Policies and Procedures

Policies of the University of North Texas Health Science Center

Chapter 12 – Research, IRB

12.201  Protection of Human Research Subjects Policy

Policy Statement

All UNTHSC faculty, staff, and students are required to adhere to the OReC-IRB Manual: Standard Operating Principles and Procedures promulgated by the Office of Research Compliance (OReC).  The protection of human research subjects is very important and regulated by federal law and guidelines. The OReC-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 OReC – IRB Manual can be found on the UNTHSC OReC-IRB website.

Application of Policy

All UNTHSC Faculty, Staff, and Students.

Definitions

None

Procedures and Responsibilities

Procedure / Duty

Responsible Party

1. 

All procedures and responsibilities listed in the OReC-IRB SOPs are to be followed by designated parties.

Vice President for Research

2. 

Ensure UNTHSC-wide compliance with the OReC-IRB SOPs and determine what training is required  to ensure knowledge of appropriate policies and assure compliance with relevant federal regulations.

Director, OReC

3. 

Determine any forms required to be created and/or maintained to comply with the OReC-IRB SOPs.

Director and staff, OReC

References and Cross-references

OReC-IRB Manual: Standard Operating Principles and Procedures                  

Click appropriate icon for download adobe acrobat icon Microsoft Word icon updated 08/12/14

Code of Federal Regulations Title 45 Part 46 (Protection of Human Subjects)

Code of Federal Regulations Title 21 Part 50 (Protection of Human Subjects)

Code of Federal Regulations Title 21 Part 54 (Financial Disclosure by Clinical Investigators)

Code of Federal Regulations Title 21 Part 56 (Institutional Review Boards)

Forms and Tools

See OReC-IRB website for latest version of appropriate IRB and OReC forms and templates


Approved:        1/25/10          

Effective:         1/25/10

Revised:           12/14/09

This page last updated 12th Aug 2014