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Human Subjects Division (HSD)

Policies, Procedures and Guidance




1. Authority, Purpose, Overview

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2. Activities that Require IRB or HSD Review

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3. Which IRB

Transfer to Another IRB

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4. IRB Review

Levels of Review

Types of Review

Applying for IRB Review

Pre-review

Review Process

Communication of Review Outcome

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5. Types of Research and Activities

Industry Trials

Cancer Consortium

FDA: Drugs, Devices, Biologics

Emergency Medicine

Genetics Research

Case Reports

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6. Additional Regulatory Requirements

Specific Federal Agencies and Their Requirements

See FDA-Regulated Research in 5. Types of Research and Activities

HIPAA

Clinical Trials Registration

GWAS data and NIH dbGaP Database

Other Regulations (Federal and State)

See Federal Training Requirements: 13. Researcher Training

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7. Populations

  • SUPPLEMENT: Protected and/or Vulnerable Populations
  • SOP Research Involving Students
  • Children

    Prisoners

    Pregnant Women, and Fetuses

    Neonates (Nonviable, or of Uncertain Viability)

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    8. Recruiting, Screening and Informed Consent

    Consent, Assent, and Authorization Templates

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    9. Risks

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    10. Privacy, Confidentiality, and Data Security

    HIPAA

    Federal Certificate of Confidentiality

    Confidentiality Agreement for Using UW Records

    Other

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    11. Financial Issues

    Release of Research Funds

    Fees

    Other

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    12. Reporting, Problems, and Compliance

    Subject Numbers

    Researcher Lack of Response

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    13. Researcher Training

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    14. IRB Structure, Membership, and Logistics

    IRB Members

    IRB Meetings and Logistics

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    15. Documentation, Minutes, and Records

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    16. Quality Improvement Program

    PAVE Program

    Internal QA program

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