Protection of the rights and welfare of research subjects is an accepted service responsibility and a requirement under federal regulation (32CFR219).
Human subjects research and related matters, including Institutional Review Board (IRB) operations and supporting USMC commands to comply with federal regulations 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 or data. 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
before using the templates below, please review the appropriate tab for your project (internal, external, student) to determine submission requirements.
with the exception of the hrpo review checklists, templates on this page are for use by submitters working within usmc commands.
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
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(Note - If you will be using contractors to support your research or if you plan to collaborate with individuals from outside the USMC, see the External Collaborators section below, as additional information is required before these individuals can be approved to work on your protocols.)
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REPORT TEMPLATES
External collaborators
If you plan to include contractors or individuals from outside the USMC on your protocol, you will need to complete either an Individual Investigator Agreement (IIA) or an Institutional Agreement for IRB Review (IAIR). Please consult with your IRB Vice Chair or the IRB Chair to determine which agreement is most appropriate for your research.
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.
The specific steps to register may change as CITI updates its website. However, key information includes:
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When asked to select your organizational affiliation, enter "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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When asked to enter your Command from the drop-down menu, note that some commands do not have "Marine Corps" in front of them (e.g., Training and Education Command).
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When asked to select an area, choose "Social and Behavioral Sciences."
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Choose the appropriate role. Researchers should choose Investigators and Key Research Personnel or the closest available role
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Choose the appropriate course(s).
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Researchers (Principal Investigators and all Associate Investigators) will be required to provide a certificate for the Investigators and Key Research Personnel - SBR course. Protocols including research support personnel should consult with the USMC IRB to determine the appropriate courses for those personnel based on their functions in the research.
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Ombudspersons will be required to provide a certificate for the Ombudsperson course.
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IRB Vice Chairs and Members will be required to provide a certificate for the IRB Chairs, Vice Chairs and Members - SBR course.
In accordance with 32CFR219 and DoD and USMC policies, you may not begin research or information collection activities without written authorization from the appropriate Marine Corps HRPP or IRB authority.
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 Submission Templates 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 or by the USMC Exemption Determination Official (EDO). Use one of the worksheets provided in the Applicability Review section under the Submission Templates tab to 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 Submission Templates 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 and documentation required based on the details of your research plans.
NOTE: All personnel working on the research protocol will need to complete training. See the Training tab on this website for more information.
Managing a Human Subjects Research Protocol During and After Research
The Principal Investigator is responsible for ensuring that all activities associated with the protocol are conducted in compliance with 32CFR219 and the USMC HRPP Policy and Procedures (both available under the References tab of this website). This includes ensuring that subjects' information and data are handled in accordance with the protocol and informed consent agreement during and after the research. It also includes requesting approval of all changes before implementing them (usually through and amendment), routine reporting, typically annually, to the IRB, reporting problems in research, and other responsibilities. Highlights are below. However, all Principal Investigators are expected to be familiar with 32CFR219, the USMC HRPP Policy and Procedures, and other guidelines that apply to their protocols.
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 Submission Templates 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 Submission Templates tab.
After Research
Subjects' Information and Data: The informed consent agreement used in the protocol is a permanent commitment to each subject and does not lose effect when the protocol is closed. Part of closing down your protocol involves ensuring that subjects' information and data are either deleted or stored in accordance with the protocol and informed consent. If your protocol and informed consent do not specify that you may retain the data, you may not. If you did not specify that you might share the data, you may not, even within your command. If you have questions, contact the USMC IRB.
Records Retention: Principal Investigators are required to retain certain protocol records for a minimum of three years. Details are available in the USMC HRPP Policy and Procedures. In some cases, these records may include sensitive information that may not be stored in places or on systems to which other people have access. If you have questions, contact the USMC IRB.
De-identification of Data: Many protocols specify that the Principal Investigator will retain de-identified data. De-identification of data can be challenging with the USMC population, especially if the protocol has a relatively small sample size or the data include open-ended survey responses, interview transcripts, or similar qualitative information. Even if names are removed, it is sometimes possible for a subject to be re-identified based on unusual clusters of characteristics, specific events described, or even habits of speech. Ideally, the details of de-identification should be addressed in the protocol and informed consent agreement. However, if there are any uncertainties, the USMC IRB may be able to advise on the best approach.
Data Repositories: If your protocol and informed consent agreement specify that you can place data in a data repository, consult with the USMC IRB before doing so to ensure the repository you have selected meets USMC requirements.
NOTE: In accordance with DoD and USMC policies, you may not begin research or information collection activities without written authorization from the appropriate Marine Corps HRPP or IRB authority.
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.
In accordance with 32CFR219 and USMC policies, you may not begin research or information collection activities without written authorization from the appropriate Marine Corps HRPP or IRB authority.
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.
NOTE: Some university departments have made arrangements with their IRBs to exclude certain categories of student research from IRB review. In such cases, the USMC HRPP will require documentation of the exclusion from the university IRB (not the department). This may take the form of a determination made for your specific project or a document stating that certain types of projects from the department are excluded. Again, this documentation must be from the IRB, not the department.
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.
NOTE: Some civilian university departments have made arrangements with their IRBs to exclude certain categories of student research from IRB review. In such cases, the USMC HRPP will require documentation of the exclusion from the university IRB (not the department). This may take the form of a determination made for your specific project or a document stating that certain types of projects from the department are excluded. Again, this documentation must be from the IRB, not the department.
This tab includes information on USMC HRPP requirements for letters of support for human subjects research and tips for requesting letters of support. The primary reference for this topic is the USMC HRPP Policy and Procedures, available under the References tab of this website. Additional information for researchers and commands supporting research is available under the website’s other tabs. It is the responsibility of the researcher to coordinate as needed to obtain letters of support. The USMC HRPP is not staffed or resourced to assist researchers with coordination or staffing.
NOTE: Regardless of whether a project is human subjects research, any project that will involve interviews, focus groups, surveys, or other types of information collections with 10 or more USMC personnel also may be subject to requirements for letters of support and installation access approvals under the requirements of the USMC Survey Control Office. Additional information is available on the Survey Control Office Information tab on this website.
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General Letter of Support Requirements
Flag officer letters: Must be from either (a) the first general officer in the chain of command above all possible subjects or (b) from a flag officer or SES in the command with oversight of the topic of the research. The letter must be signed by the actual flag officer or SES, not by an individual in an acting capacity or “by direction.”
Commanding officer letters: Must be from the LtCol or Col (O-5 or O-6 level) in command of the unit from which subjects will be recruited. The letter must be signed by the commanding officer, not by an individual in an acting capacity or “by direction.” If multiple units will be targeted, multiple letters of support may be required. Researchers whose projects will involve many commands should contact the USMC HRPP for options.
Letter content: Each command will have its own preferences for letter content and format. To meet USMC HRPP requirements, the letter must include the following:
- The title of the research. The title should be the same one used on your IRB application.
- A clear statement that the signatory approves the research.
- A point of contact (name, email, and telephone) at the command in case the USMC HRPP needs to contact them. Note that the point of contact often will be different than the signatory. That is expected and appropriate.
Internal Researchers
Internal researchers are required to provide a commanding officer letter of support meeting the requirements listed in the General Letter of Support Requirements section above.
External Researchers Funded by the USMC
External researchers funded by the USMC are required to provide a commanding officer letter of support meeting the requirements listed in the General Letter of Support Requirements section above. Researchers also should review additional information provided under the Information for External Researchers tab on this website.
External Researchers Not Funded by the USMC
External researchers not funded by the USMC are required to provide a flag officer and a commanding officer letter of support meeting the requirements listed in the General Letter of Support Requirements section above. Researchers also should review additional information provided under the Information for External Researchers tab on this website.
Student Researchers
All student researchers should review the information provided under the Student Research tab on this website.
- Students at Marine Corps University are considered internal researchers (see Internal Researcher section above).
- USMC students at other DoD schools or assigned to civilian schools as part of their duties, such as those in the Fellows Program, are considered external researchers and should contact the USMC HRPP to discuss requirements.
- USMC personnel conducting research as part of their studies at a civilian school outside of their duties are considered external researchers (see External Researchers Not Funded by the USMC section above).
- Non-DoD students conducting research are considered external researchers (see External Researchers Not Funded by the USMC section above).
Tips for Requesting Letters of Support
The USMC HRPP strongly recommends that researchers consult with the flag officer’s staff before requesting a letter of support from the flag officer or any subordinate commands. Some flag officers prefer to see their commands’ willingness to support before considering a request. Others prefer to have the first say. Additionally, each command has its own preferences regarding what information should be included in the request and for letter format and staffing.
When requesting a letter, provide information that allows the command to make an informed decision about whether it will be possible to support the project. This is not the time to “pitch” your project. Information should be focused on what the command needs to know to determine the impact of the research on its personnel and main mission, which is how they determine if they can support it. Command preferences vary, but commonly requested information includes:
- Short, clear description of the project – who is doing it, the main objectives, and, if applicable, the funding sources.
- Brief explanation of why USMC personnel are needed for the research vs other military or civilian populations.
- When you plan to conduct the research and how much leeway you have adjust your plans in accordance with unit schedules.
- Detailed explanation of what support is being requested in terms of number of personnel, time away from main duties, what subjects will be asked to do, etc. Also include any logistical or administrative requests, such as scheduling rooms, distributing study information, or helping the research team access base and find research sites.
- Explanation of the risks USMC personnel may face during and after the research. Do not say there is no risk. Include not only physical and psychological risks, but also risks associated with information systems breaches and any other risks you have identified. You also can include a brief description of mitigation measures.
- Explanation of what will happen to subjects’ personal information and data (identified or deidentified) after the research. Will you destroy it? Retain it? Share it?
- If you will be using commercial technologies to gather or analyze data (e.g., wearables or analytic software), description of what access, retention, and use rights the technology companies will have to subjects’ personal information and data.
- A very brief statement of the potential benefits of the research to the USMC, DoD, or broader society.
It is the responsibility of the researcher to coordinate as needed to obtain letters of support. The USMC HRPP is not staffed or resourced to assist researchers with coordination or staffing.
This page contains basic information on the two support scenarios listed below. For more detailed information, use the guidance provided under the References tab of this website or contact the USMC HRPP. A fact sheet on command considerations for supporting research and letters of support also is available under the Fact Sheets tab.
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General Information
The primary responsibility of commands conducting research is to ensure that its personnel are aware of and supported to comply with applicable federal regulations and DoD, DON, and USMC policies as described in the references on this website. Individuals supervising researchers should ensure that all required reviews are accomplished. If a project is determined to be human subjects research, the supervisor should have the researchers provide an overview of the requirements associated with the protocol such as required security measures for protecting subjects' information and data, requirements associated with the execution of the project, the schedule of reports to the IRB, and record retention requirements after project closure.
Contractor Involvement
If the command's research plans include having a contractor lead or support a project that has been determined to be human subjects research, ensure the lead researcher discusses this with the USMC IRB. Contractor involvement is possible, but the IRB is required to take additional steps in the review and approval process.
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.
Letters of Support
Depending on the details of the project, the command may be asked to provide one or more letters of support for the project. Details regarding this requirement are available in this fact sheet linked at the top of this page and the USMC HRPP Policy and Procedures (see References tab).
Questions
Feel free to reach out to the USMC IRB/HRPP (see Contact Us tab) with any questions you have about review processes or specific research projects.
General Information
USMC commands may be asked to support research activities conducted by other USMC commands or external researchers 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.
Review and Approval Requirements
No research or information collection activity involving USMC personnel or their data may be conducted without written authorization from the appropriate Marine Corps HRPP or IRB and, if applicable to the project, approval by the USMC Survey Control Office (SCO). All projects that have been reviewed by Marine Corps HRPP or IRB approval receive documentation including a tracking number and, if applicable, a survey control number. If you have questions regarding the approval status of a project, please contact the USMC HRPP and SCO.
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.
USMC Survey Control Office (SCO) Approval
This information is provided by the USMC Survey Control Office and is subject to change. Researchers and other performers are encouraged to contact the USMC Survey Control Office to ensure they are aware of current requirements and processes. The Survey Control Officer is Dr. Marnie Sutton (marnie.sutton@usmc-mccs.org).
NOTE: Approval by the Survey Control Office and issuance of a USMC Survey Control Number (SC#), is required even if a project has received a determination that it is not human subjects research or not research. The Survey Control Office addresses different policy requirements that apply to all information collections, not just research.
Reference
The primary reference for USMC Survey Control Office (SCO) review is MCO 5300.18 Marine Corps Survey Program. Additional references may apply to some projects. Contact the SCO for more information.
General Requirements
NOTE: The term “performer” is used below to refer to anyone proposing to conduct a survey for research or non-research purposes.
All projects that include surveys, questionnaires, focus groups, interviews, listening sessions, or any other type of questions (referred to below as surveys or information collections) must be reviewed and approved by the SCO before USMC personnel are recruited. This review requires completion of the SCO Project Information Worksheet (even if the information is already covered in your protocol). Depending on the details of the project, the SCO may require documentation that you have completed other required reviews and approvals. If additional approvals will be required, you should obtain them before submitting your package to the SCO for approval, as the survey cannot be approved by the SCO or issued a SC# until ALL approvals have been obtained. See details below.
Requirements for Electronic Information Collection
If administration of a survey will be conducted electronically, USMC performers are required to use the approved survey administration platform, Qualtrics. For long-term data collection, a survey can be administered on Qualtrics for up to three years before the survey’s approval must be renewed. In order to procure a USMC license for Qualtrics, send a request to the Survey Control Officer for a Qualtrics license. Include your full name and the email that is affiliated with your CAC.
Survey Monkey, Microsoft Forms, and other publicly available survey administration platforms may not be used by any researcher, internal or external. All external researchers must use a protected survey administration platform.
Exempted Information Collections
Although MCO 5300.18 states that there are some studies that might meet the criteria for exemption, the exemption determination must be made by the Survey Control Officer. All information collections must be submitted so that determination can be made. Additionally, even exempted surveys must be assigned a SC#, which only the Survey Control Officer can assign.
Review Process
At the current time, SCO review takes place after review by the appropriate USMC human research protection authority (see information elsewhere on this website).
During SCO review, a research analyst, who is a SME in survey construction, will review the questions for scientific rigor & quality control. Changes might be required to the questions to improve them. Once the PI receives requested changes, they will have 30 days to respond.
There are two main issues that can affect the turnaround time for SCO review. The first is not having submitted all of the required documents. The second is how quickly the PI returns edits to the SME. FYSA, one of the first things that will trigger an edit is not having language in the survey directions or privacy statement (if one is provided) that addresses the following five points regarding participants’ protection and confidentiality:
- Participation is completely voluntary
- Participants have the right to end participation at any time
- Participants do not have to answer any questions that they do not want to
- All answers will be held confidential
- The anonymity of participants will be maintained (for focus groups add: to the greatest extent possible)
If these five points are not addressed in the instructions, the SME will return the survey to have the PI include them. Ensuring that the language is present can reduce the amount of time necessary for SCO approval.
Once the questions are finalized, they will be forwarded to the Survey Control Officer to determine, among other things, if the effort is too burdensome to participants, is duplicative of other information collection efforts, and meets the scope and mission of the USMC. After all of the requisite permissions have been obtained (see below) and Survey Control Officer review is completed, the SCO will assign the questions a SC#, which will be good for three years. The SC# must be prominently displayed on all recruiting information and collection instruments.
Documentation of Other Approvals and Special Considerations
Documentation of all required approvals must be included in the submission package to the SCO.
Marine Corps Human Research Protection Review
All projects submitted for SCO review must include documentation that they have been approved by the appropriate USMC human research protection authority. This requirement applies even if the project has received a determination from an external authority stating that it is not human subjects research.
- For internal researchers: the USMC IRB or the USMC or M&RA EDO.
- For external researchers: the USMC HRPP or the M&RA or MCSC Human Research Protection Official (HRPO).
More information and contacts for these reviews are available on this website.
Additionally, there are some special requirements that may apply to some projects. Most entail approvals that must be obtained before the project can be submitted for SCO approval.
Required Letters of Support
Letters of support must be provided in the submission package to the SCO. Letters must be on official USMC letterhead and signed and dated by the official, not “by direction.” Obtaining letters of support can be a lengthy process and the details of making the request vary across commands. Researchers and performers are advised to begin the process early.
- GO/SES Letter of Support - A USMC flag officer letter of support, typically from a general officer (GO) or member of the Senior Executive Service (SES), indicating that they are aware of the objectives and methods of the information collection and that they support it, is required:
- For projects conducted by USMC personnel if an information collection will be conducted across the entire USMC to include ALL Marines.
- For all information collections conducted by external researchers or performers.
- Installation/Facility Letter of Support - If the information collection necessitates going onto an installation or facility to conduct the project, e.g., in-person focus groups, listening sessions, interviews, etc., the performer also will need to obtain a letter of support from the Base Commander of each installation, indicating that they are aware of what the information collections entails, that they support it, and that they approve performers coming onto their base to conduct the information collection.
Office of Management and Budget (OMB) Approval
OMB approval is required in two circumstances: (1) According to the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.), if a survey will include dependents, veterans, reserve members who are not on active duty, government contractors, or civilian employees asking questions about topics other than their jobs, these populations are considered to be members of the public. (2) The requirement also applies to information collections addressing topics such as suicide, substance abuse, sexual assault, sex and racial issues, COVID, burn pits, the Lejeune suit, etc. This list of controversial topics is determined by OMB and is constantly changing.
For any information collections that require OMB approval or to inquire if the topic requires OMB approval, performers should contact the Washington Headquarters Service (WHS) at whs.mc-alex.esd.mbx.dd-dod-information-collections@mail.mil . The OMB approval process can take up to 12 months if it involves particularly contentious topics because the survey needs to be posted to the Federal Register for potentially several months for public comment. Under certain circumstances, if the survey is a customer feedback instrument, OMB may be able to use a fast-track option to speed up the approval process, reducing the timeline to just a few weeks.
Union Approval
Union approval is required for any information collection that is querying civilian employees about their job. Employee surveys should be sent to Erica Ramirez-Brown (erica.ramirez-brown@usmc.mil ) and Sarah Torres-Ferrick (sarah.l.torres-ferrick.civ@usmc.mil ) for union approval. The union approval will be emailed to the performer, and a copy of that email should be included in the USMC submission package submitted for USMC approval. This process usually takes a approximately two to three weeks.
Office of Personnel Analytics (OPA) Approval
OPA approval is required for any information collection that will cross branches of the military outside the Department of the Navy. OPA approval requests should be sent to dodhra.mc-alex.dpac.mbx.dod-survey-review@mail.mil . Make sure to download the DD3128 Form to fill out & submit with your request package, along with Supporting Statement A & Supporting Statement B. This process can take several months.
Collecting Personally Identifiable Information (PII)
USMC Privacy Officer approval (either as a Privacy Impact Assessment form or a DD67) and approval of the Privacy Statement is required for all information collections that will include gathering PII. According to The Privacy Act of 1974 (as amended at 5 U.S.C. 552a), if a performer plans to obtain PII from participant (i.e., names, addresses, phone numbers, email addresses, etc.) they must have a compelling reason for collection beyond convenience or simple interest. Any study that is going to collect PII must contact the USMC Privacy Officer, Deborah Cantaoi (deborah.contaoi@usmc.mil ), to obtain permission to do so.
To be allowed to collect PII and store it electronically, there must be a System of Record Notice (SORN) that outlines the parameters of the study and grants permission for collection under those specific circumstances. If the data will be stored electronically, the USMC Privacy Officer must also indicate that the PI has access to an electronic storage device on which a Privacy Impact Assessment (PIA) has been conducted to prove that the data will be completely secure and provide a PIA form as evidence. If the data will be collected on a paper form, the USMC Privacy Officer will provide the PI with a DD67, instead. A Privacy Statement, including the authority under which the PII data collection is taking place, the SORN that grants permission to collect PII and a link to it, the purpose of the study, notification of any potential audiences outside the DOD, and participant protection language must be added to the information instrument, as well and will be reviewed by the USMC Privacy Officer.
The PIA form of DD 67 is not official until it has been signed by the USMC Privacy Officer, the Senior Component Official for Privacy (SCOP), and the Federal Chief Information Officer (CIO). Consequently, obtaining permission to collect and store PII is a process that can take months.