The guidelines, developed by a panel convened by the NAS, seek to fill a void left by the federal government, which has not offered any regulations for stem-cell research. Although the consensus of scientists is embryonic stem-cell research has the potential to provide cures and insights about various diseases, the research is controversial because obtaining the cells requires the destruction of human embryos.
"Having the guidelines will be a step toward making Congress more comfortable in putting money into the research and going against the president," Arthur Caplan, director of the Center for Bioethics at the University of Pennsylvania, told United Press International. Caplan was not involved in developing the guidelines.
The policy supported by President George W. Bush seeks a compromise between the ethical concerns and potential medical benefits. It limits federal research funding to 78 lines of human embryonic stem cells already in existence prior to his decision in August 2001. However, scientists have found most of the lines are not available. There also are concerns all of the lines could be contaminated with animal molecules, because they were grown initially on mouse and fetal-calf cells.
"I suspect you may deliver, even within the White House, enough pressure from patient advocates, bioethicists and scientists saying, 'Look, your (ethical) worries are partially met by these rules,'" Caplan said. "I think this will become a chip that proponents will play."
The Coalition for the Advancement of Medical Research in Washington, an organization that advocates embryonic stem-cell research, applauded the guidelines and appeared to be headed in the direction suggested by Caplan.
"This report is 'proof of principle' that expanding the president's stem-cell policy is the correct scientific path," CAMR President Daniel Perry said in a statement. "The strong ethical standards in this timely report should give congressional champions of research even more support to expand the current federal stem-cell policy, and should give those who are still waiting on the sidelines a reason to get in the game."
The White House did not return a phone call from UPI seeking comment.
Groups opposed to the research did not see the guidelines as a positive step.
"From our point of view, embryo stem cell research is unethical to begin with," Gene Tarne, communications director of Do No Harm, a group based in Washington, told UPI. "No amount of rules and regulations is going to make it ethical."
Regarding potential efforts by proponents to use the guidelines to persuade the Bush administration to relax its restrictions, Tarne said, "Frankly, I don't know if that's going to convince anyone who's opposed to this research."
The guidelines are voluntary, but the committee urged scientific journals, research institutions and professional societies to adhere to them to establish a uniform set of standards across the nation.
"A standard set of requirements for deriving, storing, distributing, and using embryonic stem-cell lines -- one to which the entire U.S. scientific community adheres -- is the best way for this research to move forward," committee co-chair Richard Hynes, a cancer researcher at the Massachusetts Institute of Technology in Cambridge, said in a statement.
"Heightened oversight is essential to assure the public that stem-cell research is being carried out in an ethical manner," added committee co-chair Jonathan Moreno, a biomedical ethicist and director of the Center for Biomedical Ethics at the University of Virginia in Charlottesville.
The guidelines, which were developed without the involvement of the federal government, recommend the establishment of a national panel to review stem-cell research periodically and determine if the guidelines should be updated.
The guidelines call for Embryonic Stem Cell Research Oversight committees, or ESCROs, to review embryonic stem cell research proposals, including those that involve therapeutic cloning.
Human embryos should not be grown for longer than 14 days and cloning that is intended to produce another human, also known as reproductive cloning, should not be allowed, the panel advised in the guidelines.
The guidelines also include limitations for mixing human and animal cells, also known as chimeras, which could occur when researchers need to test the therapeutic potential of human stem cells in experimental animals.
The panel recommends required approval by an ESCRO committee before human stem cells are put into animals. Members also recommended no chimeras should be allowed to breed and no human stem cells should be put into non-human primates.
The guidelines are intended to help researchers prepare for the possibility that stem-cell therapies one day will be ready for experiments in humans patients and be subject to approval by the Food and Drug Administration. The panel's recommended requirements for careful documentation of donors, informed consent and confidentiality were partially based on consultation with FDA officials, Hynes said.
Experts said the guidelines should not affect the practices of scientists working in the field very much, because most already adhere to strict policies.
"This is completely consistent with the spirit of how we've been operating all along," said Dr. Robert Lanza, vice-president of medical research at Advanced Cell Technology of Worcester, Mass., which is engaged in stem-cell research.
"We've been following most of these guidelines independently," he told UPI.
Steve Mitchell is UPI's Medical Correspondent. E-mail: firstname.lastname@example.org
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