Such research promises new treatments and possible cures for many debilitating diseases and injuries, including Parkinson's, diabetes, heart disease, multiple sclerosis, burns and spinal cord injuries. While the potential medical benefits of human stem cell technology are compelling and worthy of pursuit, the NIH believes that this area of research should be supported in accordance with strict ethical standards. And, as the draft guidelines note, "NIH understands and respects the ethical, legal and social issues relevant to human pluripotent stem cell research and is sensitive to the need to subject it to oversight more stringent than that associated with the traditional NIH scientific peer review process. In light of these issues, the NIH plans to move forward in a careful and deliberate way prior to funding any research using stem cells".
Human pluripotent stem cells hold great promise for advances in health care because they can give rise to many different types of cells, such as muscle cells, nerve cells, heart cells, blood cells, and others. Further research using human pluripotent stem cells may help scientists generate cells and tissue that could be used for transplantation to treat many diseases; improve understanding of the complex events that occur during normal human development and of what goes wrong to cause diseases and conditions such as birth defects and cancer; and change the way drugs are developed and tested for safety and potential efficacy.
The draft guidelines describe conditions that should be met before NIH funds are used to support human pluripotent stem cell research. The guidelines propose specific criteria for informed consent for the utilization of human pluripotent stems cells and the establishment of a Human Pluripotent Stem Cell Review Group to review documentation of compliance with the NIH guidelines and, when warranted, seek further information in support of a research application. In addition, the draft guidelines delineate areas of research involving human pluripotent stem cells that are ineligible for NIH funding including studies in which stem cells are used to create or contribute to a human embryo; are combined with an animal embryo; are used for reproductive cloning of a human; are derived using somatic cell nuclear transfer into a human or animal egg; or are derived from human embryos created for research purposes.
In an effort to ensure that any research utilizing human pluripotent stem cells is conducted appropriately, the NIH Director convened a Working Group of the Advisory Committee to the Director to help develop the draft guidelines. The working group included a broad spectrum of individuals with varied expertise and experience, including basic and clinical scientists, patients and patient advocates, ethicists, lawyers, and clinicians and met in a public session on April 8 to discuss draft guidelines. The Working Group also considered comments from the President's National Bioethics Advisory Commission (NBAC), Congress and the general public.
The draft guidelines will be open for public comment for 60 days. The NIH will not fund research using human pluripotent stems cells until final guidelines are published in the Federal Register and an oversight process is in place.
The draft guidelines will be available on December 2, 1999 in the Federal Register at http://www.nara.gov/fedreg/. Comments should be addressed to: Stem Cell Guidelines, NIH Office of Science Policy, 1 Center Drive, Building 1, Room 218, Bethesda, MD 20892. Comments may also be sent by facsimile transmission to Stem Cell Guidelines at (301) 402-0280, or by e-mail to: firstname.lastname@example.org.
Additional information about stem cells can be found on the NIH Web site at
http://www.nih.gov/news/stemcell/index.htm. The draft guidelines can be found on the NIH Web site at http://www.nih.gov/news/stemcell/draftguidelines.htm.