General Information
About the UAMS IRB
UAMS
IRB Contacts
UAMS
Research News
UAMS

For Researchers
Submissions
UAMS
Forms
UAMS
Reference Materials
UAMS
Policies
UAMS
Reporting Events and Deviations
UAMS
Federal Regulations
UAMS
Federalwide Assurance
UAMS
Fees
UAMS
Compliance Statement
UAMS
Online Resources
UAMS
Educational Resources
UAMS

 
How to Find Our Office
Information That Must Be Reported to the IRB

The UAMS IRB is changing the way it accepts and reviews reports of some study events. These changes are intended to allow for more efficient and meaningful reviews of incidents that may pose a risk to research subjects or others involved in research. IRB Policy 10.2 summarizes these reporting requirements.

Only events that are unexpected, are related to the research, and involve new or increased risks to subjects or others need to be reported promptly. Reportable events that result in death or that are life-threatening should be reported immediately to the IRB office or to an IRB chair. Other events that meet these three criteria are to be reported within 10 days. Events that don't meet these three criteria should be summarized and reported at continuing review.

The UAMS IRB now has tools available on its Web site to help research teams handle event reports. The Events and Deviations Tables is a tracking tool researcher teams can use throughout the year to document events as they occur. Note that there are two worksheets in this Excel workbook, one for events, such as adverse events, and one for protocol deviations/violations. The IRB strongly recommends that teams keep a running list all year long of these events, rather than trying to compile them at the last minute just before continuing review is due. 

The Continuing Review Assessment Form is designed to prompt the research team to assess all listed events to see if they indicate an increased risk or a need to amend study procedures. Investigators will be required to complete these questions at continuing review if they are submitting a separate list of events.

The Memo regarding IND Safety Reporting can be shown to study sponsors to advise them of the UAMS IRB's reporting expectations. Some sponsors may ask that all safety reports be submitted right away even if they do not meet the criteria for immediate reporting. The memo describes the IRB policy and associated regulatory requirements. 

The UAMS IRB has held classes regarding the updated reporting policy. A video of one class can be found here.
 

Back to IRB Home