Pharmaceutical Business review

NIH Publishes Draft Guidelines On Human Stem Cell Research

and to help ensure that NIH-funded research in this area is ethically responsible, scientifically worthy, and conducted in accordance with applicable law.

Internal NIH procedures, consistent with Executive Order 13505 and these Guidelines, will govern the conduct of intramural NIH research involving human stem cells.

These 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. Specifically, these Guidelines describe the conditions and informed consent procedures that would have been required during the derivation of human embryonic stem cells for research using these cells to be funded by the NIH. NIH funding for research using human embryonic stem cells derived from other sources, including somatic cell nuclear transfer, parthenogenesis, and/or IVF embryos created for research purposes, is not allowed under these Guidelines.

NIH funding of the derivation of stem cells from human embryos is prohibited by the annual appropriations ban on funding of human embryo research (Consolidated Appropriations Act, 2009, Pub. L. 110-161, 3/11/09), otherwise known as the Dickey-Wicker Amendment.

According to these Guidelines, there are some uses of human embryonic stem cells and human induced pluripotent stem cells that, although those cells may come from allowable sources, are nevertheless ineligible for NIH funding.