Preferred Label : Independent Ethics Committee;
NCIt related terms : independent ethics committee (IEC); IEC;
NCIt definition : A separate body such as an institutional, regional, national or supranational committee,
made up of medical/scientific professionals and non-scientific members, whose responsibility
it is to ensure the protection of the rights, safety, and well-being of human subjects
involved in a clinical trial. It tries to provide public assurance of that protection
by reviewing and approving the trial protocol, the suitability of the investigator(s),
facilities, methods, and materials to be used in documenting informed consent of the
trial subjects. (ICH);
Alternative definition : CDISC-GLOSS: An independent body (a review board or a committee, institutional, regional,
national, or supranational) constituted of medical/scientific professionals and non-scientific
members, whose responsibility it is to ensure the protection of the rights, safety,
and well-being of human subjects involved in a trial and to provide public assurance
of that protection by, among other things, reviewing and approving/providing favorable
opinion on the trial protocol, the suitability of the investigator(s), facilities,
and the methods and material to be used in obtaining and documenting informed consent
of the trial subjects. NOTE: The legal status, composition, function, operations,
and regulatory requirements pertaining to independent ethics committees may differ
among countries but should allow the independent ethics committee to act in agreement
with GCP as described in the ICH guideline. [After ICH E6 R2 Glossary] See also institutional
review board, ethics committee.; CDISC: An independent body (a review board or a committee, institutional, regional,
national, or supranational), constituted of medical professionals and non-medical
members, whose responsibility it is to ensure the protection of the rights, safety
and well-being of human subjects involved in a study and to provide public assurance
of that protection, by, among other things, reviewing and approving/providing favorable
opinion on, the study protocol, the suitability of the investigator(s), facilities,
and the methods and material to be used in obtaining and documenting informed consent
of the study subjects. The legal status, composition, function, operations and regulatory
requirements pertaining to Independent Ethics Committees may differ among countries,
but should allow the Independent Ethics Committee to act in agreement with GCP as
described in the ICH E6 guideline. (ICH E6 R2);
NCI Metathesaurus CUI : CL540572;
Origin ID : C142579;
UMLS CUI : C4554082;
Automatic exact mappings (from CISMeF team)
- Semantic type(s)
- concept_is_in_subset
