91̽»¨

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

91̽»¨IRB as the Single IRB

Guidance about when 91̽»¨can review on behalf of non- 91̽»¨institutions, organizations and individuals

Studies Reviewed by a Non- 91̽»¨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
• 91̽»¨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 91̽»¨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 91̽»¨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 91̽»¨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