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Professor Develops Stem Cell Guidelines

By Jiao Wang

The cloning of Dolly the sheep in 1997 was the first of many experiments that caused the public and the scientific community alike to consider the ethical, legal, scientific, and policy issues that naturally follow such a breakthrough. Although it took 277 attempts before scientists finally managed to produce Dolly, the process was considered a success and repeated many times in other animals.

As part of the Research Council and Institute of Medicine at the National Academies, MIT Professor Richard O. Hynes played a key role in drafting one of the few sets of guidelines for stem cell research. The guidelines, publicly available online, are a first attempt to regulate a vast uncharted territory we are only beginning to explore.

Although the 131-page document was not written for lay people, its attempt to set certain standards and limitations may reassure the general public that their worst fears will not be realized. The guidelines reject research involving in vitro culture of intact human embryos for longer than 14 days or until the formation of the primitive streak, a group of opaque cells whose appearance sets the stage for gastrulation. Human embryonic stem (hES) cells would not be allowed to be introduced into nonhuman primate blastocysts. Animals injected with hES cells would not be allowed to breed.

Released by the council on April 26, 2005, the report is titled “Guidelines for Human Embryonic Stem Cell Research.” It calls for the establishment of Embryonic Stem Cell Research Oversight (ESCRO) committees in all research institutions to assist in the approval of relevant experiments. While Hynes, who was co-chair of the Committee on Guidelines for Human Embryonic Stem Cell Research, acknowledges this would add another layer of bureaucracy, he believes that ESCRO committees would eventually fall in place with existing establishments that presently oversee laboratory safety and animal research.

Stem cells spark heated debate

In recent years, there has been a tremendous stir regarding the potential use of stem cells in the treatment of a wide range of diseases, including heart disease, stroke, spinal cord injuries, and burns. Dolly was created from adult stem cells — the undifferentiated cells in the body which are usually found among differentiated cells in a tissue or organ. Today, scientists believe embryonic stem cells, derived from embryos fertilized from eggs in vitro, are the more powerful of the two types. Researchers around the world are currently growing and isolating these cells in culture dishes to understand what directs them to differentiate to serve all the different functions in the body.

Although the amount of hES cell research has increased dramatically since scientists demonstrated their promise and potential benefits to society, the lack of federal aid and regulation in the area has led many to resort to private funding and to conduct research based on existing rules not entirely geared toward the nature of their research. Although some believe hES research should not be hindered because of its potential to save lives, others are concerned about the lack of oversight in the field.

Hynes said the guidelines provide a platform “for people doing research so that they know they are following the rules.” They “give scientists structure from which to work” amidst the “vacuum of regulation.”

In the public’s mind, the idea of hES cell research can conjure up images from science fiction. Chimeras, for example, are animals genetically engineered with multiple DNA templates (potentially sourced from different species) in different cells — ordinary organisms have only one set of DNA in all their body cells. The creation of such animals have led some to imagine laboratories housing creatures such as mice that can think. Many scientists believe that human cells would be unlikely to integrate successfully into a mouse embryo, given the significant difference in gestation times between the two species; nonetheless, such speculations create significant concern, even among those not opposed to stem cell research in principle.

Along the lines of recommending institutional oversight of hES cell research, the guidelines call for the creation of Institutional Review Boards to ensure that the procurement process of hES cells is properly reviewed. These boards would require the informed consent of all donors of any somatic cells, gametes, or blastocysts to be used. No cash or payments would be provided for donating blastocysts in excess of clinical need for research purposes. Finally, research should be conducted in accordance with laws and guidelines pertaining to recombinant DNA research and animal care.

Although there are currently no means of enforcing the guidelines, Hynes believes various professional societies such as the American Association of Medical Colleges will follow the recommendations. He talks about the existence of a network exerting pressure on scientists to behave themselves in accordance with community norms, saying that scientists rely on the publication of papers, the securing of grant funding, and the reputations they develop working within scientific institutions, none of which they will easily forego. Most rely to a certain extent on federal aid and thus must follow federal regulations.

President Bush’s 2001 Executive Order states that scientists can only conduct hES cell research using the nineteen stem cell lines currently available to federally funded researchers. Since then, it has been discovered that the lines are contaminated from mouse feeder cells and unfit for clinical use due to the possible transfer of mouse proteins. Although they are still useful in answering basic embryonic stem cell questions, scientists are not allowed to use lines created since 2001 with federal funding.

Bush’s policies have not only hindered research in the United States and contributed to the increasing leadership of the United Kingdom in embryonic stem cell research, they have also led to some anomalous situations in United States laboratories. Harvard University Professor of Molecular and Cellular Biology Douglas A. Melton currently maintains two separate laboratories. One relies on federal funding, uses federally approved stem cell lines; research there is conducted in accordance with federal laws. The other is privately funded and allows him to bypass certain federal regulations that may hinder his cutting-edge research.

The recommendations put forth in Guidelines for Human Embryonic Stem Cell Research are only recommendations on how to approach a problem. Although it is likely that the majority of scientists will follow them, they are not law and are still subject to change. The ending of the book itself provides a degree of flexibility in the process, saying that “a national body should be established to periodically asses the adequacy of these guidelines and to continue to discuss the issues of hES cell research.”