This booklet provides an overview of human subject research and what is not human subject research. To access and read this booklet, your computer must have adobe acrobat. For further assistance in identifying if your study is truly human subject research (in which case you would need IRB review) please call OPHS.

Focus Group Guidelines

This packet provides guidance to investigators designing focus group research studies. This includes the information required for proper IRB review and guidance on consent for focus group studies as well as sample consent forms. You must have MS word capabilities to access this document.  

We would like to extend our grateful appreciation to Dr. Coggin and Dr. Lurie, principal investigators and professors at UNTHSC for permission to use their informed consent and other research-related documents for educational purposes.

This document provides guidance and recommended procedures from OPHS and the IRB in regard to "re-contacting" research subjects either for future studies or to obtain additional information. This includes information on how to design a protocol to incorporate such element as well as information required for proper IRB review. You must have adobe acrobat capabilities to access this document (pdf).

Guidance on International Research

Federal regulations require that all international research with human subjects must have the appropriate safeguards in place to protect the rights and welfare of the subjects. This manual will provide investigators considering or designing international research guidance on the federal requirements for conducting such research. This is a pdf file and you must have adobe acrobat to access it.

Research using Human Biological Materials (Samples)

This document offers guidance on research using human biological materials. This piece specifically defines what is considered to be human biological research, evaluates the different levels of risk associated with this research, and how to conduct ethically sound research with human biologics. For more assistance or guidance on this topic, please contact OPHS.  

How to prepare a Protocol Synopsis for IRB Review

This document provides guidance to investigators on the information required for the IRB to conduct a proper review of a research protocol. As this is a pdf file, your computer must have adobe acrobat to access it. Please DO NOT INCLUDE THESE INSTRUCTIONS with your submitted IRB packet.

Guidelines for the Use of the Short (Consent) Form:

This document provides guidance to investigators on how to consent non-English speaking subjects using a Short (Consent) Form. A Short Form is a more “condensed” version of the Informed Consent document and should be used for the occasional and unanticipated recruitment of non-English speaking subjects. As this is a pdf file, your computer must have adobe acrobat to access this document.

How to fill out the Exempt Application

For EXEMPT category research, here is an EXEMPT Application with some descriptive language, hints, tips, and notes. This pdf document is for guidance only.  Do NOT print out and use this particular page as your submitted form.

Here is a question and answer document that can help you fill out the Expedited Category Review Application. If you have any questions regarding Expedited Review, please contact OPHS for further guidance. DO NOT submit this MS Word document with your IRB packet.

How to fill out a Full Board Application

Here is a Full Board Application with some description language, tips and notes. This document is only for guidance. DO NOT print out and use this pdf document as your submitted form.

SAE Guidance

This information provides investigators with guidance on how and when to report an on-site SAE for a particular study. You must have pdf capabilities to access this document or you may visit the link "SAE Guidance" for more information.

Reporting Protocol Violations

The guidance provided in this document covers the definition of a “protocol violation”, examples, reporting methods and how to avoid such events from occurring. Recall that all protocol violations must be reported within 10 working days of discovery of the event.  

Defining Protocol Violations

This manual is a lexicon created by Norman Goldfab, Chairman of the PDV Code Governing Committee for understanding and communicating protocol deviations and violations. This document also provides some examples of protocol violations and deviations within human subject research.  Please contact OPHS for any additional guidance on how to report protocol violations.

Data Storage and Security

This document provides investigators with UNTHSC recommended language for data storage and security. This verbiage can be incorporated into the protocol synopsis. You must have adobe acrobat capabilities to access this document.  

CITI Training Log-in Instructions

For first time CITI users, this provides a step-by-step process of how to complete CITI training. For further assisstance contact CITI helpdesk by visiting their "Contact Us" web page. UNTHSC-IRB does not maintain the CITI website. Note:Your computer must have adobe acrobat to read this document. 

Instructions on how to take CITI Refresher course

This document (pdf) gives instructions on how to log into CITI and take the CITI Refresher course. Recall that CITI (Basic) training is valid for only three years. After three years, a brief "refresher" course can be taken through the CITI website to renew CITI certification. This "refresher" course will need to occur every two years to avoid jeopardizing any current or newly submitted protocol.  Note that the CITI "refresher" course is ONLY for those who have already completed the Basic CITI training (for NON-first time CITI trainees).   

HIPAA Compliance Information

This provides guidance regarding the Privacy Rule and HIPAA regulations and its application to the realm of human subject research. For additional guidance, please visit "Informed Consent Guidelines" found as a link on our website.

This is a direct link to the Department of Health and Human Services. The information provided in this FAQs section gives general guidance on the privacy provisions of the Health Insurance Portability and Accountability Act of 1986 (HIPPA).

Guidance on Regulation of Human Subject Research

The following power point presentations were created by Dr. Brian Gladue, OPHS Director and IRB Chairman, as part of the course "Regulation of Human Subject Research" (BMSC Course 5400). These power point presentations may provide investigators with educational guidance on various human subject research and IRB concepts.