Human Research Handbook & Guidance

Oregon State University Institutional Review Board

Table of Contents

 

Institutional Review Board (IRB)

IRB Review

• Projects that Require IRB Review
• Exempt from Full Board Review
• Expedited Review
• Full Board Review

Principal Investigator (PI) Responsibilities

Educational Requirement

Initial Application

• Review Criteria
• Approval Process
• Common Mistakes to Avoid

• Classroom Projects
• Student Projects
• International Research Projects
• Workshop and Administrative Projects
• Deceptive Research
• Oral History Projects
• Non-OSU Proposal Reviews
• Research Involving OHSU Personnel, Sites, and Funding
• Research Approved by Other IRBs

Recruitment / Advertising

• Recruitment / Advertising Guidelines
• Underrepresented Groups: Recruitment Strategies

Informed Consent

• Informed Consent Process
• Parental Permission
• Informed Consent Waivers
• Basic Elements of Informed Consent

Race / Ethnicity of Subjects

IRB Continuing Review

• Continuing Review
• Project Revision
• Adverse Event
• Protocol Exception / Deviation
• Final Report / Closing a Project

Records Retention

• IRB Records
• Research Records / Source Documentation

Additional Protections for Special Populations

• Children
• Pregnant Women, Human Fetuses, and Neonates
• Prisoners
• Other Groups

Definitions