Theme: Clinical Trial: Informed Consent
INTRODUCCIÓN
El consentimiento informado es un acuerdo voluntario para participar en un estudio. No es simplemente una planilla que se firma — es un proceso en el cual el niño o su padre o tutor tiene un entendimiento acerca de la investigación y los riesgos.
Durante el proceso del consentimiento informado el equipo de investigación explicará los elementos claves del estudio y de qué manera usted o su hijo será involucrado.
Theme: Clinical Trial: Informed Consent
Theme: Clinical Trial: Informed Consent
Theme: Clinical Trial: Informed Consent
In this video, a mother of two sons with Duchenne Muscular Dystrophy talks about the excitement and pressure families feel when there is the possibility of participating in a clinical trial and how that excitement can blind you to the important things like attending to the informed consent.
Theme: Clinical Trial: Informed Consent
In this video, a mom discusses how participating in a clinical trial can be isolating. Not only do many trials contain restrictions about discussing your participation publicly but also because of some of the lifestyle changes that are necessary when participating.
Theme: Clinical Trial: Informed Consent
Theme: Clinical Trial: Informed Consent
Theme: Clinical Trial: Informed Consent
Informed Consent is a voluntary agreement to participate in research. It is not just a form that is signed — it is a process, in which the child or their parent/guardian has an understanding of the research and its risks. During the informed consent process, the research team will explain the key elements of the study and what you or your child’s participation will involve.
Theme: Clinical Trial: Informed Consent
In this video a Principal Investigator talks about the Informed Consent process as one where patients or parents have a conversations about the risks and benefits of the treatment proposed in the clinical trial with the goal of making the best decision for the patient/family. It is about giving informed choices to families, explaining the unknown aspects of a trial and asking the family to exercise their autonomy in making a decision.
Theme: Clinical Trial: Informed Consent
Parents of two sons, one of whom has CLN2 (Batten disease), offer advice to parents about participating in a trial — know the timeline, advocate for your child and your family. They need us, the child in the trial, as much as we need them, the company delivering the treatment. “We get to speak up.”