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 e-Protocol please contact ORIO staff for guidance.
All research involving human subjects conducted by any employee or agent of USM (faculty, staff, students, etc.) must receive IRB review and approval prior to implementation.
e-Protocol IRB Submission Process:
Step 1: 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 2: 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.
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 in to 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/.
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.
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.
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: 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.
- e-Protocol Log-in Page
- Request for e-Protocol ID
- e-Protocol FAQs
- Primary Investigator (PI): How to respond to reviewer comments, Quick Guide
- Faculty Advisor Quick Guide
- e-Protocol Amendment Quick Guide
- e- Protocol Final Report Quick Guide
If you need to take action on an existing paper-based protocol (file a revision or amendment, file for continuing review, close the project, report an adverse event, etc.) this should be done using the paper-based system described below. Note: Existing paper-based protocols may require Continuing Review and/or Amendments to submit De Novo through eProtocol.
Each paper-based submission must be submitted in two formats, as follows:
- Electronically to firstname.lastname@example.org Word .doc or .pdf format is required.
- A Hard Copy, with required signatures, to the Office of Research Integrity and Outreach, University of Southern Maine, 7 Chamberlain Ave., Portland, Maine, 04101 (hard copy submissions can be dropped off in person or sent via intercampus or regular mail)