Standard Operating Procedures of the Institutional Review Board

VIII. Monitoring of Studies and/or Reporting Noncompliance


The IRB has the authority to monitor study records to:

  • Verify that no material changes have occurred since the previous IRB approval;
  • Verify compliance with the approved protocol;
  • Verify the informed consent;
  • Exercise appropriate administrative overview to ensure that UNF policies and procedures designed for the protection of the rights and welfare of human participants are being effectively applied; or Verify compliance with IRB policies and procedures and federal regulations.

Under certain conditions, the IRB may seek verification from sources other than the principal investigator to ensure that measures for the protection of human participants are being followed and appropriately documented and that no material changes have been made to a protocol and affiliated documents since previous IRB review. Such verification may be sought for a random selection of studies, for studies which are highly complex, or for protocols or principal investigators with a history of concerns regarding compliance.

 

The IRB has the authority to suspend or terminate protocols that are found to be non-compliant with institutional policies and procedures, state laws, and/or federal laws or regulations. Other sanctions imposed by the IRB may include, but are not limited to, compliance audits, letters of reprimand, and restrictions on serving as an investigator on human subjects protocols. The IRB is responsible for reporting to appropriate officials, the FDA (if appropriate), and OHRP (if appropriate):

  • Any unanticipated problems involving risks to human participants or others;
  • Any instances of serious or continuing noncompliance with regulations or determinations of the IRB; and
  • Any suspensions or termination of IRB approval.

The chair of the IRB will review allegations of noncompliance. The chair makes a determination as to whether the alleged practices appear to (1) cause injury or any other anticipated problems involving risks to participants or others or (2) constitute serious or continuing noncompliance with IRB regulations. The IRB chair will consult additional Board members to discuss the need for a suspension. Following the consultation, the chair could suspend the study until a timely investigation and review by the convened IRB.