Resolving Non-compliance Issues

The Executive Committee of the IRB maintains the right to monitor regulatory compliance by investigators. department representatives, and faculty supervisors.  When evidence or allegations of non-compliance are presented, the committee must investigate their veracity and may solicit relevant documents, written statements and/or personal interviews in support of the investigation.

If the committee determines non-compliance has occurred or is ongoing, it first will seek to resolve the issue in a manner which will restore compliance with IRB regulations.  A report detailing the nature of the non-compliance, the individual involved, and the nature of the resolution must be filed in the IRB records.  If restoration attempts do not produce an ethical outcome acceptable to the committee, it may proceed to one of the following actions if approved by majority vote of the committee members.

1) For an Investigator - Approval is rescinded immediately for any of his/her research projects currently operating under IRB approval and consideration of any new applications for IRB review is suspended for a term to be determined by the Executive Committee (normally six months).  After the suspension, any new applications for review of research from this investigator must be subject to Full Review and will be evaluated in light of the investigator’s previous non-compliance. In addition, reports detailing the nature of the non-compliance, the individual involved, and the failed restoration attempts must be filed in the IRB records and forwarded to the office of the Provost for appropriate action.

2) For a Department Representative - A department representative to the IRB who intentionally or repeatedly misapplies IRB regulations in his/her review of research applications is suspended from the IRB immediately and for a period of one year. Reports detailing the nature of the non-compliance, the individual involved, and the  failed restoration attempts must be filed in the IRB records and forwarded to the college Provost for appropriate action. After the suspension, and with the approval of his/her department chair, the individual may apply to the committee for consideration of reinstatement.

3) For a Faculty Supervisor - A faculty supervisor who intentionally or repeatedly misapplies IRB regulations in his/her supervision of class-based research projects is suspended from such supervision immediately and for period of one year. Reports detailing the nature of the non-compliance, the individual involved, and the failed restoration attempts must be filed in the IRB records and forwarded to the office of the Provost for appropriate action.  After the ban, and with the approval of his/her department chair, the individual may apply to the committee for consideration of reinstatement.

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