A federal advisory panel endorsed the controversial new scientific field of human embryo research Tuesday, saying it holds significant promise for medical advances, but proposed a strict framework for its conduct.
The research has generated growing ethical concerns because it deals with creating and manipulating human life.
While the human embryo "warrants serious moral consideration as a developing form of life, it does not have the same moral status as infants and children," the panel said in a report to the National Institutes of Health, which will study the report further before any guidelines are finalized. The report said embryos lack feeling and individual development, and "most other qualities considered relevant to the moral status of persons." It also cited the very high rate of natural mortality at that stage.
Many scientists believe that studying the human embryo--at one week a cluster of cells no bigger than a period at the end of a sentence--could yield infinite knowledge about some of mankind's worst medical problems, including genetic diseases, infertility and cancer.
Nevertheless, the work has been condemned by abortion foes, who view it as the destruction of human life. Rep. Robert K. Dornan (R-Garden Grove) has vowed to lead a congressional effort to derail federal funding for such research.
The panel's recommendations apply only to research conducted on human embryos that are created outside the uterus--that is, embryos produced in a laboratory by mixing sperm and egg. The panel said that research should be limited "to the shortest time possible" and should not be allowed beyond 14 days, which is considered a key transition time in the development of the embryo.
This is the point at which the "primitive streak" appears, an advancing line of cells that determines the embryo's head-tail, right-left orientation and indicates the beginning of the development of individual organs.
Generally, an embryo is not regarded as a fetus until it is at least eight weeks old.
On the most controversial question--whether embryos should be made solely for research purposes--the panel condoned the practice only under two specific scientific conditions: "When the research by its very nature cannot otherwise be validly conducted" and when a "compelling" case can be made that it is necessary "for the validity of a study that is potentially of outstanding scientific and therapeutic value."
The advisory group acknowledged that the second category would likely warrant "special scrutiny" during the grant review process.
The panel was established last year by the NIH to grapple with the numerous ethical problems and to draft a blueprint to guide NIH's review of projects seeking federal funding. The report will undergo further study within NIH and be the subject of a public meeting in December. NIH Director Harold Varmus will make the final decision on guidelines to govern the work.
Although the guidelines will not apply to privately funded work, they are nevertheless expected to influence private research in that they will bring the entire field under public scrutiny and pressure.
The American Fertility Society praised the report for its "cautious, balanced and sensitive parameters for research," saying that such research was "obviously . . . of grave importance," to its organization. Nevertheless, the society said it believes human embryos "should be treated with special respect and extreme sensitivity at every level of research."
But the American Life League called such research "immoral, unethical and evil," and said that it would "pursue every moral and ethical avenue that is open to us."
Dr. William F. Colliton Jr., the league's director of medical affairs, said that the panel had "turned its back on God" and described the work as "Nazi Germany revisited," work that must be stopped.
The NIH panel explicitly recommended that research involving cloning, or "twinning," of embryos be prohibited.
Last year, researchers at George Washington University Medical Center here caused an uproar after announcing that they had experimentally cloned human embryos--that is, divided them into identical twins or triplets. Their experiment raised the specter that, since human embryos could be frozen and used later, parents could have a child and then, several years later, have that child's identical twin. Critics also raised the most extreme example of such work: that parents could have an identical twin years later to serve as an organ donor for the older child.
The response caused the researchers to announce that they would abandon any further attempts at cloning embryos.
The NIH advisory panel also recommended prohibiting research into human/animal combinations, implantation of human embryos into animals and any attempts to implant parthenotes, which are eggs that have been artificially stimulated with chemicals or electricity to begin developing in the absence of sperm.
But the panel concluded that research into the process of parthenogenesis may be valuable in understanding egg development. These so-called parthenotes die several days after they are generated and do not develop into real embryos.
The panel also sanctioned studying human embryos to gain advanced knowledge of potential genetic disorders but said such research should not be used for sex selection, except for sex-linked genetic diseases.
The panel said that donors of gametes--eggs and sperm--or embryos must give informed consent with regard to the specific nature or purpose of the research being undertaken. The panel also said that gametes or embryos for research cannot be sold or purchased.
Most U.S. human embryo research has been an adjunct to in vitro fertilization--helping infertile couples become parents.
But scientists believe that an increasing emphasis on such research will not only enhance the currently low success rates for IVF but also can provide new opportunities for understanding the mechanisms of cancer--by studying the ways cells divide--and the workings of genes.
Another potential benefit of human embryo research is as a source of cells that ultimately could serve as the basis for numerous therapies, such as bone marrow transplants, repair of spinal cord injuries or skin replacement.