Policies and procedures manual
WSU Human Research Protection Program
Table of contents
Introduction
IRB authority and activities
101 Activities requiring IRB review
102 Policy and procedure maintenance
104 Management of IRB personnel
105 Conflict of interest: members, consultants and staff
106 Signature and designee authority
Board members, management & duties
Review eligibility & administration
300 Principal investigator eligibility and submission requirements for IRB review
301 Administrative pre-review and distribution of IRB materials
302 IRB meeting administration
303 Documentation and document management
Review requirements
405 IRB meeting determinations
406 Non-compliance with IRB policies and procedures
407 Suspension and termination
408 Adverse events and unanticipated problems involving risks to subjects or others
410 Investigational drug or device
Vulnerable populations & special considerations
500 Pregnant women, fetuses and neonates
502 Research involving human subjects unable to consent
Communications
Informed consent & assent
701 Waivers of informed consent
702 Documentation of informed consent
Required PI actions & conflict of interest
800 IRB-required investigator actions
801 Conflict of interest (investigator)
Post-approval review
HIPAA
1000 HIPAA waivers/authorization/decedents/review preparatory to research
Federal agency support
1100 Department of Defense supported research
1101 Department of Justice supported research