IRB Policies and Procedures
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Files are in PDF format. Signed copies are on file in the FHCRC Institutional Review Office. |
Office of the Director Policy on Human Research Protection Program Effective date 01-11-13
Approval Date Guidelines and Turnaround Times (Policy 1.8)
Closure and Re-Open (Policy 2.9)
Communications (Policy 2.21)
Continuing Review (Policy 2.2)
Control and Distribution of Policies (Policy 1.1)
Cooperative Review Agreements (Policy 2.3)
Database PIRO (Policy 2.22)
Emergency Use of an Investigational Drug or Device (Policy 2.4)
Engagement in Research: Determining when Activities are Research involving Human Participants (Policy 1.14)
Federal Wide Assurance (Policy 1.2)
Funding Source Document (FSD) Review (Policy 2.18)
Identification and Use of Legally Authorized Representatives (LAR) (Policy 2.25)Informed Consent (Policy 2.11)
Investigational New Drugs (IND), Biologics and Investigational Device Exemptions (IDE) (Policy 1.13)
IRB Authorization Agreement (Policy 2.24)
IRB Committee Structure (Policy 1.3)
IRB Member Conflict of Interest (Policy 1.5)
IRB Requirements for Reporting to Institutional and External Officials (Policy 2.8)
IRB Review of Genome-Wide Association Studies (Policy 2.27)
IRO Website (Policy 2.23)
Maintenance and Retention of IRB Documents (Policy 2.17)
Meeting and Meeting Records (Policy 1.6)
Modification to Ongoing Activities (Policy 2.5)
Monitoring of Institutional Review Board Staff and Research Studies (Policy 2.16)
Multi-Center Study Coordination - IRB Review and Oversight (Policy 2.14)
New Application (Policy 2.1)
Noncompliance (Policy 1.9)
Privacy and Confidentiality (Policy 2.12)
Recruitment and Compensation (Policy 2.0)
Reporting Obligations for Principal Investigators (Policy 1.11)
Research Involving Department of Defense Components (Policy 2.26)
Research Involving Vulnerable Populations (Policy 2.15)
Research Participant Inquiries (Policy 2.10)
Risks To Research Participants (Policy 1.7)
Staff Structure (Policy 1.4)
Suspension or Termination of IRB Approval (Policy 1.10)
Training (Policy 2.20)
Unanticipated Problems Involving Risks to Subjects or Others (Policy 2.6)
Use of Interpreter Services and Translated Documents (Policy 2.13)
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