HSPPO reports to the Executive Vice President for Research and Innovation.

 

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.
  • Coordinates with the Human Subjects Protection Program Office Quality Assurance / Quality Improvement Program (HSPPO QA/QI) to develop and implement educational programs and tools to effectively train researchers and staff participating in human participant research and related activities.
  • Reviews the HSPPO QA/QI monitoring results 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 HRPO Committees.

Institutional Oversight

  • 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.
  • 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 HSPPO records in accordance with department policies.
  • Works closely with HSPPO QA/QI throughout 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

  • Supports and endorses cooperation with University compliance and monitoring efforts and reports instances of noncompliance to the appropriate compliance office.
  • Authorizes the suspension or termination of approved research that is not being conducted in accordance with HSPPO requirements or that has been associated with unexpected serious harm to participants.

Coordination Among Entities

  • Coordinates with the Disclosure Review Committee 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 Disclosure Review Committee to ensure that financial conflicts of interest are effectively managed, reduced, or eliminated prior to approving human research protocols.
  • Coordinates with the Research Integrity Program 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 Office of Technology Transfer to ensure that protocols involving transfer of research materials have been reviewed and approved and that transfers of materials, data or specimens are transferred 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.
  • 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 appropriate 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) or Food and Drug Administration (FDA) in accordance with Federal regulations and University policies and procedures.