SOP102: Adverse Events

Summary

On rare instances, Subjects may become injured or ill as a result of their participation in a research MRI study. This SOP establishes procedures for reporting adverse effects.

Scope

These policies apply to all investigators, research assistants, and MRI operators who use the BIAC research scanners.

Definitions

• Subject - An individual who is participating in an experimental protocol at BIAC and has not taken the BIAC safety course.

• Experimenter - The investigator, research assistant, or MRI operator who is responsible for the subject and conducting the experiment.

Policies and Procedures

An adverse event is an accident, injury, illness, or other health complaint raised by a Subject as an apparent or potential consequence of his or her participation in a research study. Adverse events should not be confused with incidental findings. Examples of serious adverse events include injury by a projectile, interruption of the functioning of a medical device such as a pacemaker or neurostimulator, or burns. An accident that does not result in injury but that exposed the Subject to potential harm should also be considered an adverse event (a projectile that just misses hitting a Subject and causes fear or anxiety in the Subject). Other adverse events might include persistent complaints about dizziness, ringing in the ears, or pain.

We do not typically consider simple discomfort in the scanner or mild complaints about anxiety for being in the scanner as adverse effects, as these are common risks that are explained to the Subject in the consent process. Nevertheless, unusually severe discomfort or a severe panic attack might qualify as an adverse event.

The border between an adverse event and a mild complaint is subjective and involves the Experimenter's judgment. The difference between an adverse event related to the experiment and an accident (such as a fall) that is unrelated to the experiment may also be unclear. How the event is labeled can be determined after the fact. Regardless of distinctions, if a Subject is injured or complains of injury for any reason, this matter must be handled appropriately and the proper authorities within Duke must be notified. In recent years there have been several highly publicized instances where investigators failed to notify the appropriate authorities within their institutions about adverse effects, and there were severe consequences for their inaction.

1. Medical Emergencies

   1. The Experimenter should consult SOP104: Medical Emergencies, if the Subject becomes injured or seriously ill in the MRI suite. Attending to a Subject's safety and well being and calling for qualified help is the first priority of the Experimenter.

2. Risk Management

   1. The Principal Investigator or Experimenter must report serious adverse events to Risk Management immediately. Risk Management advises the University on liability issues. All incidents should be reported by use of the Patient and Visitor Incident Form or by telephone to the Clinical Risk Management Office.

   2. Risk Management can also be called for assistance with patient care or visitor loss exposure or policy/procedure issues on which you have questions such as consent problems, patient rights issues, falls, and documentation of medical records.

3. Engineering and Operations

   1. The Safe Medical Devices Act requires that the institution report to the manufacturer and/or to the FDA certain incidents involving the malfunction or failure of medical devices in which an individual sustained serious injury or death. Thus, if an accident occurs that was a consequence of an equipment failure such as the MRI power monitor, this might be reportable. Immediately isolate the equipment without changing any settings and contact Engineering and Operations or call Risk Management.

4. IRB

   1. The Principal Investigator is required to report adverse events to the IRB in a timely manner -- usually considered to be 10 days. Serious adverse events related to injury or death should be reported immediately.

   2. We note that the IRB may not consider accidents, such as falls, to be adverse events in the sense that they were not a consequence of the experiment. In ambiguous situations, please contact the IRB for clarification. As always, err on the side of full disclosure.

5. Report to BIAC

   1. The Experimenter or Principal Investigator must immediately advise BIAC whenever an adverse event or other accident or incident has occurred. The BIAC office can be contacted during normal working hours. In an emergency the BIAC director, Dr. Allen Song, can be reached at home or via cell.

6. Incomplete studies

   1. In addition to reporting adverse events to the IRB, The Principal Investigator is obliged to report incomplete studies to the IRB at the time of the annual renewal. Incomplete studies are those in which the Subject withdrew before the experiment was complete. The Principal Investigator must include the reasons for the study incompletions. In most instances at BIAC, Subjects withdraw because they don't feel physically comfortable within the scanner, or because the enclosed space makes them anxious.

   2. Incomplete studies should also be noted on the BIAC scheduling calendar. The Experimenter should check the box for incomplete study, and provide details in the appropriate location on the form.