Submitting a New Protocol

For a detailed walk-through on how to submit a new protocol, please download How to Submit a New Protocol.

To get started submitting a new protocol, log in to the MyTC portal and click the Faculty, Student, or Employee Resources tab. On the right side, you will find a link to Mentor IRB. Click on the My Protocols sidebar on the left navigation menu and then click the Create New Protocol button.

If you are a student, you will be immediately prompted to list your faculty sponsor’s name. Please ensure you have communicated with your faculty sponsor before submitting a new IRB protocol.

Complete the electronic form with the appropriate information regarding your study (e.g., study title, duration, etc.). Make sure to choose the appropriate review category for your research. For more information on review categories, visit our Review Categories page.

After you have saved and submitted the electronic form along with the IRB application and any consent documents, you will then need to upload all additional materials. The IRB needs to review and approve all items that will be used throughout a research study. As such, be sure to submit all study instruments (i.e., assessments, interview protocols, focus group protocols, surveys, etc.), recruitment materials (i.e., flyers, scripts for emails, scripts for announcements, text for online postings, etc.), any other items that you will use throughout the study, and approval letters from research sites. If you need additional help reviewing your protocol, please reference our TC Reviewer Questions.

IRB Submission Documents

Each IRB protocol is reviewed on a case-by-case basis and will likely include one or several of the following documents in the drop-down menu. These same documents are also accessible through MyTC/TC Mentor IRB/Documentation. Please visit our Writing for an IRB Review page for more information on preparing IRB documentation.

When you create a new protocol in TC Mentor IRB, you will be asked to complete an electronic Primary Investigator (PI) survey. Then, you will be asked to upload the TC IRB application and applicable consent forms. Please note that the TC IRB application is what you upload as the "Protocol Description" (i.e., IRB Application Template) on TC Mentor IRB. All supplemental documents (e.g., recruitment script, survey measures, etc.) must be uploaded as individual files after submitting the electronic PI survey. Please do NOT submit all items in one packet, this will not be accepted.

To delete or replace files under your protocol in Mentor IRB, navigate to the context menu (red/gray icon resembling a notepad) to the left of the file name. Click the context menu and several options should appear, including “Delete” and “Replace." This should only be done prior to clicking the “Submit Protocol for Review” button. Once a protocol is approved, you should not edit any of the existing documents. If you need to change approved documents, submit a modification.

When you are completely satisfied with your application and materials, and everything is in its final format (without tracked changes) click the "Submit Protocol for Review" button. You may not begin recruitment or research until your documents have been reviewed and you received a final IRB approval letter.

• For existing data research, you will only need to submit TC Mentor IRB's PI survey and an IRB application, unless prompted otherwise by an IRB reviewer (please review our Sample Application for Existing Data ). Exempt existing data studies will not require recruitment or consent forms as the data is already pre-existing. However, these studies may require data sharing or data release documents, which can be found on TC Mentor IRB/Documentation.
• Student researchers must secure a faculty sponsor before submitting to IRB (please visit our FAQs for more information on faculty sponsors). 
• For any items that you will include in your protocol, read the relevant Guides & Resources prior to submission.

Once Your Protocol Has Been Submitted...

You may not begin recruitment or research until your protocol has been reviewed and you have addressed all requested revisions. 

You may only begin your research when you receive a final IRB approval letter. Recruitment of a site or use of recruitment materials may not be used until you are IRB approved. Please note your consent form bears an official TC IRB authorization stamp only after final approval. All studies with Informed Consent forms (Parent Permission or Assent forms) must contain an official IRB authorization stamp which will be applied to the documents after final approval. Copies of the official IRB authorized stamped consent form and supporting documents must be used for your research work. TC IRB is the only authorized department to issue a TC IRB authorization stamp.