IRB Procedures
Section 1 - Principles and Purpose
1.1 Ethical Principles for Human Research
1.2 Regulatory Requirements for Human Research
1.3 Maintenance of Procedures Manual
1.4 FederalWide Assurance and IRB Registration
Section 2 - Applicability
2.2 NDSU Engagement in Human Subjects Research
2.3 Collaborative, Multi-Site and Off-Site Research
Worksheet: Collaborative, Multi-Site and Off-Site Research
Section 3 - Roles and Responsibilities
3.1 Investigator and Research Team
3.2 Institutional Review Board and Institutional Official
Section 4 - IRB Structure and Administration
Section 5 - Training, Education and Outreach
5.3 Research Investigators and team members
Section 6 - Conflicts of Interest
6.1 Conflicts of Interest - IRB Review
6.2 Conflicts of Interest - Investigators and Research Team
Section 7 - IRB Review Process
7.7 Reports of Unanticipated Problems
Section 8 - Participant Protections
8.2 Privacy and Confidentiality
8.3 Data Safety and Monitoring
Section 9 - Requirements for Informed Consent
9.2 Documentation of Informed Consent
9.3 Waiver or Alteration of Informed Consent Requirements
9.4 Children as Research Participants
Section 10 - Vulnerable Groups
Section 11 - Special Research Topics
11.1 Secondary Research Use of Identifiable Information
11.2 Human Biological Specimens
11.3 Retired
11.5 Reserved
11.6 Review of FDA-Regulated Research
11.7 Review of Planned Emergency Research
Section 12 - Quality Assurance and Research Compliance
12.1 Quality Assurance Audits - Random
12.2 Directed Audits of Research
12.3 Complaints and Allegations of Noncompliance
12.4 Reporting Noncompliance, Suspensions, Terminations and Unanticipated Problems