What Is Non-compliance?
Non-compliance refers to the conduct of research that is inconsistent with the requirements or determinations of the IRB (IRB-approved research protocol, informed consent document or process) or an allegation of such non-compliance.
If the non-compliance does not require modifications to the protocol and/or consent document(s):
- log into the study under which the non-compliance occurred and submit a Report of New Information.
If the non-compliance requires modifications to the protocol and/or consent document:
- log into the study under which the non-compliance occurred and submit a Modification.
Examples of non-compliance:
- Research personnel do not obtain written consent for a study that involves the collection of discarded tissue. While no harm occurred, failure to obtain consent was a violation of the research participant's rights.
- Enrollment of participants before IRB approval has occurred and/or after IRB approval has lapsed.
- Continued treatment of participants after IRB approval has lapsed without first obtaining permission from the IRB.
- PI enrolls a participant that does not meet all of the inclusion/exclusion criteria. The criteria that were not met puts the participant at risk of harm.
- Enrollment of children, prisoners, pregnant women and fetuses, without prior IRB approval.
- Over-enrollment of participants on a single center, NU study.
- Use of an unapproved consent form.
- Use of unauthorized study personnel to conduct study procedures which carry risk of physical harm.
- A required lab test is not done whose omission poses risk of harm to participants.
- A procedure, treatment, or visit specified in the protocol is conducted outside of the required time frame and has clinical consequence; poses risk of harm to subject or others; and/or is thought to be impactful to the scientific integrity of the study.