Effective 1 October 2025, the M&RA HRPP and MCSC HRPP were consolidated into the USMC HRPP. Investigators from M&RA should visit the USMC HRPP website for applicability review worksheets and submission templates
Do I need to submit my project for review? Policy requires all research involving human subjects be reviewed and approved by an appropriate authority (EDO or IRB) before the research begins. If your project is a systematic investigation (including program evaluations and pilot studies) which includes interaction or intervention with living humans or utilizes identifiable private information about living individuals, it should be submitted for review by the HRPP/IRB office. Investigators are not authorized to make this determination themselves. Inquiries and submissions should now be directed to the United States Marine Corps Human Research Protection Program.
Individuals seeking data for research from the Manpower Information Data (MID) Branch will be instructed to submit a Personnel Data Support Request (PDSR) after completing the required HRPP or IRB review(s). Data requests involving HSR may be filtered and directed to the appropriate offices, as applicable. All requests must be in accordance with policies, regulations, and the approved project plan (documents will need to be attached to the ticket). The HRPP/IRB approval does not impose access to data but rather conveys formal approval to use data elements involving HSR. Furthermore, HRPP/IRB approval does not automatically convey approval to access data to data stewards or custodians. MID, in their capacity as data stewards, must still receive requests for data and approve or deny such requests based on submitted justification. Click here to complete a PDSR ticket: https://www.manpower.marines.mil/Divisions/Manpower-Information/#data-branch-mid Some USMC personnel have access to Private Identifiable Information (PII) on a routine basis to perform operational activities as part of daily duties. M&RA personnel who have access to Marine Corps data as part of their operational duties may not use or provide data to others for research purposes without approval from the appropriate authorities. Conducting independent human subjects research is not automatically considered operational, and access to protected PII (including the HIPAA subset) for research purposes is not permitted without the appropriate review(s). The Human Research Protection Program (HRPP) and/or the Institutional Review Board (IRB) must review projects and data requests prior to researchers’ access to USMC data for research purposes. M&RA investigators or other researchers outside the USMC on approved study protocols that includes data with identifiers may require the HRPP/IRB to review the proposed shared data elements to ensure that only the minimum necessary for the research would be provided. Data storage must be in a secure location, may not be shared (unless approved by the HRPP), and must be destroyed when instructed by the project plan or MID.
M&RA Funded/Contracted/Assisted Research
The DoD requires contracts (or other comparable agreements) and sub-contracts for activities that are or may include human research contain the Defense Federal Acquisition Regulation Supplement (DFARS) clause 252.235-7004. Activities that are funded or supported through non-contract processes or with non-NAF must provide the same or similar language. If M&RA contracts an external organization to conduct Human Subjects Research, that organization must obtain a review by an IRB. It also requires review by a Human Research Protection Official (HRPO) to ensure the specific language is included, concurrence with the reviewing IRB, and specific DoD/USMC considerations. DoD-supported HSR conducted by a non-DoD institution must obtain a HRPO review prior to award and before any human research activities can begin. The Contracting Officer’s Representative for the project should contact the M&RA HRPO to receive and complete the required checklists. Additionally, the following documents must be submitted to the HRPO: 1. Copy of Statement of Work, contract, agreement. Contracts and subcontracts without the required clause must be modified to include it before submission for HRPO review. 2. Verification of Federal Wide Assurance (FWA) or DoD Assurance number along with the IRB’s registration number with expiration dates, if conducting non-exempt research. 3. A copy of the complete protocol (application) package approved by the IRB (recruitment material/scripts, ICFs, data collection tools, ethics training certificates). 4. A copy of the HRPP or IRB’s determination/approval letter. The review type and category should be specified. 5. Letters of support from the Commanding Officers (COs) of any units from which you plan to recruit participants, request data, or request logistical or administrative support. Letters must be at the O-5 (LtCol) or O-6 (Col) level and must be signed by the actual or acting CO, not “by direction.” The HRPP POC can provide a template to ensure the appropriate content is included. 6. HRPO Checklists. Note: The contractor cannot begin performance or expend funds until they receive notice that the HRPO review was successfully completed. Failure to comply may result in a Stop Work order. See the USMC Human Research Protection Program site for more information.
All investigators who will be conducting human subjects’ research must complete Department of Navy Human Subject Research Ethics Training in order to conduct research with human participants. The ethics and human subject protections training recognized by the Marine Corps is provided by the Collaborative Institutional Training Initiative (CITI). Instructions for researchers and the link to the CITI website are below. Research personnel must complete the training every 3 years. Instructions to Register for CITI Training 1. Go to the CITI Program Training Home Page and click “register” 2. Click “Select Your Organization Affiliation.” Type and select “Department of the Navy” Create a CITI Program account 3. Enter your personal information and click “continue to step 3” 4. Create your Username and Password and click “continue to step 4” Enter Country of Residence information. Continue Registration Select “No” to earn CE credits, unless you are licensed and will independently purchase. 5. Enter your required information for the DON Insert USMC for the department Choose the appropriate role from the drop-down menu (typically Principal Investigator or Co-Investigator) Under the “Your Command” drop-down menu, choose “Deputy Commandant, Headquarters Marine Corps, Manpower and Reserve Affairs Click “Next” 6. Enter the appropriate selections and click “Next” 7. Click the box for “Social and Behavioral Sciences” (unless Biomedical focused) and click “Next” Select Investigators and Key Research Personnel – SBR 8. See Courses Ready to Begin & complete all the required modules.
United States Marine Corps HRPP/IRB: USMC Human Research Protection Program POC for Manpower and Reserve Affairs: Ms. Christina Ramirez Human Research Protection Official Exempt Determination Official IRB Vice Chair for Manpower and Reserve Affairs United States Marine Corps Email: christina.ramirez@usmc.mil Phone: 703-853-6222