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This page includes information about the requirements for reporting unanticipated problems and noncompliance.
|Type of Unanticipated Problem
||Which Form(s) Must Be Submitted to the IRB?
|Adverse Biomedical Event||Submit the Reportable New Information Supplement|
|Other Unanticipated Problems
(such as breach of confidentiality, a study participant complaint, changes made to the research without prior IRB approval to eliminate apparent hazard to participants)
|Submit the Reportable New Information Supplement|
|Third Party Safety Reports satisfying the Expedited Reporting Requirement||Submit the Reportable New Information Supplement|
|Third Party Safety Reports not satisfying the
Expedited Reporting Requirement but the
Sponsor requires the reporting of these
events to the IRB
|Submit the Reportable New Information Supplement|
When, in the opinion of the principal investigator, or PI, any adverse event meets all three of the following criteria, whether they occur on- or off-site, they must be submitted to the IRB within 10 calendar days.
Unexpected: An adverse event is unexpected when its nature (specificity), severity or frequency are not consistent with (a) the known or foreseeable risk of adverse events associated with the research procedures described in the protocol-related documents, such as the IRB-approved research protocol, informed consent document and other relevant sources of information such as product labeling and package inserts; and are also not consistent with (b) the characteristics of the subject population being studied, including the expected natural progression of any underlying disease, disorder or condition, or any predisposing risk-factor profile for the adverse event.
Related or possibly related to the research: An adverse event is related or possibly related to research procedures if, in the opinion of the PI, it was more likely than not caused by the research procedures. Adverse events that are solely caused by an underlying disease, disorder or condition or by other circumstances unrelated to the research or any underlying disease, disorder or condition are not "related or possibly related." If there is any question whether an adverse event is related or possibly related to the research, report the adverse event.
Serious: An adverse event is serious when it results in any of the following outcomes: death, risk of death, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant disability/incapacity/or change in psychosocial status, a congenital anomaly or the requirement of an intervention to prevent permanent impairment or damage.
Other unexpected problems, events, or new information which indicates research participants or others are at greater risk of harm must be submitted to the IRB within 10 calendar days.
The following are a few examples of this criteria:
The PI is responsible for assessing whether the adverse event(s) described in Third Party Safety Report(s) satisfies the expedited reporting requirement. In other words, the adverse event(s) must be unexpected, related or possibly related to the research, and serious or suggest that the research places research participants or others at a greater risk of physical or psychological harm than was previously known or recognized. Adverse events that meet these criteria must be submitted to the IRB within 10 calendar days.
If a Third Party Safety Report does not satisfy the expedited reporting requirement but the sponsor of the study requires the reporting of these events to the IRB, complete the following steps:
If the research study is permanently closed to local accrual and there are no local participants receiving interventions or long-term follow-up, then adverse events described in third party safety reports do not need to be evaluated by the PI or submitted to the IRB.
PIs and their study staff members are required to report each event of serious or continuing noncompliance relating to human subjects research that they are conducting within 10 calendar days of learning of the event.
The following noncompliance items must be reported within 10 calendar days to the IRB:
Examples of continuing noncompliance which should be reported promptly to the IRB:
The IRB will determine if the event constitutes serious or continuing noncompliance.
NOTE: Noncompliance does not include protocol deviations that are beyond the control of the principal investigator and his or her study staff (e.g., delays caused by weather or by the acts or omissions of third parties such as outside labs). However, this type of protocol deviation may constitute an unanticipated problem involving risks to research subjects or others reportable under IRB Policy 2.6 Unanticipated Problems Involving Risks to Subjects or Others.
IRB staff monitors timely reporting of adverse events. Investigators are accountable for timely reporting of unexpected and related adverse events.
Notification of the suspension will be forwarded to the appropriate division director as well as the president and director of Fred Hutch and appropriate regulatory agencies.
The occurrence of one or more of the following events in connection with any study in which Fred Hutch is enrolling research subjects or is a participating site must be reported to the IRB as soon as possible but no later than 10 calendar days after the investigator or study staff learn of the event. The following events should be reported with a Modification Supplement (see Modifications for further guidance and forms):