Getting Started

Make sure all key study personnel (KSP) associated with the project have a UT NetID (username) and password so that they can be added to and/or access the IRB electronic system. If you have a UTHSC email, you have a UT NetID. Call the Help Desk ( 901.448.2222) if you have forgotten your password.

Non-UTHSC users who do not have a UT NetID will have to be sponsored into the UT system. To request a UT Net ID for non-UTHSC individuals, email irb@uthsc.edu; please have ready the following information for UT NetID requests: name, date of birth, social security number, phone number, email address, and institution/department affiliation.  Do not send this sensitive information via regular email! Consult Encrypt Your Email for instructions on emailing confidential information.

Note: Non-UTHSC KSP must either:

1. provide IRB approval from their institution to participate in the study or an IRB Authorization/Reliance Agreement may need to be executed; OR
2. sign an Individual Investigator Agreement if they are with an institution that does not have its own IRB.  Consult the Reliance Agreement page and/or call the IRB for guidance: 901.448.4824.

Note:To access iMedRIS, researchers will need to install the Duo Mobile App to enable two-factor authentication.

All KSP associated with your project must complete the UTHSC Collaborative Institutional Training Initiative (CITI) education on the protection of human research volunteers before the IRB can approve your project. CITI courses must be passed at 85% or higher. Approved CITI training expires every 3 years.

• Our office will verify your UTHSC CITI training is up to date with each of your IRB submissions. 

TO GET CITI CERTIFICATION:

•  Go to Collaborative Institutional Training Initiative (CITI)
• Complete either
  1. The UTHSC Basic Human Subject Protections and Good Clinical Practices combination course OR
  2. The Human Subjects Training Basic Biomedical (Biomed) course AND
  3. The GCP for Clinical Trials with Investigational Drugs & Medical Devices (U.S. FDA focus) course. These courses have more modules, but for 3-year recertification, you can complete a shortened refresher course.

IF YOU OBTAINED CITI CERTIFICATION AT ANOTHER INSTITUTION/ORGANIZATION WITHIN THE LAST 3 YEARS:

• affiliate your certification with UTHSC by following the online instructions on the CITI website.

IF YOU OBTAINED HUMAN SUBJECTS PROTECTION AND GOOD CLINICAL PRACTICE TRAINING AT ANOTHER INSTITUTION (investigators new to UTHSC or collaborating from another institution):

• Completed certificate and course modules will be reviewed for reciprocity. If the coursework is not comparable, additional modules may be assigned, or researchers must complete one of the two course options noted above.

For more information about UTHSC CITI requirements, visit the Clinical Trials Tools and Resources page.

For information about UTHSC IRB policy and iMedRIS (electronic application system) training opportunities, visit our Training webpage. IRB policy training is strongly encouraged for all KSP for compliance with federal regulations, state law, and local IRB policy.

Training for IRB Policy and submissions: You may request a one-on-one training from the IRB. IRB policy and training is highly encouraged!

Go to iMedRIS to log into the electronic application system.

Terms of Use: By submitting materials through iMedRIS, you agree that all electronic signatures applied within the system are legally equivalent to your handwritten signature.

Once you log into iMedRIS, under Featured Projects click Create a New Project. Select the 1st option (UTHSC IRB Memphis Form 1: Study/Project Application) and click “Start selected Application”. 

• The application will guide you through required sections depending on your research type.
• Required questions are marked with a red asterisk (*).
• If you are unsure about a question (such as whether your project should receive Exempt/Not Human Subject Research (NHSR), Expedited, or Full Board review), contact the IRB office (901.448.4824) or refer to the Levels of IRB Review.
• Once you have completed and saved the last page of the electronic application, you will enter the Routing Form and be prompted to upload study documents (informed consent form(s), protocol, grant application, drug/device package inserts, 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) to obtain the appropriate signatures before the IRB receives it (see Step 5 below).

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, and Signoff Guide or contact the IRB office for assistance.

Questions regarding the IRB electronic application? Contact the IRB office (901.448.4824) or consult the Guides and Tips.

Before you submit an application or response to the IRB, you must route the submission to the appropriate persons for their electronic signatures (See table below).

If additional signatures are required, click YES to select additional personnel for routing in the iMedRIS Routing Form. Check off the name(s) of the individuals who will electronically sign. The system will email the individuals you selected. All required signatories will be directed to log into iMedRIS, review the submission, and electronically sign using their UT NetID and password.

Note: The UTHSC IRB will not receive your submission until all electronic signatures are complete.

Type of Submission	Required Signature(s)
UTHSC IRB Memphis Form 1: New Study/Project Application	Principal Investigator(s) (PI); all Co/Sub-Investigators; Department Chair if PI is a UT student/fellow/resident/employee/faculty member; Faculty Advisor if PI is a student, fellow, or resident; and Hospital Service Chief (for Regional One Health studies)
Response to recommendations/provisos for any submission form	PI or Co/Sub-investigator
Form 2: Change Request and Amendments	PI or Co/Sub-investigator; and Any newly added investigator
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

If you will be conducting your project at one of our partner sites (Campbell Clinic, Le Bonheur Children’s Hospital, Methodist Healthcare- Memphis Hospitals, Regional One Health, or Semmes Murphey), or if your project is associated with any of our partners, review the information on the IRB Partners webpage for  administrative requirements set by these organizations. 

If you will be conducting your project at a non-UTHSC partner site, a letter from administration at that institution permitting you to conduct research there will be required. Call the IRB with any questions: 901.448.4824.