Mount Carmel Health System

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Adverse Events

Review of Reports of On-Site Unanticipated Problems or Adverse Events

Investigators will notify the IRB promptly of any unanticipated problems involving risks to subjects or others that occur in research conducted under the purview of the IRB.

Investigators are also required to report promptly to the IRB any adverse event that is reported to the FDA or to the sponsor in accordance with FDA requirements.

The IRB should receive the completed Serious Adverse Event Report Form from the investigator within 5 working days of knowledge of the event. Deaths must be reported promptly. (Promptly usually means within one day of the knowledge of the death.)

All such reports are reviewed by the IRB. During the convened review, the IRB determines whether the research will be permitted to continue as proposed or whether changes are required. If the research will continue, the IRB also determines whether a consent form revision is required and to what extent re-consenting and/or subject notification about new information is warranted. The Committee has the authority to suspend the research if it has significant safety or other concerns.

Regardless of the type of review (expedited or convened), the investigator is notified in writing of the IRB's determinations, even if no further action is necessary on his/her part.

It is the responsibility of the IRB Chairperson to provide prompt written notification to MCHS's CEO or designee of his choosing and to relevant Federal Agencies, including OHRP and FDA (for FDA-regulated research) of any unanticipated problems involving risks to subjects or others, and of the resolution of those problems.

Review of Sponsor or Cooperative Group Adverse Events/IND Safety Reports

Investigators are required to forward adverse event/IND safety reports issued by sponsors or cooperative groups to the IRB within 15 working days of receipt. Each report should be accompanied by the completed Serious Adverse Event Report Form. Multiple reports for a single study may be grouped together on a spreadsheet and attached to the Serious Adverse Event Report Form.

The IRB may review the serious adverse events/IND safety report forms via expedited or full board review, depending on the severity and nature of the event being reported. Regardless of the type of review (expedited or convened), the investigator is notified in writing of the IRB's determinations, even if no further action is necessary on his/her part.

Review of Data and Safety Monitoring Board (DSMB) Reports

Investigators are required to forward DSMB reports to the IRB within 15 working days of receipt.

The IRB may review the DSMB reports via expedited or full board review, depending on the severity and nature of the event being reported. Regardless of the type of review (expedited or convened), the investigator is notified in writing of the IRB's determinations, even if no further action is necessary on his/her part.

When DSMBs are employed, the IRB conducting continuing review of research may rely on a current statement from the DSMB indicating that it has reviewed study-wide adverse events, interim findings, and any recent literature relevant to the research. Of course, the IRB must still receive and review reports of local, on-site, unanticipated problems involving risks to subjects or others, and any other information needed to make its continuing review substantive and meaningful.

©  2014  

Mount Carmel Health System  |  Columbus, Ohio

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