3.5 - Researcher Non-Compliance

All investigators working with human subjects have a responsibility to comply with the regulations specified in federal law and University policy designed to protect the rights and welfare of those research subjects. The most common lapses in investigator compliance are related to a misunderstanding of the application and reporting requirements, failure to submit necessary documents to the Institutional Review Board, and forgetting to submit an application to conduct research involving humans before the study commences. Most of these cases can be resolved by the IRB without jeopardizing the welfare of the subjects.

Occasionally, an investigator will either avoid or ignore the IRB. Such cases present a serious challenge to the IRB and to the University. Regardless of investigator intent, unapproved research involving human subjects places those subjects at unacceptable risk, and places the University at risk for federal sanctions.

It is the responsibility of the IRB and its staff to facilitate researcher compliance with regulations and policies governing human subject research. However, failure to cooperate with the IRB in fulfilling application and reporting requirements, and failing to respond to requests for information and documentation constitutes non-compliance. If an investigator fails to supply the IRB with requested information or documents after a third request from the IRB, the Vice Chancellor for Research and Sponsored Programs will be informed of this non-compliance. The Vice Chancellor will notify the investigator's department chair and academic dean of this non-compliance, and instruct the investigator to cease further research involving humans until they comply with all IRB requirements. Depending on the nature of the research and the level of risk to subjects, the Vice Chancellor will have the option of confiscating all data collected prior to approval of the research by the IRB.