Policies and procedures manual

WSU Human Research Protection Program

Table of contents



IRB authority and activities

100 Authority and purpose

101 Activities requiring IRB review

102 Policy and procedure maintenance

103 Training and education

104 Management of IRB personnel

105 Conflict of interest: members, consultants and staff

106 Signature and designee authority

Board members, management & duties

200 Composition of the board

201 Management of the board

202 Duties of IRB members

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

400 Exempt review

401 Expedited review

402 Amendments/study updates

403 Continuing review

404 Study completion

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

409 Reporting requirements

410 Investigational drug or device

411 International research

Vulnerable populations & special considerations

500 Pregnant women, fetuses and neonates

501 Categories of research

502 Research involving human subjects unable to consent

503 Research with children

504 Research with prisoners


600 Communications

Informed consent & assent

700 Informed consent

701 Waivers of informed consent

702 Documentation of informed consent

703 Assents

Required PI actions & conflict of interest

800 IRB-required investigator actions

801 Conflict of interest (investigator)

Post-approval review

900 Post-approval review


1000 HIPAA waivers/authorization/decedents/review preparatory to research

Federal agency support

1100 Department of Defense supported research

1101 Department of Justice supported research

1102 Department of Education

1103 National Institutes of Health

1104 Food and Drug Administration