Report on Screening U.S. Biological Research Draws Mixed Reviews

By David Ruppe
Global Security Newswire

WASHINGTON — A new report recommending nationwide screening for proposed biological research in the United States that might have value for terrorists is drawing general praise, but also criticism for not recommending mandatory participation for all facilities nationwide.

The report, produced by a committee of the National Academy of Sciences Research Council, weighs into an ongoing debate within the biological research community that has some experts favoring a federal regulatory scheme that involves creating a federal body for reviewing proposed research of concern. Others say such a system would prove unworkable and might hamper important scientific research that might produce results usable for great good, if also for malicious purposes.

The report recommends a tiered system, through which most decisions on whether to allow a particular research project would be made by a board at the facility concerned, though a federal committee might decide some particularly serious cases.

The report describes its approach as one that “relies heavily upon voluntary self-governance by the scientific community and expansion of an existing regulatory process.”

In a press release yesterday, Massachusetts Institute of Technology professor Gerald Fink, the chair of the committee called the report “a key stop in an evolving process to strike the right balance between national security concerns and the openness necessary for America’s research enterprise to thrive.”

The proposed plan calls for institutional biosafety committees, which are already in place at many institutions, to continuously review proposed experiments involving seven categories of research that might have potential use for terrorists.

The types of experiments that would be reviewed, according to the proposal, include those that might demonstrate how to render human or animal vaccines ineffective; confer resistance to antibiotics or antiviral agents; enhance the virulence of pathogens, or make nonpathogens virulent; increase the transmissibility of pathogens; alter the host range of pathogens; enable the evasion of diagnostic or detection methods; or enable the weaponization of biological agents or toxins.

Decisions about whether to allow experiments, or alternatively to decide they should be classified, mostly would be considered and made by the local committees. Certain types of experiments of particularly serious concern would also require approval by a federally appointed committee at the National Institutes of Health.

The report also recommends reviewing some completed studies to determine whether their publication might aid terrorists. It does not, however, recommend creating a regulatory system for preventing publication of such work.

“The issue of whether these results should be published needs to be resolved within the scientific community — not by government policy,” the report says.

It also proposes creating a “National Science Advisory Board for Biodefense” to provide advice to the NIH director on the benefits and risks of new research and to promote dialogue between scientists and security experts.

Rutgers University professor Richard Ebright mostly praised the report, but said it came up short by not making the reviews mandatory for all U.S. research institutions.

“The panel has correctly identified the problem [and] correctly recognized the magnitude of the problem. It has concluded correctly that the solution to the problem must involve a combination of voluntary self-governance and expansion of regulatory mechanisms,” he said.

“However, what they propose is exclusively voluntary self-governance. … They propose a strictly voluntary review process,” he said.

Ebright said research facilities that do not receive NIH funding would not be required to submit research for review, under the recommended plan.

The process “excludes most laboratories in the private sector, the government and in the defense sector,” he said.

Ebright said the plan should recommend mandatory participation backed by sanctions for nonparticipation or violations.

Lynn Klotz, a member of the Federation of the American Scientists’ Working Group on Biological and Chemical Weapons, praised the report’s recommendations, in particular, for relying predominantly on institutional committees for screening.

He said creating a national authority for screening most research would prove difficult because many types of biological research could be put to constructive or illicit purposes.

“Boy would that be a real hornet’s nest. I don’t know how you would do that. … I think that many things are going to fall into that category, where you see the potential good and the potential evil purposes. Almost everything could be used one way or another.”

Klotz also agreed with Ebright’s view that the proposed screening process should extend to all biological research facilities, not just those with institutional biosafety committees.

“Clearly a mechanism has to be in place to extend the review process to other institutions … including companies and other research facilities that do not have institutional review boards,” he said.

Ebright said the issue over mandatory compliance could easily be remedied.

“This could be changed with just a single sentence, stating that, ‘The current NIH guidelines and process for review will be used for examining the experiments of concern, [for which] the participation will be mandatory irrespective of funding source [and] there would be sanctions for nonparticipation or violation,’” he said.

The National Academy of Sciences press release yesterday said the report intended to recommend mandatory compliance.

The final version of the report released today, however, does not say participation would be mandatory, Ebright said.

“The full report on pages 89 and 90 says that this is a goal for the long term,” he said.

At an academy briefing on the report today, Ronald Atlas, member of the committee that produced it, said participation by institutions not funded by NIH would be voluntary, but that he expected that participation would occur.

“The sense is that this is a bottom-up approach, in which collegiality within the scientific community and peer pressure will be critical across the system,” he said.

Ebright said of such participation, “If it’s not mandatory, it doesn’t exist.”

[EDITOR'S NOTE: This National Academy report was partially funded by the Nuclear Threat Initiative, the sole sponsor of Global Security Newswire, which is published independently by National Journal Group.]

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