Feds consider supporting human embryo research
Feds consider supporting human embryo research
Human stem cells could be included in funding
A national bioethics group proposes easing federal bans on human embryo research, while the U.S. Department of Health and Human (HHS) Services is loosening the purse strings to fund this research.
Under new guidelines being developed by the HHS and the National Institutes of Health (NIH), medical researchers exploring the potential of human pluripotent stem cells soon may be able to use federal funds to conduct all or part of their studies. In addition, a draft report on stem-cell research by the president’s National Bioethics Advisory Commission (NBAC) proposes amendments to legislation that bans the use of federal funds to conduct research that involves risk to or destruction of human embryos; embryos are destroyed in the process of harvesting stem cells.
Embryonic pluripotent stem cells have incredible potential for medical advancements, including treatments for diseases such as diabetes and Parkinson’s. Stem cells also have the potential to develop replacement cells and possibly organs for people requiring transplants, explains Hessel Bouma III, professor of biology at Calvin College in Grand Rapids, MI, and a recognized expert in ethical issues involving human genetics and cell biology. "These are cells that still have the potential to differentiate into almost all types of tissue."
Is there a middle ground?
In the early stages of embryonic development, the cells are "totipotent," meaning there is still the potential to develop an entire mature organism from the cell. The term "pluripotent" means the cells are more specialized but still can differentiate into all of the different types of specialized cells.
However, research in this area does bring to light many ethical challenges that have yet to be addressed universally, Bouma and others maintain. Embryonic stem cells must be derived from early human embryos, either those that have never been implanted in the uterus or those that are derived from fetal tissue (a nonliving embryo obtained from a spontaneous or elective abortion). The harvesting of stem cells necessitates the destruction of the embryo in the process.
"It comes down to what level of respect do we accord these elements of human beings," says Bouma. "Some people argue that [the embryo] is just like hair or skin or any other tissue sample, then there are those people who say that the embryo is a human being in its earliest form and should be treated as such."
There has been little ethical exploration of a middle ground, whereby the embryo would be accorded more "respect" than just a mere tissue sample but would not command the same considerations as a research subject that a human being would, he contends.
In an effort to institute some ethical limits on the rapidly accelerating pace of genetic research, Congress passed laws prohibiting use of federal funds on projects that involve the destruction of human embryos or that would put an embryo at risk of destruction. Federal law does, however, permit the use of federal funds in support of research involving fetal tissue but with strict limitations. (See p. 79.)
After asking its counsel to strenuously review the applicable law, HHS recently determined that funding research using pluripotent stem cells already derived from embryos was permissible under current federal law. The NIH then began the process of determining specifically what kinds of research would be permitted and in what context the research could be funded with federal dollars.
According to NIH director Harold Varmus, MD, the availability of federal funding has the potential to significantly increase the frequency and progress of such research.
"There are a number of advantages to using public funds for research," Varmus told members of the Senate Appropriations Subcommittee on Labor, Health and Human Services, Education and Related Agencies on January 26. "Perhaps the most important reason is the fact that federal involvement creates a more open research environment — with better exchange of ideas and data among scientists — more public engagement and oversight. In addition, federal support increases the fiscal resources and expands the pool of talented investigators — particularly in academia — both of which accelerate the tempo of scientific discovery."
Guidelines coming soon
Varmus convened a special working group of the Advisory Committee to the Director to develop guidelines on what research may and may not be supported with federal money. (For excerpts from the draft guidelines, see p. 79.)
That group has formulated a draft report that is expected to be revised and published in the Federal Register for public comment in the next few weeks, says Mary Grosch, spokeswoman in the NIH’s office of the director. The working group also is expected to develop a proposed oversight mechanism for the NIH to use to evaluate research proposals that involve use of these cells.
Currently, the NIH plans to allow funds to be used for research that uses pluripotent stem cells, but those funds cannot be used to derive the cells from the embryos; that would still have to be funded privately. However, following the HHS finding on the legal issue of using pluripotent stem cells, President Clinton asked the NBAC to consider the developments in stem-cell research and develop ethical guidelines for their use in research.
Bouman, who has read both an early draft of the NIH working group report and a draft report of the NBAC recommendations (available on the NBAC Web site at: http://www.bioethics.gov), says the president’s advisory commission is finally addressing the ethical issues that might support limited use of human embryos in clinical research.
In addition, the commission also has recommended circumstances under which it is ethically plausible to derive stem cells from human embryos and has recommended changes to proposed legislation banning this practice. "We are beginning to have a framework for discussing how these embryos can be treated with an appropriate amount of respect and awe," Bouman says.
The NIH committee also will take the NBAC ethical recommendations into consideration when developing its policy on funding, Varmus says.
The NBAC report, which is still not in its final form, recommends against use of embryos that are created by cloning techniques or from donated gametes because that involves, in essence, human embryos scientifically created solely for the purpose of research.
However, use of embryos leftover from in vitro fertilization and other procedures might be considered ethical because they were created for another, separate purpose but never used.
The report strongly recommends that the possibility of using leftover embryos for research never be addressed during the process of creating the embryos. "You don’t want a situation of infertility clinics saying, Hey, we’ll just make as many embryos as we can and don’t worry, we can just donate the leftovers to research," Bouma says.
The ethical debate also touches on a little-acknowledged problem in the area of genetic research that led to advances in infertility treatment, he adds. "Worldwide, it has been estimated that there are more than a million embryos stored. We have to address the question of what to do with them."
Obviously, it would have a significant impact on the planet if all of the embryos were implanted, born, and became people, he says. Is it more ethical, he asks, to destroy them? Or are there other options that can ethically be considered?
Sources
• Hessel Bouma, III, Professor of Biology, Calvin College, 3201 Burton S.E., Grand Rapids, MI 49546. E-mail: [email protected].
• National Institutes of Health, Office of Science Policy and Planning, Building One, Room 218, 9000 Rockville Pike, Bethesda, MD 20892-0166.
• National Bioethics Advisory Commission, 6100 Executive Blvd., Suite 5B01, Rockville, MD 20892-7508. For a copy of the Draft Report: The Ethics of Use of Stem Cells in Research, access the commission Web: http://www.bioethics.gov.
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