The National Institutes of Health (NIH) has put on display at the Federal Register its final Guidelines for research involving human pluripotent stem cells. The Guidelines detail the procedures to help ensure that NIH-funded human pluripotent stem cell research is conducted in an ethical and legal manner.
Such research promises new treatments and possible cures for many debilitating diseases and injuries, including Parkinson's disease, diabetes, heart disease, multiple sclerosis, burns and spinal cord injuries. The NIH believes the potential medical benefits of human pluripotent stem cell technology are compelling and worthy of pursuit in accordance with appropriate ethical standards. The NIH has developed the Guidelines for stem cell research in a careful and deliberate way to assure that the ethical, legal, and social issues relevant to human pluripotent stem cell research are addressed prior to NIH funding of that research.
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 Guidelines prescribe the documentation and assurances that must accompany requests for NIH funding for research using human pluripotent stem cells from human embryos or fetal tissue. The Guidelines state specific criteria for informed consent and establish a Human Pluripotent Stem Cell Review Group to review documentation of compliance with the NIH Guidelines. In addition, the Guidelines delineate areas of research involving human pluripotent stem cells that are ineligible for NIH funding.
In an effort to help ensure that any research utilizing human pluripotent stem cells is appropriately and carefully conducted, the NIH sought the advice of scientists, patients and patient advocates, ethicists, clinicians, lawyers, the National Bioethics Advisory Commission (NBAC), members of Congress, among others in drafting these Guidelines. The draft Guidelines were published for public comment in the Federal Register and after reviewing and considering all comments, the NIH will publish the final NIH Guidelines in the Federal Register on August 25, 2000.
Members of the Human Pluripotent Stem Cell Review Group will be named shortly, after which NIH will begin accepting requests for funding.