April 26, 2005 --The National Academy of Sciences has recommended new ethical guidelines for human embryonic stem cell research, hoping to set common standards for states, universities, and companies.
Experts say they hope that researchers who use stem cells in the search for new cures will adopt the voluntary guidelines. The proposal includes establishing independent boards to review future studies involving human embryos. A ban is recommended on any financial payments to individuals or clinics involved in the donation of sperm, eggs, or embryos.
The U.S. lacks nationwide standards for most embryonic stem cell research because federal funding for studies is highly limited. A decision by President Bush in August 2001 restricted funding for research on embryonic stem cells to some 77 stem cell lines that were already in existence at the time.
Federal rules on embryonic stem cell research apply only to research on these lines.
Embryonic stem cell research is controversial because the stem cells are taken from a human embryo, which is destroyed in the process.
Most states have no policy on embryonic stem cell research. Four states, including California and Massachusetts, have laws set up for state-funded research. Several other states have banned the cloning technologies needed to conduct the studies. The result has been a patchwork of standards that experts warn could be a hurdle as future scientists seek to collaborate on research studies, academy committee members say.
Guidelines Call for Research Oversight Committees
Experts have also expressed a desire to set early limits on the research, calling for restrictions on stem cell research involving the transfer of human cells into laboratory animals. Guidelines also call for strict standards of informed consent for donors whose cells or embryos could be used in future stem cell studies.
"There's significant public support for this research, it's ongoing, and there needs to be thought about how it's to be done properly," says Richard O. Hynes, PhD, a cancer researcher from the Massachusetts Institute of Technology and a co-chairman of the committee issuing the recommendations.
The standards call for a strict record-keeping system that tracks the source and genetic makeup of all embryos used in research. It also calls for strict confidentiality standards designed to protect the privacy of any donors who elect to give their eggs, sperm, or embryos for study.
The guidelines echo several international standards by limiting research to embryos that are within 14 days of fertilization.
They also advise all universities, companies, or any other groups that conduct stem cell studies to establish embryonic stem cell research oversight committees. These committees -- made up of scientists, ethicists, lawyers, and others -- would provide "an additional level of review" to monitor all stem cell studies. Panelists say the committees would provide review over the institutional review boards that now monitor human subjects' research at most institutions.
The academy issued the guidelines in response to a request from scientific organizations that have long called for unified ethical standards. Researchers remain concerned that differing rules could make it impossible for scientists to share research materials or study designs across state lines.
'Playing From the Same Guidebook'
Experts also say the rules were designed to reassure the public that stem cell research will proceed with tight ethical strictures.
"We're also concerned that the general public sees that the scientists are all playing from the same guidebook," Hynes says.
Experts called for a ban on all payments for cells or embryos, a measure Hynes says was necessary to keep the donations "altruistic" and free of questions of financial conflicts of interest.
That recommendation could prove controversial because many companies already pay women who donate their eggs for use by in vitro fertilization clinics, says Janet D. Rowley, MD, a professor of medicine at the University of Chicago and a member of the panel.
"That's, I think, going to be an issue where some people may accept the guidelines and some do not," she tells WebMD.
"It was the consensus of the panel that it should err on the side of being conservative in these matters," says Rowley, the only academy panel member who also sits on the President's Council on Bioethics, a White House group largely opposed to most forms of embryonic research.
Tuesday's recommendations would probably put the academy at odds with the President's Council, Rowley says.
The academy's recommendations call for a ban on all cloning intended as a means to reproduce a child. Several bills in Congress also seek to ban the practice, often called "reproductive cloning."
But panelists say they did not consider whether so-called "therapeutic cloning" meant for disease research should also be banned.