Preferred Label : Vulnerable Subjects;
NCIt related terms : Vulnerable Population;
NCIt definition : Volunteers for clinical studies who may be unreasonably persuaded to participate by
perceived benefits, or fear of punishment by superiors.;
Alternative definition : CDISC: Individuals whose willingness to volunteer in a clinical trial may be unduly
influenced by the expectation, whether justified or not, of benefits associated with
participation, or of a retaliatory response from senior members of a hierarchy in
case of refusal to participate. Examples include subordinate members of a group with
a hierarchical structure, patients with incurable diseases, persons in nursing homes,
unemployed or impoverished persons, patients in emergency situations, ethnic minority
groups, homeless persons, nomads, refugees, minors, and those incapable of giving
consent. (ICH); CDISC-GLOSS: Individuals whose willingness to volunteer in a clinical trial may be
unduly influenced by the expectation, whether justified or not, of benefits associated
with participation, or of a retaliatory response from senior members of a hierarchy
in case of refusal to participate. NOTE: Examples are members of a group with a hierarchical
structure, such as medical, pharmacy, dental, and nursing students, subordinate hospital
and laboratory personnel, employees of the pharmaceutical industry, members of the
armed forces, and persons kept in detention. Other vulnerable subjects include patients
with incurable diseases, persons in nursing homes, unemployed or impoverished persons,
patients in emergency situations, ethnic minority groups, homeless persons, nomads,
refugees, minors, and those incapable of giving consent. [After ICH E6 R2 Glossary]
See also human subject, patient, human subject, data subject, clinical research subject,
participant, study participant.;
NCI Metathesaurus CUI : CL540653;
Origin ID : C142747;
UMLS CUI : C0949366;
Automatic exact mappings (from CISMeF team)
- Semantic type(s)
- UMLS correspondences (same concept)
- concept_is_in_subset
