IRB Procedures

Human Research Protection Program: Operating 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

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

 Associated Form:  Collaborative, Multi-Site and Off-Site Worksheet

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

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 team members

Section 6—Conflicts of Interest

6.1 IRB review

6.2 Investigators and research team

Section 7—IRB Review Process

7.1 Exempt Determinations

Associated Form:  Protocol Submission Checklist (Exempt)

7.2 Criteria for IRB Approval

7.3 Expedited Review

7.4 Full Board Review

Associated Form (7.3 and 7.4): Protocol Submission Checklist

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



11.6 Review of FDA-Regulated Research

11.7 Review of Planned Emergency Research

11.8 Oral History Research

Section 12—Quality Assurance and Research Compliance

12.1 Quality Assurance Audits—Random

Associated Form:  Audit Checklist - Research Records

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

13.1 Certification of IRB Approval

13.2 Indefinite Plans for Human Subjects Research

Last updated: September 11, 2014 8:04 PM

Student Focused. Land Grant. Research Institution.

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