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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 . . . [Full Text of this Article]

Lainie Friedman Ross, MD, PhD
lross@uchicago.edu
MacLean Center for Clinical Medical Ethics

Louis H. Philipson, MD, PhD
Department of Medicine
University of Chicago
Chicago, Illinois

RELATED LETTER

Ethics of Hematopoietic Stem Cell Transplantation in Type 1 Diabetes Mellitus—Reply
Julio C. Voltarelli, Carlos E. B. Couri, Ana B. P. L. Stracieri, Maria C. Oliveira, Daniela A. Moraes, Fabiano Pieroni, Marina Coutinho, Kelen C. R. Malmegrim, Maria C. Foss-Freitas, Belinda P. Simões, Milton C. Foss, Elizabeth Squiers, and Richard K. Burt
JAMA. 2007;298(3):285-286.
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RELATED ARTICLE

Autologous Nonmyeloablative Hematopoietic Stem Cell Transplantation in Newly Diagnosed Type 1 Diabetes Mellitus
Júlio C. Voltarelli, Carlos E. B. Couri, Ana B. P. L. Stracieri, Maria C. Oliveira, Daniela A. Moraes, Fabiano Pieroni, Marina Coutinho, Kelen C. R. Malmegrim, Maria C. Foss-Freitas, Belinda P. Simões, Milton C. Foss, Elizabeth Squiers, and Richard K. Burt
JAMA. 2007;297(14):1568-1576.
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