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according to ohrp, a problem is an “unanticipated problem” when it meets which of the following

According to OHRP, a problem is considered an “unanticipated problem” when it is unexpected, related or possibly related to the research, and suggests that the research places subjects or others at greater risk of harm than was previously known or recognized.

Core OHRP Criteria

In OHRP guidance, an unanticipated problem must meet all of the following:

  • Unexpected in nature, severity, or frequency relative to what is described in the protocol, consent form, or known characteristics of the study population.
  • Related or possibly related to participation in the research (i.e., it is at least reasonably likely to have been caused by the research procedures).
  • Suggests greater risk of physical, psychological, social, economic, or other harm to subjects or others than was previously known or recognized.

So, when presented as multiple-choice, the correct option is the one that states:

Unexpected, related or possibly related to the research, and suggests the research puts subjects or others at greater risk.

Why This Definition Matters

  • It helps researchers and IRBs determine which incidents must be promptly reported and possibly trigger protocol changes or added protections.
  • Examples include serious side effects not described in the consent form, or a data breach that exposes identifiable, sensitive participant information, both of which increase risk beyond what was anticipated.

TL;DR:
A problem is an OHRP “unanticipated problem” only when it is unexpected , related or possibly related to the research , and indicates increased risk to subjects or others compared with what was previously known.

Information gathered from public forums or data available on the internet and portrayed here.