Committee on Human Rights in Research

	Adverse Events

Adverse Event Reporting Form Adobe PDF | Microsoft Word Adverse Event & IND Safety Reporting Table Adobe PDF | Microsoft Word

Definition of Adverse Event

An adverse event (AE) is defined as any occurrence that has unfavorable and/or unintended effects on research subjects, regardless of severity or study-relatedness. AEs may manifest as new findings (signs, symptoms, diagnoses, laboratory results) or alterations in pre-existing conditions. AEs must be monitored throughout the entire course of a study, as well as during a reasonable follow-up period after study completion.


Definition of Serious Adverse Events and Unexpected Adverse Events

1. Serious Adverse Events include death, life threatening adverse experiences, hospitalization or prolongation of hospitalization, disability or incapacitation, overdose, congenital anomalies and any other serious events that may jeopardize the subject or require medical or surgical intervention to prevent one of the outcomes listed in this definition.
2. Unexpected Adverse Events are occurrences that were not anticipated as risks in the IRB-approved protocol and consent form, or occur at a greater frequency or intensity than anticipated. It is the responsibility of investigators involved in multicenter protocols to report any serious and/or unexpected AEs (as defined above) in subjects at other sites to the NYPH-WMC IRB within 30 working days of their own notification.

Reporting Obligations:
Investigators must notify the NYPH-WMC IRB in writing within 5 working days of the occurrence of all serious and/or unexpected adverse events (AEs) in NYPH-WMC research subjects, whether or not the events are considered study-related. A summary table of serious and/or unexpected adverse events MUST accompany each report.

All serious and/or unexpected adverse events that warrant reporting by the above definitions must also be summarized in the Continuing Review. The Continuing Review should contain an assessment of any AEs reported by the investigator to the FDA and other regulatory agencies since the time of the last review, whether or not the events were considered serious or unexpected at the time of their occurrence. In some circumstances, investigators may petition the IRB for an exemption from the routine reporting of specific adverse events. Exemptions may be granted from the reporting of events that would otherwise be considered serious, if they can be shown to be frequent and expected occurrences in the population under study.

For example:
Febrile neutropenia, bacteremia or fungemia occurs frequently in subjects receiving myelosuppressive chemotherapy. An investigator working with this population may be granted exemption from the routine reporting of these events, but would still be expected to report any accompanying dire complications, such as septic shock.


Exemptions may also be granted for serious events that are highly unlikely to be study-related by their nature and/or by the nature of the study.

For example:
Patients with brittle diabetes may experience frequent episodes of hyperglycemia. An investigator who is drawing blood once in order to study the genetics of diabetes may apply for exemption from reporting hyperglycemic episodes based on their expected frequency of occurrence, and the improbability that hyperglycemia would be study-related.


Exemptions from adverse event reporting must be requested prospectively in writing and apply only to the specific protocol for which the application is made. Exemptions are granted at the discretion of the IRB, and may be withdrawn by the IRB without explanation or opportunity for appeal.

Contact

IRB Adverse Events Administrative Aide
Office of Research and Sponsored Programs
Weill Cornell Medical College
1300 York Avenue, Box 5
New York, NY 10065

Email:
irb@med.cornell.edu

Telephone:
(212) 821-0656, 0577
Fax: (212) 821-0660