Letters Section Editor: Robert M. Golub, MD, Senior Editor.
To the Editor: We believe that the study of autologous hematopoietic stem cell transplantation for treatment of newly diagnosed type 1 diabetes mellitus (DM) by Dr Voltarelli and colleagues1 raises serious ethical concerns regarding participant selection and study design.
Although the researchers were able to get research ethics approval in Brazil, the participant selection fails international standards of research ethics. Virtually every country in the world, including Brazil, is a signatory to the Declaration of Helsinki, international research ethics standards written by the World Medical Association. According to the Declaration of Helsinki, “For a research subject who is . . . a legally incompetent minor, the investigator must obtain informed consent from the legally authorized representative in accordance with applicable law. These groups should not be included in research unless the research is necessary to promote the health of the population represented and this research cannot instead be performed on legally competent persons.”2 Research involving pediatric participants is ethical if it will promote the health of children and the research cannot be performed on adults. Although the majority of individuals with type 1 DM present in childhood, a significant number present in young adulthood. Thus, it is possible to have performed this research first on adults instead of enrolling 8 minors (<18 years) among the first 15 participants.
Ross LF, Philipson LH. Ethics of Hematopoietic Stem Cell Transplantation in Type 1 Diabetes Mellitus. JAMA. 2007;298(3):285-286. doi:10.1001/jama.298.3.285-a