Getting Started

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.

Non-UTHSC affiliated users, who do not currently have a UT NetID, will have to be sponsored into the UT system. To request a UT Net ID for non-UTHSC affiliated individuals, please contact Anna-Marie Smith at asmith509@uthsc.edu. The following information will need to be provided for each UT NetID request: name, date of birth, social security number, phone number, email address, and institution/department affiliation.  Please do not send this sensitive information via regular email. Consult Encrypt Your Email for instructions about emailing confidential information.

Note: Non-UTHSC affiliated key study personnel must either (1) provide IRB approval from their institution’s IRB for their participation in the study or an IRB Authorization/Reliance Agreement may need to be executed; 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 Reliance Agreement page and/or call the IRB for guidance at 901.448.4824, as this can sometimes be a complicated issue.

Note: Prior to accessing iMedRIS, researchers will need to install the Duo Mobile App.  The University requires this two-factor authentication to protect against cyber-attacks.

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:

1. Log into iMedRIS with your UT NetID and password.
2. Click the "Logout" button in the upper right-hand corner of the screen.
3. You will receive an email when your iMedRIS access has been set up by Electronic Research Administration.
4. All iMedRIS/IRB correspondence will be sent automatically to your UT email account or the email address you provide to Electronic Research Administration.

All KSP associated with your project must complete the required 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 (i.e. completion of the UTHSC CITI training course within the past 3 years) upon 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. (the full course must be completed every 3 years for recertification) 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 recertification every 3 years, you can complete a shortened refresher course.

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

• completion certificate and course modules will be reviewed for reciprocity. If the coursework is comparable, UTHSC will accept their training. 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 to foster compliance with federal regulations, state law, and local IRB policy regarding the protection of human subjects.

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.

Terms of Use: In submitting materials through iMedRIS, you hereby intend that all electronic signatures executed by you within iMedRIS Integrated Research Information System are the legal equivalent of your traditional hand-written signature.

Once you log into iMedRIS, under Featured Projects click Create a New Project. On the screen, select the 1st option, UTHSC IRB Memphis Form 1: Study/Project Application and click the gray button “Start selected 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 should receive Exempt/Not Human Subject Research (NHSR), Expedited, or Full Board review), please contact the IRB office at 901.448.4824 or refer to the
   Levels of IRB Review located on the IRB website.
• 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(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) 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, and 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.

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)
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 any of our affiliate 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 affiliates, please review the information found on the IRB Affiliates webpage to find out about and address administrative requirements set by these organizations. 

However, if you will be conducting your project at a non-UTHSC affiliated site, a letter from administration at that institution permitting you to conduct research there will be required - please call the IRB if you have any questions: 901.448.4824.