Stem Cell Research Standards Offered

With human embryonic stem cell research advancing more quickly than the government’s appetite for regulating it, a national science panel issued a wide-ranging set of guidelines Tuesday to prevent scientists from crossing delicate moral and ethical boundaries.

Among the many recommendations in the 131-page report is a prohibition against allowing people to produce embryos for profit, and an admonition against transplanting the cells into animals in a way that might make them assume some human qualities. The report, commissioned by the National Research Council and the Institute of Medicine, also bars transplantation of human stem cells into monkeys or other primates.

The guidelines “should satisfy the public that this research is being done for the best interests of tens of millions of patients,” said Daniel Perry, president of the Coalition for the Advancement of Medical Research, a stem cell research advocacy group. “It’s not something that’s being done ad hoc by rogue scientists.”

Though voluntary, the guidelines could become de facto regulations here and abroad if the fledgling California Institute for Regenerative Medicine adopts them and requires its collaborators to adhere to them as well.

California’s influence has already been felt. The recommendations were finalized ahead of schedule so the state stem cell agency could use it as a template for its own ethical and scientific standards, which must be in place before it can begin distributing $3 billion in grants, as approved by state voters last year.

The willingness to accommodate California’s needs reflects the state’s anticipated dominance in the field due to an investment that dwarfs all other funding sources -- including the federal government.

Bob Klein, chairman of the stem cell agency’s board, said Tuesday he hoped that after review, the board would be able to adopt the guidelines at “the earliest possible date.”

The recommendations are designed to assure scientists and the public that embryonic stem cell research is conducted in a manner that recognizes the sensitive nature of the work.

Though the guidelines failed to appease social conservatives who oppose embryonic stem cell research, scientists predicted the proposals would be eagerly adopted by universities and other institutions. “This document lays out the right principles for approaching these issues, and some excellent details about how to do it,” said Larry Goldstein, who studies embryonic stem cells at the UC San Diego School of Medicine and the Howard Hughes Medical Institute. “I would argue strongly that we should base our own practices on this, and I hope the state of California will do likewise.”

The guidelines are intended to fill a vacuum created by the Bush administration’s limitations on embryonic stem cell research. In 2001, President Bush decided to restrict federal funding to embryonic cell lines already in existence, which effectively meant only a small number of lines fell under federal oversight. The lines he approved, Bush noted, came from embryos that already had been destroyed. At the same time, he banned any federal spending on research that would lead to the destruction of more embryos, which occurs when new lines are created.

But the federal restrictions do not extend into private or state-funded research. The result is that research has surged ahead of a national agreement on how it should be conducted.

Embryonic stem cells hold the possibility of breakthrough medical therapies based on their ability to become any type of cell in the body. Doctors could treat patients with juvenile diabetes, for example, by growing new islet cells capable of making insulin.

At the heart of the new guidelines is the establishment of embryonic stem cell research oversight committees made up of scientists, legal experts, ethicists and members of the public.

The oversight committees would review all requests to create lines of stem cells from embryos supplied by fertility clinics or through a procedure called nuclear transfer, also known as therapeutic cloning.

One key strategy of the guidelines is to ensure that the field, which has enormous commercial potential, is free from financial conflicts of interest.

To that end, researchers in need of embryos may not take part in decisions regarding the creation of embryos in fertility clinics, the guidelines state. Couples may not be paid for donating excess embryos to researchers, and women who allow scientists to harvest their eggs may be reimbursed only for their out-of-pocket expenses.

Donors must understand that they will not share in the financial benefits that may flow from the cells they provide, the guidelines say.

“This is to avoid inducements for people to do this for a profit motive,” said Richard Hynes, an MIT cancer researcher who led the committee with Jonathan Moreno, director of the Center for Biomedical Ethics at the University of Virginia. “It should be an altruistic motive. This should not be a commercial activity.”

The panel also emphasized the need to obtain informed consent from donors of genetic material and prohibited the derivation of stem cells from embryos created with sperm from anonymous donors to sperm banks.

“If you’re going to take that genome and immortalize it forever, the person might want to know,” said Keith Yamamoto, a professor of cellular and molecular pharmacology at UC San Francisco School of Medicine, who endorsed the guidelines.

The identity of donors should remain confidential, the panel said.

In addition to the on-site committees, the panel recommended that a national body be created to provide a forum for issues that arise as embryonic stem cell research continues and to ensure that research guidelines are reviewed periodically.

Despite the guidelines’ restrictions, Goldstein of UC San Diego said, they could actually accelerate the pace of research.

“In the absence of clear regulation, when you want to do something that somebody thinks is controversial, you take a lot of time discussing what you should do and how you should do it,” he said. “If you have to reinvent the wheel every time there’s a new problem, it’s slower.”

Zach Hall, interim president of California’s stem cell agency, said in a statement with Klein that the guidelines also laid the groundwork for a “much-needed national consensus” on stem cell research.

But opponents of embryonic stem cell research said the guidelines created only an illusion of consensus.

“The authors [of these guidelines] obviously don’t share the ethical perspective of most Americans,” said Douglas Johnson, legislative director of the National Right to Life Committee.

For staunch opponents of embryonic stem cell research such as Sen. Sam Brownback (R-Kan.), no guidelines would make the science morally acceptable.

The proposal, he said, is merely an attempt “to put a good face on an unethical line of research.”

He said the guidelines also distracted people from paying more attention to research on stem cells from adult tissue, which raises fewer ethical issues.