Question

According to OHRP, a problem is an 'unanticipated problem' when it meets which of the following criteria: a. Unexpected, related or possibly related to the research, suggests that the research does not put the subjects or others at greater risk b. Expected, related or possible related to the research, suggests the research puts others at greater risk c. Unexpected, related or possible related to the research, suggests the research puts subjects or others at greater risk d. Unexpected, unrelated to the research but still occurring with a subject, suggests the research puts others at greater risk

Answer 1

The correct answer is C.

The OHRP defines an "unanticipated problem" as the one which meets the following criteria:

• Unexpected: could not be prevented in advance and therefore is not included in the reserach-related documents which describe the different protocols of action. Also, it could not be forecasted according to the characteristics analyzed about the population of interest.
• Related or possibly related to the research. trouble or incident that has been very likely caused by the procedures related to the research
• Suggests the research puts subjects or others at greater risk if compared to the risks that were forecasted when designing the reserach. It can refer to economic, physical or social types of harm.