Office of Sponsored Research

Institutional Review Board (IRB)

The purpose of the UT Tyler IRB is to review research proposals that involves human beings before the research is initiated in order to facilitate ethically-conducted research for the protection of human subjects. Proposals are reviewed based on the ethical principles outlined in the Belmont Report: beneficence, justice, and respect for persons. The principles are reflected as standards of practice in the Code of Federal Regulations established by the Department of Health and Human Resources, Title 45.

Office of Human Research Protection Information

• Policy and Guidance
• DHHS Home Page

Training Modules: Protection of Human Subjects in Research

IMPORTANT: All PIs and Co-Investigators must complete the following on-line training modules before any IRB submissions are approved.

• Module 1: Historical and Ethical Issues
• Module 2: The Basics
• Module 3: Vulnerable Research Populations
• Module 4: Informed Consent
• Module 5: HIPAA
• Module 6: IRB Review
• Module 7: Ongoing Protections Post IRB Approval
• Module 8: International Research IRB Approval

IRB Handbook

Handbook Table of Contents Policies
Responsibility and Scope of the UT Tyler IRB	3
Responsibilities of the Principal Investigator	4
Types of Reviews by the UT Tyler IRB	6
Decisions of IRB Reviews	12
Submissions of Proposals	14
Procedures for Investigating and Reporting Incidents of Research Misconduct and Non-Compliance	16
Suspension/Termination of Investigations	19
Unanticipated Problems or Adverse Event/Death	20
Policy on Management of Human Subject Complaints and Assurance of Confidentiality	22
Informed Consent	23
HIPPA Privacy Rule Policy in Research	28
UT Tyler HIPAA Requirements	31
Policy on Protection of Pregnant Women, Human Fetuses and Neonates in Research	37
Protection of Prisoners in Research	43
Policy on Informed Consent of Children	47
Protection of Children involved in Research	48
Compliance and Monitoring	55
Unaffiliated Investigator Agreement	57
External Reviews Conducted by the University of Texas at Tyler Institutional Review Board	58
The University of Texas at Tyler Institutional Review Board Review of IRB Policies, procedures and Forms	59
Policy on Student Course-Related Research Projects	60
Information for IRB Members
General Information for IRB Members	66
IRB Member Agreement	67
Streamlining IRB Meetings: What You Can Do?	69
IRB Links to Forms	70

Download: PDF

Forms

Please contact the IRB Chair, Dr. Gloria Duke, with any questions regarding which form to submit.

• IRB Modification Request Form
• IRB Adverse Event Report Form
• IRB Continuing Review Form
• IRB Dean-Chair Approval of Study Form
• IRB Discontinuance of Study Form
• IRB Exempt Research Application Form
• IRB Expedited Research Application Form
• IRB Full Board Review Application Form
• IRB Informed Consent Template
• IRB Member Agreement Form
• IRB Research Misconduct and Non-Compliance Form
• HIPAA Research Participant Authorization to use Protected Health Information
• HIPAA Application for Protected Health Information Use
• HIPAA Request for Approval or Waiver of Authorization to use Protected Health Information

2012-2013 IRB Members

• Gloria Duke, PhD, Chair, Nursing
• Leonard Brown, PhD, Computer Science
• Danita Alfred, PhD,  Nursing
• Cindy Azghani, RN, BSN  (external member)
• Dennis Combs, PhD,  Psychology
• Patricia Bowden, RN, MSN, Nursing
• David Strong, PhD, Literature & Languages
• Andrew Schmitt, PhD, Psychology
• John Clark, PhD, Criminal Justice
• Justin Velton, PhD, Communications