The 'IRB Guidelines' are currently under revision and will be retitled, 'Human Research Protection Program - Operating Procedures'. These changes are necessary to improve access to information, provide additional procedural details, and ensure compliance with federal regulations.

Newly revised sections will be posted as they are approved by the IRB, replacing applicable information from the previous 'IRB Guidelines'.

Human Research Protection Program: Operating Procedures

Section 1 - Principles and Purpose

1.1 Ethical Principles for Human Research

1.2 Administration of the HRPP

1.3 Maintenance of Operating Procedures

Section 2 - Applicability

2.1 Human Subjects Research

2.2 NDSU Engagement in Human Subjects Research

2.3 Collaborative, Multi-Site and Off-Site Research

Section 3 - Roles and Responsibilities

Section 4 - IRB Structure and Administration

4.1 IRB Membership

4.2 IRB Meeting Procedures

4.3 IRB Records

Section 5 - Training, Education and Outreach

5.1 IRB Chair and members

5.2 IRB staff

5.3 Research investigators and research team

5.4 Research participant outreach

Section 6 - Conflicts of Interest

Section 7 - IRB Review Process

7.1 Exemption Determinations

7.2 Criteria for IRB Approval

7.3 Expedited Review

7.4 Full Board Review

7.5 Protocol Amendments

7.6 Continuing Review

7.7 Reports of Unanticipated Problems

Section 8 - Participant Protections

8.1 Risks and Benefits

8.2 Privacy and Confidentiality

8.3 Data Safety Monitoring

Section 9 - Requirements for Informed Consent

9.1 Consent Process

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

10.1 Children

10.2 Prisoners

10.3 Other 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 International Research

11.5 FDA-Regulated Research

11.6 Emergency Research

11.7 Clinical Research (behavioral, biomedical)

11.8 Oral History 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 Unantcipated Problems

Section 13 - Sponsored Research

IRB Guidelines for the Protection of Human Participants in Research:

Section I, Part A, the Institutional Review Board

Section I, Part B, Project Submission, Review and Approval

Section I, Part C, Investigator Reporting Requirements

Section I, Part D, Guidelines for Special Types of Research

Section II, Part A, Requirements for Informed Consent, the Information Process

Section II, Part B, Documentation of Informed Consent

Section II, Part C, Consent/Assent Procedures for Minors

Section II, Part D, Suggested Formats for Consent Forms

Section III, Regulatory Compliance