The Institutional Review Board (IRB) is responsible for protecting the welfare and rights of individuals who are subjects of any research, whether funded or unfunded, whether on or off campus, which is conducted by Health Science Center faculty, staff or students. Proposals for external sponsorship should be submitted to the IRB via the Office for the Protection of Human Subjects (OPHS) prior to submission to the sponsor to insure approval, but must be approved prior to award and initiation of the project. Internally funded and unfunded projects must be approved prior to initiation of the activity.

For questions regarding submission of research proposals, please call the Office for the Protection of Human Subjects (OPHS) at (817) 735-0409 to schedule an appointment.

• Compliance with Multiple Project Assurance Statement
• Belmont Report
• HIPAA Compliance Information   
• HIPPA Privacy Provisions - Questions and Answers

Training Links

• CITI Course in The Protection of Human Research Subjects
• NOTICE
• FAQ

Recommended Reading for Human Subject Researchers

These resources offer guidelines and information that will assist researchers and IRB members in understanding the policies and principles that govern research with human subjects and the issues they affect.

• OHRP (Office for Human Subjects Protections)
• Declaration of Helsinki
• IRB Forum
• Good Clinical Practice in FDA-Regulated Clinical Trials

Forms

• IRB Application Form (PDF Version)         Download Adobe Reader here...
• Conflict of Interest (PDF Version)
• Exempt Review Form (PDF Version)    (MS-Word Version)
• Progress Report (PDF Version)     (MS-Word Version)     
• Serious Adverse Event Report for SAE's at UNTHSC
• Serious Adverse Event Report for SAE's at Other Sites
• IRB Board Action (restricted file access)
• Application for Change of Study Personnel
• Instructions for Preparation of Human Subjects Protocol Summary
• HIPAA Research Waiver

OPHS Staff

Brian A. Gladue, Ph.D. - Director - OPHS - Ph: (817) 735-5083
Email: bgladue@hsc.unt.edu

Debbie Ceron - OPHS Compliance Coordinator - Ph: (817) 735-5483
Email: dceron@hsc.unt.edu

Heather Cline - OPHS Compliance Coordinator - Ph: (817) 735-5457
Email: hcline@hsc.unt.edu

Jill Kurscher - OPHS Compliance Coordinator - Ph: (817) 735-0424
Email: jkurschn@hsc.unt.edu

Itzel Pena - OPHS Compliance Coordinator - Ph: (817) 735-0673
Email: ipena@hsc.unt.edu

Mary Wilson - Administrative Services Officer - Ph: (817) 735-0409
Email: mwilson@hsc.unt.edu

For an alpha listing of all Research Office staff - Click Here

IRB Members

IRB Schedule 2008-2009 - Effective September, 2008