PNNL Human Research Protection Program

• 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

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

SBMS Subject Area Links

• SBMS Subject Area
• Definitions
• Exhibits
• Forms
• References

PNNL in the Community

Assurance:
FWA00004696 - IRB00000285 - IRB00005670

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