How to Report an Adverse Event

Adverse Events in Human Subjects Research   

Adverse events in the context of human subjects research encompass a wide range of unexpected occurrences, from medical complications and adverse reactions to interventions to breaches of confidentiality. Recognizing and reporting these events is not just best practice; its a fundamental ethical and regulatory responsibility shared by researchers and their respective institutions.    

Researchers, as stewards of scientific inquiry, have an ethical duty to protect the rights, safety, and dignity of research participants. This includes identifying and reporting any event that may cause harm or discomfort to a participant, no matter how seemingly minor. Transparency and commitment to participant well-being underscore the ethical principles of beneficence and respect for persons, as articulated in the Belmont Report.    

Furthermore, regulatory bodies and oversight agencies, such as Institutional Review Boards (IRBs), the Food and Drug Administration (FDA), and the National Institutes of Health (NIH), have established strict guidelines and requirements for reporting adverse events in human subjects research. Compliance with these regulations is not merely a matter of protocol, it's a legal obligation.    

The significance of adverse event reporting lies in its potential to mitigate harm, inform future research endeavors, and uphold the trust of research participants and the public. By promptly identifying and addressing adverse events, researchers and institutions contribute to the continuous improvement of research practices and ensure the credibility and integrity of the research enterprise.    

• This page serves as a guide to researchers and research staff, providing essential information on how to recognize, document, and report adverse events in human subjects research. It underscores our collective commitment to the ethical conduct of research, the welfare of participants, and the advancement of knowledge for the betterment of society.    

An adverse event is any untoward or undesirable occurrence or experience that a research participant encounters during the course of a research study. Adverse events can vary in severity, ranging from mild discomfort or inconvenience to serious harm or injury.  Adverse events are undesirable, harmful or detrimental to a research participant's physical, psychological, or social well-being.  They can result from various factors, including the research intervention or study procedures, an underlying medical condition, or unrelated circumstances. Adverse events include both known risks associated with the research and unexpected events that were not previously anticipated or disclosed in the informed consent process.    

Adverse Event Examples:  

• Mild - temporary discomfort or inconvenience that does not cause lasting harm, such as minor bruising at an injection site after receiving a vaccine.  
• Moderate - events that may require medical attention but are not life-threatening, such as nausea or a headache.  
• Severe - serious events that pose a threat to the participant's life, health, or well-being, such as an allergic reaction (anaphylaxis) to an investigational drug or a heart attack during a stress test. 
• Social Adverse Event - events that impact a participant's social well-being or relationships, such as loss of employment due to a research-related illness or breach of confidentiality leading to privacy concerns.  
• Unanticipated Event - any event that was not foreseen or disclosed in the informed consent process that is not a known risk associated with the research. For example, the unexpected discovery of a previously unknown side effect of a drug being studied.  
• Non-Compliance Event - an event involving a breach of the study protocol or deviations from the approved research procedures, such as a participant not following medication instructions or a researcher not adhering to data collection protocols.  
• Loss of Data or Confidentiality - events that compromise the security or confidentiality of participant data, such as a data breach, unauthorized access to research records or the accidental release of identifying information.  
• Withdrawal Due to Adverse Event - instances where a participant chooses to withdraw from the study due to an adverse event, even if the event is not severe.    

Reporting the Adverse Event:    

1. Promptly notify the PI or responsible investigator leading the study.  
2. Use the Reporting Adverse Events Form to document all relevant details about the adverse event, including the date, time, location, individuals involved, and any immediate actions taken.  
3. Assess the severity and immediacy of the adverse event to determine the appropriate course of action. Is immediate medical attention needed? Or access to community mental health counseling resources?  
4. Provide appropriate care or medical attention to the affected participant if the event warrants immediate intervention.  
5. Report the event to the IRB by completing and submitting the Adverse Event Report Form. Remember to include a detailed description of the adverse event, its potential causes, and any actions taken to mitigate them. Submit the Adverse Event Report Form to irb_chair@utpb.edu. 

Timelines for Reporting Adverse Events:  

1. Immediate Reporting: Serious and unexpected adverse events that pose an immediate threat to the safety or well-being of research participants, such as life-threatening reactions or events requiring hospitalization, should be reported to the IRB immediately. In many cases, this means reporting within 24 hours of becoming aware of the event. 
2. Prompt Reporting: Adverse events that are unexpected and potentially serious but do not require immediate action should be reported to the IRB promptly. The specific definition of "prompt" reporting can vary but is generally within 5-10 business days. 
3. Regular Reporting: For adverse events that are expected, mild to moderate in severity, or not immediately serious, report these events on a regular schedule, such as during routine progress reports, continuing reviews, or at intervals specified by the IRB. 

Please note: After the initial report of an adverse event, you or your study team may be required to provide follow-up information to the IRB, such as additional details, participant outcomes, or corrective actions taken.    

You will receive confirmation of your adverse event report from the IRB Chair.  

Adverse Event Report Steps:  

1. IRB will review the adverse events report to assess its nature, severity, and potential relationship to the research. The IRB will consider whether the event was expected or unexpected and whether it poses immediate risks to participant safety. Adverse events will be classified as:  
   • Serious and Unexpected - events that are severe, unexpected, and may be related to the research.  
   • Serious but Expected - events that are severe but were previously known risks associated with the research.  
   • Non-serious and Unexpected - events that are not severe but were not anticipated.  
   • Non-Serious and Expected - events that are not severe and were known risks associated with the research. 
2. The IRB will recommend immediate actions to the PI, such as halting the study or taking other immediate actions to protect participants.  
3. The IRB may request additional information or clarification from the researcher or study team regarding the adverse event, including investigational product details or other relevant documentation.  
4. The IRB will convene a meeting to conduct an ethical review of the adverse event. During this review, the IRB will consider factors such as participant welfare, risks and benefits of the researcher, and the appropriateness of any actions taken in response to the event. The IRB will also assess whether there is a reasonable possibility that the adverse event was caused by the research intervention or procedures. 
5.  Based on its review, the IRB will provide recommendations or actions to address the adverse event. These actions may include:  
   • Continuation of the study with modifications. 
   • Temporary or permanent suspension of the study.  
   • Revision of the informed consent process or documentation.  
   • Changes to the study protocol or procedures.  
   • Additional monitoring or safety measures. 
6. The IRB will then communicate its decisions and recommendations to the researchers or study team promptly and provide guidance on any required actions.  
7. If required by applicable regulations or guidelines, IRB may report certain adverse events to regulatory authorities, such as the FDA or other relevant agencies.  
8. The IRB may continue to monitor the study and the resolution of the adverse event, ensuring that any necessary corrective actions are taken and that participant safety remains a priority.  

Adverse Events Reporting Form