Reportable Events

In the course of working on a protocol, and most typically during Continuation Reviews or Post-Approval Monitoring, a researcher or reviewer might discover activities that were performed that were not in line with the expectations established under the approved protocol. It may also be the case that an activity was supposed to occur, per the approved protocol, and did not take place. In those cases, a researcher or reviewer has discovered a Reportable Event.

There are five types of Reportable Events. This page helps staff and faculty in identifying, reporting, and processing each kind of Reportable Event. Select an event from the menu to learn how it is defined, and how it gets processed.

Deviations

Deviations are the most common type of Reportable Event. A Deviation is a notable variance from the procedures, processes, and/or activities associated with an approved or exempted protocol which does not indicate the existence of previously unknown or unapproved risks to participants. An easy way to think about whether something is a Deviation is to consider whether it would have been approved as an amendment if it had been submitted before its occurrence. Examples of common deviations include:

• Adding CITI-trained research staff to the study team absent IRB approval for their addition
• Recruiting participants above the +15% threshold of the approved numbers of participants, with appropriate justification relative to the study aims
• Utilizing recruitment materials that changed compensation from $5 (the approved materials’ amount) to $15 (unapproved, but used, materials’ amount) for study participation lasting no more than an hour

When a Deviation is identified by a member of the IRB, the IRB member should request a Reportable Events submission from the Principal Investigator of the study. When a member of the study staff discovers a Deviation, they should submit a Reportable Events submission for processing.

Reportable Events submissions are processed by the first HRP Analyst to receive the form. It is reviewed for accuracy, and sent to the HRP Director, Chair, or to the Institutional Official (in that order of availability). If the report represents variances that are more than a Deviation (those categories are defined in the next tabs), the report will be forwarded on to the IRB Chair for a determination regarding next steps. In general, when the Reportable Event is a Deviation, the Report Form is simply made available to the IRB for notice & comment at the next scheduled meeting. Once the IRB has had an opportunity for notice and comment, the Reportable Event submission is filed to the appropriate protocol file. If any follow up is needed, the HRP Office will reach out to the study team.

Unanticipated Adverse Events

Occasionally, an Unanticipated Adverse Event (UAE) or Unanticipated Adverse Problem (UAP) occurs during the conduct of research. These UAEs are identifiable by the following three criteria, all of which must be met:

1. The event was unanticipated, meaning that the nature, severity, or frequency of the event is not consistent with the determinations and approvals in place at the time that the IRB approved it;
2. The event was adverse, meaning that the event was an untoward or unfavorable occurrence for one of your participants, including abnormal signs, symptoms, or outcomes.
3. The event is related or possibly related to participation in the study.

Unanticipated Adverse Events need to be reported to the IRB as soon as is feasible. The first question the IRB Chair must address is whether the UAE constitutes a “serious” UAE. An Unanticipated Adverse Event is serious if it results in any of the following:

• Death
• Places participants at immediate risk of death
• Hospitalization;
• A persistent or significant disability/incapacity;
• A congenital anomaly or birth defect;
• Significant distress or anxiety; or
• May jeopardize the participant’s health and require further intervention to prevent one of the other outcomes listed here.

Serious UAEs require the Convened IRB to reconsider the protocol’s risks. If the IRB Chair determines that the UAE is not serious, they must next determine whether the UAE suggests that the risks of participation are greater than were previously known. Generally, the IRB Chair will consult with another IRB member or colleague with relevant scientific expertise in order to make that determination. It is not unusual for a study to be paused while the IRB Chair consults with the appropriate personnel to render this determination.

Finally, the IRB Chair may implement interim measures regarding the study, in order to minimize the occurrence of future Unanticipated Adverse Events. The UAE/UAP, along with all of the steps implemented by the IRB Chair and consultants, will be reported to the Convened IRB for further consideration at its next available meeting.

Noncompliance

Noncompliance is a failure (whether intentional or unintentional) to comply with applicable federal, state, or local laws or regulations; requirements or determinations of the IRB; or university policy regarding research involving human human subjects. Noncompliance can be an action or an omission.

Any type of reportable event could constitute Noncompliance, but in most cases, the reportable event is disposed of via the processes outlined above. If the reportable event cannot be processed via the Deviation or Unanticipated Adverse Event processes, it will be processed as Noncompliance.

There are two avenues for processing Noncompliance, and the process undertaken depends on whether the Noncompliance is initially considered to be serious or continuing.

Serious Noncompliance is any noncompliance which, in the judgment of the IRB, places human subjects at elevated or unreasonable risk; decreases potential benefits to participants; jeopardizes the safety, welfare, or rights of research participants or others; compromises a research participant’s ability to render informed consent; or compromises integrity of the human research protection program.

Continuing Noncompliance is any action or omission which, in the judgment of the IRB Chair or Convened IRB, demonstrates a pattern of noncompliance over time and/or across research projects. Such a pattern suggests that the likelihood of noncompliance will continue without intervention.

If the Noncompliance is minor (i.e. not serious or continuing), it is processed by the IRB Chair or the Institutional Official. An abbreviated investigation will take place, findings will be reported to the IRB Chair or IO, and that HRP leader will design a Corrective Action Plan.

If the Noncompliance is Serious or Continuing, an investigation will take place, and findings are submitted to the Convened IRB for consideration. The Convened IRB will render a final determination regarding the Serious or Continuing nature of the Noncompliance, and also designate a Corrective Action Plan. Serious or Continuing Noncompliance requires notification of the Noncompliance to institutional leaders, sponsors, and other parties as deemed relevant by the Convened IRB.

Out of Compliance

A protocol is out of compliance when a passive lapse, which can be easily corrected, has been discovered. For a protocol to be out of compliance rather than noncompliant, that lapse must not impact the rights or welfare of research participants or any of the approval criteria previously documented by the IRB. 

A protocol that is out of compliance may remain that way for five business days, or a shorter timeframe if the HRP Director determines that a shorter timeframe for correction is warranted. Documentation regarding the correction of the lapse must be provided to the HRP Office no later than five business days from its discovery, or the event will move into the Noncompliance processing steps. 

Examples of an out of compliance scenario include:
- Lapse in CITI Training by one of the study team members in a minimal risk protocol where the person whose training has lapsed has not interacted with research participants or their identifiable information since the training expiration occurred;
- Research data remaining on a personal device after it has been copied to an approved long-term storage device, where no breach in confidentiality has occurred; or
- Failure to remove a research assistant whose information was not on recruitment or informed consent material and who recently stopped working on the project. 

Several lapses in this category could amount to Noncompliance, if the lapses demonstrate a pattern of ineffective oversight. However, this category was created primarily to assist researchers in bringing protocols back into compliance quickly when minor issues are discovered, as often happens in the realities of the research environment.