Table of Contents
PURPOSE ..... 4
OVERVIEW ..... 4
1.1 The HRPP ..... 4
1.2 What is the IRB? ..... 5
1.3 The OSP's Role ..... 5
1.4 Federal Wide Assurance ..... 5
1.5 Guiding Documents and Regulations ..... 5
Definitions ..... 5
Required Written Procedures ..... 6
ROLE AND AUTHORITY OF THE IRB ..... 7
COMPOSITION AND MANAGEMENT OF THE IRB ..... 8
3.1 Appointment of Members ..... 8
3.2 Affiliations of Members ..... 8
3.3 Qualifications of Members ..... 8
3.4 OSP Staff as Alternate Members ..... 9
3.5 Meeting Attendance and Determination of Quorum ..... 9
3.6 Placing IRB Members on Inactive Status ..... 9
TRAINING REQUIREMENTS ..... 10
4.1 IRB Members ..... 10
4.2 OSP Staff and the HRPP Specialist ..... 10
4.3 Researchers ..... 10
PREPARING FOR RESEARCH REVIEW ..... 11
5.1 OSP as Main Point of Contact ..... 11
5.2 KSU Requirements Regarding Exempt Research ..... 11
5.3 Applications for Exempt Determination and IRB Review ..... 12
Application Forms ..... 12
Other Required Documents ..... 12
5.4 Screenings of Protocols ..... 12
5.5 Protocol Review Timeline ..... 13