Report an Event

Contents

• Reportable events
• Deviations
• Reporting Timeline

Background

The primary purpose of IRB review is to assure the protection of the rights and welfare of the human subjects. In order to fulfill its obligations during the conduct of a research study, an IRB must have, among other things, information concerning unanticipated problems involving risk to human subjects in the study.

What is a Reportable Event?

A Reportable Event is any incident, experience or outcome that meets all of the following criteria:

1. Unexpected (in terms of nature, severity, or frequency) given (a) the research procedures that are described in the IRB-approved documents, such as the protocol and informed consent document; and (b) the characteristics of the subject population being studied;
2. Related or possibly related to participation in the research (possibly related means there is a reasonable possibility that the incident, experience, or outcome may have been caused by the procedures involved in the research); and
3. Suggests that the research places subjects or others at a greater risk of harm (including physical, psychological, economic, or social harm) than was previously known or recognized.

Reportable Events must be reported promptly to the IRB.

What is the difference between a Reportable Event and an Adverse Event?

The CU-Boulder IRB defines an adverse event as any unfavorable and unintended sign, symptom, or disease that is temporally associated with research participation, whether or not it is considered related to the research participation. Adverse events encompass both physical and psychological harms.

Only some adverse events are Reportable Events. Most adverse events that occur in the context of research are expected. The known or foreseeable risk of adverse events associated with the research are described in the IRB-approved documents. If a subject has an adverse event that is consistent with those described in the documents - in nature, severity, and frequency - then the adverse event is not a Reportable Event. However, if a subject has an adverse event that is not described in the documents, or is of a greater severity than those described in the document, then that would be a Reportable Event.

To determine whether an adverse event must be reported to the IRB promptly, the following questions should be asked:

1. Is the adverse event unexpected? Unexpected refers to the nature, severity and/or frequency of the event.
2. Is the adverse event related or possibly related to participation in the research?
3. Does the adverse event suggest that the research places participants or others at a greater risk of harm than was previously known or recognized?

If the answer to all three questions is yes, then the adverse event is also a Reportable Event.

Adverse events that are not Reportable Events must be reported to the IRB at continuing review, using the Continuing Review eForm. At that time, the IRB will consider all events together, to determine if changes to the research plan or consent form should be made.

What are some examples of Reportable Events?

1. Breach of privacy or confidentiality.
2. Loss of study records.
3. Higher than expected volume/frequency of adverse events.
4. An adverse event of greater severity/magnitude than expected.
5. Higher than expected volume/frequency of protocol deviations.
6. Higher than expected drop-out rate.
7. New information that indicates a change to the risks or potential benefits of the research, such as:

• An interim analysis or safety monitoring report indicates that frequency or magnitude of harms or benefits may be different than initially presented to the IRB.
• A paper is published from another study that shows that the risks or potential benefits of the research may be different than initially presented to the IRB.

What is a Deviation?

A protocol deviation is any change, divergence, or departure from the study design or procedures of a research protocol that has not been approved by the IRB. If a protocol deviation:

• harmed participants or others,
• indicates participants or others may be at increased risk of harm,
• could adversely affect the safety or welfare of participants,
• compromises the integrity of the research data, or
• was made to the research without prior IRB approval in order to eliminate apparent immediate harm,

then the deviation it must be reported to the IRB promptly.

Deviations that do not meet these criteria should be reported at continuing review, using the Continuing Review eForm. When in doubt, it is better to submit a Deviation eForm, allowing the IRB to make the determination rather than failing to submit a report that should have been submitted.

• Note: A "planned" protocol deviation is considered to be an amendment. If you plan to deviate from your approved protocol, you must submit an amendment for IRB approval prior to implementation.

What are some examples of Deviations that must be reported at Continuing Review?

Deviations that pose no conceivable threat to participant safety or scientific integrity should be reported at continuing review, using the Continuing Review eForm. Examples of such deviations include:

1. A participant misses a clinic visit and the only available re-schedule date is slightly outside the study visit window (no study procedures or medication doses are missed).
2. Participant fails to initial every page of the consent form.
3. Missing original signed consent, but have a copy of the participant signed consent.
4. Participant fails to return physical activity diary.

Within what time period should Reportable Events and Deviations be submitted to the IRB?

The deadline for reporting begins when the PI learns of the event. The reporting may occur at one of the following times:

1. Immediately (within 24 hours) upon learning of a study-related death, study personnel will notify the IRB via e-mail by providing a brief summary of the event. Then, within 1 week (five business days), the PI or designee will submit a Reportable Event in eRA.
2. For any other problem or event requiring reporting to the IRB, the PI or designee will submit to the IRB a Reportable Event or Deviation in eRA as soon as possible, but no later than 10 working days from notification of event.

Note: This is a different obligation to report from that outlined in the contract or grant between the PI and the sponsor. The PI and/or sponsor will also have different reporting requirements for the FDA.

How do I submit a Reportable Event to the IRB?

PIs or their designee should report the event via eRA. To create the Reportable Event submission, go to the Submissions page for the protocol. Choose "Reportable Event" from the dropdown. Click the Add New button. Complete the eForm and submit for review.

How do I submit a Deviation to the IRB?

PIs or their designee should report the event via eRA. To create the Deviation submission, go to the Submissions page for the protocol. Choose "Deviation" from the dropdown. Click the Add New button. Complete the eForm and submit for review.