Guidelines For Reporting Unanticipated Problems And Adverse Events
All unanticipated problems and/or serious adverse events having to do with participant safety and well-being in IRB-approved research must be reported promptly to the IRB. Note that such incidents can include physical harm and/or social/behavioral harm, e.g., breach of confidentiality or undue stress/anxiety.
STUDENT INVESTIGATORS SHOULD DISCUSS WITH THEIR PRINCIPAL INVESTIGATOR (FACULTY) ANY ANTICIPATED PROBLEMS OR ADVERSE EVENTS IMMEDIATELY. STOP THE RESEARCH ACTIVITY.
Initial reports may be made via phone, email, or fax, by the Principal Investigator and must be reported to the IRB as soon as possible, but within no more than 1 week (7 calendar days) of learning of such an event/problem. Furthermore, the Principal Investigator must submit this form to the IRB, with any additional sheets needed to provide a complete description of the event and actions taken with regard to the subject and the study, as soon as possible but within no more than 2 weeks (14 calendar days) of learning of such an event/problem.
Submit report to IRB Chair. See Contacts.
Unanticipated problem involving risks to participants or others
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 a participant’s participation in the research; and
- suggests that the research places participants or others at a greater risk of harm (including physical, psychological, economic, legal, or social harm) related to the research than was previously known or recognized.
Unexpected adverse event
Any adverse event occurring in one or more participants in a research protocol, the nature, severity, or frequency of which is not consistent with either:
(1) the known or foreseeable risk of adverse events associated with the procedures involved in the research that are described in (a) the protocol-related documents, such as the IRB-approved research protocol, any applicable investigator brochure, and the current IRB-approved informed consent document, and (b) other relevant sources of information, such as product labeling and package inserts; or
(2) the expected natural progression of any underlying disease, disorder, or condition of the subject(s) experiencing the adverse event and the participant’s predisposing risk factor profile for the adverse event.
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 participant’s participation in the research, whether or not considered related to the participant’s participation in the research. Adverse events may also be psychological in nature.
- Possibly related to the research: There is a reasonable possibility that the problem, event, incident, experience or outcome may have been caused by the procedures involved in the research.
Serious Adverse Event
Any adverse event temporally associated with the participant’s participation in research that meets any of the following criteria:
- 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 (examples of such events include allergic bronchospasm requiring intensive treatment in the emergency room or at home, blood dyscrasias or convulsions that do not result in inpatient hospitalization, or the development of drug dependency or drug abuse).
For additional information, please consult:
Government Regulations: Office of Human Protections: www.hhs.gov/ohrp/policy/advevntguid.html
Applicable Regulations: 45 CFR 46.103(5) 21 CFR 56.108(b)