Angela Bain IRB Administrator abainugaedu 7065423821 Reportable New Information RNI And RNI is how investigators report to the IRB the following situations that may occur in the conduct of their research ID: 549890
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Slide1
Navigating Non-Compliance
Angela Bain,
IRB Administrator
abain@uga.edu
706-542-3821Slide2
Reportable New Information (RNI)
And RNI is how investigators report to the IRB the following situations that may occur in the conduct of their research:
Unanticipated problem involving risks to subjects or others
Adverse Events
Protocol violations and deviationsSlide3
Unanticipated problem involving risks to subjects or others
Unexpected (in terms of nature, severity, or frequency) given the research procedures
Related or possibly related to participation in research
Suggests that the research places subjects or others at a greater risk of harm than was previously known or expected. Slide4
Adverse Events
Unexpected Adverse Event
Nature, severity, or frequency is not consistent with the known foreseeable risks associated with the protocol
Serious Adverse Event
Results in death
Is life threatening
Requires hospitalization
Results disability
Results in congenital anomaly/birth defectSlide5
Protocol Deviations
Accidental or unintentional changes to, or non-compliance with the protocol that does not increase risk or decrease benefit; does not significantly affect subject’s rights, safety or welfare.
Failure to collect an ancillary self-report questionnaire.
Weighing a participant with shoes on.
Vital signs obtained prior to informed consent.
Performing a planned procedure on a different timetable than previously specified in the research protocol because of an unforeseen disruption such as a subject’s vacation.Slide6
Protocol Violations
Accidental or unintentional change to, or non-compliance with the IRB approved protocol that
increases risk
or
decreases benefit
,
affects the subjects rights
, safety, or welfare, or the integrity of the data:
Inadequate informed consent
Enrollment of subjects not meeting inclusion/exclusion criteria
Improper breaking of the blinding of the study
Inadequate record keeping
Mishandled samplesSlide7
The Investigator submitted an RNI
What now?Slide8
HSO Staff conducts a pre-review –
If it is determined to not pose an increase of risk to participants, it is reviewed by the IRB Chair and designee.
If it is determined to pose an increase of risk to participants, it is reviewed by the full committee. The committee will confirm whether risks to participants has been increased due to the event and will determine further action such as suspending, terminating, or modifying the research. The committee will also determine noncompliance.Slide9
When is it noncompliance?
Noncompliance is defined as conducting research in a manner that violates federal law, state regulations, or institutional policies. Slide10
What does the IRB do?
The IRB has the following determinations to make:
Serious vs Non-Serious
Continuing vs Non-ContinuingSlide11
Non-Serious Noncompliance
Minor
or technical violations which result from inadvertent errors, inattention to detail, or failure to follow operational procedures which do not pose immediate risk to subjects, the environment, or researchers, and/or violate research subject’s rights and/or welfareSlide12
Serious Noncompliance
Failure
to adhere to the laws, regulations, or policies governing research that may reasonably be determined to
:
a
. Involve substantive harm, or a genuine risk of substantive harm, to the safety, rights, or welfare of human or animal research subjects, research staff, or others
.
b
. Result from deliberate disregard for the laws, regulations, or policies governing research that substantively compromise the effectiveness of the institution’s research oversight programSlide13
Continuing Noncompliance
Persistent
failure to adhere to the laws, regulations, or policies governing research and can represent either minor or serious noncompliance.Slide14