Reporting and Management of Concerns
Questions, concerns, complaints, allegations of undue influence, allegations or findings of non-compliance, or input regarding the Human Research Protection Program may be reported orally or in writing. Employees or students are permitted to report concerns on an anonymous basis. Concerns MUST be reported to the IRB Chairs, HRPP management, and Institutional Official or Legal Counsel.
Role of QA/QI
QA/QI is responsible to investigate allegations and findings of non-compliance when requested by the IRB Chairs or designee or HRPP management. The IRB, the IRB Chairs, or the HRPP management will evaluate and manage all allegations and findings of non-compliance.
Employees who report in good faith possible compliance issues should not be subjected to retaliation or harassment as a result of the reporting. Concerns about possible retaliation should be immediately reported to the HRPP management, or Institutional Official.