Non-Compliance Policy | Webster University

Non-Compliance Policy

Non-compliance is the failure to follow federal IRB guidelines and the policy of Webster University for the protection of human subjects.

Incidents of non-compliance must be reported to ensure protection of human subjects and adherence to University policy. Unapproved research involving human subjects may place those subjects and the researcher at risk. All incidents of suspected non-compliance must be reported to the Chair of the IRB Committee.

Non-Compliance Review Procedure

The Chair of the IRB will convene a meeting of the members of the IRB Committee and a representative of the Faculty Senate to determine if there is an issue of non-compliance. Approval of the research may be suspended while the investigation is conducted. The following steps are taken:

  • The Chair will notify the project investigator (PI)(s) that a non-compliance review has been initiated.
  • The PI(s) are invited to submit a written explanation of the possible non-compliance.
  • The PI(s) may also be asked to appear before the IRB committee.
  • If after deliberation, the Committee determines that non-compliance has not occurred, the PI(s) will be notified in writing.

If the IRB determines that there has been an issue of non-compliance:

  • appropriate action to protect human subjects will be taken; 
  • action can be remedial and may include education for the PI(s) on protection of human subjects;
  • and/or follow up reports to the IRB Committee related to the particular issue may be required.

If the Committee determines there is a serious issue of non-compliance:

  • the PI(s) will be notified, and
  • a Committee consisting of the Chair of IRB, the Chair of the department of the particular faculty PI(s), the Dean of the school/college of the faculty PI(s), President and Senior VP,  and Chair of Faculty Senate will be convened to further review the incident.
    • If it is determined that there are serious issues of non-compliance, disciplinary action will be taken. 
      • For faculty this may include suspension of the research and/or constraints on presenting or publishing the research.
      • For students this may include suspension of the research or not accepting the thesis.
    • The PI(s) will be notified in writing the decision of the Committee. 

If the PI(s) believes that the IRB has erred in the decision, the University Grievance Procedure may be initiated. Refer to the Student Handbook for additional information: