For some 75 years, we have held the position that those who participate in medical research may do so only after giving their assent. This is problematic in pediatric research as the subjects lack the legal capacity to do so, and we must rely upon permission from parents to include their children in research, supported by the child’s agreement or assent.
However, the information provided to children often defeats the purpose of providing it. Assents are frequently excessively long, unnecessarily repetitive, written in a technical manner, presented as formal documents almost resembling contracts, and include provisions relating to data privacy crafted by lawyers which may be near impenetrable for most children. As a result, a child’s “agreement” to participate based on the information provided may be fictional, and instead be the result of some inherent trust in the investigator or research nurse.
In this webinar, medical ethicists will discuss what investigators, Ethics Committees, IRBs and – ideally – sponsors can do to reverse this trend and create assent documents which achieve their intended purpose of allowing a child to understand the trial in which they are being asked to participate.
Dr. Harris Dalrymple, PhD (Med), PhD (Law), Executive Director, Center for Pediatric Clinical Development, ICON
Dr. Dalrymple holds 40 years’ experience in the pharmaceutical and CRO industries, and has been involved in pediatric clinical trials for nearly 20 years, covering a wide range of indications. Originally a pharmacologist, he holds a master’s degree in medical law and ethics and he was awarded doctorate degrees in both medicine and law, the latter for his thesis on legal and ethical issues raised by the conduct of clinical trials involving pregnant women.
Dr. Dalrymple worked for Pfizer for nearly 25 years, primarily in clinical development where he led many programs that brought new drugs to the market. Upon leaving Pfizer, he joined PPD, where he served as the operational lead for a strategic partner, and as the vice-chair of the Pediatric Working Group he helped to establish there. Since March 2017, he has held the position of Executive Director, Scientific Affairs, and Vice-Chair, CPCD. His interests include assent/consent and ethical issues in clinical trials. He also lectures on medical law and ethics in the clinical trial setting for the British Association of Pharmaceutical Physicians Faculty of Pharmaceutical Medicine.
Gianna “Gigi” McMillan, DBe, Acting Graduate Director for the Bioethics Institute, Loyola Marymount University
Dr. McMillan develops academic curriculum and teaches Research Ethics at Loyola Marymount University in Los Angeles. She received her master’s degree from LMU and her doctorate from Loyola Chicago. Dr. McMillan has been an adviser to the Children’s Brain Tumor Foundation, the National Brain Tumor Society, and the Pediatric Brain Tumor Consortium.
She has extensive experience as a Subject/Patient Advocate on local and national IRBs, was a member of the Subpart A Subcommittee for the Secretary’s Advisory Committee on Human Research Protection and is a member of the FDA’s Pediatric Advisory Committee. Dr. McMillan has served on the board of the American Society for Bioethics and Humanities and is currently on the Board of PRIM&R (Public Responsibility in Medicine & Research). She is the Director of Community Engagement for the academic journal Narrative Inquiry in Bioethics. Her primary interests are consent issues in clinical research and the use of narrative as an educational tool in bioethics.
Dr. Joe Brierley, MBChB, MRCP, FRCPCH, MA, Paediatric Intensivist, Director of Bioethics, Great Ormond Street Hospital, London
Dr. Joe Brierley is a Paediatric Intensivist and the Director of Bioethics at Great Ormond Street Hospital in London. He is the chair of the Royal College of Paediatrics and Child Health Children’s Ethics and Law Special Interest Group and previously held the position of president of the European Society of Paediatric & Neonatal Intensive Care.
Who Should Attend?
- Research and Development
- Clinical Research
- Medical Affairs
- Scientific Affairs
- Regulatory Affairs
- Clinical Affairs
- Project Management
- Clinical Operations
- Risk Management
- Healthcare Professionals
- Patient Advocacy groups and their members
- Anyone who has an interest in the future of pediatric research
What You Will Learn
Join this webinar to learn about:
- The problems with current assent processes used in pediatric research
- Why pediatric assent documents are often misunderstood
- How stakeholders can create clear documents to educate pediatric patients
ICON plc is a world-leading healthcare intelligence and clinical research organisation. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organisations. We develop new innovations, drive emerging therapies forward and improve patient lives. With headquarters in Dublin, Ireland, ICON operates from 150 locations in 47 countries and has approximately 38,000 employees as of July 1, 2021.
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