La Sperimentazione Clinica in Oncologia. 1: Aspetti di Etica nella Preparazione dei Protocolli di Ricerca. (Human Experimentation in Oncology. 1: Ethical Issues in Research Protocols Design).

摘要

The document describes the main aspects that researchers should consider in the design of human experimentation protocols, and particularly of clinical trials in oncology. Cancer clinical trials are characterized by several ethically relevant peculiarities. Among these there are, for example, the informed consent and the risk/benefit balance. The main aspects of protocol organization and of the protection of human subjects are described. The text is complimentary to another forthcoming report on the ethics of oncology trials. The text is addressed to researchers and clinicians who perform clinical trials; the complementary report is addressed to the members of ethics committees.