Reporting To The IRB: Investigator Noncompliance

By Lauri Carlile, EVP, Global Review Services

In clinical research, the term "noncompliance" is not specifically defined, leading to confusion for researchers working with multiple institutional review boards (IRBs). Advarra's IRB has defined noncompliance as any action that fails to comply with regulations, the IRB's handbook, or the IRB's requirements.

Noncompliance can range from minor to serious and may be unintentional or willful. Serious noncompliance affects the rights and welfare of subjects or compromises the scientific integrity of the research. Continuing noncompliance is a pattern of repeatedly failing to comply.

Reporting noncompliance concerns is crucial to protect research participants. By promptly reporting noncompliance, researchers can ensure ethical research conduct and protect the rights and welfare of participants.