Protocol violations (or serious non-compliance) emerge when there is a conspicuously bad variance in a research study between the protocol that has been reviewed and approved by the IRB and the actual activities being performed. Reporting of violations are made using the Kuali Protocols Portal; all reports will be held in the strictest of confidence and discussed within the confines of the fact-finding committee. The Kuali Protocol User Guide has a searchable table of contents to the specific sections of Guide to assist you in creating this report.
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
Protocol violations may cause 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, or impact on ethical principles.
Examples of violations include:
- an instance that expose subjects or others to risks of harm that are not a part of the approved research protocol
- conducting human subjects research without IRB approval
- making substantive changes to a previously approved protocol without IRB approval
- conducting project activities that adversely affect the integrity of human subjects protections or subjects rights or welfare
Violation Investigation Procedure
Incidents of alleged or known inadvertent, careless or reckless, or intentional violations will be investigated by the IRB via the following steps:
The IRB chair will create a fact finding committee, composed of:
- the IRB Chair
- the Research Compliance Officer
- the Associate Vice President for Research
- two or more representatives from the PI’s department or discipline, and
- 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 reporting of the incident to the Office for Human Research Protections (see Guidance on Reporting Incidents to OHRP).
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 that a change of PI funded by an external funding agency 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 ORPC. 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. The VPR, however, cannot overturn the IRB’s decision.