Section 1: Ethical Principles, Regulations, and Definitions
Section 2: Lines of Authority, Responsibilities, and Record-keeping
- 2.1 IRB Jurisdiction
- 2.2 IRB Autonomy
- 2.3 Institutional Official: Selection and Responsibilities
- 2.4 IRB Chair: Selection, Responsibilities, and Evaluation
- 2.5 IRB Member: Selection, Responsibilities, and Evaluation
- 2.6 Consultants, Observers, and Guests
- 2.7 Legal Counsel
- 2.8 Principal Investigator Responsibilities
- 2.9 IRB Administrative Office Resources
- 2.10 Records and Files
- 2.11 Convened IRB Meeting Minutes
- 2.12 Storage of Research Data and Informed Consent Documents
- 2.13 Single IRB Review
- 2.14 DF/HCC CCSG Protocol Review and Monitoring Requirements
Section 3: Credentials, Education, and Training
Section 4: Research Activity Review
- 4.1 Department/Division Scientific Review of Human Subjects Research
- 4.2 Convened IRB: Operational Review Procedures
- 4.3 Expedited Reviews
- 4.4 Exemptions
- 4.5 Amendments and Revisions
- 4.6 Protocol Exception Requests
- 4.7 Continuing Review and Administrative Update
- 4.8 Activation/Release, Approval, and Expiration Dates
- 4.9 Verification of No Material Changes Since Prior IRB Review
- 4.10 Ancillary Review: Additional Human Subject Protection Review
- 4.11 Disapprovals and Appeal
- 4.12 Data and Safety Monitoring Plans
- 4.13 Multi-Site Research When a Children's Investigator Oversees an Operation's Coordinating or Statistical Center
Section 5: Reporting, Unanticipated Problems, Noncompliance
- 5.1 Internal and External Reporting
- 5.2 Reportable Events: Unanticipated Problems and Adverse Events Involving Risks to Research Subjects and Others
- 5.3 Noncompliance: Investigations and Determinations
- 5.4 Suspensions, Terminations, Administrative Closures, Investigator-Initiated Voluntary Suspension or Termination
- 5.5 Research Related Injury
- 5.6 Managing Research Participant/Family Concerns and Complaints
- 5.7 Coordination Between Program for Patient Safety and Quality and Institutional Review Board Office
Section 6: Informed Consent/Assent
- 6.1 General Information - Informed Consent and Parental Permission
- 6.2 Special Considerations - Assent and Parental Permission
- 6.3 Waivers and Alterations of Informed Consent/Parental Permission/Assent Children
- 6.4 Informed Consent with Non-English Speakers
- 6.5 Informed Consent Decision Monitoring Program
- 6.6 Remote Consent: Process and Documentation
- 6.7 Exception from Informed Consent Requirements for Emergency Research
- 6.8 Collecting Data from Pregnant Partners of Research Subjects
Section 7: Drugs, Biologics, and Devices
- 7.1 Drugs, Biologics, and Dietary Supplements Regulations
- 7.2 Expanded Access: Investigational Drugs
- 7.3 Patients Hospitalized with Investigational Drug from Another Institution/Investigator or with Supply of Drug Not Approved in the United States
- 7.4 Requirements for Sponsor-Investigators of Investigational Drugs (INDs)
- 7.5 Investigational Devices
- 7.6 Requirements for Sponsor-Investigators of Investigational Devices (IDE)
- 7.7 Humanitarian Use Devices
Section 8: Vulnerable Populations
- 8.1 Children
- 8.2 Incarcerated Youth and Prisoners
- 8.3 Sex Assigned at Birth, Birth Control, and Pregnancy Testing
- 8.4 Pregnant persons, Fetuses, and Neonates
- 8.5 Children in State Custody
- 8.6 International and Cross-cultural Research
- 8.7 Community Based Participatory Research (CBPR)
- 8.8 Guidelines for Review of Research Involving Vulnerable Populations Not Covered by Subparts B, C, and D
- 8.9 Research Involving Adults with Decisional Impairment
Section 9: Guidance for Special Topics/Procedures
- 9.1 Extending Anesthesia and Sedation for Research Purposes
- 9.2 Skin Biopsy Guidelines
- 9.3 Extra Endoscopy Biopsies for Research Guidelines
- 9.4 Research Blood Drawing Guidelines
- 9.5 Secondary Use of Human Biological Specimen Data
- 9.6 Certificates of Confidentiality
- 9.7 Special Confidentiality Issues When Performing Research Related Imaging
- 9.8 Requirements for Mental Health Safety Plans in Research Protocols
- 9.9 Genetic Research Guidance: Non-Paternity with Trios
- 9.10 Investigator Self-Experimentation
- 9.11 Community Consultation and Public Disclosure Guidance for Exception from Informed Consent Research (EFIC)
- 9.12 Data Sharing Requirements for Individual Participant Level Data
- 9.13 Use of Non-secure Email and Texting in Research
Section 10: Recruitment and Remuneration
Section 11: Funding Agency Certifications and Requirements
- 11.1 Coordination of Certification of Institutional Review Board Review and Acceptance of Grants and Contracts for Sponsored Research
- 11.2 Research Involving Department of Defense Funding
- 11.3 Research Funded by Department of Education and School Based Research
- 11.4 Research Involving Department of Justice Funding
- 11.5 NIH Genomic Data Sharing