HRPP Training
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. Extramural researchers who have completed training through a different organization must either complete CITI training again or provide transcripts for previously completed training in order to demonstrate equivalency.
CITI Training Home Page
DON HRPP Training and Education Guidance
Instructions to Register for CITI Training
1. Go to the CITI Training website and click the “register” button under Create an Account
2. Under the “Participating Institutions” drop-down menu, select “Department of the Navy”. Click “continue to step 2”
3. Enter your personal information and click “continue to step 3”
4. Create your user name and password and click “continue to step 4”
5. Enter your demographic info and click “continue to step 5”
6. Enter the appropriate selections and click “continue to step 6”
7. Enter the DON-required info. Under the “Your Command” drop-down menu, choose “M&RA” or the applicable unit and click “continue to step 7”
8. Click the appropriate box…likely the first one, and click next. Click the box for “social and behavioral sciences” and click next
9. Choose the appropriate role and click next
10. Choose “No, not at this time” when asked “Are you required to complete the CITI Good Clinical Practice course for the Department of the Navy?” and click next
11. Choose “No, not at this time” when asked “Are you required to complete the CITI Responsible Conduct of Research (RCR) for the Department of the Navy? ” and click next
12. Click “Finalize registration”
13. Click on the appropriate course and conduct the training
Investigator Information
M&RA Internal Research
Because M&RA has an Institutional Agreement with the USMC Institutional Review Board (IRB), we follow their policies and procedures for getting our research reviewed. The steps are described in Chapter 9 of the USMC HRPP Policy and Procedures Manual (found in the References section to the right).
The first step a Primary Investigator (PI) takes is getting 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 are not authorized to make this determination themselves. 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, the PI must submit a full protocol, per the Manual, to the IRB. The M&RA HRPP POC is available to facilitate this process. Please use the Applicability Review Worksheet found on the right of this page under ‘Checklists’.
The full protocol will include the following documents at a minimum (found in Chapter 10 of the Manual):
-IRB Action Request (Appendix D)
–Full Protocol (Appendix E)
–Investigator Affirmation (Appendix F)
–Scientific Review (Appendix J)
–A copy of the informed consent document, if required
–Training documentation for the PI and training plan for all associate investigators to include CITI training and project specific training.
–Proof of CITI training for scientific reviewer
–For protocols determined to be greater than minimal risk, additional requirements are found in Chapter 11
Once again, the HRPP POC is available to facilitate submitting the protocol to the IRB.
M&RA Contracted Research
When M&RA has contracted with an extramural performer to conduct HSR, the extramural performer is required to have the study reviewed by an external IRB, but the protocol must still go through a Human Research Protection Official (HRPO) review to ensure compliance with the Defense Federal Acquisition Regulation Supplement (DFARS) on contracts to perform Human Subject Research. The Contracting Officer’s Representative for the project will fill out both HRPO checklists below and the following documents will be submitted to the HRPO:
–HRPO Checklist A
–HRPO Checklist B
–Contractor IRB Determination Letter (Category of Exemption or Expedited Review must be indicated)
–Approved Protocol (Contains Approved Consent Forms)
–Training Certificates for the research team. The Principal Investigator and all members of the team who will be interacting with subjects or the identifiable data will complete CITI training or provide proof of equivalent training from their institution.
–Federal Wide Assurance (FWA) and DoD or DON Addendum
–Statement of Work
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 IRB. If the researcher’s IRB requires a letter from the Marine Corps before they will review the research plan, the researcher may submit the complete protocol to the HRPP POC prior to IRB approval. In either case, the HRPP POC will route the protocol to the appropriate division for consideration. The HRPP POC will also serve as the intermediary between the researcher and M&RA as appropriate. Once the research has SES/GO approval, the package must go through a Department of Navy (DON) review.
The purpose of the DON Review is to ensure compliance with the DoDI 3216.02 and other service directives. Under the DoDI, military subjects are considered a vulnerable population and are afforded additional protections.
The documents required for a DON Review include:
1. Verification of Federal Wide Assurance (FWA) and expiration date for the Primary Investigator’s (PI) Institution.
2. Effective 1 February 2016, DoN will no longer require or issue the Navy Addendum to the FWA.
3. A copy of the complete protocol, to include the recruitment plan and scripts (i.e. how the PI plans to gain access to and solicit volunteers, etc). The emphasis in asking for the detailed recruitment plan is to ensure that there is no inadvertent real or perceived command influence in the service member’s decision to participate in the research.
4. A copy of the IRB approval. If the research is found to meet one of the categories for Exempt Research or Expedited Review, the category needs to be specified.
5. Copies of the IRB approved Informed Consent documents.
6. Proof of completion of CITI training for Extramural Performers for PI (or comparable research ethics training as accepted by DON HRPP). 7. The Command approval letter for solicitation of volunteer subjects from within their command/population.