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State council backs stem cell rules

But critics fear scientists at risk

State regulators appointed by Governor Mitt Romney adopted rules for stem cell research yesterday that Harvard University and most of Boston's major hospitals and research centers opposed, fearing they could subject scientists to criminal penalties for certain research activities.

The university and medical institutions say a section of the regulations, approved by the Public Health Council, goes beyond the scope of the stem cell law the Legislature passed last year, after overriding Romney's veto. The measure was seen as giving encouragement to research on human embryonic stem cells in Massachusetts because it lifted a requirement that such research be approved by local district attorneys.

Democratic legislators reached last night said they plan to review the regulations.

``We are deeply disappointed by the council's action," B.D. Colen, a Harvard University spokesman, said last night. ``We believe that it has inappropriately criminalized an action neither specified nor criminalized by the Legislature."

Harvard has made stem cell research a priority, launching a $100 million fund-raising effort two years ago to pay for its scientists' work. Embryonic stem cells have the capacity to become any cell in the body, and scientists say the research could lead to insights into disease and possibly treatments.

The research has triggered opposition from antiabortion groups, however, because current methods of obtaining stem cells require destroying embryos, which critics say is equivalent to taking a human life.

In vetoing the stem cell bill, Romney said he could not sanction the creation of human embryos by scientists only to see them destroyed for research. He supports research using embryos left over from in vitro fertilization, but opposes creating cloned human embryos in order to harvest stem cells -- a procedure permitted under the law and that two Harvard teams are pursuing.

The new regulations don't appear to restrict any work that is publicly known to be underway or currently planned at Harvard. But in written testimony submitted to the state Department of Public Health in May, Partners Healthcare, Dana-Farber Cancer Institute, Harvard , and six of its affiliated hospitals and research centers said the regulations might inhibit scientists from participating in important aspects of stem cell research that will be conducted in other states.

In particular, the organizations objected to language in the regulations that they said expanded a prohibition explicitly stated in the law -- on creating fertilized embryos for the sole intent of ``donating" the embryo for research -- to the creation of a fertilized embryo for the sole intent of ``using" it for research. That wording, the opponents say, applies the prohibition to the scientists, which they say the Legislature did not intend.

In a memo to the council, the Public Health Department's deputy general counsel, Melissa J. Lopes, responded that the law grants the agency broad authority to write regulations and implicitly bans the creation of fertilized embryos solely for use in research.

State Representative Peter Koutoujian , chairman of the House Committee on Public Health , said he was surprised and concerned by the council's decision. The Waltham Democrat said the Legislature now will have to review the regulation.

``We're not dealing with mad scientists," Koutoujian said, ``and to treat them as criminals, I believe, will inhibit the very research that we seek to promote."

Romney, who is widely believed to be weighing a run for president in 2008, has come under fire in the past year for putting his political stamp on the state Department of Public Health.

In May, he completed an overhaul of the Public Health Council, abruptly ousting members who championed a ban on giving away infant formula at hospital maternity wards. Earlier in the year, the health agency, at the governor's direction, introduced a new abstinence education plan for state schools.

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