Protocol Deviations or Issues of Non-Compliance

As stated in the federal regulations ( 45 CFR 46.113), all protocol deviations and/or instances of noncompliance with IRB regulations must be reported to the IRB by the principal investigator as soon as the violations are discovered. The IRB has the authority to suspend or terminate approval of research not being conducted in accordance with the IRB’s requirements or that has been associated with unexpected serious harm to subjects. Failure to comply may result in an individual investigator’s ability to conduct research but can also affect the ability of all others at UMBC to perform human participant research. The IRB also may “sanction,”  “suspend,” or “terminate” approval if there has been serious or continuing non-compliance with the policies, requirements or determinations of the IRB.

Investigators are responsible for conducting human with participants in compliance with federal regulations and UMBC’s policies and procedures. Non-compliance or deviations generally do not have substantive effects on the safety or well-being of research participants, do not affect the value of the data collected (meaning the violation does not confound the scientific analysis of the results), or do not result from willful or knowing misconduct on the part of the investigator(s); and do not violate any ethical principles.

Examples of non-compliance or deviations include:

  • altering an IRB approved process or documents without prior IRB approval
  • failure to obtain informed consent from participants
  • inadequate supervision of research team activities involving human subjects
  • initiating changes to the research protocol without prior IRB approval
  • lapse in obtaining approval for continuing review
  • failure to obtain IRB approval prior to starting research activities
  • failure to file protocol modifications
  • failing to take appropriate IRB training
  • enrolling more subjects than approved by an IRB

Problems such as these are often caused by an investigator failing to communicate effectively with the IRB.  When such instances are discovered, the IRB will act promptly to halt the research, ensure remedial action regarding compliance with federal and institutional human participant protection requirements. Investigators not in compliance with IRB procedures will not be able to process new protocols or renew current projects until all concerns have been addressed.

Reporting Procedure

Investigators can almost always avoid protocol deviations by being aware of the IRB requirements and following the approved protocol.  If an issue of protocol deviation or non-compliance occurs, an investigator must immediately submit a report of a protocol deviation using Kuali Protocols Portal for review immediately upon discovery. This report will serve as the documentation for modifying the particular protocol; investigators must await IRB approval before implementing anticipated changes or modifications. The Kuali Protocol User Guide has a searchable table of contents to the specific sections of Guide to assist you in creating this report.

Following the review of the deviation, the IRB chair will notify the investigator of a need to meet discuss the deviation and develop a plan to avoid such actions in the future. The results of the meeting will determine what must be done to correct the conditions that lead to the deviation and what must be communicated to the research participants. Participant enrollment may be suspended pending resolution of the problem or concern. The IRB chair will present a summary of the deviation or non-compliance at the next scheduled convened IRB meeting.

Have a Kuali technical issue or problems with access?  Contact the ORPC on this online form and we’ll send your issue to VPR Research Administrative Systems

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