Preparing for IRB Submission
Follow the steps below for submissions to the UTHSC IRB. Should you have any questions, do not hesitate to contact the UTHSC IRB office at (901) 448-4824.
If you are a student, resident, or fellow, the UTHSC IRB accepts and supports you taking on the role of Principal Investigator. However, you must identify a Faculty Advisor for your project. Your Faculty Advisor should be someone who has conducted human subjects research and is familiar with the UTHSC IRB submission process and IRB policies. He/she will be a resource and a mentor to guide you through submitting your research application to the IRB and conducting your study after you receive IRB approval. Please note that the UTHSC IRB electronic application will prompt you to name a Faculty Advisor.
Taking on the role of Principal Investigator for research studies can be challenging. Not only are you responsible for the overall conduct of the study, but you are also responsible for all of those individuals working on the study. Please review the UTHSC IRB policy related to the Responsibilities of Investigators before you begin your project.
Step 1: Get a UT NetID if you do not have one
Make sure that all key study personnel (KSP) associated with the project have a UT NetID (username) and password because the IRB electronic system, iMedRIS, uses the UT NetID system to allow and monitor access. If you do not have a UT NetID, then you will not be able to log into iMedRIS. In addition, if any of the KSP associated with your project do not have a UT and iMedRIS account, you will not be able to add them to your project. If you have been issued a UTHSC email account, then you have a UT NetID; a call to the HELP desk at (901) 448-2222 may be necessary if you are unsure of your NetID status or have forgotten your password.
For non-UTHSC affiliated users who do not currently have a UT NetID, a UT faculty/staff member on your study team will have to sponsor the non-UTHSC individual into the UT system. We have provided instructions to request a sponsored NetID. Note: Non-UTHSC affiliated key study personnel must either (1) provide IRB approval from their institution’s IRB for their participation in this study or have their institution’s IRB sign an IRB Authorization Agreement where their IRB will rely on our IRB’s review; OR (2) if they are not affiliated with an institution that has its own IRB, they must sign an Individual Investigator Agreement. Consult the directions found on our Tools & Guides webpage under IRB Agreement and call the IRB for guidance at (901) 448-4824, as this can sometimes be a complicated issue.
Note: Once you receive your UT NetID and password and your iMedRIS account has been set up, all iMedRIS/IRB correspondence will be sent automatically to your new UT email account. You may contact the HELP Desk at (901) 448-2222 for assistance in having your new UT email forwarded to another email account you check every day such as your Methodist, Le Bonheur, or Regional One Health email, etc.
Step 2: Get your iMedRIS access set up
When you have a UT NetID and password, you have the ability to log into iMedRIS; however, you will not have all of the buttons you need to begin an application.
To obtain full iMedRIS access, you must do the following:
- Log into iMedRIS with your UT NetID and password.
- Click the "Logout" button in the upper right-hand corner of the screen.
- Send an email to Margaret Sularin, Sr. Regulatory Specialist, naming the department with which you are affiliated so that your account may be fully activated. (For non-UTHSC accounts such as UTK and GSM accounts: Contact Tricia Page or Michelle Clayton).
- All iMedRIS/IRB correspondence will be sent automatically to your UT email account. You may contact the HELP Desk at (901) 448-2222 for assistance in having your new UT email forwarded to another email account you check every day such as your Methodist, Le Bonheur, or Regional One Health email, etc.
Step 3: Get human subjects protection training for all key study personnel (KSP)
All KSP associated with your project must complete the required education on the protection of human research volunteers before the IRB can grant final approval for your project: the Collaborative Institutional Training Initiative (CITI) or the National Institutes of Health (NIH) Course. Approved training for both of these courses expires every 3 years; therefore, you must take the CITI refresher course or retake the NIH course every 3 years.
Collaborative IRB Training Initiative (CITI) Program
If you have completed the Group 3 CITI training modules with UTHSC within the last 3 years, this information will be verified by our office and added to your IRB submission. If you or your KSP completed the CITI certification with another institution/organization within the last 3 years, you can affiliate your certification with UTHSC by following the online instructions on the CITI website.
If you or your KSP needs CITI certification, go to Collaborative Institutional Training Initiative (CITI) and complete the Group 3 CITI training modules associated with UTHSC.
Note: if you are an investigator or other key study personnel and will conduct an NIH-funded clinical trial in the future, you must take the CITI Good Clinical Practice (GCP) module in addition to Group 3.
If you need any assistance or have any questions regarding the CITI training, please contact Melanie Saucier at (901) 448-4824.
National Institutes of Health (NIH) course
Visit course registration page to complete the NIH Protecting Human Research Participants course. Note: if you are an investigator or other key study personnel and will conduct an NIH-funded clinical trial in the future, you must also take the NIH Good Clinical Practice training course.
Attach a copy of your NIH completion certificate to your IRB submission via iMedRIS.
Step 4: Create/Complete an IRB electronic submission
Training for IRB Policy and iMedRIS submissions: You may request a one-on-one training from the IRB. IRB policy and iMedRIS training is highly encouraged!
Go to iMedRIS to log into the electronic application system.
Once you log into iMedRIS, click the blue Study Assistant tab on the left side of your screen. Next, click Add a New Project to start a new application. When starting a new application in iMedRIS, please note:
- The application will guide you through the required sections depending on the type of research you are conducting.
- Be sure to click Save and Continue to Next Section to save your responses and move to the next section of questions in the application.
- Required questions of the application will be marked with a red asterisk (*).
- If you forget to respond to a question, the system will give you a prompt.
- If you are unsure about a question (such as whether your project will be reviewed as exempt, expedited, or full board), please contact the IRB office.
- Once you have completed and saved the last page of the electronic application, you will enter the Routing Form and be prompted on the next few pages to upload any study documents (informed consent form, protocol, questionnaires, etc.).
- Finally, you will be able to route the application and all associated documents to all investigators, the UTHSC department chair (if applicable), the Faculty Advisor (if applicable), and the Regional One Health division chiefs (if applicable) so that the appropriate signatures are obtained before the IRB receives it (see Step 5 below for further information).
Be sure to check the Workflow Tracking in iMedRIS to verify where your submission is in the electronic process and to ensure the UTHSC IRB receives it. Consult the Routing, Workflow Tracking, & Signoff Guide or contact the IRB office for assistance.
Should you have any questions regarding the IRB electronic application, do not hesitate to contact the IRB office at (901) 448-4824. In addition, consult the Guides and Tips.
Step 5: Obtain the appropriate electronic signatures
Before you submit an application or response to the IRB, you must route the submission to the appropriate persons for their electronic signatures. See the table below for the required signatures.
If additional signatures are required, you will click YES to select additional personnel for routing in the iMedRIS Routing Form. Check off the name(s) of the appropriate individuals who will apply their electronic signatures. The system will send an email notification to all the individuals you selected, to their UT email address. All required signatories will be directed to log into iMedRIS, review the submission, and apply their electronic signatures using their UT NetID and password.
Note: The UTHSC IRB will not receive your submission until all persons have applied their electronic signatures.
|Type of Submission||Required Signature(s)|
|Form 1: New Application||
|Response to recommendations/provisos for any submission form||PI or Co/Sub-investigator|
|Form 2: Change Request and Amendments||
Form 3: Continuing Review
Form 4: Reportable Unanticipated Problems/Events
Form 6: Advertising/Recruitment Materials
Data Safety Monitoring Board/Annual Reports
Pre-Audit Submission Form
Submit Miscellaneous Documents
Form 7: Study Closure
|PI or Co/Sub-investigator|
Step 6: Address appropriate institutional requirements
If you will be conducting your project at any of the following sites, or if your project is associated with any of the following organizations affiliated with the UTHSC IRB, be sure to call the corresponding number or visit the website to find out about and address administrative requirements set by these organizations:
If you will be conducting your project at a non-UTHSC affilated site, a letter from administration at that institution permitting you to conduct research there may be required - call the IRB for guidance at (901) 448-4824.