Preferred Label : Institutional Review Board;
NCIt synonyms : Human Subjects Protection and Institutional Review Board; Human Subjects Protection Review Board;
NCIt related terms : IRB; Institutional Review Board (IRB); independent review board; independent ethics committee; committee for the protection of human subjects;
NCIt definition : A specially constituted independent review body comprised of medical, scientific and
non-scientific members established and designated by an entity to ensure the protection
of the rights, safety and well-being of human subjects recruited to participate in
biomedical or behavioral research according to the requirements outlined in Title
38, part 16 (same as Title 45, part 46 and Title 21, part 56) of the U.S. Code of
Federal Regulations. IRB responsibilities include reviewing, approving, and providing
continuing review of trial protocol and amendments and of the methods and material(s)
to be used in obtaining and documenting informed consent of the trial. Other equivalent
committees with the same or similar functions are also considered to be IRBs.;
Alternative definition : NCI-GLOSS: A group of scientists, doctors, clergy, and consumers that reviews and
approves the action plan for every clinical trial. There is an Institutional Review
Board at every health care facility that does clinical research. Institutional Review
Boards are designed to protect the people who take part in a clinical trial. Institutional
Review Boards check to see that the trial is well designed, legal, ethical, does not
involve unneccesary risks, and includes safeguards for patients.; CDISC-GLOSS: An independent body constituted of medical, scientific, 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 study by, among other things, reviewing,
approving, and providing continuing review of study protocol and of the methods and
material to be used in obtaining and documenting informed consent of the study subjects.
[ICH E6 1.31]; CDISC: An independent body constituted of medical, scientific, and non-scientific
members, whose responsibility is to ensure the protection of the rights, safety and
well-being of human subjects involved in a study by, among other things, reviewing,
approving, and providing continuing review of study protocol and amendments and of
the methods and material to be used in obtaining and documenting informed consent
of the study subjects. (ICH E6 R2); MRCT-Ctr: A team of people who review studies to protect the rights and welfare of
study participants. (https://mrctcenter.org/glossaryterm/institutional-review-board-irb/);
Codes from synonyms : CDR0000044680; CDR0000044679;
Origin ID : C16741;
UMLS CUI : C0086911;
Automatic exact mappings (from CISMeF team)
- Semantic type(s)
- UMLS correspondences (same concept)
- concept_is_in_subset
