Robert M. Nelson, MD, PhD

SmartTots Steering Committee, Member Scientific Advisory Board, Co-Chair
Robert M. Nelson, MD, PhD

Robert M. Nelson, MD, PhD

FDA Office of Pediatric Therapeutics

Scientific Profile

Areas of Specialty: Dr. Nelson is Board Certified in Neonatal-Perinatal Medicine and Pediatric Critical Care Medicine, and specializes in pediatric research ethics.

Research Activities: Dr. Nelson is a former Chair of the FDA Pediatric Advisory Committee, the FDA Pediatric Ethics Subcomittee, and the American Academy of Pediatrics Committee on Bioethics. His research focuses on the ethics of pediatric clinical trials involving FDA regulated products and the different aspects of parent and child decision-making regarding research participation. As a Senior Pediatric Ethicist and Lead Medical Officer in the FDA’s Office of Pediatric Therapeutics, Dr. Nelson investigates the ethical aspects of trial designs, control groups, animal models, as well as the risks and possible benefits of pediatric research, including international studies.

Dr. Nelson has served as a professor of pediatrics, bioethics, critical care, and anesthesiology at various universities for over twenty years. He also serves as editor for the American Journal of Bioethics (AJOB) Primary Research and a reviewer for numerous other pediatric/ethics-based journals. Dr. Nelson has published over 150 articles, editorials, reviews, and book chapters, focusing on important factors in research participation decision-making and ethical conflicts in pediatric experiments and research. With extensive understanding of the ethical aspects associated with pediatric research, Dr. Nelson brings unique perspective to the SmartTots Scientific Advisory Board.


Steering Committee, Member
Scientific Advisory Board, Co-Chair

U.S. Food and Drug Administration (FDA)

Senior Pediatric Ethicist and Lead Medical Officer, Office of Pediatric Therapeutics


Harvard University – PhD, Study of Religion (1993) Harvard University – AM, Study of Religion (1985) Yale Divinity School – MDiv (1980) Yale University School of Medicine – MD (1980) Wesleyan University – BA, Chemistry (1974)

Recent Research Funding

  • Stakeholder’s Views on Research Design: The Duchenne Muscular Dystrophy Community
    National Institute of Neurological Disorders and Stroke (2008-2010)
    Principal Investigator
  • Developing a Measure of Voluntary Consent for Protocol-Based Treatment Decisions
    National Cancer Institute (2006-2008)
    National Science Foundation (2006-2009)
    Principal Investigator
  • Decision Making by Adolescents and Parents about Research Participation: A Qualitative Study of the Influence of Risk Perception
    The Greenwall Foundation (2003-2004)
    Principal Investigator

Honors and Achievements

  • Group Recognition Award, Center for Drug Evaluation and Research, FDA Pediatric Research Equity Act Retrospective Review Working Group (2010)
  • Group Recognition Award, Office of the Commissioner, FDA September 2009 FDA-NICHD Planning Committee (2010)
  • Institutional Clinical and Translational Science Award, Research Ethics Program, NIH National Center for Research Resources (2006-2009)
  • Special Recognition Award, Center for Drug Evaluation and Research, FDA Rare Disease Working Group (2008)
  • Commissioner’s Award of Excellence, Office of the Commissioner, FDA (2008)
  • Distinguished Service Award, Applied Research National Association (2000)

Medical Training

Pediatric Critical Care Fellowship, University of California San Francisco (1987-1988)
Medical Ethics Fellowship, University of California San Francisco (1985-1988)
Neonatology Fellowship, University of California San Francisco (1985-1987)
Teaching Fellowship, History of Science and Core Program, Harvard University (1984-1985)
Clinical Pediatrics Fellowship, Harvard Medical School (1980-1983)
Pediatrics Internship and Residency, Massachusetts General Hospital (1980-1983)

Professional Affiliations

  • American Academy of Pediatrics
  • The Society of Critical Care Medicine
  • National Institutes of Health, Data Safety Monitoring Board, Division of Lung Diseases
  • Data Safety Monitoring Board, Vermont-Oxford Neonatal Network
  • FDA Anti-Infective Drugs Advisory Committee, Pediatric Subcommittee
  • Institute of Medicine Committee on Research Involving Children
  • Pediatric Advisory Committee, FDA

Selected Publications

Nathan AT, Hoehn KS, Ittenbach RF, Gaynor JW, Nicolson S, Wernovsky G, Nelson RM. Assessment of parental decision-making in neonatal cardiac research: a pilot study. J Med Ethics 2010;36(2):106-110.

Hoehn KS, Nathan A, White LE, Ittenbach RF, Reynolds WW, Gaynor JW, Wernovsky G, Nicolson S, Nelson RM. Parental perception of time and decision-making in neonatal research. J Perinatol 2009;29(7):508-11.

Borasino S, Morrison W, Silberman J, Nelson RM, Feudtner C. Physicians’ contact with families after the death of pediatric patients: a survey of pediatric critical care practitioners’ beliefs and self-reported practices. Pediatrics 2008;122(6):e1174-8.

Hoehn KS, Wernovsky G, Rychik J, Gaynor JW, Spray TL, Feudtner C, Nelson RM.What factors are important to parents making decisions about neonatal research? Arch Dis Child Fetal Neonatal Ed 2005;90(3):F267-9.

Rossi WC, Reynolds W, Nelson RM. Child assent and parental permission in pediatric research. Theor Med Bioeth 2003;24(2):131-48.

Hedrick HL, Nelson RM. Handling ethical conflicts in the clinical setting. Semin Pediatr Surg 2001;10(4):192-7.

Committee on Bioethics, AAP (Nelson RM, Botkin JR, Levetown M, Moseley KL, Truman JT, Wilfond BS, Bowes WA, Kazura A, Krug EF, Caniano DA, Frader JE, King NMP). Fetal therapy- ethical considerations. Pediatrics 1999;103(5):1061-3.