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 stepsPDF 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 Kimberly Prachniak, Associate Director, at kprachni@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 on the Training link on the left side of the screen, or go to www.citiprogram.org and complete the online certification modules for Group 3.

If you or your KSP completed the Group 3 CITI certification with another institution or organization within the last 3 years, you can affiliate your certification with UTHSC by completing the following steps:

  • Log onto the CITI website
  • Once logged in, click the link Affiliate with another institution
  • Choose University of Tennessee Health Science Center - Memphis from the drop down list of Participating Institutions and click Submit
  • After updating any necessary information, click Submit
  • On the next screen, scroll down to ensure that Group 3 is checked under CITI Course Enrollment Questions
  • Scroll to the bottom and click Continue
  • Affiliation with UTHSC is now complete
  • You will need to return to the main menu and click the link Incomplete under required modules.
  • Click Re-enter and complete the Integrity Assurance Statement by clicking the link near the top.

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 have logged into iMedRIS, click on the Project Assistant tab on the left. Next, click on Add a new Project to begin the electronic application.  The electronic application will guide you through the research questions you must address depending on the type of research study you will be conducting.  After you complete the electronic application, you will be prompted to upload master protocols, investigator's brochures, surveys, questionnaires, consent form(s), and other study documents. You will then be able to route the application and associated documents to all persons who must sign off before the IRB receives it (explained in Step 5 below).

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

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

Regional One Health
Maria van Werkhooven, BVM, FACHE
Director, Office of Medical Research
(901) 545-7453
mvanwerkhooven@regionalonehealth.org
www.the-med.org/the-med/employees-physicians/researchexternal link icon

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)

Registrations
(converting an exempt paper study to an iMedRIS study)

Principal Investigator (PI) only

Response to recommendations/provisos for any submission form

PI or Co/Sub-investigator

New Application

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

Revisions (Form 2), Continuation (Form 3), Adverse Events (Form 4x), etc.

PI or Co/Sub-investigator