St. Cloud State University commits to the assurance that it will comply with the Department of Health and Human Services (HHS) regulations codified at 45 CFR 46, Subparts A – D, the Revised Common Rule, for the protection of human subjects involved in research.
Definitions
Noncompliance: A violation of SCSU IRB Procedures or HHS 45 CFR part 46 policy, failure to comply with IRB requirements as communicated to the principal investigator(s), and/or noncompliance that otherwise fails to meet the criteria for continued or serious noncompliance in which major concern for participant safety or well-being or research integrity is not present, as determined by the IRB Committee.
Continued Noncompliance: Repeated separate instance of documented noncompliance.
Serious Noncompliance: Willful violation of SCSU IRB Procedure or HHS 45 CFR 46 policy or any noncompliance that is a concern for participant safety or well-being or research integrity as determined by the IRB Committee. Concurrently occurring instances of noncompliance might meet the definition of serious noncompliance when considered as a whole.
Protocol Violation: Any deviation from the approved protocol that a) impairs the participant's ability to make a decision to participate, b) intrudes on participants' rights and well-being, c) increases risk to participation, d) produces concerns in the analysis or reporting of data, or e) otherwise is deemed problematic as per the IRB after reviewing the deviation.
Note that all protocol violations are serious violations as the principal investigator(s) proposed, and agreed to, the terms of the investigation. Thus, no claim of ignorance is possible in defending a protocol violation.
It is the responsibility of the IRB Committee, the principal investigators, the research team, and the SCSU research community to report any perceived noncompliance or protocol violations to the IRB Co-Chairs, the IRB Administrator, or the Institutional Official.
In reporting noncompliance or violations, all efforts will be taken to protect the confidentiality of those who are reporting. Self-reporting will be taken into consideration, particularly for serious noncompliance and protocol violations.
When reporting concerns, document the approximate dates of the activities, who was involved, who is responsible for overseeing the activities, and any additional materials that would help the IRB Committee make a determination of noncompliance or protocol violation.
It is IRB procedure that false accusations of noncompliance or protocol violations are a matter of research misconduct.
The IRB Committee, by the authority of the Institutional Official, might respond to noncompliance or protocol violations with any reasonable consequence, including but not limited to one or more of the following (see below). In the case of student research, any action from the IRB will extend to any and all faculty mentors listed on the IRB protocol.