Pertinent Definitions

The following IRB Definitions related to UPIRTSOs come from IRB Policy 18:

A.    Unanticipated Problem Involving Risks to Subjects or Others (UPIRTSO): Any event or information possibly related to the research that was unforeseen and indicates that the research procedures, approved by the IRB and carried out as expected, caused harm (including physical, psychological, economic, or social harm) to participants or others, or indicates that participants or others are at increased risk of harm than was previously known or recognized.

B.    Adverse Event: Any unfavorable or unintended sign, symptom, or disease temporally associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.

C.    Serious Adverse Event: Any adverse event that results in any of the following outcomes: death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant disability/incapacity, or a congenital anomaly/birth defect, or other medical events, based upon appropriate medical judgment, that may jeopardize the patient or subject and may require medical, surgical, behavioral, or other intervention to prevent one of the outcomes listed in this definition.

D.    Unanticipated or unexpected event: Any problem, event, information occurring that is new or where the nature, severity, or frequency is not consistent with either (1) the procedures involved in the research that are described the approved protocol, investigator brochure, or consent document and 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.

E.   Probably related: In the opinion of the PI, the incident, experience, or outcome may be reasonably associated with the procedures involved in the research.

F.    Serious Problem: Any event, problem, or information, including research information security, that may reasonably be regarded as presenting a genuine risk of substantive harm to the safety, rights, or welfare of human research subjects, research personnel, or others, including their rights to privacy and confidentiality of identifiable private information; or substantively compromising the HRPP or research information security program.

G.   Internal: Any occurrence involving subjects enrolled in a study approved by the ETSU IRBs and directed by a PI affiliated with ETSU or the JHQVAMC.

H.   External: Any occurrence involving subjects enrolled in a multi-site, collaborative study that are not under the purview of the ETSU IRBs.

I.    Prompt Reporting: Events must be reported to the IRB within 10 business days using the appropriate report xform; for VA, reporting must occur within 5 business days.