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. The study submission is entered in OnCore done by the Office of Clinical Research before the investigator or study team completes the IRB submission in InfoEd. More information can be found here.
Navigating the IRB
Navigating the IRB is a three-session introductory course designed to help investigators and research staff understand and work effectively with the Institutional Review Board at UTMB. The course covers the role of the IRB, the process of designing and submitting research protocols for review, and the requirements for obtaining informed consent from study participants.
Upon successful completion of the course, participants will receive a certificate of completion and 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