Types of IRB Review

• Step-by-step instructions for deciding whether you need review
• Resources for deciding whether your project is research with human subjects, exempt, or if you need expedited or full board review

UW IRB as the Single IRB

Guidance about when UW can review on behalf of non-UW institutions, organizations and individuals

Studies Reviewed by a Non-UW IRB

• Guidance on identifying the correct IRB
• Obtain authorization from HSD
• Consent Requirements
• Researcher Responsibilities
• Industry Research

Consent and Recruitment

• General guidance and tipsheets
• Guidance , templates, example consent forms for designing the consent process and form
• Cold contact recruitment
• Recruiting at Valley Medical Center

Other Review Considerations

• Paying subjects
• Return of individual results
• Genomic Data Sharing
• Financial conflict of interest
• UW injury compensation
• International research
• Artificial Intelligence

Report Safety or Compliance Events

• Guidance on reporting
• SOP RNI Reporting by Researchers
• Research inquiries
• Contact hsdreprt@uw.edu with questions, complaints, or concerns about UW research

Specific Federal Agency Requirements

• Food and Drug Administration
• Department of Defense
• Department of Energy
• Department of Justice
• Environmental Protection Agency

Clinical Trials

• ClinicalTrials.gov registration and reporting requirements
• Guidance about the UW policy requirement to develop a Diversity Plan for Clinical Trials

Privacy and Confidentiality

• Data security protections
• Certificate of Confidentiality
• Mandatory state reporting

HIPAA

• HIPAA guidance
• HIPAA SOP
• Case report guidance

Protected and Vulnerable Populations

• Pregnant women and neonates
• Children
• Prisoners
• Participants At Risk Of Suicide

Funding and Support

• Delayed Onset Human Research (DOHR)
• Just In Time
• Grant approval and certification

Post Approval Verification and Education (PAVE) Monitoring Program

• SOP PAVE Evaluation
• Post-Approval Verification and Education Guidance

Access to Unapproved Drugs, Biologics, and Devices

• All Expanded Access mechanisms
• Single Patient Emergency or Compassionate Use
• Humanitarian Use Device (HUD)

Emergency Medicine Research

Exception from Informed Consent for Emergency Research

Human Subjects Regulations

• Ethical principles
• Authority and responsibilities of HSD and the UW IRB
• Human subjects regulations

The Convened IRB

• Convened IRB meetings
• IRB review outcomes
• Options for IRB Actions
• SOP Guests at IRB Meetings
• Information for IRB Guests

IRB Members

• SOP IRB Members
• IRB member standards and responsibilities
• IRB reviewer conflict of interest