Ethics of DNA Vaccine Transfer for Clinical Research.

Several experimental human DNA vaccines are currently undergoing Phase I, II, and III clinical trials in order to investigate their efficacy and safety. Human clinical trials must follow guidelines and procedures that have been approved by the regulatory authorities and ethics committees. Ethical clinical research is much more than applying an informed consent to participants. In this chapter we will review the ethical standards and provide a framework to evaluate and design ethical clinical research. Despite being universal standards supported by universal guidelines, they must be adapted to the conditions in each country where the clinical research is being conducted.