© 1999 by Oxford University Press
Journal of the National Cancer Institute, Vol. 91, No. 5, 407-408,
March 3, 1999
© 1999 Oxford University Press
NEWS |
Panel Finds In Utero Gene Therapy Proposal Is Premature
How can consent be informed when the "patient" is a fetus? Is it appropriate to begin clinical trials involving prenatal gene therapy when the potential risks to the mother, the fetus, and the child's possible offspring are not fully understood? And how would such trials be designed?
These and other ethical questions are being deliberated as a result of the recent proposal to the National Institutes of Health Recombinant DNA Advisory Committee to begin human trials of in utero gene transfer (See News, Oct. 21, 1998.)
For now, working groups at the third NIH Gene Therapy Policy Conference on
"Prenatal Gene Transfer: Scientific, Medical and Ethical Issues" have concluded
that there is insufficient preclinical data to support starting phase
" Minimal" Risks
IRB Oversight
Stretching Consent?