Skip to main content

Unanticipated Problem Involving Risk to Subjects or Others (UPIRSO)

Written by Chad Henderson on .

« Back to Glossary Index

The phrase “Unanticipated Problems Involving Risks to Subjects or Others”, commonly abbreviated to “Unanticipated Problems” or “UPIRSO,” is found but not defined in the Department of Health and Human Services (DHHS) regulations (Common Rule). The DHHS Office for Human Research Protections (OHRP) and the UNC-Chapel Hill Office of Human Research Ethics (OHRE) defines UPIRSO as follows:

UPIRSO (DHHS OHRP): Any incident, experience, or outcome that meet all of the following criteria:

  1. is 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;
  2. is related or possibly related to a subject’s participation in the research; and
  3. suggests that the research places participants or others at a greater risk of harm (including physical, psychological, economic, or social harm) than was previously known or recognized. OHRP: Unanticipated Problems Involving Risks & Adverse Events Guidance

UPIRSO (UNC-Chapel Hill OHRE): Any incident, experience, outcome, or new information that:

  1. Is unexpected (in terms of nature, severity, or frequency); and
  2. Is at least possibly related to participation in the research; and
  3. Indicates that subjects or others are at a greater risk of harm (including physical, psychological, economic, legal or social harm) than was previously known or recognized. UNC-Chapel Hill OHRE SOP 1401
« Back to Glossary Index