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Maintaining :: Undesirable events

Undesirable Events

Unexpected and undesirable events are inherent to scientific study; if we could predict outcomes perfectly, why bother conducting studies? While the IRB expects you to provide as much information as is possible about potential harms to participants and to conduct your study such that participants will be protected from those harms, the possibility for harm is still there. When something goes awry, you should record the event and you may be obligated to report the incident to our office, and we may be obligated to report the incident to the Office of Human Research Participants (OHRP). The purpose of this reporting chain is not meant to be punitive but instead to re-evaluate the protocol and determine if risk levels in the protocol need adjusting and participants need additional disclosure. This section will describe specific scenarios in which these incidents occur, define the procedure for submitting an incident report, and outline the procedures following a report submission.

Section Topics

Reporting Requirements
Reporting Procedure

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