IRB – Submission Help/Training Resources

IRB Submission Workshop – Coming Soon

The IRB Office is hosting a series of drop-in workshops to help investigators and coordinators with their submissions in InfoEd. Bring your questions and study information, and staff and computers will be available to work on IRB submissions.

InfoED Human Subject Module Guides

InfoED Human Subject Module Video Tutorials

OnCore Training Guides

For the latest OnCore training guides, please visit Research at UTMB/OnCore Training or click the link below:

https://research.utmb.edu/research-at-utmb/oncore-training

    Additional Human Subjects Training

    • Introduction to Human Subject Research: UTMB Policies, Requirements and Systems
    • A customizable 2-3 hour classroom presentation delivered to your group. We highlight key policies for conducting human subject research at UTMB, including training on Conflict of Interest, Informed Consent, Working with the IRB, and the OnCore and InfoEd systems. This training is Ideal for groups of new residents, medical students or junior faculty. We deliver to you on your schedule. Contact Research Education to schedule.

    • Introduction to OnCore e-Research
    • OnCore is a web-based clinical trials management system, and is the initial entry point for ALL submissions to the IRB.

      All new protocol submissions to the UTMB IRB, regardless of whether they are clinical trials or not, must be initiated through OnCore before submission via InfoEd. Training will introduce the user to OnCore, and demonstrate the steps necessary to begin a study in the OnCore eResearch system. Training in OnCore is mandatory before access can be granted for the system. If you intend to submit a new protocol to the IRB, you must complete OnCore training session and learn the new process and how to navigate within OnCore eResearch.

      Training is online or in a classroom setting. Visit the Training Calendar to register for a class, or self-enroll in the online version in the online learning system UTMB Learn. If you have trouble, please contact Research Education to have this training assigned to you for completion online at your convenience.

    • Navigating the IRB
    • Navigating the IRB is a 3-part introduction to working with the IRB at UTMB. It is designed for investigators and study staff alike and includes information about the role of the IRB, designing and submitting protocols for IRB review and the proper method for obtaining informed consent. Upon completion of the course, participants will receive a certificate, and will receive credit for basic OnCore training.

    Session 1: Overview of the Institutional Review Board

    Objectives:

    • Define an IRB and discuss its role at UTMB Identify the regulatory agencies and regulations that govern IRBs
    • List key best practices when working with protocols subject to IRB review

    Session 2: Getting Started - Initial Submissions and Ongoing Research Review

    Objectives:

    • Be able to explain the steps necessary to file an initial submission to the IRB
    • Know the various steps and procedures involved in a protocol review
    • Understand when events need to be reported to the IRB

    Session 3: Obtaining Informed Consent

    Objectives:

    • Explain the informed consent process Identify the required elements of a consent form

    DHHS Office for Human Research Protection Training