informed consent form


Also found in: Dictionary, Acronyms.

informed consent form

EBM
The document used in a clinical trial that explains to potential participants the risks and potential benefits of a study, and the rights and responsibilities of the parties involved. The informed consent document provides a summary of a clinical trial (including its purpose, the treatment procedures and schedule, potential risks and benefits, alternatives to participation, etc.) and explains an individual's rights as a subject. It is designed to begin the informed consent process, which consists of a dialogue between the subject and the research team; if the individual then decides to enter the trial, he or she gives his or her official consent by signing the document.
References in periodicals archive ?
In the first part, the Flesch's readability formula adapted to Turkish by Atesman and the readability formula developed by Cetinkaya and Uzun (14, 15) applied to the informed consent form to determine the level of readability that allowed a reader-free evaluation at the beginning.
qp.2ov.sk.ca/ Policy on informed consent: The documents/En2lish/Statutes/ CAS adopts the CCPA patient Statutes/C10-1.pdf informed consent form as a a.3 The Chiropractors' mandatory part of the patient Association of Saskatchewan, records (Unit V- K.1).
In order to fulfill this knowledge gap, this study sought to learn the perception of the participants of clinical trials in relation to the informed consent form and describe the significance of the participation in the research.
(2004) Developing the informed consent form: a review of the readability literature and an experiment.
It suffices to note that the Informed Consent Form (ICF) may be of the short form format or the standard long form format.
FDA has amended its regulations to require the inclusion in informed consent forms for certain clinical trials a statement that information about the trial will be posted on www.clinicaltrials.gov, the US National Institutes of Health/National Library of Medicine (NIH/NLM) registry.
The informed consent form was designed to educate and inform subjects before they enter into a clinical trial that there is merit to the proposed study, that they will be treated fairly and ethically, and that their well-being will not be compromised in any way by the study.
He found several anomalies in the informed consent form, which is meant to be filled in by those taking the vaccine.
Family members' signing of the informed consent form for the competent is very common, especially in the case of serious diseases.
To address this issue, the core sections of the informed consent form were translated into Polish within the application, and translators assisted providers in explaining the English-language procedure details to patients.