The ethics of type 1 diabetes prediction and prevention research.

There are approximately one million cases of type 1 diabetes in the US, and the incidence is increasing worldwide. Given that two-thirds of cases present in childhood, it is critical that prediction and prevention research involve children. In this article, I examine whether current research methodologies conform to the ethical guidelines enumerated by the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, and adopted into the federal regulations that protect research subjects. I then offer two policy recommendations to help researchers design studies that conform to these ethical requirements.