IRB Submission Process and e-Protocol Resources
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.
Step 1: Complete the required training. Please complete the “Social and Behavioral Research – Basic/Refresher” through CITI. A link to the training and further instructions can be found on our website here: http://usm.maine.edu/orio/irb-training. When you register for CITI you will need to choose to affiliate with the University of Maine System. Note: 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.
Step 2: Request an e-Protocol User ID. Please fill out the form on our website here:http://usm.maine.edu/orio/request-e-protocol-user-id. You will receive an email within a few days with a User ID and a temporary password for the e-Protocol system.
Step 3: Review the IRB Guidance. Please make use of the guidance documents and websites available, including informed consent templates. You can find these guidance items on our website here: http://usm.maine.edu/orio/irb-guidance. Specifically, the informed consent guidance can be found here: http://usm.maine.edu/orio/informed-consent.
Step 4: Log into e-Protocol. 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.
Step 5: Create a protocol. 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.
Step 6: Answer the protocol questions. Answers should be succinct and written in plain language. The form can be navigated via the “next,” “previous,” and left hand navigation bar options. If a question does not apply to your project, please answer “n/a”. If you leave a question blank the system will not let you submit the protocol to the IRB. Note: Do not hit the back button in your web browser.
Step 7: Upload attachments. The form has 3 places for attachments to be uploaded. The informed consent section, the assent section (if applicable), and an attachments section.
Note: It is required to attach CV or Resume for each research staff, and faculty advisor.
Step 8: Submit the form. 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: As a student with a faculty advisor, once you submit the protocol your faculty advisor logs into eProtocol to review your work, checks their approval on the Obligations tab, then submits for IRB review.
- e-Protocol Log-in Page (external link)
- Request for e-Protocol ID (pdf)
- e-Protocol FAQs (pdf)
- e-Protocol Sample
- Primary Investigator (PI): How to respond to reviewer comments, Quick Guide (pdf)
- Faculty Advisor Quick Guide (pdf)
- e-Protocol Amendment Quick Guide (pdf)
- e-Protocol Annual Review/Continuing Review Quick Guide (pdf)
- e- Protocol Final Report Quick Guide (pdf)
- Study Completion Form (docx)
- Adverse Event Report Form (doc)