Adverse Events
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The responsible project investigator (RPI) must promptly report to the IRB Office and to his or her departmental executive officer unanticipated problems (involving human subjects) that arise during the course of the research project and that fall into either of the following categories:
Category A—Any Serious Adverse Event that Occurs within 48 Hours of Participation in the Research
Serious adverse events are those resulting in death, a life-threatening experience, hospitalization or prolongation of existing hospitalization, a persistent or significant disability or capacity, or a congenital anomaly or birth defect. Every serious adverse event must be reported, even if the event does not appear to be associated with the research protocol. If applicable, also file an FDA Adverse Event Report (at http://www.fda.gov/cder/aers/). In addition, the IRB Office 217.333.2670; irb@illinois.edu) should be notified within 24 hours of discovery of any serious adverse event.
Category B—Any Event for which All Three of the Following are True:
(1) Subject or Risks to Subject or Others Adversely Affected—An event or outcome has occurred that has resulted in harm to the subject, has affected the subject detrimentally, has worsened as a result of their participation, or that has resulted in increased risk to the subject or to others, whether or not the risk has actually resulted in harm (for example, misplacing a subject's research records would constitute an increased risk event that should be reported).
(2) Unexpected Event—The event or outcome was not described as a risk of participation in the research, or, though described as a risk, the event or outcome has occurred with unexpected severity or frequency.
(3) Possibly, Probably, or Definitely Related Event—The event or outcome was definitely related to participation in the research or it's reasonable to conclude that the event or outcome was related to participation, or it's possible the event or outcome was related but sufficient information is not yet available to assess the likelihood of this possibility.
All events or outcomes that fall into either Category A or B must be reported to the IRB Office by submission of the Adverse Events form within 5 days of the incident. In addition, the IRB Office 217.333.2670; irb@illinois.edu) must be notified within 24 hours of discovery of any serious adverse event.
If any emergency occurs during the research, investigators should call 911 and provide the following information:
- type of injury and assistance needed,
- number of victims,
- location and instructions on how to get there, and
- relevant names, including that of the victim, and telephone numbers.
Other unanticipated problems that do not fall into either Category A or B, above, such as subject complaints (with or without withdrawal from participation) about the conduct of a research project, should be promptly reported to the IRB Office so that appropriate documentation, investigation, and resolution can occur in a timely fashion.
TopAdverse Events from Exercise Testing
The following protocol should be used by all UIUC researchers for categorizing and reporting adverse outcomes resulting from exercise testing:
- Qualified, attending medical personnel will categorize
the test outcomes (including posttest events) as one of
the following, using the criteria
that follow:
- Benign events that fall within the "normal" set of outcomes for the tests;
- "Abnormal" outcomes that do not, by themselves, warrant termination of the test and that do not cause the subject to stop the test or complain; or
- Adverse Events or Serious Adverse Events that are not "normal" outcomes, that warrant termination of the test, or that cause the subject to complain or terminate the test of their own volition.
- In Type III events, the test will be immediately terminated and the subject attended. As needed, this could include on-site medical treatment, referral to hospital for immediate follow-up care, or call for Emergency Medical Services (EMS), transport to hospital, and emergency treatment. Except where EMS are involved, the subject will be asked to stay at the testing lab for observation for at least half an hour after his or her condition is stable.
- In all Type III cases, the research staff will attempt to contact the subjects' personal physician (or the person covering his or her practice, as available) by phone, to apprise him or her of the test outcome and the treatment given. Except where EMS are involved, this first phone call will be made after the subject is stable and before the subject leaves the testing lab. If no person-to-person contact can be made with the subject's physician (or their substitute) within this time frame, this fact will be documented and repeated attempts will be made and documented until contact is made.
- Within 48 hours of the test, for both Type II and III events, the outcomes, treatments, and documentation of phone calls and other correspondence (e.g., with EMS) will be described in a written report to the subject's personal physician in a recorded delivery letter, copied to the subject.
- All Type III events must be reported to the IRB Office by phone or e-mail (217.333.2670; irb@illinois.edu) within 24 hours of the event and described on an Adverse Events form (with physician reports attached) that is submitted within 5 days of the event.
- The number of Type II and III events should be reported by the Responsible Project Investigator (RPI) in every project's renewal report for continuing review.
Type II Indications—"Abnormal" outcomes that do not, by themselves, warrant terminating the exercise test
- Occasional premature beats at rest and which are more frequent with exercise, or the appearance of a new but nonsustained arrhythmia.
Type III Indications—Adverse Events or Serious Adverse Events that should result in terminating the exercise test*
Absolute Indications
- Drop in systolic blood pressure of 10 mm Hg or more from baseline blood pressure despite an increase in workload, when accompanied by other evidence of ischemia
- Moderate to severe angina
- Increasing nervous system symptoms (e.g., ataxia, dizziness, or near syncope)
- Signs of poor perfusion (cyanosis or pallor)
- Technical difficulties monitoring the ECG or systolic blood pressure
- Subject's desire to stop
- Sustained ventricular tachycardia
- ST elevation (1.0 mm Hg or more) in lead without diagnostic Q-waves (other than V1 or a VR)
Relative Indications
- Drop in systolic blood pressure of 10 mm Hg or more from baseline blood pressure despite an increase in workload, in the absence of other evidence of ischemia
- ST or QRS changes such as excessive ST depression (>2 mm horizontal or downsloping ST-segment depression) or marked axis shift
- Arrhythmia other than sustained ventricular tachycardia, including multifocal PVCs, triplets of PVCs, supraventricular tachycardia, hear block or bradyarrhythmia
- Fatigue, shortness of breath, wheezing, leg cramps, or claudication
- Development of bundle-branch block or intraventricular conduction delay that cannot be distinguished from ventricular tachycardia
- Increasing chest pain
- Hypertensive response (systolic bp of more than 250 mm Hg and/or a diastolic BP of more than 115 mm Hg
* From ACSM's Guidelines for Exercise Testing and Prescription, 6th edition
Summary of Exercise Test Reporting Protocol
| Event Type | Description | Research Team Action | Report to Subject's MD | Report to IRB |
|
I |
Benign events that fall within the
"normal" set of outcomes for the tests |
Continue tests as planned |
Send First Class letter within 48 hours
of test |
In aggregate in renewal report |
| II | "Abnormal" outcomes that
do not, by themselves, warrant termination of the test
and that do not cause the subject to stop the test or
complain |
Continue tests as planned, observe subject for 30 more minutes | Send Recorded Delivery letter within 48 hours of test | In aggregate once per month and in renewal report |
| III |
Adverse Events or Serious Adverse Events that are not "normal" outcomes, that warrant termination of the test, or that cause the subject to complain or terminate the test of their own volition |
Stop tests, observe subject for 30 more minutes after stable, attend or call EMS as needed | Call patient's personal
MD after patient is stable and before subject leaves testing
lab (except in EMS cases), or make repeated attempts until
person-to-person contact is made; and send Recorded Delivery
letter within 48 hours of test |
By phone within 24 hours, on Adverse Event form within 5 days of event, and in aggregate in renewal report |