IRB Guidelines are currently under revision and will be retitled, 'Human Research Protection Program - Operating Procedures'. These changes are necessary to improve access to information, provide additional procedural details, and ensure compliance with federal regulations. Sections will be posted as they are approved by the IRB, and will replace information in the previous version. When a section changes any current procedures and requirements, investigators will be informed and have an opportuntiy to provide comment.

Those sections below containing links replace information from the previous 'IRB Guidelines'. Investigators may post any comments or suggestions on the IRB Update Listserv Blackboard course.

Human Research Protection Program: Operating Procedures

Section 1 - Principles and Purpose

Section 2 - Applicability

Section 3 - Roles and Responsibilities

Section 4 - IRB Structure and Administration

Section 5 - Training, Education and Outreach

5.1 IRB Chair and members

5.2 IRB staff

5.3 Research investigators and research team

5.4 Research participants

Section 6 - Conflicts of Interest

Section 7 - IRB Review Process

7.1 Exemption Determinations

7.2 Criteria for IRB Approval

7.3 Expedited Review

7.4 Full Board Review

Section 8 - Research Risks and Harms

Section 9 - Informed Consent and Subject Selection

Section 10 - Vulnerable Groups

Section 11 - Special Research Topics

11.1 Use of Confidential Records

11.2 Human Biological Specimens

11.3 Secondary Analysis of Existing Data

Section 12 - Quality Assurance and Research Compliance

Section 13 - Sponsored Research