Informed Consent - Module 4m Sec 3

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Module 4 Objectives
Continuing Review
Unanticipated Developments
Adverse Events
Consent Document Revisions
Quiz

Adverse Events

T
he unfolding of adverse events is a serious and important development. Adverse events are unexpected problems whose nature, severity, or frequency are not described accurately in the study protocol. It is the researcher’s responsibility to analyze the impact of an adverse event. Is this an isolated event or is it more common? Does this event have severe consequences or is the outcome unaffected? What is the appropriate ethical action to be taken?

Incidents where subjects have been seriously harmed should be reported to the IRB immediately. The IRB should always be informed of any problems or accidents in the study. The death of a participant, whether related to the study or not, should also be reported to the IRB immediately.

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