IRB Unanticipated Problem and Adverse Event Policy  

An Adverse Event refers to any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (e.g., 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 physical and psychological harms. They occur primarily in the context of biomedical research, although they may occur with social and behavioral research. Unanticipated Problems encompass “other” events that may arise during the course of research.

Circumstances for reporting Unanticipated Problems

A PI must submit an unanticipated problem report if all three of the following criteria (in accordance with federal regulations) are met:

1. An incident, experience, or outcome is unexpected (in nature, severity, or frequency), given the procedures described in the IRB-approved research protocol and informed consent document; and given the characteristics of the research subject population.
2. An incident, experience, or outcome is related to or possibly caused by participation in the research.
3. An incident, experience, or outcome suggests that the research places subjects or others at a greater risk of harm (including physical, psychological, economic, or social harm) than previously realized or anticipated.

An unanticipated problem may warrant corrective actions in the research protocol or the informed consent process/document in order to ensure the safety, welfare, or rights of participants. Some possible corrective actions may include:

1. changes to the research protocol initiated by the PI prior to obtaining IRB approval to eliminate immediate hazards to subjects;
2. modification of inclusion or exclusion criteria to mitigate the newly identified risks;
3. implementation of additional procedures for monitoring subjects;
4. suspension of enrollment of new subjects;
5. suspension of research procedures in currently enrolled subjects;
6. modification of informed consent documents to include a description of newly recognized risks; and
7. provision of additional information about newly recognized risks to previously enrolled subjects.

Circumstances for reporting Adverse Events

A PI must submit an unanticipated problem report if all three of the following criteria (in accordance with federal regulations) are met, OR if it is a serious adverse event.

1.       The adverse event is unexpected because the nature, severity, or frequency of the event is not consistent with either:

a)      the known or foreseeable risk of adverse events associated with research procedures described in the IRB-approved research protocol or the current IRB-approved informed consent form.

b)      the expected natural progression of any underlying disease, disorder, or condition of the subject(s) experiencing the adverse event and the subject’s predisposing risk factor profile for the adverse event.

2.       The adverse event is related to or possibly caused by participation in the research. Adverse events may be caused by one or more of the following:

a)      the procedures involved in the research;

b)      an underlying disease, disorder, or condition of the subject; or

c)       other circumstances unrelated to either the research or any underlying disease, disorder, or condition of the subject. 

Adverse events determined to be at least partially caused by a) (above) would be considered related to participation in the research, whereas adverse events determined to be solely caused by (b) or (c) would be considered unrelated to participation in the research. 

3.       The adverse event suggests that the research places subjects or others at a greater risk of harm than previously realized or anticipated. Any serious adverse event requires immediate reporting to the IRB, which has the authority to suspend or terminate approval of research associated with unexpected serious harm to subjects. An adverse event is considered serious if it:

a)      results in death;

b)      is life-threatening (places the subject at immediate risk of death from the event as it occurred);

c)       results in inpatient hospitalization or prolongation of existing hospitalization;

d)      results in a persistent or significant disability/incapacity;

e)      results in a congenital anomaly/birth defect; or

f)       based upon appropriate medical judgment, may jeopardize the subject’s health and may require medical intervention to prevent one of the outcomes listed above.

Instructions for reporting an Unanticipated Problem–Adverse Event

w  Review the reporting timeframe below to ensure prompt response.

w  Complete the report form using MS Word or similar word-processing software (no handwritten applications).

w  Respond to all items as applicable, or the report may be returned to you for additional information. Attach additional pages as necessary.

w  Obtain all necessary signatures before submitting your report: PI, Faculty Advisor (if not the PI), and Co-Investigators.

w  Submit all forms in a sealed envelope to:  IRB, Office of Research Services & Sponsored Projects in the University Services Building #203. After business hours, please place materials in mail slot.

Required Timeframe for Reporting Unanticipated Problems–Adverse Events

Please direct all questions to:  irb@seattleu.edu  or (206) 296-2585