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NIH Requests Comments on Imminent Draft Guidelines on Embryonic Stem Cell Research

Legislative Update
April 21, 2009

The National Institutes of Health (NIH) is requesting public comment within thirty days of the publication of draft guidelines on the use of embryonic stem cells by researchers who receive federal funding, which are expected to be published in the Federal Register on April 24. The guidelines are being issued in response to a March 9 Executive Order (EO 13505) from President Obama that directed the NIH to review existing regulations on stem cell research and issue new guidelines.

The EO 13505 lifted Bush Administration restrictions on the use of federal funding for embryonic stem cell research. The prior policy limited the use of federal funds to research on embryonic stem cell lines that were derived prior to August 9, 2001. Congress twice tried to overturn the restrictions imposed by President Bush in the previous two Congressional sessions, but both efforts were vetoed by the President and Congress was unable to overturn the vetoes.

Under the recent EO, federal funding still cannot be used to develop new embryonic stem cell lines, but it can be used to study existing cell lines and others created in the future. The EO directed the NIH to establish new guidelines within 120 days.

The draft guidelines would allow funding for research using human embryonic stem cells that were derived from embryos created by in vitro fertilization (IVF) for reproductive purposes and were no longer needed for that purpose. Funding will continue to be allowed for human stem cell research using adult stem cells and induced pluripotent stem cells.

NIH funding for research using human embryonic stem cells derived from other sources, including somatic cell nuclear transfer (SCNT), pathogenesis, and/or IVF embryos created for research purposes, are not allowed under the guidelines. NIH funding of the derivation of stem cells from human embryos is prohibited by the annual appropriations ban on funding human embryo research, otherwise known as the Dickey-Wicker Amendment.

NAEVR has supported expanded embryonic stem cell research due to the promise it holds for the more than 100 million Americans suffering from debilitating diseases and disorders, such as cancer, Alzheimer’s, spinal cord injuries and diabetes, which results in sight-impairing diabetic retinopathy. Embryonic stem cell research also holds the promise of treatments for other eye diseases, such as age-related macular degeneration (AMD, the leading cause of vision loss in the elderly), glaucoma, and retinitis pigmentosa. As recently as April 19, researchers from the Institute of Ophthalmology at University College of London and Moorfields Eye Hospital reported on a potential therapy to treat AMD by replacing a layer of degenerated retinal cells with new ones created from embryonic stem cells.

NAEVR will work with the Association for Research in Vision and Ophthalmology (ARVO) to develop an appropriate vision community response to the request for comments.