Office of Human Subject Research Protection Program (OHSRPP)
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CHRISTUS Institutional Review Board
The CHRISTUS Health Institutional Review Board (IRB) protects the rights and welfare of subjects participating in research. Under FDA regulations, an IRB is an appropriately constituted group that has been formally designated to review and monitor biomedical research involving human subjects. In accordance with FDA regulations, an IRB has the authority to approve, require modifications in (to secure approval), or disapprove research. The involvement of human subjects in research is not permitted until the IRB has approved the research protocol. The CHRISTUS Health IRB abides by the CHRISTUS Health policies and procedures, Catholic Church Directives, Belmont Report, Food, and Drug Administration, and the Office of Human Research Protections federal regulations.Our Services
- Initial Protocol and Informed Consent form Review
- Annual Continuing Review of Protocol and Informed Consent
- Protocol and Informed Consent form Amendment Review
- Exempt and Expedited Research Review
- Quality Improvement (QI) and Quality Assurance (QA) Review
Our Meeting Times
CHRISTUS Health IRB will convene for a monthly meeting on the third Thursday of each month from 8 a.m. - 10 a.m. Research submissions are due two weeks prior to the meeting.
Contact Us
For assistance, the Office of Human Subjects Research Protection staff are available Monday – Friday from 8:00 am until 5:00 pm CST. Please feel free to also get in contact with our director, Phyllis Everage.
OHSRPP Team
Self-Help Documents and Helpful Links
Guidance Documents
- Adding a Facilitated CR or Closure Form
- Adding CV ML or CITI to your iRIS profile
- CHRISTUS Health IRB Submission Deadlines and Meeting Dates
- CHRISTUS Health Process for Single Patient Emergency Use Submission
- CHRISTUS Health QIQA Guidance
- CHRISTUS Health Statement of Compliance
- CIIACC New Investigator Checklist
- Common IRB Definitions
- Facilitated Review Submission Process
- How to Affiliate with CHRISTUS Health in CITI
- How to Answer Stipulations
- How to Log into and Create a CITI Account
- How to request an iRIS account
- How to submit a QI/QA project to iRIS
- PHI Identifiers
- Protocol Deviation Standard Operating Procedure
- QI/QA Guidance
- QI/QA Review Process in iRIS Decision Tree
- Research vs QI Decision Tree
- Serious Adverse Event Reporting Standard Operating Procedure
- Short Form Consent Instructions
- Step by Step Submission Detailed Process
- Transfer of IRB Authority Guideline
- Vulnerable Special Populations
Forms and Templates
- Assent ages 13-17 Template
- Assent ages 7-12 Template
- CHRISTUS Health Informed Consent Template Clincard
- CHRISTUS Health Standard Language for Pregnancy Prevention in Research Consents
- CHRISTUS Short Form (English)
- Consent - Parental Permission of a Minor Informed Consent Template
- Consent - Survey Informed Consent
- Consent - Telephone Script Consent
- Delegation of Authority Log
- Letter of Sponsorship and Support Template
- Principal Investigator Conflict of Interest
- Protocol Development Tool and Guidance
- Recruitment Flier Template with Appendix
- Request to Waive Use of the CHRISTUS Health IRB
- Request to Waive Use of the CHRISTUS Health IRB Form
- Research Protocol template
- Sample Modified Informed Consent
- Sample Modified Informed Consent HIPAA
- Site Training Log
- Study Enrollment Log
- Sub Investigator Conflict of Interest
- Voluntary Participation in a Clinical Research Study by a CHRISTUS Health or CHRISTUS Health Affiliate Employee
External Links
- U.S. Food and Drug Administration
- SOCRA - Society of Clinical Research Associates
- U.S. Department of Health & Human Services - Office for Human Research Protections (OHRP)
- CITI - Collaborative Institutional Training Initiative
- Code of Federal Regulations 21 CFR Part 56 IRB
- Code of Federal Regulation 45 CFR Part 46 Protecting Human Subjects
- The Belmont Report
- The Declaration of Helsinki
- The Institutional Review Board - Discussion and News Forum
- ClinicalTrial.gov
- The Association of Clinical Research Professionals (ACRP)
- Clinical e-Protocol Writing Tool