When California voters approved the sale of $3 billion in bonds to pay for embryonic stem cell research, their votes offered few indications of what type of research citizens were willing to accept and how far scientists could go to procure stem cells. In fact, the state’s Proposition 71 remained silent on ethical questions about whether doctors could pay women to purchase their eggs — as most fertility clinics do — or transfer animal stem cells into human fetuses, and vice versa.
Making their own guidelines:
On the federal level, few government agencies have stepped in to develop standardized guidelines for researchers after President George W. Bush restricted federal funding for new embryonic stem cell lines, leaving what the National Academy of Sciences has called “a patchwork of regulations” that varies state by state and throughout a community of very confused scientists.
After receiving requests from scientists across the nation, the NAS came out last month with a set of its own voluntary guidelines, hoping to find the right mix of scientific independence and social ethics. The NAS report was unusual in that the impetus came from the scientific community instead of the government, which usually commissions similar studies. In fact, as a congressionally chartered body, the academy is designed to serve as the federal government’s chief scientific adviser.
“Because federal funding for embryonic stem cell research has been very limited, the federal government hasn’t established many guidelines in this sphere,” said University of Virginia biomedical ethics professor Jonathan D. Moreno, who co-chaired the committee that wrote the guidelines. “The feedback [on our recommendations] has been almost uniformly very positive.”
The new guidelines suggest prohibiting doctors from paying donors who offer stem cells for research and would require researchers to collect consent from couples whose embryonic stem cells would be used in studies. In addition, the recommendations urge a prohibition against using cells from embryos grown in cultures that are older than 14 days — when the central nervous system begins to form — and back a ban on the transplantation of animal cells into human fetuses, creating mixed organisms called “chimeras.”
Perhaps most importantly, the guidelines call for the creation of new Embryonic Stem Cell Research Oversight committees, made up of scientists, ethicists and members of the public, to review new research proposals at each institution and company engaged in studies involving stem cells.
Members of the scientific community have largely praised the new guidelines.
“They’re excellent and I hope that many American institutions will move to implement them,” said UCSD cellular and molecular medicine professor Larry Goldstein, who was one of the authors of Proposition 71. “They allow the research to move forward and to do so in an ethical manner.”
In addition, the new guidelines have won accolades from California Institute for Regenerative Medicine’s interim President Zach Hall and the institute’s Independent Citizens’ Oversight Committee Chair Robert Clein, whose joint statement called the recommendations “an important step in forging a much-needed national consensus that will guide institutions, scientists and funding agencies in this new field of research.”
The institute will be responsible for spending the state’s $3 billion embryonic stem cell research budget, and its governing committee will likely adopt the NAS guidelines as the institute’s interim ethical standards at a meeting later this week.
However, the report has been called inadequate by the Oakland-based Center for Genetics and Society, which also backs embryonic stem cell research. The center criticized the guidelines for stopping short of supporting the creation of a federal agency to license and oversee all research involving human embryos and cells derived from them, similar to governmental bodies found in Canada and Britain.
“This is certainly a shortcoming of what NAS could do, and it was disappointing to see them back off the kind of regulatory structure that is in place in the United Kingdom and Canada,” CGS Associate Director Marcy Darnovsky said.
The center also faulted the guidelines for falling short in protecting the women who provide eggs for research by failing to require that independent doctors — those not connected with the research projects — be on hand to care for donors.
Overall, Darnovsky said a merely voluntary approach was not enough to properly regulate a field that faces $3 billion in incentives for new research. In addition, she worried that the ESCRO committees envisioned by NAS would be too cozy with the doctors they would supposedly be overseeing.
“One concern is that they’re too close to the people. The gardeners are too close to the chicken coop,” Darnovsky said. “There is not sufficient distance that would give people assurances and give these people on the ESCRO committee the room to consider what is being proposed.”
Darnovsky’s fears may not be implausible.
Federal regulations already require local institutional review boards to approve all research that involves human subjects and the use of human gametes and embryos in the generation of new stem cell lines. UCSD has four such IRBs.
In addition, all organizations and companies that receive federal research funding must have an institutional biosafety committee to approve any project that uses recombinant DNA. Created in the 1970s, when the specter of human cloning first appeared on the government’s radar, IBCs have generally been viewed by the scientific community as a great success in self-governance through nonbinding guidelines.
However, a report released last October by the Sunshine Project, an activist organization opposing biological weapons, has questioned the effectiveness and transparency of local IBCs. In a survey of minutes kept by the committees, the organization concluded that IBCs were largely dominated by the biotechnology industry they were supposed to be regulating.
For example, at University of Hawaii — which operates labs that work with potential biological-weapons agents — the group found sparse minutes limited largely to back-slapping notes recording how much the university and biotech company Monsanto really enjoyed working with each other. The minutes showed no evidence that the IBC reviewed any research or lab safety conditions.
But other than a few outrageous examples, Sunshine Project’s report stopped short of actually recording a trend — because more than 75 percent of the surveyed biotech companies failed to turn over minutes from their committees, despite federal law requiring them to do so. The government’s own labs did only slightly better, with four of 10 turning over comprehensive minutes.
Like several examples cited by the Sunshine Project, Darnovsky said she feared that ESCRO committees would be reluctant to block colleagues’ attempts to secure funding for their projects.
“It just makes it very hard for people on committees like that to buck requests from colleagues and puts them in an untenable position,” she said.
However, Darnovsky admitted that the alternative — a government agency to oversee the research — posed problems of its own, opening up the door for politics to influence science.
“I think that’s something that really has to be taken into account, and [an agency] has to be set up with real isolation from government interferences,” she said. “It is tricky, and I’m sure it’s why there is so much reluctance about setting up centralized regulation.”
On an issue with such high political stakes as stem cell research, which echoes many moral arguments central to the debate over abortion, there is little doubt that any new government effort would face stiff partisan pressures. Already the response to the NAS recommendations is split largely among partisan lines.
For example, Sen. Dianne Feinstein (D-Calif.), a supporter of embryonic stem cell research, issued a statement backing the guidelines, concluding that lawmakers “should be doing all that we can to encourage this pioneering research to go forward.”
The same day, on the other side of the political debate, research critic Sen. Sam Brownback (R-Kan.) criticized the recommendations as a “distraction.”
“These so-called ‘guidelines’ for destructive human embryonic stem-cell research try to put a good face on an unethical line of research,” he stated in a press release. “They attempt to frame the issue as ‘how to conduct ethical research,’ but the guidelines entirely miss the point: We should not be destroying young human lives for the benefit of others.”
These guidelines are not the first time the stem cell debate has taken on a larger moral question. When Bush appointed UC San Francisco cell biologist Elizabeth Blackburn to his newly formed blue-ribbon President’s Commission on Bioethics in 2002, he called her a “distinguished” researcher. However, Blackburn’s appointment was not renewed in 2004, largely because of her outspoken support for stem cell research, which the president had already decided was unethical for the government to fund.
Blackburn was trumpeted as a martyr by the left-leaning Union of Concerned Scientists, who pointed to her termination as evidence of the politicization of science by the Bush administration. Sen. John Kerry (D-Mass.) repeated the accusation in his 2004 campaign to replace Bush.
The NAS report acknowledged that regulation of embryonic stem cell research has to walk the precarious line between science and ethics.
“Scientific inquiry should not proceed unfettered, without consideration for the ethical and public-policy imperatives of the society in which it operates,” stated Moreno and committee co-chair, Massachusetts Institute of Technology cancer-research professor Richard O. Hynes, in the preface to the recommendations. “Ethical concerns need to be balanced against the duty to provide the best medical care possible, enhancing the quality of life and alleviating suffering for many people. The challenge to our society is to achieve that balance.”
Goldstein said he and his colleagues did not oppose rules to guide their research, as long as they were done right.
“Scientists are willing to be regulated, as long as we get to have input in the regulatory system,” he said. “I think all of us who are going to do this research want a set of agreed-upon standards so that we don’t step across the line.”
The main question, it seems, is whether those standards should come from the scientists themselves or be imposed by the government. The NAS report backed the former, though Moreno said this was because the academy does not have the authority to impose mandatory rules.
In 2003, when a different NAS committee urged increased regulation of research that could be used by international terrorists, UCSD School of Medicine Deputy Dean David N. Bailey offered his own suggestion: The answer may be somewhere in between, with society accepting self-regulation as long as it is effective and calling on government action when voluntary guidelines fail.
“If you do not have any segment of society regulating itself, you have regulations imposed on it,” Bailey said at the time. “I think that’s what’s happening here. If science is irresponsible, then I think society will jump in and start mandating and regulating control.”
