Office of Research Compliance
Lois Levy, Research Compliance Manager
- Additional resources from the Provost's office will allow us to keep five members of the IRB on board all summer to perform expedited reviews.
- These same five members form a subcommittee of the full IRB that will be able to convene and review any protocols requiring full committee review during the summer.
Also, effective immediately, all IRB applications must be submitted through the new MENTOR IRB system. Mentor IRB is available through the TC Portal under "Research>Human Subjects Research Protocol". Everyone with an active UNI should be able to access Mentor. Investigators with previously-approved studies at TC will soon find their protocols listed in Mentor, but will not find the full application and consent forms there. Full instructions on the use of Mentor are available on the Mentor Login Page. There are separate instructions for applicants and advisers.
If you're logged on to the TC Portal, you have access to Mentor without signing on again. If not, you'll be prompted to select your institution ("tc") and enter your UNI and password. Overall, the Mentor application is very similar to the form that has been in use over the last seven years, broken into sections.
There's a web form for basic information about your study, followed by prompts to upload your Protocol Description, Informed Consent and other documents. The Protocol Description and Consent forms are available within Mentor to download, fill out, then attach to your study. Mentor is self-contained, so all the other supplementary materials and instruction provided on the OSP website are available there as well.
Mentor has extensive online support as well as highly responsive tech support via email. The first time users of the system we surveyed during the testing/implementation phase found it fairly easy to figure out. It makes a lot of applicant tasks MUCH easier:
- You can check your application's status online
- No more need for a hard copy with physical signatures
- Stamped consent forms and approval letters are available as soon as they are prepared and can be printed and downloaded throughout the life of the project
- There's a compliance check to ensure you have all necessary components of the proposal
- A list of protocols you may have submitted since 2010 will be available to you when you log on at some point in June. As Mentor becomes populated with applications created entirely in the system, revisions and renewals should become much easier.
Faculty will receive an email when they are listed as an adviser on a student protocol, which includes directions for accessing Mentor. Follow the directions contained in the email, and once you're logged on to Mentor, click on "Student Protocols" on the left. There, you will find a list of protocols awaiting your approval. You will need to click through, review the different sections and approve the Protocol for submission to the IRB. No student protocol can move forward until the adviser has approved it.
NO STUDY CAN BEGIN (INCLUDING RECRUITMENT OF SUBJECTS) WITHOUT FIRST HAVING RECEIVED IRB APPROVAL.
STUDENTS: You can only submit your study to the IRB AFTER your academic advisor has approved the protocol through the Mentor system. As such, you must log back in after you have received approval from your academic advisor to submit to the IRB.
NOTE FOR DISSERTATION STUDIES: Please note that the IRB will only review dissertation studies after the proposal hearing has been passed, and note that regardless of the type of study, no study can begin (including recruitment of subjects) without first having received IRB approval.
MODIFICATIONS: To change a study that has been approved by the IRB, you will need to request a modification. To do so, scroll to the bottom of the page of your study, and find the "Modifications" tab. From there, click on the "Upload New Modification" button. You will need to upload a Memo describing what you are changing and why, along with the revised application to reflect your revised study and any other documents (such as recruitment materials, Consent forms, etc.) that need to change as a result of your modification. If you have multiple additional documents that you need to upload, then after you submit your modification, you should click on the page icon (with the maroon lines) next to your modification entry and select "Upload Additional Docs." NOTE THAT YOU CANNOT BEGIN IMPLEMENTATION OF A MODIFICATION UNTIL AFTER IT HAS BEEN APPROVED BY THE IRB.