Effective Reporting and Management of Concerns in HRPP
Learn about the reporting and management protocols for concerns, complaints, allegations, and non-compliance in the Human Research Protection Program (HRPP). Understand the responsibilities of the Institutional Review Board (IRB) and Investigator/Officer of the Organization (IO/OO) in addressing such issues and taking corrective actions promptly.
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Presentation Transcript
REPORTING AND MANAGEMENT OF CONCERNS
o Questions, concerns, complaints, allegations of undue influence, allegations or findings of non-compliance, or input regarding the HRPP may be reported orally or in writing REPORTING AND o The IRB has the responsibility to investigate allegations and findings of non-compliance and take corrective actions MANAGEMENT OF CONCERNS o The IO/OO has the responsibility to investigate all other reports and take corrective actions o Report within 5 days
oContact the IRB office with questions (cuhs@harvard.edu) REPORTING oSubmit Report of New Information (RNI) in ESTR AND MANAGEMENT OF CONCERNS oContact the IO/OO oAra Tahmassian, Ph.D. (ara_tahmassian@harvard.edu)
o Not noncompliance or an unanticipated problem o Minor noncompliance: Noncompliance that is neither serious nor continuing IRB DETERMINES: o An unanticipated problem involving risks to subjects or others NON- COMPLIANCE? o Serious or continuing non-compliance with the regulations or the requirements or determinations of the IRB o Necessitates suspension or termination of IRB approval
oModify protocol or consent process oGive additional info to participants oObservation by IRB and/or monitor IRB DETERMINES: ACTION PLAN oRequest PI receive training oNotify other relevant parties oTransfer, suspend, or terminate study
For more on reporting see: oHRP-101 HUA Human Research Protection Program Plan REPORTING AND oHRP-103 HUA Investigator Manual MANAGEMENT OF CONCERNS oHRP-321 WORKSHEET Review of Information Items o Researcher Responsibilities After Review in the IRB Lifecycle at cuhs.harvard.edu
