Clinical Research IRB

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 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 Clinical Research Office at (512) 324-7991 for assistance.  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.

Brackenridge IRB Policy and Procedures

IRB Process Guidelines (pdf)
Institutional Review Board Policies and Procedures (pdf)

Training

Human Subjects Research Training -
All individuals who participate in clinical research activities at Seton (including investigators, coordinators, data managers, analysts, etc.) must complete human subjects training every 3 years and proof of such training should be on file with the Clinical Research department.  Online human subjects training can be obtained  at the National Cancer Institute website.

Other institutional training may also be considered on an individual basis, (e.g. UTMB, UT-Austin) in lieu of NCI training.
 
All PIs must ensure that all study members complete human subjects training before the initiation of any study.
 
Please keep a copy of your certificates of completion and forward copies of these to Rene Sewell.

IRB Board Member Training
All Brackenridge IRB board members must complete online educational modules.  A copy of certificates must be on file with the Clinical Research department.  The OHRP online training module can be found at http://www.nihtraining.com/ohsrsite/cbt/index.html
 
Other institutional training may also be considered on an individual basis, (e.g. UTMB, UT-Austin) in lieu of this training..
 
Please keep a copy of your certificates of completion and forward copies of these to Rene Sewell.

Forms

Adult Informed Consent Template (Microsoft Word Document)
Pediatric Informed Consent Template (Microsoft Word Document)
Adverse Event Reporting Form (pdf)
Documentation of Compliance with Educational Mandate for Conducting Research with Human Subjects (pdf)