Protocol and Procedure Manual

IRB Manual Table of Contents (for research January 20, 2019 and prior):

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Chapter 1:  Introduction

1. Ethical Principles in research; Role of IRB
2. Applicability of Policies & Procedures

Chapter 2:  Definition of Research

Chapter 3:  Research Risks & Levels of Review

1. Determining the Level of IRB Review
2. When Submission to the IRB is Requires
3. Exempt Research
4. Expedited Review
5. Research Requiring Full IRB Review

Chapter 4: Criteria for IRB Approval of Protocols

1. General Guidelines-Federal and State Regulations
2. Informed Consent
   1. Elements of Informed Consent
   2. Who May Obtain Consent
   3. Standard Consent and Documentation
   4. Waiver of Consent or Alterations to Elements of Consent
   5. Waivers of Documentation Consent
   6. Assessment of Participant’s Understanding of Consent
   7. Consent from Emancipated Individuals
   8. Consent from Individuals Under 18 Years of Age
   9. Deception in Research
   10. Consent by Phone/Fax
   11. Witnessing of Consent
   12. Requirement for Witness Signature on the Consent Form
   13. Consent for Participants Not Fluent in English
   14. Consent Forms in Research Records
   15. Re-Consenting Participants
   16. Long-Term Follow-Up
   17. Observation of Consent Process
   18. Assent from Children or Decisionally Impaired Individuals
   19. Consent form illiterate Participants
   20. Consent from Legally Authorized Representatives
   21. Waiting Period Requirement
   22. Staged Consent Process
   23. Informed Consent for International Research
   24. Informed Consent with Certificate of Confidentiality
   25. recommendations for Translation of Documents
   26. HIPAA and Research

Chapter 5: Vulnerable Populations

1. Pregnant Women, Fetuses, or Neonates
2. Prisoners
3. Epidemiologic Research Involving Prisoners
4. Children
5. Economically or Educationally Disadvantaged
6. Heritage University Students
7. Heritage University Employees
8. Decisionally Impaired
9. HIV-Infected Individuals
10. Members of the Armed Forces
11. Non-English Speaking Individuals
12. Indigenous Populations

Chapter 6: IRB Application and Review Procedures

1. Human Subjects Research Training
2. Advance Submission
3. Content of Research Proposal
4. Review and Approval of Proposals
   1. Requests for Exempt Status
   2. Expedited Review
   3. Full Board Review
5. Approval Timeframes
6. Applications for Continuation of Previously Approved Studies
7. Study Modifications
8. Appeal Process

Chapter 7: Monitoring the Conduct of Research

1. Oversight Responsibilities
   1. Investigator Responsibilities and Reporting Requirements
   2. Unexpected Events and Adverse Reactions
2. IRB Monitoring of Approved Studies
3. Routine Monitoring
4. Monitoring and Verification of Safety and Compliance
5. Federally-Funded Clinical Trials
6. Suspension or Termination of Research
7. IRB Reporting Requirements

Chapter 8: IRB Documentations

1. Maintenance of Research Records
2. Timeframes for Record Retention

Chapter 9: IRB Membership and Management

1. Board Member Appointments and Responsibilities
2. Liability
3. Physical Resources and Administrative Support

Chapter 10: Definitions

Appendices

• Belmont Report
• DHHS Code of Federal Regulations [45 CFR 46]
• Federal Drug Administration (FDA) Regulations [21 CFR 50]
• Declaration of Helsinki
• Nuremberg Code