IRB Renewal Application
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CONFLICT OF INTEREST
Have any conflicts of interest been identified that have not already been disclosed to the SPCC IRB? Do any of
the participating study investigators or other key personnel (or their immediate family/significant other) have a
financial or intellectual interest in, or are receiving compensation from, the sponsor or the drugs, devices or
technologies used in this research? If additional conflicts have been identified, explain the conflict and any
Do you have or anticipate (within the year) any financial relationships (e.g., consulting, speaking, advisory
boards, patents, equity, options) that could be perceived to overlap or present a conflict of interest with the
current proposal? If yes, describe the overlap.
RISK ASSESSMENT & MANAGEMENT
Since the initial IRB review or last renewal:
Have there been any events requiring prompt reporting to the IRB, such as a study-related adverse event of any
severity, injury, or protocol deviation/violation, that was both unanticipated and indicated that the research
places subjects or others at a greater risk of harm (including physical, psychological, economic, or social harm)
than was previously known or recognized? If yes, please summarize the events. State whether the incident was
promptly reported to the IRB by submitting the IRB Unexpected Event Report Form (if not already completed,
submit the form along with this application).
Has the occurrence of the event(s) changed your current risk-benefit assessment (increased potential for risk or
decreased potential for benefit to study participants)? Explain your answer and how you responded.