The protection for the rights and welfare of research subjects is an accepted service responsibility. The Marine Corps Human Research Protection Program (HRPP) ensures research activities conducted involving people follow the ethical principles for Respect for Persons; Beneficence and are just.
The Marine Corps established an Institutional Review Board (IRB) in order to review research to ensure the protection of the rights and welfare of human research subjects. The IRB has jurisdiction over all research involving human subjects. The IRB is authorized to review, recommend approval to the Institutional Official, require modifications in, or withhold approval or suspend approval of research involving human subjects. No human subject research in any form (including recruitment, consent, or data collection) can take place without proper review and approval by the Marine Corps IRB and Institutional Official.
All persons engaged in the conduct, review, and approval of human subject research is required to complete ethics training.
A person is engaged in research if he/she interacts/intervenes with human subjects or will have access to identifiable data. The training is valid for three years. A copy of the training completion report is required to be submitted with the IRB application package.
The training is offered online through CITI and is expected to take four hours to complete. Training is valid for three years.
Collaborative Institutional Training Initiative (CITI) Registration Instructions
The instructions to register are:
Go to the link above and click the "register" button under Create an Account
Under the "Participating Institutions" drop-down menu, select "Department of the Navy" and click "continue to step 3"
Enter your personal information and click "continue to step 4"
Create your user name and password and click "continue to step 5"
Enter your demographic info and click "continue to step 6"
Enter the appropriate selections and click "continue to step 7"
Enter the DON-required info. Under the "Your Command" drop-down menu, choose "MCCDC" or "TECOM" or "USMC" or MARCORSYSCOM or the applicable unit and click "continue to step 8"
Click the appropriate box...likely the first one, and click next. Click the box for "social and behavioral sciences" and click next
Choose the appropriate role (IRB Administrator, Investigators and Key Research Personnel) and click next
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
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
Click "Finalize registration"
Click on the appropriate course and conduct the training
Q. Does the HRPP apply to the research I am doing?
A. If your study meets the definition of Human Subject Research, then the HRPP applies. Principal Investigators cannot make this determination themselves. They must submit their study details to the IRB for an applicability review. Please see Applicability Review Flowchart for more information on how to do this.
Q. I am sure my study is going to be found human subjects research, do I still need to do an applicability review or can I begin by just completing a full HRPP application?
A. No, an applicability review needs to be conducted for ALL studies regardless of the likelihood that they will/will not be found to be human subjects research. Information in the applicability review can be re-used when completing the full application.
Q. How long will the HRPP process take?
A. This depends on a number of factors, such as whether your study is found to be human subjects research, whether you are using external consultants, and how much time is spent completing forms. Even if your study is found to not be human subjects research, the process can take up to a week from when you submit the forms. If your study is found to be human subjects research the process will be significantly longer. Please make sure to plan accordingly.
Q. My study needs to go out tomorrow, but I did not go through the appropriate process for HRPP, can you speed the process up for me?
A. No, HRPP incorporates elements and individuals from throughout the Marine Corps and Navy chains-of-command; it is not possible to skip steps in the process or to force individuals to speed up the time frame.
Q. How do I submit a package to the Institutional Review Board (IRB)?
A. Please see the HRPP homepage for more information on how to do this.
Q. I have received feedback from my HRPP representative to make changes to my protocol, do I have to make all of them?
A. Yes, if you are receiving feedback from your HRPP representative, this means that your current protocol is unlikely to pass review. If all changes are not made it will delay the process, so make sure to be thorough when adjusting your protocol.
Q. Can I use SurveyMonkey?
A. It depends on what the survey is asking, what demographic information you are collecting, and if you want to use the free or the licensed version. Please contact the USMC Survey Office for more information.
Q. I was contacted to participate in a study or take a survey. How do I know that it has been reviewed by an IRB?
A. Studies that have been reviewed by the IRB require participants to be given an informed consent. If you did not receive an informed consent, you should contact the Principle Investigator or the HRPP POC to determine if the study has been reviewed.
Q. My research is “exempt,” what does that mean?
A. Exempt Research is still Human Subject Research (HSR) and needs to be reviewed by the IRB. The difference between exempt and non-exempt research is the informed consent process. Exempt research doesn't require documentation of informed consent. Please contact the HRPP POC for more information.
Q. Does Marine Corps support extramural research?