13.2 Reporting and Screening of Allegations ..... 49 13.3 Investigations of Allegations ..... 49 13.4 Procedures for Reviewing Potential Serious or Continuing Noncompliance ..... 50 13.5 Noncompliance and Research Misconduct ..... 51
SUSPENSION OR TERMINATION OF IRB APPROVAL ..... 52 14.1 Suspension ..... 52 14.2 Termination ..... 52 14.3 Continuation of Research after Suspension or Termination ..... 52 14.4 Reporting of Suspension or Termination ..... 52
RECORDS AND DOCUMENTATION ..... 53 15.1 General Requirements ..... 53 15.2 Minutes of IRB Meetings ..... 53 15.3 Documentation of Findings ..... 54 15.4 Documentation of Approval Periods ..... 54 15.5 Copies of Revised Protocols ..... 55 15.6 Retention of IRB Records ..... 55
REVISING AND UPDATING HIRPP POLICIES AND PROCEDURES ..... 55
REFERENCING FEDERAL REGULATIONS AND GUIDANCE ..... 56
PURPOSE
To provide a comprehensive outline of policies, procedures, and guidance for research by KSU faculty, staff, and students involving human subjects, including the composition and role of the Institutional Review Board (IRB) and the procedures the IRB will follow when reviewing and approving research, and to facilitate compliance with federal requirements regarding the protection of human subjects, including but not limited to 21 CFR § 56 and 45 CFR § 46. The policies and procedures outlined herein respond to and are aligned with the revisions made to 45 CFR § 46 in 2018.
I. OVERVIEW
1.1 The HRPP
The HRP P is a comprehensive and dynamic system of shared responsibility to ensure the protection of human subjects participating in research. The IRB is an important component of an HRP P, but it is only one part of an overall organizational effort to protect human subjects that involves administrators, faculty, staff, and students. The HRP P recognizes that individual researchers bear responsibility for following ethical principles, adhering to regulatory requirements, and avoiding conflicts of interest. The HRP P also recognizes that ongoing training, education, and communication regarding the protection of human subjects are vital to research integrity and compliance.