How to Request a Modification to a Previously Approved Institutional Review Board (IRB) Study

UMaine Alert

Posted: April 19, 2024 - 1:32 PM

At approximately 9:24 a.m. on Friday, April 19, a University of Maine graduate student was struck by a university vehicle on Long Road at the University of Maine campus in Orono. The student reports that they are at a local hospital with minor injuries.

Emergency services, including the Orono Fire Department, University Volunteer Ambulance Corps, University of Maine Police Department, Orono Police Department and Penobscot County Sheriff’s Office responded to the scene.

The university vehicle involved in the incident was a Chevrolet Express van. It was being operated by a university employee.

Counseling services and support are available for students, faculty or staff who may have been affected. The Counseling Center can be reached at 207-581-1392 and the Dean of Students Office can be reached at 207-581-1406.

The scene has been cleared and Long Road is now accessible. An investigation is being conducted by the University of Maine Police Department with assistance from the Penobscot County Sheriff’s Office Crash Reconstruction Unit. Any witnesses to the incident are encouraged to contact Lt. Noel Santiago at noel.santiago@maine.edu.

Follow these simple steps to modify an existing study:

Using a different color font (or track changes), edit all applicable sections of the previously approved application (make sure you are using the final approved copy). Make sure new recruitment materials (emails/flyers), new measures, new consent forms, etc., are included, as applicable. Note that changes in the procedure often need to be reflected in the consent (e.g., adding measures may increase the time needed to complete the study). This edited application should be one document (Word only; no PDF).
Please note that if you have already collected data but now want to change methods/measures going forward, you need to retain all of your original approved materials in the application and then add the modification describing what you want to do differently in the future.
You should clearly designate the original procedures vs. the new procedures. The application needs to reflect the entirety of the project.
Send an email to umric@maine.edu requesting the modification. The email should reference the title and number of the approved application, and briefly describe the modification. Attach the updated application and send.

When is a modification really a new study?

If the proposed modification includes changes to two or more of the following criteria, the IRB would consider this to be a new study and the investigator would need to submit a new study application.

Study population
Study procedures
Study purpose

Change in Personnel

If you simply need to update personnel on an approved study, you do not need to edit the approved application. An email referencing the study title and number along with name of person(s) to be added, years of human subjects research experience, role on the project, and email is sufficient. If the Collaborative Institutional Training Initiative (CITI) training was not completed through UMaine, please also provide the training certificate.

Some personnel changes may also require a change to other sections of the application such as the consent document, and recruitment materials. In such cases, the application should be modified to include these changes and submitted as a modification for review.

Please contact the IRB office with any questions.