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 ?
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.
The ever-growing number of studies on the readability of informed consent forms used in health research (Nielsen-Bahlman, Panzer & Kindig 2004, p.
The subject should be presented with an Informed Consent Form (ICF) prior to initiating any study-related procedures.
It is worth noting that the current practice of approving clinical trial applications, including approval of the informed consent forms at IRB, does involve the input of the public.
The survey showed that 43 per cent of informed consent forms were signed by family members of competent patients, 32 per cent were signed by both of them and only 25 per cent were signed by the patients themselves.
In fact, an informed consent form was recently developed by SART to help its members ensure that all SART clinics have the information they need to apprise patients of the potential risks of ART treatments, she said.
According to GCP favourable opinion needs to be obtained prior to initiation of a trial from the IRB/IEC for trial protocol, written informed consent form, consent form updates, and subject recruitment procedures.
Nurses involved in research should consult the IRB prior to official submission of the proposal and informed consent form to learn of specific individual IRB requirements.
release form, protocol, informed consent form, case report forms, investigator brochure, drug accountability form, and contact information for FFF Enterprises and Cangene Corporation); IRB approval (i.
In spite of the obstacles discussed below, NIIP administered a program that immunized 45 million in 10 weeks, which resulted in doubling the level of immunization for persons deemed to be at high risk, rapidly identifying adverse effects, and developing and administering an informed consent form for use in a community-based program.
Most sponsors will provide you with a sample informed consent form (ICF) customizable for your practice, and, if deemed necessary, proposed advertising content.
The package insert and the patient informed consent form have been updated and now contain a new warning that there have been suicides reported in patients taking isotretinoin.