The year-long voluntary moratorium on research to engineer strains of the H5N1 avian influenza virus that can transmit between mammals has already borne fruit. Claims of public-health benefits have received thorough scrutiny, and the researchers involved have better explained the biosafety and biosecurity precautions that they take. The debate has drawn attention to, and exposed gaps in, the rules that govern ‘dual-use’ research — work that can bring public benefit but might also be used for harmful purposes. The row has also, for example, prompted long-overdue national guidelines in the United States and made funders everywhere more aware of the need to assess risky research proposals proactively. In short, the moratorium — the lifting of which is announced this week (see page 460) — has seen serious thought on the complex issues involved.

In the past year, the debate’s focus has somewhat shifted from bio­terrorism concerns — which, being classified, are difficult for outsiders to evaluate — towards biosafety issues. And it has concentrated attention more broadly on how best to regulate ‘gain-of-function’ research: work intended to increase the transmissibility, host range or virulence of pathogens. The United States is the main funder of such research, and what it decides is key to international thought. The proposed framework for assessing H5N1 gain-of-function research, outlined by the US National Institutes of Health at an international meeting in Bethesda, Maryland, in December, spells out several criteria that such research would need to meet before being funded.

One can quibble with some ambiguities in the wording of those proposals, but overall the framework should serve as an important checklist. The criteria include sensible questions, such as whether safer, alternative approaches exist that could address the same scientific points. Researchers already accept the need for regulations in areas such as animal welfare, and an extra layer of review for gain-of-function H5N1 research — which will affect only a few projects — is a small price to pay for improved public confidence in safety and oversight.

Flu researchers have been generous with their time over the past year. They have engaged in public debates and expressed their often-conflicting views in commentaries in scientific journals. The polarization of views between proponents and opponents of such research has, however, too often resulted in reiterations of entrenched viewpoints, rather than substantive discussions. Whether justified or not, there remains a perception among many critics that the debate has taken place largely behind closed doors, and has been dominated by flu scientists and research funders who have vested interests in the outcome.

The lifting of the moratorium by researchers must not be seen as closure of the debate.

As several critics point out, the assessments of the relative risks and benefits of such research remain restricted to largely qualitative arguments. The formal, quantitative risk assessment common in the nuclear power and other industries could have helped to nail down and quantify risks, and would have informed the debate better. One year on, an irreproachable, independent risk–benefit analysis of such research, perhaps convened by a body such as the World Health Organization (WHO), is still lacking.

When it comes to mitigating risks, it is gratifying that the WHO guidelines on mammalian-transmissible H5N1 research, released last July, go beyond simply discussing the required level of biocontainment facility. They also recommend that labs doing such work should conform to international risk-management standards, thus encouraging a culture of safety in all procedures and practices.

The guidelines go on to state [original emphasis]: “Given the potential of these newly developed laboratory-modified H5N1 strains to start a pandemic, it is important that facilities that are NOT able to identify and appropriately control the risks associated with these agents REFRAIN from working with them.” Those are sensible words, but unfortunately lack any means of enforcement.

The lifting of the moratorium by researchers must not be seen as closure of the debate. The potential risks of the work demand exceptional precautions in any future research. It is clear that the immediate practical applications of gain-of-function flu research remain largely hypothetical, and that its true value lies in long-term fundamental research to improve understanding of the transmissibility and pathogenicity of the virus. That makes it even more incumbent on researchers and authorities to exercise the greatest responsibility and prudence.