IRB Procedures
Human Research Protection Program: Operating Procedures
section 1—Principles and Purpose
1.1 Ethical Principles for Human Research
Section 2—Applicability
Section 3—Roles and Responsibilities
Section 4—IRB Structure and Administration
Section 5—Training, Education and Outreach
Section 6—Conflicts of Interest—Added 6/8/2012
Section 7—IRB Review Process
Section 8—Participant Protections
Section 9—Requirements for Informed Consent
9.2 Documentation of Informed Consent
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
11.4 RESERVED
11.5 RESERVED
11.6 Review of FDA-Regulated Research
Section 12—Quality Assurance and Research Compliance
12.1 Quality Assurance Audits—Random
12.2 Directed Audits of Research
12.3 Complaints or Allegations of Noncompliance
12.4 Reporting Noncompliance, Suspensions, Terminations and Unanticipated Problems
Section 13—Sponsored Research
Last updated: November 16, 2012 9:45 AM
