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
Documents on this site marked (.pdf) are in Portable Document Format (PDF). To view or print these documents, use Adobe Reader which is free and available directly from Adobe's web site.