• Information about who may participate in the study.
• Detailed information on any bad effects (risks) as well as any good effects (benefits) that may occur in the study.
• Identify who will have access to your personal information, and who will be able to use information obtained from the study.
• Identify who you may ask for more information about the study or about your rights as a participant in the research study.

You may change your mind at any time and leave the study. It will have no effect on your work, command or relationship with DEVCOM ARL.

The PI has overall responsibility for the study. Study staff may conduct some of the tasks associated with the study, such as making appointments, conducting the consent process and collecting information during the study.

• The PI is available to answer questions about the study.
• The DEVCOM ARL Human Protection Administrator is available to answer questions about your rights as a research subject.
• If you would like more information about how research is conducted, how it is overseen, or if you have questions about your rights as a research subject, please contact:
  usarmy.apg.devcom.mbx.arl-irb-office@army.mil