NIH Lifts Stem Cell Funding Ban, Issues Guidelines
Review group to be established, then funding applications to be accepted
By Kate Devine
Ever since the isolation and culturing of human pluripotent stem cells in 1998, the debate has intensified regarding legal, ethical, and social ramifications associated with research use of these cells that are capable of developing into many different specialized tissues.1, 2 In order for the National Institutes of Health to clarify its position on research with these cells, in January 1999, it placed a moratorium on use of human pluripotent stem cells derived from embryos and fetal tissue in federally funded research. After receipt and review of about 50,000 public comments, NIH lifted this moratorium by issuing the "National Institutes of Health Guidelines for Research Using Human Pluripotent Stem Cells".3
In the guidelines, effective August 25, NIH states it believes that potential benefits of human pluripotent stem cell technology are worthy of pursuit and, thus, it is allowing research use of these cells. "The purpose of the NIH guidelines is to prescribe procedures to help ensure that NIH-funded research using human pluripotent stem cells is conducted in an ethical and legal manner," says Lana Skirboll, director of the NIH Office of Science Policy. "By issuing these guidelines, the NIH aims to enhance the scientific and ethical oversight of this important arena of research and the pace at which scientists can explore its many promises."
The guidelines specify that NIH funds may be used to derive human pluripotent stem cells from fetal tissue but not from human embryos. Additionally, human embryo cells must have been the result of in vitro fertilization and fertility treatment clinical-needs excess. The guidelines also delineate other areas of research involving human pluripotent stem cells that are ineligible for NIH funding, such as research in which human pluripotent stem cells are used to create a human embryo.
Federally funded researchers wishing to use human pluripotent stem cells must submit information that includes: a signed assurance the cells were derived in accordance with the guidelines, a sample informed consent document without patient identification information, and an abstract of the protocol used to derive the cells. NIH says it will establish a Human Pluripotent Stem Cell Review Group (HPSCRG) to ensure documentation meets guideline compliance. After review group members are named, NIH will begin accepting requests for funding.
This is an action viewed by many as an opportunity to advance treatments regarding debilitating and life-threatening diseases. The Federation of American Societies for Experimental Biology has endorsed the guidelines, stating that it is the responsibility of biomedical researchers receiving public funds to pursue research to improve people's health. It acknowledged, however, that the value of such cells cannot be fully appreciated until appropriate investigations are conducted. Commenting on a promising technique whereby lupus patients' harvested peripheral blood stem cells were administered prior to chemotherapy,4 Anne Traynor, assistant professor of medicine at Northwestern University Medical School says, "It is too early to say whether embryonic stem cells would be of further benefit for this disease." Many patient organizations, though, have supported the issuance of the guidelines because such research holds promise for new treatments for debilitating diseases and injuries, such as Parkinson's disease, diabetes, heart disease, multiple sclerosis, burns, and spinal cord injuries. S
Kate Devine can be contacted at kdevine@the-scientist.com.
References
1. E. Russo, "Hearing sets stage for stem cell funding debate," The Scientist, 13[1]:3, Jan. 4, 1999.
2. E. Russo, "Congress revisits stem cell issue," The Scientist, 14[10]:14, May 15, 2000.
3. Department of Health and Human Services, National Institutes of Health guidelines for research using human pluripotent stem cells, Federal Register, 65[166]:51975-81, Aug. 25, 2000.
4. A. Traynor et al., "Treatment of severe systemic lupus erythematosus with high-dose chemotherapy and haemopoietic stem-cell transplantation: A phase I study," The Lancet, 356:701-7, Aug. 26, 2000.
the-scientist.com |
