Gene therapy progress and prospects: bringing gene therapy into medical practice: the evolution of international ethics and the regulatory environment.

The concept and application of ethical principles in the context of medical research is changing rapidly. This is especially true for fast moving fields such as gene therapy, a relatively new but rapidly maturing field offering opportunities to influence health at a fundamental level, which may become a cornerstone of medicine. By 2004, over 700 gene therapy clinical protocols had been initiated worldwide, and two highly publicized gene therapy-related side effects have helped to shape recent ethical debate. These events have influenced not only clinical trial design but also public opinion and systems of independent oversight. Both the science of gene therapy and the regulatory environment are continually evolving. How well the field is able to respond to these challenges will determine the extent to which gene therapy will ultimately be integrated into medical practice.