Preferred Label : Informed Consent;
NCIt related terms : INFORMED CONSENT OBTAINED; Formal Consent;
NCIt definition : Consent by a patient to a surgical or medical procedure or participation in a clinical
study after achieving an understanding of the relevant medical facts and the risks
involved.;
Alternative definition : NCI-GLOSS: A process in which a person is given important facts about a medical procedure
or treatment, a clinical trial, or genetic testing before deciding whether or not
to participate. It also includes informing the patient when there is new information
that may affect his or her decision to continue. Informed consent includes information
about the possible risks, benefits, and limits of the procedure, treatment, trial,
or genetic testing.; CDISC: A process that provides the subject with explanations that will help in making
decisions about whether to begin or continue participating in a study, after having
achieved an understanding of the potential risks and benefits. Informed consent is
an ongoing, interactive process rather than a one-time information session.; CDISC-GLOSS: A process that provides the subject with explanations that will help
in making decisions about whether to begin or continue participating in a study, after
having achieved an understanding of the potential risks and benefits. informed consent
is an ongoing, interactive process rather than a one-time information session. NOTE:
Under 21 CFR 50.20, no informed consent form may include any language through which
the subject or the representative is made to waive or appear to waive any of the subject's
legal rights, or releases or appears to release the investigator, the sponsor, the
institution, or its agents from liability for negligence. In some cases, when the
prospective subject is unable to provide legal consent, permission to participate
may be obtained from a legally-authorized representative. [US FDA 21 CFR 50.20] See
also consent form.; MRCT-Ctr: The process of learning and discussing the details of a research study before
deciding whether to take part. (https://mrctcenter.org/glossaryterm/informed-consent/);
Codes from synonyms : CDR0000044677;
Origin ID : C16735;
UMLS CUI : C0021430;
Automatic exact mappings (from CISMeF team)
- Currated CISMeF NLP mapping
- Semantic type(s)
- UMLS correspondences (same concept)
- concept_is_in_subset
