Human Research Protection Program (HRPP)

GETTING STARTED

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.

You must have a written HRPP determination or approval before starting any project (including recruitment and data collection) that collects data from or about living individuals.

Note: If the project involves funding and/or includes a contract/agreement, reference the HRPO review section.

Should my submission package go to the M&RA HRPP or USMC HRPP office?

The M&RA HRPP oversees all human subjects research conducted by Marines and civilians under the auspices of Headquarters, Manpower and Reserve Affairs. In addition, we facilitate submission of research protocols to the USMC Institutional Review Board.
As such, determination/applicability reviews, exempt determinations, and HRPO reviews (M&RA funded) are completed by the M&RA Exempt Determination Official / Human Research Protection Official.

All other project submissions, including those requiring an administrative review, are reviewed by the USMC HRPP/IRB office. The M&RA HRPP office will act accordingly as a direct liaison or vice-chair when facilitating non-exempt or external performer’s requests. Projects that do not engage M&RA (divisions or personnel) should contact the USMC HRPP office for guidance.

SUBMISSION Information

M&RA Investigators:

The first step an M&RA Primary Investigator (PI) completes is an HRPP Applicability Review. Through this process the Exemption Determination Official will determine if the proposed study meets the definition of Human Subject Research (HSR). Please note that investigators and commands are not authorized to make this determination themselves. M&RA personnel should complete an Applicability Review (Internal M&RA Projects) by submitting the Project Information Sheet following this Applicability Review Guidance with all pertinent documents to the M&RA HRPP office for a determination. 

If the study is not HSR, the determination official will issue a memo to that effect, and the study may proceed without IRB oversight.
If the study is HSR and not Exempt, the PI must submit a full protocol submission package to the USMC IRB. The M&RA HRPP POC will complete a preliminary review and facilitate this process.

External Investigators

Independent Extramural Research

Studies relating to behavioral health, military benefits, and manpower policies typically fall under the Deputy Commandant, M&RA. To ensure the Marine Corps’ interests and the interests of Marines and their family members are protected, independent extramural research must be approved at the Senior Executive Service (SES) or General Officer (GO) level in the appropriate stake-holder division. To begin the process, please become familiar with the information on this page, and then contact the M&RA HRPP Point of Contact (POC).
The M&RA HRPP POC will need a full study protocol as presented to the extramural researcher’s HRPP or IRB. The HRPP POC will serve as the intermediary between external researchers, M&RA, and the USMC IRB, as appropriate. The project must go through a USMC HRPP Administrative Review.

Independent/extramural investigators who are not employees or agents of HQMC, M&RA may be covered by the M&RA assurance only with written agreement of commitment to relevant human subject protection policies and USMC/M&RA oversight.

Documents required for the review include:
1. Verification of Federal Wide Assurance (FWA) and expiration date for the Primary Investigator’s (PI) Institution.
2. A copy of the complete protocol, to include the specific USMC recruitment plan, scripts, consent forms, and data collection tools.
3. A copy of the HRPP or IRB’s determination/approval. The review type and category should be specified.
4. Proof of completion of CITI training for Extramural Performers for PI (or comparable research ethics training as accepted by DON HRPP).
5. USMC letters of support. Contact the HRPP for template (language).

CONSIDERATIONS

• Are prohibited from influencing their subordinates to participate in research. 
• Must not be present at any research participant recruitment sessions or during the consent process for DoD-affiliated personnel. Excluded supervisors or those in chain of command may participate in separate research recruitment sessions, if applicable.  

GUIDANCE

While some (proposed) activities may have been determined to not meet the definition of research with human subjects, they may be subject to other regulations or DoN and USMC policies, such as the Privacy Act, data protections, and DON records management. Regardless of the determination, M&RA personnel are responsible for ensuring compliance with all applicable regulations and are expected to conduct projects ethically.

If in the course of an operational or assessment activity an individual intends to utilize the findings for another purpose or to generalize the information beyond the program, they must obtain a determination from the HRPP.

Projects that include a survey (including interviews, focus groups, questionnaires, etc.) will be referred to the USMC Survey Control Office after the HSR applicability review.
Letters of approval or support may be required. Contact the M&RA HRPP POC or SCO for guidance.

Ancillary reviews may be required if the proposed activity includes collecting information from members of the public, queries civilian employees about their position/job duties, addresses topics of interest determined by OMB, collects PII, and/or crosses branches of the military outside of the Navy. Although outside the scope of the HRPP, guidance and information are provided to support compliance and project implementation. See the M&RA HRPP Preparation Tips and Form Guidance. 

DEFINITIONS

Request for Use of United States Marine Corps Data in an HRPP/IRB Approved Projec

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.

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.

The USMC IRB serves as the IRB of record for Manpower and Reserve Affairs.

The IRB is a committee established to review research to ensure the protection of the rights and welfare of human research subjects. According to 32 CFR 219, an IRB shall review and have authority to approve, require modifications in (to secure approval), or disapprove all research activities covered by this policy, including exempt research activities under § 219.104 for which limited IRB review is a condition of exemption.

M&RA has an Institutional Agreement with the USMC IRB. The committee is responsible for ensuring human research subjects’ rights are protected. USMC IRB approval is required for all M&RA human subject research. M&RA holds at least one membership position on the USMC IRB.

For projects and studies requiring review by the USMC HRPP/IRB office, or if you are looking for more information regarding the USMC administrative review process, please contact the USMC HRPP office at USMC_HRPP.FCT@usmc.mil.

Reminder: There are instances when additional submissions to the IRB are required throughout the life cycle of the project (modifications, progress reports, reportable events, closure). Submission coordination is completed via the M&RA Vice Chair.

United States Marine Corps HRPP/IRB: USMC Human Research Protection Program (marines.mil)

Resources

Belmont Report

SECNAVIST 3900.39E

32 CFR 219

DoDI 32.1602

MCO 3900.18

10 USC 980

DoDI 6025.18

45 CFR 46

DFARS CLAUSE 252.235-7004

DON HRPP Training and Education Guidance

M&RA HRPP Policies & Procedures

Submission Forms & Templates

The M&RA Institutional Official has appointed the HRPP Human Protection Director as M&RA’s HRPO and EDO.

Ms. Christina Ramirez
Manpower and Reserve Affairs
Human Research Protection Director
Human Research Protection Official
Exempt Determination Official
Vice Chair, USMC Institutional Review Board
 
Mailing Address:
Headquarters, Marine Corps (HQMC)
Manpower Plans and Policy Div (MP Div)
Manpower Studies &Analysis Branch (MPA)
3280 Russell Road Quantico, VA 22134
 
Email: christina.ramirez@usmc.mil  
Phone: (915) 240-8799