|
|
Any event or outcome that was previously unforeseen and indicates that participants or others are at an increased risk of harm. OHRP considers unanticipated problems in general to include any incident, experience, or outcome that meets all of the following criteria:
- unexpected: not previously identified in nature, severity, or degree of incidence in the investigational plan or application (including a supplementary plan or application);
- related or possibly related to participation in research (there is at least a reasonable possibility that the incident, experience, or outcome may have been caused by the procedures involved in the research; and
- increased risk of harm: 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.
Examples include:
- Theft of a laptop computer which contained research participants' sensitive, identifiable information (not encrypted).
- Breach of confidentiality which places the participant at risk of criminal liability; or
- Administration of an investigational product to a patient who is not a participant in the research.
|
|