807: Report of Review Findings For External Reviews
Based on the Quality Monitoring Review (aka Q-Review), suspected serious or continuing noncompliance will be verbally reported immediately to the UNR RIO Director. The chair of the IRB will be informed within five business days.
Examples of review observations that may be considered serious or continuing noncompliance:
- A pattern of no documentation or no evidence of informed consent from subjects enrolled in the research.
- A pattern that subjects did not meet eligibility criteria as stated in the IRB approved protocol.
- A pattern of changing or altering the IRB approved practices and procedures.
- The IRB approved practices and procedures not completed.
- Evidence of a serious adverse event or unexpected adverse event of moderate or greater severity that appears to be associated with the research intervention and was not reported to the IRB.
- Inadequate supervision of study conduct, study staff, oversight of subjects that puts subjects at increased risk.
- Initiating research activity prior to IRB approval.
- Enrolling or continuing to engage subjects in research related activities after approval of the study has expired.
- Misrepresentation of information related to the human subjects research protocol or performance of the research.
- Apparently intentional violation of laws, regulations or institutional policies governing the conduct of human subjects research.
A draft of the Report of Review Findings, prepared by the QI Officer who conducted the review, will be sent to the Principal Investigator, the RIO Director, and the chair of the IRB within twenty business days of completing the review. The PI will have at least five (5) business days, or a mutually agreed upon duration, to provide an explanation of the circumstances (extenuating or otherwise) that could account for certain findings, and an acknowledgement of findings requiring correction.
Once the findings in the draft report are agreed upon by the PI and QI Officer, changes, if any, will be made to the report and the final Report of Review Findings will be issued to the PI.