HRPP HOME
Introduction
• Mission
• Program Overview
• Policies & Procedures
The Institutional Review Board (IRB)
• Independence, Authority & Jurisdiction
• Responsibilities
• Structure & Composition
• Membership
• Administration
• Contact Information
Governing Principles, Standards & Regulations
• The Belmont Report
• Standards
• Federal & State Regulations
• Institutional Policies
• Conflict of Interest
• Regulations that Do Not Apply
Defining Human Subject Research
• Is It Research
• Research Activities That Require IRB Review
• Activities That Do Not Require IRB Review
• Best Practices
Organizational Structure / Roles and Responsibilities
• Institution
• Institutional Official
• IRB
• Investigators
• Sponsors
• Subjects and the Community
Education & Training
• Research Management, Investigators & Support Staff
• IRB Members & Support Staff
The Informed Consent Process - Selecting, Recruiting, and Consenting Subjects
• Selecting Subjects
• Recruiting Subjects
• Consenting Subjects
• Writing Consent Forms (46, 116)
• Waiver or Alteration of Consent
• Waiver of Documentation of Consent
• Consent Obtained by Collaborating Institutions
Items for Consideration
• Table of Contents
IRB Review and Approval
• Proposal Development
• Criteria for IRB Approval
• Initiating IRB Review
• Levels of IRB Review
• Exempt
• Expedited
• Full Board
• Reviewing the Consent Process
• Determining Frequency of Review and Additional Monitoring
• Reporting IRB Approval to Clients
After Approval - Conducting Human Subject Research
• Forms & Directions
• Continuing Review
• Amendments, Modifications, Changes & New Findings
• Unanticipated Problems, Noncompliance, and Suspension or Termination of IRB Approval
• Additional Monitoring & Oversight
• Study Completion
Program Assessment & Oversight
Accreditation
Questions, Suggestions, and Concerns
New Information and Important Changes
• Office for Human Research Protections
• New EPA Rule - Pesticides, Pregnant Women & Children
• Tuskegee Syphilis Study
Other Sites of Interest
IRB Library
SBMS Subject Area Links
• SBMS Subject Area
• Definitions
• Exhibits
• Forms
• References
PNNL in the Community
Assurance:
FWA00004696 - IRB00000285 - IRB00005670
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