About FDA
The Office of the Commissioner (OC)
2010 Preceptors
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Pediatric Ethicist Office of Pediatric Therapeutics Office of the Commissioner (OC) Rockville, MD Background B.A. - Wesleyan University M.D.- Yale University School of Medicine M.Div. - Yale Divinity School Ph.D.- Harvard University FDA Experience – 3 Years |
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Research Interests My research has focused on two broad areas of pediatric research ethics: the ethical aspects of pediatric clinical investigations involving FDA regulated products, and empirical investigations into different aspects of parent and child decision-making concerning research participation. At FDA, specific areas of interest include ethical aspects of different trial designs, the choice of control groups (including placebo controls), the use of animal models, the assessment of research risks and the possibility of direct benefit, and ethical aspects of international pediatric research. My academic research has focused on risk perception, voluntary choice, and the balancing of risks and potential benefits in making a decision about the design of clinical trials. My academic research has been funded by the Greenwall Foundation, the National Science Foundation, and the National Institutes of Health. Proposed Research Project for FDA Commissioner’s Fellow The FDA Commissioner’s Fellow participating in this research program will be exposed to all aspects of FDA oversight of pediatric product development, including drugs, biologics and devices. More specifically, the Fellow will be able to observe, discuss and analyze the ethical aspects of pediatric product development. The Fellow will be able to select a more focused project on some aspect of pediatric research ethics, and have access to the necessary FDA resources. Pediatric research is increasingly international with working relationships between FDA and other international regulatory authorities. This offers an opportunity for a Fellow to explore the ethical issues raised by multi-national pediatric research involving both developed and developing countries. Project Requirements M.D. and/or Ph.D. in a relevant discipline. Ideally, the candidate will have some experience in health policy, legislation or law, along with a familiarity with the ethics and regulation of human subjects protections. Select Recent Publications Miller VA, Reynolds WW, Ittenbach RF, Luce MF, Beauchamp TL, Nelson RM. Challenges in measuring a new construct: perception of voluntariness for research and treatment decision making. J Empir Res Hum Res Ethics. 2009 Sep;4(3):21-31. 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 Jul;29(7):508-11. Reynolds WW, Nelson RM. Empirical data and the acceptability of research risk: a commentary on the charitable participation standard. Arch Pediatr Adolesc Med. 2008 Jan;162(1):88-90. Morris MC, Besner D, Vazquez H, Nelson RM, Fischbach RL. Parental opinions about clinical research. J Pediatr. 2007 Nov;151(5):532-7, 537.e1-5. Nelson RM: Minimal Risk, Yet Again. Journal of Pediatrics. 150(6): 570-72, 2007. Bagley SJ, Reynolds WW, and Nelson RM: Is a “Wage-Payment” Model for Research Participation Appropriate for Children? Pediatrics. 119(1): 46-51, 2007. Reynolds WW, Nelson RM. Risk perception and decision processes underlying informed consent to research participation. Soc Sci Med. 2007 Nov;65(10):2105-15. Morris MC, Nelson RM. Randomized, controlled trials as minimal risk: an ethical analysis. Crit Care Med. 2007 Mar;35(3):940-4. Baer GR and Nelson RM: Ethical Challenges in Neonatal Research: Summary Report of the Ethics Group of the Newborn Drug Development Initiative. Clinical Therapeutics. 28(9): 1399-1407, 2006. Pulsipher MA, Nagler A, Iannone R, and Nelson RM: Weighing the risks of G-CSF administration, leukopheresis, and standard marrow harvest: Ethical and safety considerations for normal pediatric hematopoietic cell donors. Pediatr Blood Cancer. 46(4):422-33, 2006.
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