Ethics, Risk, and Informed Consent in Research with Juveniles; Experts Explore Ethical Considerations in Pediatric Research

The New York Academy of Sciences and NYU Grossman School of Medicine are pleased to present the 5th in a series of bioethical conferences — this year focused on Ethical Considerations in Research in Pediatric Populations. The conference will take place on September 13 and 14, 2022. This virtual conference, sponsored by Johnson & Johnson, will convene leaders in healthcare, research, medicine, advocacy, and ethics to explore important questions about the participation in research by young people who have not attained the legal age for consent to treatments or procedures in biomedical studies.

Experts will explore important topics including consent, assent, and privacy in pediatric research. They will discuss COVID-19 research in children, government regulation, and small sample size in studies in genomics and rare diseases. Topics will also include health and research disparities, population-based disease prevention through the lens of nutrition, and anticipated developments in pediatric research.

“This will be a very important conference because one of the biggest challenges in clinical research is dealing with children and newborns. And it’s really for ethical reasons. They can’t consent,” said Arthur Caplan, PhD, Professor of Bioethics at the NYU Grossman School of Medicine, and the chair of the conference’s scientific organizing committee. “They can’t give their permission to be in experiments. But at the same time, many interventions are aimed at diseases that only children get. So you’ve got to use them as your subjects. There’s really no alternative.  Research on kids has been an ethical challenge for a long time, and we’re pulling together some of the best experts in the country and a few from around the world to really go head on to address this tough, tough challenge.”

“Questions of ethics in clinical research involving juveniles are very complex,” said Melanie Brickman Borchard, PhD, MSc, Director of Life Sciences at the New York Academy of Sciences and another of the conference’s scientific organizers. “We do not need to dig too deep into the history of medical research to find abusive practices. But when trials are possible and designed appropriately, and with risk-benefits adequately evaluated, including children in research studies frequently helps ensure evidence-based treatments are available for young people. This conference will explore safeguards to protect children while ensuring pediatric research continues to support the discovery of new and effective therapies for this vulnerable population.”  

Keynote presentations and speakers:

  • Ethical Issues in Pediatric Research: Past, Present and Future. Stephen P. Spielberg, MD, PhD, a leader in pediatric pharmacology in academia and industry, and in regulatory affairs.
  • The Impact of Health Disparities in Adolescent Pediatric Research. Maria Eva Trent, MD, MPH, Johns Hopkins University.
  • The Future of Pediatric Research. Lynne Yaom MD, Director, Division of Pediatric and Maternal Health Center for Drug Evaluation and Research (CDER), FDA.

Ethics in COVID-19 research with juveniles will be a special focus of the conference.  “As a pediatrician who runs a clinical program, in my opinion, children remain an afterthought when it comes to designing and implementing trials, and developing vaccines,” said Perdita Taylor-Zapata, PhD, a Program Lead for NIH, who is also a member of the conference’s scientific organizing committee. “So even though vaccines were available to adults early in the pandemic, it took almost two years to get an effective vaccine for children, especially for young children. And while there needs to be a buffer and adequate safety precautions, the fact that children had two years of delay in receiving a vaccine is, for me, an ethical issue. Children need to be considered up front in the drug development process. And that is one of the reasons this conference is so important, for we will be discussing how to make sure children are at the table when we’re developing programs, when we’re developing vaccines, and when we’re developing drugs.”

The conference will explore areas in which there has been very little research in juvenile populations, including mental health, nutrition, and the health effects of pollution. Questions of when older juveniles might have a voice in decision-making—and can give “assent”—will also be covered. “Obviously kids can’t consent, but there’s a lot of debate about when you define somebody as a child,” Dr. Caplan said. “So if you’re 17 years old, a lot of people would say you’re mature enough to make many medical decisions. You may not want that person to decide what music you want to hear in your office, but they can understand medical information and decide whether they want to be in a study or not.”

“Furthering medical advancements and access to new medicines for pediatric populations is an essential societal healthcare goal,” said Sam Maldonado, MD, Vice President, Johnson & Johnson Global Medical Organization. “The reality is that the current conduct of clinical research in society’s youngest members is fraught with significant challenges and ethical considerations. Johnson & Johnson is proud to sponsor this conference to further the dialogue regarding the ethical considerations for research in pediatric populations.”

Additional panelists and moderators include:

  • Diana W. Bianchi, MD, Eunice Kennedy Shriver National Institute of Child Health and Human Development, NIH
  • Joe Brierley, MBChB, FRCPCH, FFICM, MA, Great Ormond Street Hospital (GOSH) 
  • Michael Cabana, MD, PhD, American Association of Pediatrics; Albert Einstein College of Medicine; Children’s Hospital at Montefiore
  • Ronald Cohn, MD, FACMG, Hospital for Sick Kids 
  • Christine Grady, MSN, PhD, NIH Clinical Center
  • Barbara Pahud, MD, PhD, Pfizer
  • Donna Snyder, MD, MBE, U.S. Food and Drug Administration (FDA) 

Click for a full list of speakers.

Click for the agenda.

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