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 >  VIII. Adverse Events (AE) Reporting to the IRB

VIII. Adverse Events (AE) Reporting to the IRB

A. Purpose
Federal regulations require Principal Investigators to report promptly to the IRB all "unanticipated problems involving risk to human subjects or others". These reports enable the IRB to monitor potential risks in studies that have been approved and to take appropriate action. Adverse events are "unanticipated problems" include risks of physical or psychological harm, unexpected threats to confidentiality, problems arising from the patient recruitment process and/or consent process, and adverse events as set forth in Adverse Event report. In studies, which employ interviews or the use of questionnaires, a subject's strong adverse reaction to questions could be considered an "unanticipated problem event as described below involving risk" and should be reported to the IRB.

The IRB requires that adverse events defined by the FDA as either "serious" adverse events or "unexpected" adverse events are reported to the IBRA.

Serious Adverse Event means any adverse experience associated with the study article that results in any of the following outcomes: death, a life-threatening experience, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant disability/incapacity, or a congenital anomaly/birth defect. Important medical events that may not result in death, be life-threatening or require hospitalization may be considered a serious adverse event when, based upon appropriate medical judgment, they may jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the outcomes listed in this definition.

Unexpected Adverse Event is any adverse experience associated with the study article for which the specificity or severity is not consistent with the current investigator brochure, or, if an investigator brochure is not required or available, the specificity or severity of which is not consistent with the risk information described in the general investigational plan or elsewhere in the current application, as amended. "Unexpected" refers to an adverse experience that has not been previously observed.

Associated with the study article means that there is a reasonable possibility that the experience may have been caused by the study article.

Adverse events must be reported on the official form (see below) to the IRB within 7 days of occurrence, and significant adverse events must be reported immediately. All forms must be submitted to the NYUCD Office of Research. Industry-sponsored studies also require reporting of significant adverse events (SAE) immediately after occurrence.

The timing of reporting of AEs varies depending upon the type of study and the severity of the AE. An overview of timing of reporting is:
Event When AE is to be reported to IRB
  • Adverse drug reactions Within 15 calendar days
  • Unanticipated adverse device effects Within 10 calendar days
  • Human gene therapy protocols Immediately
  • Unanticipated risks to subjects Immediately

    For additional details of AE reporting, see the NYUSM site (see below).

    B. Process
    Every clinical research study should anticipate the possibility of adverse events (AE) and significant adverse events (SAE), despite, in some circumstances, the extremely rare likelihood of an adverse event. All investigators associated with the clinical investigation must be familiar with the necessity to report AE and SAE to the IRB and other authorities (e.g., NIH, industry sponsor) as dictated by the protocol.

    OSP IRB Applications
    No standard forms exist for the OSP IRB. Therefore, use the NYUSM forms (see below) or write a letter containing the pertinent information when reporting an AE or SAE to the OSP IRB.

    NYUSM IRB Applications
    Policy & Procedures of the IBRA (Appendix 14). Retrieve from: http://research.med.nyu.edu/research-resources/important-forms-researchers

    Serious Adverse Event Report to IBRA (Appendix 15). Retrieve from: http://research.med.nyu.edu/research-resources/important-forms-researchers