Sponsors and clinical trial study investigators are required to report information that may represent unanticipated problems involving risks to participants and others to Goodwyn Institutional Review Board within 10 working days. You do not need to report problems that are not unanticipated.
An unanticipated problem is one that is (1) unforseen and (2) indicates that participants or others are at increased risk of harm. Unanticipated problems involving increased risk might be indicated in the following:
•Unanticipated problems involving risks to participants or others (see above definition) including but not limited to:
•Unexpected, related adverse events
•A breach of confidentiality or privacy that involves real or potential risk such as unauthorized use or disclosure of protected health information (PHI)
•Unanticipated adverse device effects (new information about the effect on health or safety or any life-threatening problem or death caused by, or associated with, a device, if that effect, problem or death was not previously identified in nature of severity, or degree of incidence or any other unanticipated, serious problem associated with a device that relates to the rights, safety, or welfare of subjects)
•Unanticipated problems identified by sponsors and communicated to investigators in aggregated reports regarding adverse events.
•New information indicating a change to the risks or benefits of the research including but not limited to:
•Interim analysis or Data and Safety Monitoring Board (DSMB) summary reports that indicates that frequency or magnitude of harms or benefits may be different than initially presented ti the IRB
•Publication that shows that the risks or potential benefits of the research may be different than initially presented to the IRB
•Change in FDA labeling or withdrawal from marketing
•Incarceration of a participant in a protocol not approved to enroll prisoners
•Complaints from participants or others involved in the research that indicate unexpected risks or cannot be resolved by the research team
•Site visit monitoring reports, all audits, inspections and subsequent reports including Department of Health and Human services (DHHS), FDA, NIH, NCI, and cooperative groups that are conducted for specific cause
•Changes to the protocol taken without prior IRB review to eliminate an apparent immediate hazard to a research subject, or a protocol deviation (an accidental and unintentional change or departure from the IRB approved protocol that placed one or more participants at risk, or has the potential to occur again)
•Reported or observed non-compliance