Unanticipated Problems
Situations that need to be reported to the IRB
Situations which deviate from the approved research procedures or which cause harm to participants must be reported to the IRB. These are known as unanticipated problems and adverse events. Serious adverse events and unanticipated problems must be reported to the IRB within a week of the event or within a week of the PI becoming aware of the event. Non-serious adverse events or unanticipated problems should be reported to the IRB the next time the project is up for review.
Unanticipated Problems
An unanticipated problem is any incident, experience, or outcome that meets all of the following criteria:
- Unexpected (in terms of nature, severity, or frequency) given (a) the research procedures that are described in the protocol-related documents, such as the IRB-approved research protocol and informed consent document; and (b) the characteristics of the subject population being studied;
- 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
- 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.
Example: An Investigator conducting longitudinal research on college students’ experiences throughout two years of college loses a laptop that contains a file with participants’ names, participant ID codes, phone numbers, and email addresses.
Issues of non-compliance (such as conducting research activities without an active IRB approval or enrolling participants beyond the approved number) fall into this category.
Adverse Events
An adverse event is any event that includes any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the subject’s participation in the research, whether or not considered related to the subject’s participation in the research.
Adverse events encompass both physical and psychological harms. They occur most commonly in the context of biomedical research, although on occasion, they can occur in the context of social and behavioral research.
Example: An Investigator is conducting a qualitative analysis of how participants diagnosed with borderline personality disorder evaluate their out-patient therapy groups. The consent form indicates that participating in the interview may lead to a participant experiencing emotional or psychological distress. While discussing another member of the therapy group in an interview, a participant becomes upset and the Investigator ends the interview and calls the group therapist to meet with the participant.
Serious Adverse Events
Some adverse events fall into the category of serious adverse events. Serious adverse events include any of the following:
- results in death;
- is life-threatening (places the subject at immediate risk of death from the event as it occurred);
- requires inpatient hospitalization or prolongation of existing hospitalization;
- results in a persistent or significant disability/incapacity;
- results in a congenital anomaly/birth defect; or
- any other adverse event that, based upon appropriate medical judgment, may jeopardize the participant’s health and may require medical or surgical intervention to prevent one of the other outcomes listed in this definition.
Reporting to the IRB
To immediately report an unanticipated problem or adverse event to the IRB, submit an amendment application. For non-serious events, your report can be included in your next planned amendment or continuing review. If the project concludes before a continuing review is required, then include your report in the closure request.
Your report should include:
- A detailed description of the event including how and when the event occurred, how many participants were involved in the event, and your involvement in the event
- A statement describing any harms experienced by participant(s) and any additional risks participants may be subject to as a result of the incident.
- A detailed description of your plan of how to respond to the incident and any follow-up actions that will be taken.
Situations that need to be reported to the IRB
Situations which deviate from the approved research procedures or which cause harm to participants must be reported to the IRB. These are known as unanticipated problems and adverse events. Serious adverse events and unanticipated problems must be reported to the IRB within a week of the event or within a week of the PI becoming aware of the event. Non-serious adverse events or unanticipated problems should be reported to the IRB the next time the project is up for review.
Unanticipated Problems
An unanticipated problem is any incident, experience, or outcome that meets all of the following criteria:
- Unexpected (in terms of nature, severity, or frequency) given (a) the research procedures that are described in the protocol-related documents, such as the IRB-approved research protocol and informed consent document; and (b) the characteristics of the subject population being studied;
- 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
- 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.
Example: An Investigator conducting longitudinal research on college students’ experiences throughout two years of college loses a laptop that contains a file with participants’ names, participant ID codes, phone numbers, and email addresses.
Issues of non-compliance (such as conducting research activities without an active IRB approval or enrolling participants beyond the approved number) fall into this category.
Adverse Events
An adverse event is any event that includes any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the subject’s participation in the research, whether or not considered related to the subject’s participation in the research.
Adverse events encompass both physical and psychological harms. They occur most commonly in the context of biomedical research, although on occasion, they can occur in the context of social and behavioral research.
Example: An Investigator is conducting a qualitative analysis of how participants diagnosed with borderline personality disorder evaluate their out-patient therapy groups. The consent form indicates that participating in the interview may lead to a participant experiencing emotional or psychological distress. While discussing another member of the therapy group in an interview, a participant becomes upset and the Investigator ends the interview and calls the group therapist to meet with the participant.
Serious Adverse Events
Some adverse events fall into the category of serious adverse events. Serious adverse events include any of the following:
- results in death;
- is life-threatening (places the subject at immediate risk of death from the event as it occurred);
- requires inpatient hospitalization or prolongation of existing hospitalization;
- results in a persistent or significant disability/incapacity;
- results in a congenital anomaly/birth defect; or
- any other adverse event that, based upon appropriate medical judgment, may jeopardize the participant’s health and may require medical or surgical intervention to prevent one of the other outcomes listed in this definition.
Reporting to the IRB
To immediately report an unanticipated problem or adverse event to the IRB, submit an amendment application. For non-serious events, your report can be included in your next planned amendment or continuing review. If the project concludes before a continuing review is required, then include your report in the closure request.
Your report should include:
- A detailed description of the event including how and when the event occurred, how many participants were involved in the event, and your involvement in the event
- A statement describing any harms experienced by participant(s) and any additional risks participants may be subject to as a result of the incident.
- A detailed description of your plan of how to respond to the incident and any follow-up actions that will be taken.