| / English Dictionary |
INFORMED CONSENT
| Pronunciation (US): |  | (GB): | |
I. (noun)
Sense 1
Meaning:
Consent by a patient to undergo a medical or surgical treatment or to participate in an experiment after the patient understands the risks involved
Classified under:
Nouns denoting communicative processes and contents
Hypernyms ("informed consent" is a kind of...):
consent (permission to do something)
Context examples:
EXAMPLE(S): obtain informed consent, verify eligibility criteria, enroll, registration to a study, randomize, assignment to a treatment arm, start of on-study period, complete study visits, end of on-study period, exit trial, break treatment blind, protocol violation, premature withdrawal
(Defined Study Subject Milestone, NCI Thesaurus/BRIDG)
Also called informed consent.
(Consent process, NCI Dictionary)
IRB responsibility include but not limited to the 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.
(Institutional Review Board, NCI Thesaurus)
The release from the requirement to obtain informed consent during a study that is granted by Human Subject Protection committee for a research institution for a protocol that is being reviewed by the Institutional Review Board.
(Consent Waiver, NCI Thesaurus)
EXAMPLE(S): assignment to a treatment arm, registration to a study, start of on-study period, end of on-study period, obtain informed consent, verify eligibility criteria, enroll, randomize, complete study visits, exit trial, break treatment blind, protocol violation, premature withdrawal
(Defined Administrative Activity, NCI Thesaurus/BRIDG)
The Clinical Research Shared Resource provides Cancer Center investigators with assistance in identification of prospective patients and determination of patient interest and eligibility to participate in clinical trials, in procurement and maintenance of the informed consent process, coordination of follow-up visits in conformance with protocol, hospital admission and discharge planning, coordination and safe administration of investigational agents, toxicity monitoring and reporting in compliance within Cancer Center and FDA regulations and the guidelines of GCP.
(Clinical Research Support Shared Resource, NCI Thesaurus)
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