Noncompliance occurs when research involving human participants is conducted in a manner that disregards or violates federal regulations, the policies or procedures of the Institutional Review Board (IRB), or institutional policies governing human research. Noncompliance with respect to human research participant protection violates the University Federalwide Assurance Registration (FWA). Even in the absence of intent, an unapproved or otherwise noncompliant research activity may place a research participant at unnecessary risk.
This policy sets forth the definition and examples of noncompliance; the procedures for reporting an allegation of noncompliance to the IRB; and the procedures for the IRB’s management of such allegations, and if appropriate, of confirmed noncompliance.
The purpose of sanctions initiated by the IRB against human subjects researchers:
- The use of sanctions is intended to promote compliance with federal and state laws and regulations, and with University System of Georgia and Georgia Southern University (GS) policies. Actions based upon non-compliance by the IRB are not intended as punishment against any individual or group of human subjects researchers.
Allegation: An assertion in the form of a complaint, concern or inquiry made by a party which has not yet been proven or supported by evidence.
Confirmed Noncompliance: An allegation of noncompliance that has been verified as a result of an investigation and/or a for-cause audit.
Continuing Noncompliance: A repeated pattern or un-rectified instance of noncompliance by an individual investigator or research staff member either on a single protocol or multiple protocols.
Noncompliance: Failure to comply with federal regulations; the policies or procedures of the IRB; or institutional policies governing human research.
Examples of noncompliance include:
(1) conducting human participant research without IRB approval (e.g., before approval; after expiration of approval and in the absence of a continuation application submitted to the IRB; during a suspension of IRB approval; after termination of IRB approval);
(2) disregarding or otherwise violating IRB-approved informed consent procedures (e.g., failing to obtain consent/assent, using unapproved or outdated consent, assent, and information sheets, missing signatures, failing to document consent process);
(3) deviating from the protocol approved by the IRB;
(4) modifying an approved protocol without IRB consent;
(5) failing to report or late reporting unanticipated problems;
(6) failing to maintain adequate records;
(7) failing to train research team members in the proper procedures; and
(8) failing to follow recommendations by the IRB to ensure the safety of research participants.
Noncompliance involving one or more of the following:
(1) bringing harm to research participants;
(2) exposing research participants to a significant risk of
(3) compromising the privacy and confidentiality of research participants;
(4) causing damage to scientific integrity of the research data that has been collected;
(5) engaging in willful or knowing noncompliance;
(6) impacting ethical principles adversely.