Letters Section Editor: Robert M. Golub, MD, Senior Editor.
In Reply: Drs Ross and Philipson argue that our study of stem cell transplantation was unethical because (1) research involving pediatric participants is unethical unless it will promote the health of children and the research cannot be performed in adults, according to the Declaration of Helsinki, and (2) age-matched controls were needed to determine the extent of the benefits and adverse effects of the treatment.
The study was approved by local and national institutional review boards, which imposed no lower limits for patient age (0-35 years). Nevertheless, we included only patients older than 13 years. All patients and 1 of their parents signed the informed consent. The first minor patient was included only after 3 adult patients had undergone transplantation, 2 of them successfully.
Voltarelli JC, Couri CEB, Stracieri ABPL, Oliveira MC, Moraes DA, Pieroni F, Coutinho M, Malmegrim KCR, Foss-Freitas MC, Simões BP, Foss MC, Squiers E, Burt RK. Ethics of Hematopoietic Stem Cell Transplantation in Type 1 Diabetes Mellitus—Reply. JAMA. 2007;298(3):285-286. doi:10.1001/jama.298.3.285-b