The Presidential Commission for the Study of Bioethical Issues (Bioethics Commission) has just posted to Bioethics.gov a new educational module on informed consent in the context of pediatric medical countermeasure research. The module integrates material from the Bioethics Commission’s March 2013 report Safeguarding Children: Pediatric Medical Countermeasure Research.
The aim of this module is to help teachers and students understand the components of the consent process in the specific context of pediatric medical countermeasure (MCM) research, which investigates interventions to be used for children in the event of a bioterrorism attack. Pediatric MCM research raises complex ethical and regulatory issues. Children cannot ethically or legally give informed consent to participate in research, because their autonomy forms over time and is not fully developed until adulthood. In addition, pediatric MCM research that would take place before a bioterrorism attack occurs (pre-event) is ethically distinct from pediatric MCM research that would take place after an attack (post-event), due to differing risks and potential direct benefits for participants.
The moral and legal equivalent of informed consent in pediatric research involves two components: informed parental permission, and meaningful and developmentally appropriate child assent. In Safeguarding Children the Bioethics Commission’s recommendations emphasize the importance of informed parental permission and meaningful child assent in all pediatric MCM research.
Through discussion questions, scenarios, and exercises this module encourages students to consider the ethical complexities of informed consent in more depth, and offers a timely example and application of the process. The module highlights important differences between pre-event and post-event pediatric MCM research. For example, parents considering enrolling their child in pre-event research need to be well-informed about the lack of any potential direct benefit to their child; and in post-event research, the process of obtaining parental permission might be complicated if parents and children are in different locations.
This module is the latest addition to the Bioethics Commission’s series of modules on informed consent, which includes background material and modules discussing informed consent in the diverse contexts of historical U.S. Public Health Service STD research in Guatemala, whole genome sequencing, and incidental and secondary findings. By introducing students to the ethical nuances of informed consent in pediatric MCM research, this latest module adds a new dimension to the considerable resources the Bioethics Commission has developed on this important topic.
In addition, this module is the first the Bioethics Commission has developed based on its report Safeguarding Children. Future modules from this report, to be released soon, will cover topics including vulnerable populations and compensation for research-related injury.
All Bioethics Commission educational materials are freely available at www.bioethics.gov/education. The Bioethics Commission encourages feedback on its materials at firstname.lastname@example.org.