Glossary of Terms
Glossary is usually defined as an alphabetical list of technical terms in some specialized field of knowledge. This knowledge base glossary provides a collection of knowledge base documents that define many technical terms. These terms are arranged alphabetically, but you can quickly jump to a specific term by selecting its first letter from the index of the knowledge base glossary below.
1 Glossary Terms Found.
Unanticipated Problem Involving Risks to Subjects or Others
Any information that is (1) unanticipated, (2) related to the research, and (3) indicates that subjects or others are at increased risk of harm.
For Department of Defense (DOD) research the term Unanticipated Problem Involving Risks to Subjects or Others includes any incident, experience, or outcome that meets ALL three of the following conditions:
-Is unexpected (in terms of nature, severity, or frequency) given the procedures described in the research protocol documents (e.g., the IRB-approved research protocol and informed consent document) and the characteristics of the human subject population being studied.
-Is related or possibly related to participation in the research (in this Instruction, possibly related means there is a reasonable possibility that the incident, experience, or outcome may have been caused by the procedures involved in the research).
-Suggests that the research places human subjects or others at a greater risk of harm (including physical, psychological, economic, or social harm) than was previously known or recognized, even if no harm has actually occurred.