Getting Started - Preparing for IRB Submission

With all of the Federal and State regulations as well as local policies and procedures, conducting a research study can seem like a daunting task.  We hope the information below will help guide you through the process and simplify some of the issues related to research with Human Subjects.  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 advisor/mentor will be a resource and will help guide you through the research process.  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 also you are responsible for all of those individuals working on the study.  Please review the UTHSC IRB policies and procedures related to the Responsibilities of Investigators before you begin your project.

Step 1: Get a UT Net ID

Make sure that all key study personnel (KSP) associated with the project have a UT username and password, as the IRB electronic system, iMedRIS, uses the UT Net ID system to allow access. If you do not have a UT Net ID, 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 Net ID; a call to the HELP desk (448-2222) may be necessary if you are unsure of your Net ID status or have forgotten your password.

For non-UTHSC affiliated users who do not currently have a UT Net ID, a UT faculty/staff member will have to sponsor the non-UTHSC individual into the UT system. This may be accomplished through the following steps  PDF icon

Once all KSP associated with the project have a UT Net ID and password, each user must log into iMedRIS for the first time at https://ris01.uthsc.edu. Next, he/she will immediately click the "Logout" button in the upper right hand corner of the screen. Finally, he/she must contact Margaret Sularin, Sr. Regulatory Specialist, at msularin@uthsc.edu and indicate the department with which he/she is affiliated so that his/her department access can be set up and the account can be fully activated.

Note: Once you receive your UT Net ID and password and your iMedRIS account has been set up, all iMedRIS correspondence will be sent automatically to your new UT email account. You may contact the HELP Desk at (901) 448-2222 to have your new UT email forwarded to another email account such as Methodist, yahoo, gmail, etc. (or you can click “Webmail” at the top of any UT webpage and click “Click here to Manage Your Account,” following the steps for forwarding mail).

Step 2: Get human subjects protection training for all key study personnel

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) online Course at phrp.nihtraining.com/users/login.php

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 needs CITI certification, click the Training tab on the left side of the screen, or go to www.citiprogram.org and complete the Group 3 CITI training modules associated with UTHSC.

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 need any assistance or have any questions regarding the CITI training, please contact Melanie Saucier at 448-4824.

National Institutes of Health (NIH) course

Step 3: Create/Complete an IRB electronic submission

Click on the iMedRIS Login button on the left side of the screen or go to https://ris01.uthsc.edu to log into the IRB electronic system.

Terms of Use: In submitting materials through the 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, you will see a blue Study Assistant tab on the left side of your screen.  Click that tab.  Then 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, 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 to upload any study documents (informed consent form, protocol, questionnaires, etc.); and
  • 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 Guidelocated by clicking on the tab on the left named iMedRIS Guides & Tipsor 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 printable Guides and Tips located under the iMedRIS Guides & Tips page to the left. If you need more individualized assistance, you may request a one-on-one training from the IRB.

Step 4: Be sure to 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 listed below to inquire about and address any administrative requirements set by these offices:

Methodist Healthcare - Memphis Hospitals /
UTMP (UT Methodist Physicians)

Rexann G. Pickering, Ph.D., CIP, RN
Administrator, Human Protection
(901) 516-2323
rexann.pickering@mlh.org 
Institutional Requirements

Le Bonheur Children’s Hospital
Sheon Lynch, MSA, MT (ASCP)
Administrative Director
(901) 287-6208
sheon.lynch@lebonheur.org 
Institutional Requirements

Regional One Health
Maria van Werkhooven, BVM, FACHE
Director, Office of Medical Research
(901) 545-7453
mvanwerkhooven@regionalonehealth.org 
Institutional Requirements

Step 5: Be sure to 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. Note that the IRB does not receive your submission until all persons have signed. See the table below for the required signatures. If additional routing is required, after you attach any documents to your application or response form, answer “yes” to the question regarding additional routing and then check off the appropriate names.

Type of Submission

Required Signature(s)

New Application

PI; all Co/Sub-Investigators; Dept. Chair if PI is a UT student/fellow/resident/ employee/faculty member; Faculty Advisor if PI is a student, fellow, or resident; & Hospital Service Chief (for Regional One Health studies)

Response to recommendations/provisos for any submission form

PI or Co/Sub-investigator

Revisions (Form 2)

PI or Co/Sub-investigator; & any newly added investigator

Continuation (Form 3), Adverse Events (Form 4), etc.

PI or Co/Sub-investigator