Alert

ORIO will no longer process Legacy submissions after July 1, 2025. Please reach out to usmorio@maine.edu if you have questions.

If you would like to submit a project to the USM Institutional Review Board (IRB), please follow the submission steps below.

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. 

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.  

Cayuse is a “smart form”, it will depend on your choices throughout the form as to what you will be filling out. The screenshots will show all the choices available. Each document below is a pdf.

May 4, 2023 Initial Submission training Zoom recording

Creating a New Human Subject Research submission:

Start Initial Human Subject Research Submission

Study Design Section

Study Selection Section

Study Procedures Section

Participant Protections (Consent) Section

Complete Submission and Certification Routing

If applicable:

Data and Safety Monitoring

HIPAA

International Research

Study Products

Note: If you have changes, complete a Modification BEFORE submitting a Renewal.

Creating a Determination of Human Subject Research
Determination practice sheet in MS Word
-Includes submission of Faculty Led Student Classroom Projects

Creating a Modification

Creating a Renewal/Continuing Review

Creating an Incident Report

Creating a Closure/Completion of a protocol

Creating a Determination for Future Research

Replying to Reviewer Comments

Find Documents After Approval

Delete a Submission

Delete an Unsubmitted Study

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 UMS CITI will be considered on a case-by-case basis. HRPP 031 Education Requirements (pdf)
  • Definition of 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.
  • Note: Submissions for Human Subject Research determination are not required to complete a training; however, if it is determined that the submission is human subject research, then the training will be required.

Cayuse User ID Request: https://forms.gle/SUUNkEmL2EE3AKEW7

You will receive an email with a temporary password. Please follow the email’s instructions. It takes 24 hours to sync the new user to Cayuse.

After you receive a User ID and temporary password use the link in the email to log into Cayuse.

University of Southern Maine Faculty/Staff/Students use your Employee/Student ID to log in as Single Sign On.

Note: Be careful when copying the password provided so that it does not have a space before/after. If having issues logging in, try to clear your browser’s cache and refresh. If you are still having issues, please contact usmorio@maine.edu.

USM Login: https://usm-maine.app.cayuse.com

Guest login: https://usm-maine.app.cayuse.com/guest

After logging in to Cayuse you will Select “Human Ethics” from under the Products drop-down. Click on the New Study button. Refer to Cayuse Resources for guides.

Under “Studies” you may see your Legacy protocol approvals. You may start modifications, renewals, incident reports, or closures from these.

If you do not see the Legacy protocol you are looking for, please contact the ORIO office at usmorio@maine.edu

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. 

Note: Please use the form’s navigation and not the browser.

Attachments can be made throughout the form and and in the Attachments section.

Note: It is required to attach CV/Resume and human subject research training report for each research staff and faculty advisor. 

For Legacy Modification and Renewal submissions, upload documents that were in eProtocol.

Each Principal Investigator/Faculty Advisor will need to “certify” each submission, including responding to comments.

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.