Burke Simmerman, a staffer on Stagger's committee, said last week he believes a combination of administrative and House pressure will force Kennedy to take action on the Senate bill. The House will act on the bill soon, he said, and if the bill passes, some action will have to follow on the Senate side.
Harvard would also probably prefer some type of legislation rather than enactment of Section 361. But the University has shown it will not accept legislation without strong federal override provisions. Michael F. Brewer, director of the government section of the Office of Government and Community Affairs, explained Harvard believes uniform national standards are necessary to protect researchers from excessive red tape caused by overlapping state and federal regulations. Such regulations would allow them to conduct research in any university they want, so they would not have to choose their university based on local regulations. Brewer also said the overlapping enforcement of federal and state guidelines creates bureaucratic chaos, and wastes valuable energies.
Because of these views, Harvard has engaged in intensive lobbying focusing on the House side, where Harvard and two other universities formed a loosely organized group known as "Friends of DNA," which produces a monthly newsletter to keep approximately 75 universities on the mailing list informed of the progress of DNA legislation. The Friends of DNA also hired Nan Nixon to represent the group to legislators. Nixon later registered as an official lobbyist. Staffers described Harvard lobbying as arrogant and aggressive, but Harvard administrators said they believed their lobbying was not extraordinarily aggressive.
Harvard has maintained a much lower profile on the Senate side, although Steven Merill, a staffer on the Senate Science and Technology subcommittee, said last week the lobbying "may be out of the ordinary for a university--especially a particular university." But generally, because of the murkiness of the legislative situation in the Senate, Harvard has not expressed a very firm position on the Senate bill.
Another twist in the effort to regulate DNA research is the recent proposal to make the NIH guidelines more lenient, lowering the containment restrictions on certain viruses used in the research and giving the local biohazards committees more leeway. While the proposals cannot be approved for at least a few months, sources involved in monitoring DNA legislation say the director of NIH has already given tacit consent to the proposal.
Many critics of the proposals, such as Pamela Lippe, legislative assistant for the environmentalist lobby, Friends of the Earth, say the NIH move is purely political, an attempt to soften the standards before any legislation goes into effect. Dr. Bernard Talbot, a spokesman for NIH, denies this charge, saysing the proposals originated a year ago, before the present legislation was drafted.
King is openly skeptical about NIH's motives. He says the director of NIH said in a guidelines meeting he wanted to get the revisions approved before the legislation went into effect. Many observers also question the data upon which the recent proposals are based. NIH cites a lessening of scientists' fears about the danger of recombinant DNA research; many scientists have testified at public hearings they believe they initially exaggerated the potential danger of recombinant DNA research. However, other scientists, including King, maintain that NIH is "weakening the guidelines without any scientific criteria whatsoever." He noted that the NIH data base has no risk assessment program to determine exactly how dangerous such experiments may be.
"There is constant pressure to push for the lowest common denominator--there's only one way these restrictions are going, and that's down," King said. He added the NIH is not accountable to the public, but is an autonomous institution with responsibility for guiding and funding research.
Another controversial NIH proposal is the issue of greater autonomy for local biohazards committees. NIH's new proposals would allow these groups to grant preliminary approval for research, allowing the researcher to begin his experiments, with a review by NIH to follow. Talbot said this provision would eliminate bureaucratic red tape and frustrating delays for scientists. Matthew S. Meselson, Cabot Professor of the Natural Sciences, supported Talbot's contentions earlier this spring when he testified against a state bill that would have imposed more restrictions on research.
Macy D. Koehler, the biohazards safety officer for the University, says the proposed change is welcome. The old system "is a phenomenal waste of time and paper," she added. Some critics, however, believe this provision might entrust too much power to local committees, whose objectivity they question. Zimmerman noted that the local committees, which are vulnerable to pressure from local universities and scientists, approve at least 60 per cent of the projects they review. Dr. Daphne Kmely, an officer at NIH, said stopping research that is already underway is difficult, if not impossible.
Harvard DNA researchers are subject to both the University's own biohazards committees and the Cambridge Biohazards Committee. Harvard has three such committees, two at the Med School and one at the Faculty of Arts and Sciences. The Faculty biohazards committee is comprised of one undergraduate, one graduate student, a postdoctoral fellow, a lab employee, a faculty scientist, and a community member, with Koehler as an ex-officio member. With this varied membership, Koehler says, the committee can be objective in its evaluations and enforcement of NIH regulations. However, skeptics could point to the case last year of Dr. Charles A. Thomas, then a Harvard researcher, who was accused of conducting experiments above the containment level of his lab. The alleged violation was not reported until a local citizen complained to NIH. Harvard subsequently filed a report.
Reports issued by the Med School and NIH released earlier this spring state Thomas essentially followed the NIH guidelines although he did not have NIH approval for the experiments. Thomas is now on leave in California.
The Cambridge Biohazards Committee acts as a further check to possible abuses of recombinant DNA experimentation. The Commission of Public Health, the City Manager, and the City Council must approve the group's decisions, in an attempt to neutralize universities' pressures on the review board, Dr. Donald Cressler, the committee chairman, says.
The melange of institutions regulating recombinant DNA research and the chaotic legislative attempts to oversee such experimentation vastly complicates the efforts to standardize regulations. The success or failure of devising a satisfactory regulatory process is still an open question. Less uncertain is Harvard's future role. As a sponsor of much of the important recombinant DNA research conducted in the country, Harvard has a huge stake in this issue. The University will clearly continue to use its considerable lobbying clout to shape the outcome.