What is an adverse event?
An adverse event is any injury, problem, or unfavorable occurrence experienced by human participants or others during conduct of research activities. Adverse events may or may not be caused by the research protocol. They are recognized as occurring in the same span of time with the research. For example, if a participant were to trip and skin her knee walking into the protocol space, this would be an adverse event that is associated with the research (the participant would not have been in the room if not for the research activity) but not caused by it. An adverse event may be anticipated and thus listed in the risks section of your protocol. If it is not included in the risk section of your protocol, it would be considered unanticipated.
Unanticipated Problems should meet the following 3 criteria:
- Must be unexpected in terms of nature, severity, or frequency. (e.g. if your protocol lists headache witha duration of 1 hour or less, but the subject complains of a headache for 3 hours, this would be considered unanticipated)
- Must be related or possibly related to the participation in research
- May suggest the research places subjects or other persons at a greater risk of harm then previously recognized
The following are potential examples of unanticipated problems:verbal or written participant complaint that goes beyond the risks stated in your protocol
- including a participant that does not fit within your inclusion criteria (i.e. above or below your age range)
- laptop with participant data stolen or lost
- participant suffers a mild to severe physical reaction due to participation in research that goes beyond the risks stated in your protocol
- participant tripping and getting hurt in the data collection location
- Changes made to the research without prior IRB approval in order to eliminate apparent immediate harm.
- Any unplanned change to the research protocol or plan taken without prior IRB review
Investigators must report to the IRB Chair any injury or unanticipated problems within 72 hours of its occurrence.
When should I report an Unanticipated Problem or Injury?
Investigators must report to the IRB unanticipated problems that occur in relation to the research study within 3 days of its occurrence, including: complaints received from a research participant, parent, or guardian; incidents involving physical, psychological, or social harm to participants, breaches of confidentiality, and other incidents that meet the three criteria for unanticipated problems. If you are not sure whether an event qualifies as a reportable event, it is recommended that you report it.
Please review our policies and procedures for more details.
All adverse events are reported through the iMedris system.
Investigators should use their best judgment regarding the nature and degree of a reportable injury. In general, anything serious enough to warrant medical or psychiatric intervention is reportable. Also reportable are verbal or written complaints from subjects in which they proclaim that participation presents substantial discomfort, risk, and/or endangerment beyond that explained to them or as otherwise stated in the consent form. Additionally, any events that suggest a change in the research protocol to better protect participants from risks are reportable.
What do I do if we receive a subject complaint?
Investigators or research staff must report to the IRB, any complaints received from a research participant, parent, or guardian within 3 days of its occurrence. The IRB Chair will track receipt of any complaints and follow-up with any necessary mitigation.
The IRB Chair will contact the PI in response to a research participant’s concern. The PI is required to respond to that request at the first possible opportunity and address the questions posed by the IRB Chair. If an amendment to the protocol or consent form is required, the PI must submit this amendment with the appropriate amendment application through iMedris to the IRB within 7 working days.
A summary of all subject complaints and any repeated non-compliance will be reported to the full IRB committee at the regularly scheduled meetings. The IRB committee will consider any repeated non-compliance as a serious matter and may consider a vote to suspend the IRB approval of research in accordance with 45 CFR 46.113.
What happens after I submit an Unanticipated Adverse Event or Injury?
The IRB Chair will track receipt of any submission and follow up with the IRB Committee on any necessary mitigation. You should expect a response from the IRB within 72 hours or less. The response may include a request for more information or a suggested amendment to your protocol.
TCNJ’s Research Misconduct Policy promotes compliance with federal requirements (42 CFR Part 93) for reporting scientific misconduct investigations and adopting institutional actions in response to findings of scientific misconduct. Please refer to TCNJ’s Research Misconduct Manual of Procedures for details.