All human subjects research must be approved by an Institutional Review Board (IRB) and the Seton Clinical Research Steering Committee (CRSC). Institutional Review Boards (IRB) review all study protocols to ensure the protection and ethical treatment of human subject research participants as well as the scientific integrity of the research. The UMC Brackenridge IRB (BHIRB) and the Austin Multi-institutional IRB (AMIRB) serve the local investigator community. For assistance as to the most appropriate IRB to use for your study, please contact the Office of Research Administration at 512-324-7991. In general, studies with federal funding or internal Seton funding may use the BHIRB.
Please scroll down this page for BHIRB policies and procedures, study member training requirements and available forms.
UMC Brackenridge IRB Policy and Procedures
Institutional Review Board Policies and Procedures (pdf)
Training Requirement
CITI Training Program
All individuals who participate in clinical research activities at Seton (including investigators, coordinators, data managers, analysts, etc.) are required to complete specific CITI Training modules before conducting research involving human subjects. The protocol will not grant final approval unless required training has been completed.
The CITI Program is used by over 830 participating institutions and facilities from around the world. Over 600,000 people have registered and completed a CITI course. The intent is to provide ongoing certification for several areas of human subjects research. This is a free service for our research teams.
Select Ascension Health as the participating institution.
There are 4 learner groups include: investigator, study coordinator, IRB member, other study team member (e.g. data management personnel, administrative assistants). Users can select more than one user group after they complete the prior user group.
All modules are accessible for anyone, but only a select number of the total available modules are required for each learner group. We encourage all users to complete as many extra modules as they deem appropriate for their research area.
Updating of training certification will be required every 3 years. For current affiliated research groups, if human subjects training was completed within the last 3-years, the required start time for transition to the CITI modules will be at the time of renewal of HS training. All new investigators or study team members will be required to complete CITI modules.
The site can be accessed through the following link:
http://www6.miami.edu/citireg/
For CITI Training Instructions and information, click: Training Requirements - CITI Program
Links & Resources
Office of Clinical Research Administration forms
IRB Process Guidelines (pdf)
Frequently Asked Questions - Humanitarian Device Exemptions
Categories of Research that may be Reviewed by the IRB through an Expedited Review Procedure
Seton is proud to have four hospitals – the only hospitals in Central Texas - that have earned the