Unit Role
Principles, Standards, and Guidance
Education and Awareness
Administration and Management
Institutional Oversight
Monitoring
Noncompliance
Coordination Among Entities
Records and Reporting
Unit Role
The Human Research Protection Office (HRPO) helps to ensure that all Washington University research involving human participants is conducted in accordance with Federal and State regulations and University and sponsoring agency policies and procedures instituted to protect the rights and welfare of human research participants. HRPO upholds this commitment to the protection of human participants involved in research regardless of the funding source and regardless of the location of the research. HRPO supports the Washington University duly established and independent Institutional Review Boards (IRBs), which review and approve protocols for all research involving human participants.
HRPO reports to the Executive Vice Chancellor for Medical Affairs.
Principles, Standards, and Guidance
- Promotes a culture of compliance and oversees adherence to the ethical principles outlined in the Belmont Report, the Declaration of Helsinki, Federal and State regulations, and University and sponsoring agency policies and procedures instituted to protect the rights and welfare of human research participants.
- Develops and implements institutional policies and procedures to help ensure the protection of human research participants.
Education and Awareness
- Disseminates information and provides guidance regarding compliance with Federal regulations and University and sponsoring agency policies and procedures.
- Develops and implements educational programs and tools to effectively train researchers and staff participating in human participant research and related activities.
- Reviews the monitoring results from other compliance units to assist in the implementation of education and process enhancements that will raise performance standards related to conduct of research involving human participants.
Administration and Management
- Represents the University to Federal and State regulatory agencies.
Develops and maintains electronic systems and technology solutions related to the administration of human participant research. - Recruits and appoints members to serve on the IRB.
Institutional Oversight of the IRBs
- Maintains the sole institutional authority to review, approve, require modifications to, or disapprove human research activities.
- Approves, disapproves, or requires changes to protocols or proposed changes to protocols for all research involving human participants.
- Reviews approved research protocols at intervals appropriate to the degree of risk, but no less than once per year.
- Reviews proposal budget to verify adequate funding is available to protect the rights and welfare of human research participants.
- Helps to ensure that all consent documents include the required elements of consent in accordance with Federal and State regulations and University and sponsoring agency policies and procedures.
- Approves all alterations to or waivers of informed consent.
Monitoring
- Conducts internal monitoring of HRPO records in accordance with department policies.
- Works closely with other WU compliance offices with regard to the monitoring of open human research protocols to help facilitate cooperation and assure compliance with Federal regulations and University and sponsoring agency policies and procedures.
Noncompliance
- Reviews reports of noncompliance and is responsible for required reporting to federal regulatory entities.
- In collaboration with the IRB, may authorize the suspension or termination of approved research that is not being conducted in accordance with IRB requirements or that has been associated with unexpected serious harm to participants.
Coordination Among Entities
- Coordinates with the Conflicts of Interest Review Committees to ensure that all potential financial conflicts of interest related to human research protocols are disclosed in accordance with Federal regulations and University and sponsoring agency policies and procedures.
- Coordinates with the Conflicts of Interest Review Committees to ensure that financial conflicts of interest are effectively managed, reduced, or eliminated prior to approving human research protocols.
- Coordinates with CCS to help ensure that CCS-supported clinical studies comply with Federal and State regulations and University and sponsoring agency policies and procedures instituted to protect the rights and welfare of human research participants.
- Coordinates with the Committee on Research Integrity to help ensure that the institutional response to knowing, serious, or continuing violations is accurate, appropriate, and in accordance with Federal and State regulations and University and sponsoring agency policies and procedures.
- Coordinates with the Institutional Biosafety Committee to ensure that protocols involving human gene transfer have been reviewed and approved in accordance with Federal, State, and local regulations, and University and sponsoring agency policies and procedures instituted to protect the rights and welfare of human research participants.
- Coordinates with the Research Office to monitor and impose restrictions on international exchanges of information, items, and/or activities.
- Coordinates with the Radiation Safety Committee to ensure that protocols involving radiation have been reviewed and approved in accordance with Federal and State regulations and University and sponsoring agency policies and procedures instituted to protect the rights and welfare of human research participants.
Records and Reporting
- Creates and maintains records for all IRB proceedings and all protocols submitted for review.
- Reports findings of determinations made by expedited review procedures to the IRB.
- Notifies appropriate individuals and entities of actions to suspend or terminate research that is not being conducted in accordance with IRB requirements or that has been associated with unexpected serious harm to participants.
- Reports changes in IRB membership to the Office of Human Research Protection (OHRP) in accordance with Federal regulations and University policies and procedures.