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

Draft Manual (effective January 21, 2019)

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Contact Us

Winona Wynn, PhD
IRB Chair

(509) 367-3041 cell

Jerrilyn Stevens
Office of the Provost/Vice President for Academic Affairs 

IRB Office Location:
Heritage University
Petrie Hall, Office 1133


Amendment Form

Consent Form Template

Continuation of Research (IRB-2)

Reviewer Checklist*
*Researchers may find this IRB reviewer checklist useful to review before submitting their IRB application and other documentation.

Committee Members

Winona Wynn, PhD
Non-Scientific Member, Chair
(509) 952-0245 cell

Dr. Tony Stephas
Scientific Member

Dr. Maxine Janis
Scientific Member
(360) 513-2808 cell

Daniel Liestman
Non-Scientific Member
(253) 632-5657 cell

Dr. Yusuf Incetas
Non-Scientific Member
(270) 640-6570 cell

Elese Washines
Non-Scientific, Community Member

Dr. Daniel Mick
Scientific Member, Alternate
(503) 954-6699 cell

Elizabeth Torres
Non-Scientific, Community Member Alternate