What are some of the ethical protections in the study?
The study has undergone formal ethical review and received approval from Institutional Review Board (IRB) at the National Cancer Institute. The participating hospitals and the Coordinating Center in Italy also have formally constituted ethical bodies which have reviewed the study. The IRB’s in Italy and in the United States revisit the study on a yearly basis. All study subjects received a detailed informed consent that they signed in order to participate. Subjects could refuse to participate in any part of the study, for example, an individual could elect to complete a questionnaire, but refuse to contribute any blood. No tissue was obtained, if it was required for clinical tests. All study procedures were conducted using standard operating procedures (SOPs) to maximize patient and staff safety, and to insure the scientific integrity of the results. Data were stored free of patient identifiers.
