NOHSP Definitions - L

A glossary of terms and concepts found in the Nemours HSP policies and procedures. References and resources are located in the policy noted by HSP### after each definition.

L

Legally Authorized Representative: An individual or judicial or other body authorized under applicable law to consent on behalf of a prospective subject to the subject’s participation in the procedure(s) involved in the research. Individuals who meet this definition, but are not parents and do not meet the DHHS and FDA definition of guardian, (are not authorized under applicable law to consent on behalf of the child to general medical care) may not grant permission for a child to take part in research. (HSP#033)

Legal Guardian: A person who has the authority to consent on behalf of the child to general medical care.

Note that individuals who are designated as a “legal guardian” under state law, such as foster parents, may not have the authority to consent for a child’s general medical care and therefore cannot consent on behalf of the child to this research.
Note that individuals who are not designated as a “legal guardian” under state law, such as social service case worker, may have the authority consent for a child’s general medical care and therefore can consent on behalf of the child to this research. (HSP#033)

Life Threatening: Diseases or conditions where the likelihood of death is high unless the course of the disease is interrupted. It is not required that the condition be immediately life-threatening, rather the individual must be in a life-threatening situation requiring intervention before review at a convened meeting of the IRB is feasible. (HSP#034)

Limited Capacity: A clinical judgment that an adult is either temporarily or permanently unable to make a fully informed, independent decision concerning research participation. (HSP#054)