Protocol Deviations and Violations

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. The IRB also has "sanction,"  "suspend," or "terminate" approval if there has been serious or continuing non-compliance with the policies, requirements or determinations of the IRB.

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 and the investigator sends a letter to the IRB Chair acknowledging the error that was made.

Minor Protocol Deviations

As stated in the Researcher's Guide, investigators are responsible for conducting human with participants in compliance with federal regulations and UMBC's policies and procedures. Failure to comply with these administrative regulations 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. Non-compliance with regulations may be seen as protocol deviations. 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); do not result from willful or knowing misconduct on the part of the investigator(s); and do not violate any ethical principles.

Common deviations in investigator compliance include:

· unreported changes in the IRB approved protocol or consent documents

· misuse or non-use of the IRB approved informed consent documents

· lapse in obtaining approval for continuing review

· failure to obtain IRB approval prior to starting research activities

· failure to file protocol modifications.

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.

Deviation Reporting Procedure

 

Investigators can almost always avoid protocol deviations by being aware of the IRB requirements and following the approved protocol.  If a protocol deviation does occur, an investigator must immediately submit a protocol deviation reporting form to the IRB for review immediately upon discovery. This form will serve as the documentation for modifying the particular protocol; investigators must await IRB approval before implementing anticipated changes or modifications.

Click on the below to download:

Protocol deviation reporting form

Following the review of the reporting form, the IRB chair will notify the investigator in writing of the 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 (if anything) to correct the conditions that lead to the deviation and what (if anything) 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, process, facts, and conclusions at the next scheduled convened IRB meeting.

Protocol Violations

Protocol violations emerge when there is a variance in a research study between the protocol that has been reviewed and approved by the IRB and the actual activities being performed. Reports may come from a variety of sources: participants, community members, research staff, etc. Reporting of violations will be made, in writing, to the IRB Chair; all reports will be held in the strictest of confidence and discussed within the confines of the fact-finding committee.

Protocol violations are those that:

· are un-approved by the IRB that caused substantive harm to research participants

· cause damage to the scientific integrity of the data collected

· result from evidence of willful or knowing misconduct on the part of the investigator

· impact on ethical principles

Violation Investigation Procedure

 

Incidents of alleged or known protocol violations may be investigated by the IRB via the following steps:

The IRB chair will create a fact finding committee, composed of

1. the IRB Chair

2. the Human and Animal Protections Research Office Administrator

3. the Associate Vice President for Research

4. two or more representatives from the PI's department or discipline, and 

5. a representative from the UMBC Legal Counsel.

This committee will analyze all information gathered regarding the protocol violation and compare it to the approved protocol.  When necessary, the committee will consult with experts in the specific discipline of research in order to make definitive, unbiased and educated decisions regarding the violation. A conclusion will then be made regarding the seriousness of the violation.

If the hearing committee finds any of the protocol violations criteria noted above, the IRB Chair will immediately suspend the protocol. (Note: this does not preclude the IRB chair from suspending the protocol in advance of the hearing if, in the chair's assessment, the conditions in 45 CFR 46.113 have been met and warrant an emergency protocol suspension). If suspension of the protocol results from harm to the enrolled research participants, the IRB chair will request that the PI's department chair assign PI duties to another qualified person. (Note: This change of PI also requires approval of the grant sponsor). In this situation the official action will be the suspension of the investigator (45 CFR 46.109 (d)).

Depending on the nature or the seriousness of the violation, the committee may elect to direct the IRB to audit all protocols that involve the investigator in question. If the findings of the hearing committee support research misconduct, the Vice President for Research will be notified. A summary of the violation, process, facts, and conclusions will be presented at the next scheduled IRB meeting. The IRB chair will notify the investigator in writing with copies to the PI's department chair, the appropriate dean, the Vice President for Research, and the Office for Human Research Protections. If an investigator disagrees with the findings or requirements of the Committee, investigators have the right to appeal the committee's decision to the Vice President for Research.

Last updated 04/28/2008

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