Unanticipated Problem
From Bilat-Wiki
|
Translations missing. Please help us to translate this therm |
NHLBI: any incident, experience, or outcome that meets all of the following criteria: 1) unexpected 2) related or possibly related to participation in the research; and 3) suggests that the research places subjects or others at a greater risk of harm than was previously known or recognized. OHRP provides detailed information in What are unanticipated problems?
