The University of Iowa
Human Subjects Office

iii. Serious adverse device effects (either anticipated or unanticipated) occuring in a UI subject

Manuals

Printer-friendly versionPrinter-friendly version

If a subject is enrolled by UI\VAHCS investigators, the investigator must report either serious adverse device effects or unanticipated adverse device effects.  By definition, these effects must be associated with the use of the device.

An unanticipated adverse device effect is any serious adverse 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 the frequency, specificity, or severity of which has not previously been identified in the investigational plan or application, or any other unanticipated serious problem associated with a device that relates to the rights, safety, or welfare of subjects (21 CFR 812.3).

Investigators must report any serious adverse device effect occurring in a UI\VAHCS subject to IRB-01 or IRB-03 using the Reportable Event Form (REF).  This form includes a description of the effect, the date of occurrence, the type of risk, whether the effect was unanticipated, the outcome, and an assessment of degree of relatedness to the research.  The form also includes the proposed actions to be taken by the investigator with regard to modifying approved study materials (including change in consent documents or other notification procedures) and notifying current subjects.  Reports from the investigator to the IRB must be submitted via HawkIRB within ten working days of the event or within 10 working days of the PI becoming aware of the event.

Reports of serious and anticipated adverse device effects occurring in a UI\VAHCS subject are reviewed by an IRB Chair to verify that the effect would be considered “anticipated” based on the information previously reviewed and approved by the IRB.  If the Chair verifies that this information is correct, the Chair signs the report through the HawkIRB system.

Reports of serious and unanticipated adverse device effects occurring in a UI\VAHCS subject are reviewed by the UI\VAHCS IRB Chair and/or UI IRB in the following manner:

  1. The IRB chair compares the content of the REF with the previously approved project materials such as applications, informed consent document(s), protocols, investigator brochures, or other supporting documents to determine whether this event meets the definition of an unanticipated problem involving risk to subjects or others.
  2. If the chair agrees the event meets the definition of an unanticipated problem involving risks to subjects or others, the chair determines whether the event represents minimal risk of harm or more than minimal risk of harm to subjects enrolled in the research study.
  3. If the event represents minimal risk of harm, the chair reviews and signs the report through the HawkIRB system.
  4. If the event represents more than minimal risk of harm to subjects enrolled under the UI\VAHCS study, the report is referred to the convened IRB for review.  The full board determines whether subjects must be notified of the new information, and if so, the method of notification and whether any study materials (e.g. consents, protocol) must be updated to reflect the new information.
     

All reports of serious adverse device effects occurring in a UI\VAHCS subject are electronically filed with the appropriate research study.  These reports are also reviewed by the IRB at the time of continuing review.  In addition, reports of all serious adverse device effects for all projects reviewed by the Chair or full board IRB are provided by e-mail to all IRB-01 or IRB-03 members on a monthly basis.

Unanticipated serious adverse device effects occurring in a non-UI subject

FDA regulations (21 CFR 150(b)(1)) require the sponsor to report the results of any evaluation of an unanticipated serious adverse device effect to all reviewing IRBs and participating investigators.  Any such reports are initially received by the investigator who is in turn responsible for reporting this information to the IRB-01 or IRB-03.  By definition, these effects must be associated with the use of the device.

Investigators must report any evaluation of unanticipated serious adverse device effects conducted by the sponsor occurring in a non-UI\VAHCS subject to IRB-01 or IRB-03 using the Reportable Event Form (REF).  This form includes a description of the effect, the date of occurrence, the type of risk, the outcome, and an assessment of degree of relatedness to the research.  The form also includes the proposed actions to be taken by the investigator with regard to modifying approved study materials (including change in consent documents or other notification procedures) and notifying current subjects.  Reports from the investigator to the IRB must be submitted via HawkIRB within ten working days of the event or within 10 working days of the PI becoming aware of the event.

All reports of unanticipated serious device effects occurring in a non-UI\VAHCS subject are reviewed in the following manner:

  1. The IRB chair compares the content of the REF with the previously approved project materials such as applications, informed consent document(s), protocols, investigator brochures, or other supporting documents to determine whether this event meets the definition of an unanticipated problem involving risk to subjects or others.
  2. If the chair agrees the event meets the definition of an unanticipated problem involving risks to subjects or others, the chair determines whether the event represents minimal risk of harm or more than minimal risk of harm to subjects enrolled in the research study.
  3. If the event represents minimal risk of harm, the chair reviews and signs the report through the HawkIRB system.
  4. If the event represents more than minimal risk of harm to subjects enrolled under the UI\VAHCS study, the report is referred to the convened IRB for review.  The full board determines whether subjects must be notified of the new information, and if so, the method of notification and whether any study materials (e.g. consents, protocol) must be updated to reflect the new information.
     

All reports of unanticipated serious adverse device effects occurring in a non-UI\VAHCS subject are electronically filed with the appropriate research study.  These reports are also reviewed by the IRB at the time of continuing review.  In addition, reports of all unanticipated serious adverse device effects for all projects reviewed by the full board are provided by e-mail to all IRB-01 or IRB-03 members on a monthly basis.