If you would like to submit a research activity involving human subjects to the USM Institutional Review Board (IRB) for the Protection of Human Subjects for review, please follow the submission steps below.

If you have any questions about whether or not you should be using eProtocol please contact ORIO staff for guidance. 

Thirty (30) days prior to starting data collection fill out and submit the on line form.  Answer all questions fully and in sufficient detail to allow reviewers to make the determinations required.  Only complete protocol submissions will be accepted for review.  The ORIO will notify you (via email) when a submission to ORIO is received in its complete on line form.

All research involving human subjects conducted by any employee or agent of USM (faculty, staff, students, external, etc.) must receive IRB review and approval prior to implementation. e-Protocol login

Complete the either Social & Behavioral Research Investigators: “Social and Behavioral Research – Basic/Refresher” or applicable Biomedical Research Investigators: “Biomedical Research – Basic/Refresher” through CITI. A link to the training and further instructions can be found on our website HERE.  When you register for CITI you will need to choose to affiliate with the University of Maine System. 

  • Each member of the research staff and faculty advisor (if applicable) will need to complete this training before a protocol can be submitted for review.
  • External to USM, enter link to an equivalent CITI report (that lists the modules in the course) on the User ID request or email to usmorio@maine.edu.
  • Any training other than CITI will be considered on a case-by-case basis. HRPP 031 Education Requirements (pdf)
  • Research staff are considered to be persons who 1) obtain data about living individuals for research purposes through intervention or interaction with them; 2) obtain individually identifiable private information for research purposes; 3) obtain informed consent of human research participants.
  • Note: National Science Foundation (NSF) grantees are also required to take the Responsible Conduct in Research online training.

Fill out the form on our website here: https://forms.gle/SUUNkEmL2EE3AKEW7.  When you receive the User ID and a temporary password for the e-Protocol system, you will have 24 hours to set it. If you missed the deadline, hit reset password on the login page, or contact ORIO at usmorio@maine.edu.

Make use of the guidance and resources documents and websites available, including informed consent templates. 

After you receive a User ID and temporary password you can now log into the online submission system, e-Protocol. Please make sure to read the information listed on the e-Protocol login page https://usm.keyusa.net/.

NOTE: e-Protocol is currently compatible with Firefox and Internet Explorer only. You will also need to disable pop-up blockers in order to use the system. The pop-up exception for a single site:  https://usm.keyusa.net:443

After logging in to e-Protocol you will see an option to create a protocol. Your protocol will be created in a new window. You are able to save your work and leave the system as you would like. Refer to e-Protocol Resources below.

Personnel: Anyone with access to identifiable data or direct access to research subjects must be on the protocol.

Answers should be succinct and written in plain language. 

Most questions can be answered in a complete sentence. If you leave a question blank the system will not let you submit the protocol to the IRB. N/A is not an appropriate response for most questions.

Note: The form can be navigated via the “next,” “previous,” and left hand navigation bar options  Do not hit the back button in your web browser.

The form has 3 places for attachments to be uploaded: informed consent, [child] assent, and an attachments section.

Note: It is required to attach CV/Resume for each research staff, and faculty advisor. 

Obligations on the left hand Navigation bar, check off Primary Investigator.

There is a check for Completeness button on the left hand Navigation bar.

Click the “Submit Form” button on the left hand navigation bar when you are ready to submit the form to the IRB for review.

You will receive an email notification when the protocol has been sent, accepted, sent to the IRB, if/when the reviewers have any questions or changes, and again when the project has been approved. 

Note: For a student with a faculty advisor, when the student submits it goes into the advisor’s e-Protocol que for their review. The faculty advisor then checks off their Obligations then Submit Form to the IRB.