informed consent form


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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 ?
An informed consent form for each of nine contraceptive products currently under clinical investigation at Family Health International was assessed for readability using the Fry Formula, the Dale-Chall formula, and the SMOG formula.
As part of their participation, respondents reviewed the informed consent form with a physician researcher or a study coordinator.
Participants will be asked to sign an informed consent form, complete a questionnaire and provide a cheek swab sample for genotyping.
The approval is conditional exclusively upon a minor change to the informed consent form that has already been filed with the FDA.
A few years ago our doctor, who is an alternative doctor, and others worked with the state legislature to get an informed consent form for patients to sign.
Sixty volunteers with HG-PIN, who were made aware of the study details, agreed to sign an informed consent form and were enrolled in this double-blind, placebo-controlled study.
Capacity to give informed consent and voluntarily sign and date the informed consent form, approved by an IRB/IEC/REB, prior to the conduct of any study specific procedures.
Participants will sign an informed consent form, complete a survey, have their waist measured and have blood drawn.
The Informed Consent Form is a very critical step in the study trial process that involved human subjects and may well serve as a veritable source of maintaining compliance with stipulated regulations.
The text includes bibliographies relevant to past violent campus events, and appended material on assessing and responding to disturbed students, risk assessment guidelines, mandated educational programs for at-risk students, and the informed consent form for counseling at the author's campus.
Consultation You should expect a thorough consultation where the trainer sits down with you and asks you to complete a health questionnaire and an informed consent form.