Policies and Procedures

Policies of the University of North Texas Health Science Center Chapter 8 – Research and Innovation, IRB

8.104 Protection of Human Research Subjects Policy

Policy Statement

All UNTHSC faculty, staff, and students are required to adhere to the ORC-IRB Manual: Standard Operating Principles and Procedures promulgated by the Office of Research Compliance (ORC). The protection of human research subjects is very important and regulated by federal law and guidelines. The ORC-IRB Manual: Standard Operating Principles and Procedures (SOPs) is subject to change pursuant to changes in state or federal law, as well as changes in federal regulations and regulatory agency guidance. As a result, the most current version of the UNTHSC ORC – IRB Manual can be found on the UNTHSC ORC-IRB website.

Application of Policy:

All UNTHSC Faculty, Staff, and Students.

Definitions:

None

Procedures and Responsibilities

Procedure / Duty	Responsible Party
All procedures and responsibilities listed in the ORC-IRB SOPs are to be followed by designated parties.	Vice President for Research
Ensure UNTHSC-wide compliance with the ORC-IRB SOPs and determine what training is required to ensure knowledge of appropriate policies and assure compliance with relevant federal regulations.	Director, ORC
Determine any forms required to be created and/or maintained to comply with the ORC-IRB SOPs.	Director and staff, ORC

References and Cross-references:

North Texas Regional IRB Manual: Standard Operating Principles and Procedures

NOTE: The Principles and Procedures outlined in this manual are for the North Texas Regional Institutional Review Board (IRB). All institutions affiliated or associated with the North Texas Regional IRB must follow these Principles and Procedures. The UNTHSC Office of Research Compliance / ORC (formerly known as the Office for the Protection of Human Subjects or OPHS) supports the North Texas Regional IRB.