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Informed Consent for Pediatric Clinical Trial Participants

Imagine you are part of a medical research team, and are tasked with gaining informed consent from potential participants. The study will seek to test an experimental drug with patients suffering from late-stage leukemia. The sample will be divided into a control group and the experimental group. Participants in the control group will be given a placebo, which could increase the progression of their disease. The sample will be composed of children.

Discuss how you would go about seeking the consent of participants.

What questions would you expect from their parents/guardians?
How much information should you share with the children?
Should this type of study involve children, given the risks of speeding the progression of the disease?

Solution Preview

Informed consent for pediatric patients requires two elements: parental permission and patient assent when developmentally appropriate. Emancipated minors may also be able to provide informed consent on their own.

The websites below will provide useful additional information to help you complete your task. The first link specifically addresses pediatric research studies:
http://www.tchin.org/resource_room/c_art_18.htm
http://www.nocirc.org/consent/bioethics.php
http://pediatrics.aappublications.org/content/95/2/314.abstract
http://www2.aap.org/sections/bioethics/PDFs/Curriculum_Session4.pdf
http://virtualmentor.ama-assn.org/2006/10/jdsc1-0610.html

Parents and guardians will usually be concerned about the safety of the experimental drug and placebo, the length of duration of the trial, whether they will be aware of the treatment their children are receiving, side effects, or complications to watch out for. Experimental drugs that are able to reach the level of ...

Solution Summary

This solution explains the process for obtaining consent in clinical trials in the pediatric population. It also discusses potential questions from parents or guardians, the amount of information to be shared with children, and the risks and benefits of doing clinical trials in children with late stage leukemia.

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