Under discussion. A German ethics council is recommending more oversight of dual-use research that can be used for good and evil—the topic of a U.S. government video (above).

Under discussion. A German ethics council is recommending more oversight of dual-use research that can be used for good and evil—the topic of a U.S. government video (above).

National Institutes of Health

German Ethics Council: Government Should Regulate Dangerous Research

The German government should step in with legislation to regulate so-called dual use research of concern (DURC), the type of science that can benefit mankind but may be dangerous in the wrong hands, says a report issued today by the German Ethics Council. The government should set up a national committee to review DURC proposals in advance, says the report. In addition, the panel says action is needed to raise awareness about the issue, both at home and internationally.

Critics of dual-use research welcomed the call for tighter regulations. "This is an admirable, comprehensive, and compelling report," says Peter Hale, founder of the Foundation for Vaccine Research in Washington, D.C., who has lobbied for limiting dual-use research. The document, "for the first time, contains a set of substantive recommendations that will hopefully inform/inspire debate and action in other countries," Hale writes in an e-mail to ScienceInsider. "The report should be required reading for governments around the world."

Some scientists, however, say the recommendations place needless burdens on researchers and may hamper science. Lars Schaade, vice president of the Robert Koch Institute (RKI) in Berlin, says he supports some of the council's proposals, such as developing a code of conduct for German scientists and compulsory biosecurity training, but does not see the need for new legislation and a national DURC committee. "Local committees at universities can review DURC proposals just as efficiently," Schaade says, "and they may have more support from scientists."

The German government had asked the  council to study the issue in the wake of the fierce debate over two studies a few years ago—one led by Ron Fouchier of Erasmus MC in Rotterdam, the Netherlands, and the other by Yoshihiro Kawaoka at the University of Wisconsin, Madison—that sought to find out which genetic mutations make the H5N1 bird flu virus more easily transmissible between humans. Critics said that the studies, which were eventually published in Science and Nature, might help aspiring bioterrorists.

The council's 300-page report (PDF, in German; click here for a summary in English) says current regulations are insufficient. It says that German law should classify 10 types of research as DURC, such as studies that increase the transmissibility and infectious potential of a pathogen, expand its host range, make it more stable, or make it more difficult to detect.

(That list is an expanded version of what researchers call the seven deadly sins, introduced in a landmark U.S. biosecurity report issued in 2004. The sins were ultimately formalized in several new sets of U.S. government rules requiring research funding agencies to screen proposals for DURC, and for researchers proposing certain kinds of DURC experiments to receive extra review from public funders. U.S. officials are also considering rules that would require universities to review DURC and develop plans for reducing risks.)

In Germany, the council recommends that researchers be legally required to submit proposals to a new national DURC committee that would weigh the risks and benefits of the research; if rejected, the government and other funders should not support the work, it says.

Stephan Becker, a virologist at the Philipps University of Marburg who has followed the debates closely, says he's "impressed by the amount of work that went into this expert statement," but not in favor of new laws to regulate scientists' work. "Personally I do not believe that the demanded legislation will solve the problem," Becker says. "In my opinion it is all about education, building of awareness, and communication."

RKI’s Schaade also objects to the idea, supported by some members of the council, to introduce an additional approval procedure, to be conducted by a federal authority such as RKI. RKI carries out research itself; getting involved in judging other researchers' proposals might be regarded as a conflict of interest, he says. "What if we reject a proposal for some flu study and then a Robert Koch researcher gets a related study approved?" Schaade asks. "It would not be a good idea."

The council sees a guiding role for Germany internationally. Scientists and scientific organizations "should embark on an international process of reflection on the possible benefits and the risks of DURC," the report says, and the government should try to reach an international agreement about DURC policy. Germany is also asked to lobby for DURC rules within the massive research programs of the European Union, with perhaps a DURC committee at the European level to review research proposals.

The question is what the German government will do with the report. German science minister Johanna Wanka appeared noncommittal today. "We don't want to immediately force something on the scientific community," she was quoted as saying today by a website for physicians. "New legislation is the last link in the chain," she said in the Süddeutsche Zeitung.

That would be too bad, says virologist Simon Wain-Hobson of the Institut Pasteur in Paris, who testified before the council in August. "If virologists are unhappy, it is because they don't want to face up to the changing world," Wain-Hobson says. "We do need DURC committees."