IRB Procedures

These Standard Operating Procedures (SOPs) have been developed and approved by the IRB to document standard processes and procedures governing the human subjects protection program at NDSU.

  1. Principles and Purpose
    1. Ethical Principles for Human Research
    2. Regulatory Requirements for Human Research
    3. Maintenance of Procedures Manual
    4. FederalWide Assurance and IRB Registration
  2. Applicability
    1. Human Subjects Research
    2. NDSU Engagement in Human Subjects Research
    3. Collaborative, Multi-Site and Off-Site Research
    4. Worksheet: Collaborative, Multi-Site and Off-Site Research
  3. Roles and Responsibilities
    1. Investigator and Research Team
    2. Institutional Review Board and Institutional Official
  4. IRB Structure and Administration
    1. IRB Membership
    2. IRB Meeting Procedures
    3. IRB Records
  5. Training, Education and Outreach
    1. IRB Chair and Members
    2. IRB staff
    3. Research Investigators and team members
  6. Conflicts of Interest
    1. Conflicts of Interest - IRB Review
    2. Conflicts of Interest - Investigators and Research Team
  7. IRB Review Process
    1. Exempt Determinations
    2. Criteria for IRB Approval
    3. Expedited Review
    4. Full Board Review
    5. Protocol Amendments
    6. Continuing Review
    7. Reports of Unanticipated Problems
  8. Participant Protections
    1. Risks and Benefits
    2. Privacy and Confidentiality
    3. Data Safety and Monitoring
  9. Requirements for Informed Consent
    1. Consent Process
    2. Documentation of Informed Consent
    3. Waiver or Alteration of Informed Consent Requirements
    4. Children as Research Participants
  10. Vulnerable Groups
    1. Children
    2. Prisoners
    3. Other Vulnerable Groups
  11. Special Research Topics
    1. Secondary Research Use of Identifiable Information
    2. Human Biological Specimens
    3. Retired
    4. International Research
    5. Reserved
    6. Review of FDA-Regulated Research
    7. Review of Planned Emergency Research
    8. Oral History Research
  12. Quality Assurance and Research Compliance
    1. Quality Assurance Audits - Random
    2. Directed Audits of Research
    3. Complaints and Allegations of Noncompliance
    4. Reporting Noncompliance, Suspensions, Terminations and Unanticipated Problems
  13. Sponsored Research
    1. Certification of IRB Approval
    2. Indefinite Plans for Human Subjects Research

Keywords:
IRB SOPs, Standard Operating Procedures, policies 
Doc ID:
148565
Owned by:
Kristy S. in NDSU Research and Creative Activity
Created:
2025-02-24
Updated:
2026-10-16
Sites:
NDSU Research and Creative Activity