At a minimum, to ensure compliance, the investigator is responsible for:
1. Determining the IRB requirements for reporting with respect to what needs to be reported, when it should be reported, and the procedure for submitting the report.
2. Setting up systems to ensure that reportable events are identified and submitted to the IRB in a timely manner.
Examples of the type of events that may be reportable include: o An unanticipated problem, which may be defined as any unexpected event that affects rights, safety or welfare of subjects. The event could be physical such as an adverse drug experience or adverse device effect. The event could also involve some harm or risk (i.e. breach in confidentiality or harm to a subject's reputation). o Serious adverse event, which may be defined as a death, life-threatening adverse drug or device experience, inpatient hospitalization or prolongation of existing hospitalization, a persistent disability/incapacity, or a congenital anomaly/birth defect. o Protocol exception, which may be defined as enrollment of a research subject that fails to meet protocol inclusion/exclusion criteria. o Protocol deviation, which may be defined as a departure from the protocol as approved by the IRB for a single subject. o Data and Safety Monitoring Plan or Board summary reports. o Complaints concerning subject rights submitted by subjects or concerned parties, family members, or study personnel.
The IRB will use the reports to assess whether the risks/benefit ratio is still reasonable, whether changes in the informed consent document or study procedures are needed, or whether re-consent is necessary. IRB requirements for reporting vary regarding what should be reported, when the reports should be submitted, and the format of the reports. Check with your IRB to determine its specific