Standard Operating Procedures
Section 1 - Principles and Purpose
1.1 Ethical Principles for Human Research
1.2 Regulatory Requirements for Human Research
Section 2 - Applicability
2.2 NDSU Engagement in Human Subjects Research
2.3 Collaborative, Multi-Site and Off-Site Research
Associated Form: Collaborative, Multi-Site and Off-Site Worksheet
Section 3 - Roles and Responsibilities
Section 4 - IRB Structure and Administration
Section 5 - Training, Education and Outreach
Section 6 - Conflicts of Interest
Section 7 - IRB Review Process
Associated Form: Review Guide
Section 8 - Participant Protections
8.2 Privacy and Confidentiality
Associated Materials: Confidentiality and Data Security Guidelines for Electronic Research Data
Section 9 - Requirements for Informed Consent
9.2 Documentation of Informed Consent
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
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