Allegation of Noncompliance
It is the responsibility of all FHCRC employees and agents and persons conducting research for which FHCRC IRB is the IRB or record to report any serious or continuing noncompliance or suspected serious or continuing noncompliance of which they become aware.
An allegation of noncompliance by definition is "an assertion that noncompliance has or may have occurred that requires further investigation to determine whether noncompliance has in fact occurred."
- The Allegation of Human Subjects Research Noncompliance Reporting Form is used to report third-party allegations of noncompliance. [download word doc]
- Complete and submit the form to the Director of the Institutional Review Office (J6-110).
- If the report involves the IRO Director or members of the Institutional Review Board (IRB), please submit the completed form to the Office of the Director (D1-060) or the Office of the General Counsel (J6-205).
- Reports of Noncompliance from the Investigator or study staff should use the Expedited Reporting Form for Unanticipated Problems or Noncompliance. [download word doc]