Tight regulation and oversight will be needed of efforts to make genetic modifications to human cells that can be passed on to offspring, a panel set up by the American Association for the Advancement of Sciences said this week.
Proponents of germline gene therapy have previously asked that it should not be regulated more heavily than other kinds of experimental medicine (see Nature 392, 317; 1998). Such a move, they argue, could slow efforts to develop germline gene therapy, which aims to combat genetic diseases by targeting cells in a prospective parents' testes or ovaries, or by conducting gene therapy on an embryo.
But the recommendation of the AAAS panel reflects its conclusion that, for all its promises, germline therapy remains problematic because unintended genetic changes could be passed to a new child along with intended benefits.
“There would need to be compelling scientific evidence to prove that these procedures are safe and effective,” says Mark Frankel, the report's co-author and director of the AAAS Scientific Freedom, Responsibility and Law programme. Such evidence has not yet materialized.
Rather than pursuing germline therapy, the AAAS report urges scientists to focus on making changes in cells that will not be passed to the next generation. It also encourages more research into methods to correct genetic ‘misspellings’.
Without first improving either of those two approaches, germline gene therapy can be neither safe nor effective, Audrey Chapman, director of an AAAS program on biomedical ethics and a co-author of the report, said at a press conference on Monday.
Robert Cook-Deegan, a Georgetown University bioethicist, called for a new body to be set up to monitor germ line gene therapy experiments in animals, perhaps modelled on the National Institute of Health's Recombinant DNA Advisory Committee (RAC). It would eventually decide whether human clinical trials should go forward.