The protection for the rights and welfare of research subjects is an accepted service responsibility and a requirement under federal law (32CFR219).
Human subjects research and related matters, including Institutional Review Board (IRB) operations and supporting USMC commands to comply with federal law and DoD, DON, and USMC policies, are overseen by Human Subjects Protection Programs (HRPPs). The Marine Corps has three HRPPs, each of which is responsible for different functions. Each HRPP is led by an SES-level Institutional Official and has a primary point of contact (see Contact Us tab).
- The Manpower and Reserve Affairs (M&RA) HRPP is the primary contact for projects conducted by or funded by M&RA.
- The Systems Command (MCSC) HRPP is the primary contact for projects conducted by or funded by MCSC.
- The USMC HRPP is the contact for projects conducted by or funded by all other Marine Corps commands and for all projects by external performers that are not funded by the Marine Corps, but will use Marine Corps personnel, data, or assistance. The USMC HRPP also includes the USMC Institutional Review Board (IRB), which provides IRB services to all three HRPPs.
This is the USMC HRPP website. For definitive information about the M&RA and MCSC HRPPs, reach out to those offices.
The USMC HRPP operates under an institutional assurance approved by the Surgeon General of the U.S. Navy, registration number DoD N-40078 (expiration 30 Nov 2028).The USMC IRB's registration number is DON-IRB-00030 (expiration 30 Nov 2028).
Human research protection points of contact for various organizations and functions are listed below. If you are not sure of the right point of contact or do not have contact information for a listed individual, send an email to USMC_HRPP.FCT@usmc.mil and the staff of the USMC Human Research Protection Program will forward your message to the appropriate point of contact.
USMC HRPP and USMC IRB
- Projects conducted by USMC personnel:
- Applicability reviews/determinations for projects proposed by all Marine Corps organizations except M&RA and MCSC (see below).
- Exemption determinations for projects conducted by all Marine Corps organizations except M&RA and MCSC (see below) - USMC Exemption Determination Official (EDO) review
- Review and oversight of human subjects research conducted by USMC personnel through the USMC IRB.
- Projects conducted by external individuals/organizations:
- Review of projects funded by USMC organizations other than M&RA or MCSC (see below) – USMC Human Research Protection Official (HRPO) review.
- Review of projects not funded by the USMC, but involving USMC personnel or data– Administrative Review
Contacts – Dr. Kerry Fosher, Director | Ms. Yvette Bethune-Cherry, HRPP Specialist
Phone - Primary: 571-289-6448| Alternate: 703-853-6222
Email - USMC_HRPP.FCT@usmc.mil
M&RA HRPP
- Projects conducted by USMC personnel:
- Applicability reviews/determinations for projects conducted by M&RA personnel.
- Exemption determinations for projects conducted by M&RA personnel – M&RA EDO review (capability expected in Jan 2025).
- Facilitation of all M&RA human subjects research conducted under the oversight of the USMC IRB – M&RA IRB Vice Chair.
- Projects conducted by external individuals/organizations.
- Review of projects funded by M&RA – M&RA HRPO review.
Contact – Ms. Christina Ramirez
Website - M&RA HRPP
MCSC HRPP
- Projects conducted by USMC personnel:
- Applicability reviews/determinations for projects conducted by MCSC personnel
- Exemption determinations for projects conducted by MCSC personnel – MCSC EDO review (capability expected in FY24).
- Facilitation of all MCSC human subjects research conducted under the oversight of the USMC IRB – MCSC IRB Vice Chair.
- Projects conducted by external individuals/organizations:
- Review of projects funded by MCSC – MCSC HRPO review.
Contact – Mr. Mark Richter
Additional Points of Contact
The additional organizations listed below have Vice Chairs on the USMC IRB who may be able to assist researchers in their commands.
- Education Command/Marine Corps University
- Operations Analysis Division, CD&I
- Training and Education Command
APPLICABILITY REVIEW
The templates in this section should be used by all USMC commands except M&RA. Submitters from M&RA should use the templates in the following section.
Applicability review WORKSHEET / STUDY INFORMATION SHEET (M&RA ONLY)
The templates in this section should be used submitters from M&RA only. Submitters from all other USMC commands should use the templates in the previous section.
protocol submission
REPORT TEMPLATES
HRPO Review Templates
All persons engaged in the conduct or review of human subject research are required to complete ethics training.
For DON personnel, the training is offered without charge online through CITI. Training is valid for three years.
If unsure which course you must complete, contact the USMC HRPP for more information.
Collaborative Institutional Training Initiative (CITI) Registration Instructions
The instructions to register are:
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Go to the link above and click Select Your Organization Affiliation
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Type "Department of the Navy" in the dialog box and then agree to the terms of service, privacy policy, affirm your affiliation, and then click Create a CITI Program Account
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Enter your personal information and Continue to Step 3
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Create your user name and password and Continue to Step 4
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Enter the appropriate selections and Finalize Registration
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Enter the required information for Institutional Email, department, role, office phone, and Command. Under the Your Command drop-down menu, choose the appropriate command. Some commands do not have Marine Corps in front of them (Training and Education Command).
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Select the appropriate box or boxes. Most likely you will only need to select the first box.
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Click the box for Social and Behavioral Sciences
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Choose the appropriate role (IRB Administrator, Investigators, and Key Research Personnel)
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Begin your training!
Note: If you are a Marine or USMC civilian employee conducting research as part of your studies at a DoD or civilian school, please refer to the Student Research tab.
Marines, USMC civilian employees, and other military personnel assigned to USMC commands typically will have their projects reviewed by the USMC IRB. Individuals assigned to M&RA or MCSC should contact the M&RA HRPP or MCSC HRPP for more information - see Contact Us tab. All others should use the information below and the templates provided under the Application Materials tab and send their submissions to their organization's IRB Vice Chair or directly to the USMC IRB.
Is the project human subjects research?
The first stage in most projects is an Applicability Review to determine whether or not the project meets the definition of human subjects research in 32CFR219. Researchers and commands are not authorized to make this determination. It must be made by an authorized individual from the USMC IRB. Using one of the worksheets provided in the Applicability Review section under the Application Materials tab, provide the information we need to make the determination. Include attachments as needed. Formal documentation of the determination will be provided for your records.
Protocol submission
If your project is determined to be human subjects research, you will need to submit a full research protocol using the templates in the Protocol Submission section under the Application Materials tab. You must review the USMC HRPP Policy and Procedures (available under the References tab) before drafting your materials, as it includes guidelines for researchers and requirements for some protocol elements, such as informed consent agreements. We also strongly recommend consulting with your organization's vice chair or the IRB before submitting, as there is some variation in the types of information required based on the details of your research plans.
Amendments
If you need to make changes to your research plans, personnel, or any other aspect of your approved human subjects research protocol, you will need to submit an amendment. To request review of a proposed amendment, use the Action Request template and provide edited versions of whatever documents are being changed. To facilitate review of amendments that involve substantive changes to the protocol or informed consent document, we recommend that you provide one copy with tracked changes and one clean copy.
Reporting Problems
All researchers must be familiar with the requirements for addressing and reporting unanticipated problems, adverse events, and misconduct as set out in the USMC HRPP Policy and Procedures. During your research, if you encounter any such problems, immediately notify the IRB Chair so an appropriate course of action can be identified. In some cases, you may be required to document the incident(s) using the Unanticipated Problem / Adverse Event Report template, which can be found in the Reports section of the Application Materials tab.
Routine Reporting
When your human subjects research protocol is approved, you will be advised regarding a schedule of progress reports or continuing reviews. Additionally, you will be required to submit a final report when your research is complete. The templates for these reports are available in the Reports section of the Application Materials tab.
The Marine Corps supports a variety of research conducted by external researchers. Even if the research has been approved by an IRB or received a determination that it is not human subjects research, review by the Marine Corps is required before recruiting Marine Corps personnel (military or civilian) to participate in the project or making requests for Marine Corps data.
Projects Funded by the Marine Corps
If the project is funded by the Marine Corps, review by the appropriate Human Research Protection Official (HRPO) is required. If the project is funded by Systems Command or Manpower and Reserve Affairs, refer to the Contact Us tab to reach the HRPOs in those organization. If the project is funded by any other Marine Corps organization, contact the USMC HRPP and refer to this fact sheet for more information. If you are new to conducting research with Marines or the military, this fact sheet may be helpful.
Projects Not Funded by the Marine Corps
If the project is not funded by the Marine Corps, Administrative Review by the USMC HRPP is required. Contact the USMC HRPP and refer to this fact sheet for more information. If you are new to conducting research with Marines or the military, this fact sheet may be helpful.
Student Researchers
Refer to the student research tab.
The Marine Corps supports student research when feasible. All projects conducted by students that involve interaction with Marine Corps participants (e.g., interviews, surveys, focus groups, questionnaires, etc.), observations of Marine Corps personnel, or use of personnel datasets must be reviewed by the USMC HRPP. This requirement applies even if the project has been approved by the IRB at the student’s school or received a determination that it is not human subjects research.
Students who are new to research or to conducting projects that involve military personnel, data, and/or installations are advised to contact the USMC HRPP early in the research design process to determine review requirements that may apply to their projects. In addition to review by the USMC HRPP, other Marine Corps and, in some cases, other government review processes may apply to certain projects. These reviews can be complex and lengthy and it is critical to budget sufficient time to get all necessary approvals and endorsements.
Marine Corps University Students
Individuals assigned/attached to Marine Corps University as students who are conducting projects as part of their studies at Marine Corps University (MCU) have their projects reviewed by the Marine Corps IRB. Contact the MCU IRB Vice Chair for additional information.
Students at Other DoD Schools
Students conducting projects as part of their studies at DoD schools will have their projects reviewed by their school’s IRB. Once the IRB review is complete, the project must be submitted to the USMC HRPP (see contact tab) for Administrative Review and approved before Marine Corps personnel (military or civilian) are recruited to participate or requests for Marine Corps data are submitted. This fact sheet provides basic information on Marine Corps review requirements. However, students are encouraged to reach out to the USMC HRPP to determine the specific requirements for their projects and assistance in understanding the process.
Marine Corps Students at Civilian Schools
Whether attending a civilian school as a private activity or as part of a Marine Corps program, students conducting projects as part of their studies at civilian schools will have their projects reviewed by their school’s IRB. Once the IRB review is complete, the project must be submitted to the USMC HRPP (see contact tab) for Administrative Review and approved before Marine Corps personnel (military or civilian) are recruited to participate or requests for Marine Corps data are submitted. This fact sheet provides basic information on Marine Corps review requirements. Students are encouraged to reach out to the USMC HRPP to determine the specific requirements for their projects and assistance in understanding the process.
Other Students at Civilian Schools
Other individuals conducting projects as part of their studies at civilian schools will have their projects reviewed by their school’s IRB. Once the IRB review is complete, the project must be submitted to the USMC HRPP (see contact tab) for Administrative Review and approved before Marine Corps personnel (military or civilian) are recruited to participate or requests for Marine Corps data are submitted. This fact sheet provides basic information on Marine Corps review requirements and this fact sheet provides key information about conducting research with Marine Corps personnel. Students are encouraged to reach out to the USMC HRPP to determine the specific requirements for their projects.
General Information
USMC commands may be asked to support research activities in a number of ways such as:
- Providing letters of support.
- Allowing researchers to recruit personnel to participate in research.
- Providing logistical support for researchers (e.g., scheduling rooms for interviews, assisting with base access, distributing information about the research, etc.).
- Providing access to USMC data.
This fact sheet provides basic information commands should consider when asked to support a research activity.
Requirement for Voluntary Participation
In accordance with 32CFR219, participation in human subjects research must be voluntary and individuals must be informed of their rights and the risks posed by the research. This process is known as voluntary informed consent. Commands may distribute information about research participation opportunities, but must avoid any actions or communications that could be construed as influencing an individual's decision-making. Also, researchers may ask that command leadership not be present during recruiting activities and the informed consent process. This is normal and expected.
Command Requirements
Approval of a research protocol by an Institutional Review Board (IRB) or the USMC HRPP does not create a requirement for commands to support the research. Additionally, there is no funding source that can compel a USMC command to support research activities. See the fact sheet linked above for more information.
Questions
Feel free to reach out to the USMC HRPP (see Contact Us tab) with any questions you have about review processes or specific research projects.