Moving forward on shifting sands: ethical regulation of gene therapy clinical trials in the United kingdom.

摘要

The regulatory landscape for development and application of gene therapies worldwide is complex and surprisingly variable. This has been a source of considerable frustration to investigators in both academia and industry who are eager to bring novel therapies into the clinic. With this in mind, many countries are considering how to simplify the process while retaining good scientific and ethical oversight. The UK National Research Ethics Service (NRES) has recently taken the step of disestablishing its Gene Therapy Advisory Committee (GTAC). The reaction to this move has been somewhat mixed, so it is worth taking a closer look at its purpose and function as the gene and cell therapy community enters an era of increasing clinical activity and commercialization of products.