There is a growing convergence of concern about new technologies in the life sciences that are raising significant societal, ethical, environmental and security risks. Global public engagement must be a priority for deliberation about these technologies and for developing a set of common red lines.

The genome-editing technique CRISPR-Cas9 is the latest in a series of technologies to hit the headlines. This week Chinese scientists used the technology to genetically modify human embryos – the news coming less than a month after a prominent group of scientists had called for a moratorium on the technology. The use of ‘gene drives’ to alter the genetic composition of whole populations of insects and other life forms has also raised significant concern.

But the technology posing the greatest, most immediate threat to humanity comes from ‘gain-of-function’ (GOF) experiments. This technology adds new properties to biological agents such as viruses, allowing them to jump to new species or making them more transmissible. While these are not new concepts, there is grave concern about a subset of experiments on influenza and SARS viruses which could metamorphose them into pandemic pathogens with catastrophic potential.

In October 2014 the US government stepped in, imposing a federal funding pause on the most dangerous GOF experiments and announcing a year-long deliberative process. Yet, this process has not been without its teething-problems. Foremost is the de facto lack of transparency and open discussion. Genuine engagement is essential in the GOF debate where the stakes for public health and safety are unusually high, and the benefits seem marginal at best, or non-existent at worst. As a previous piece on this blog noted in relation to CRISPR-Cas9, where there have been calls for a similar process: “A moratorium without provisions for ongoing public deliberation narrows our understanding of risks and bypasses democracy.”

Particularly worrisome about the GOF process is that it is exceedingly US-centric and lacks engagement with the international community. Microbes know no borders. The rest of the world has a huge stake in the regulation and oversight of GOF experiments. From prior experience, they are likely to follow US initiatives. The regulations that emerged following the 1975 Asilomar conference on recombinant DNA are a prime example of this. GOF needs a globally representative group from all parts of society to recommend policy approaches.

The international character of the GOF controversy was evident from the start. The experiment that sparked the current debate – engineering H5N1 bird flu virus to become air transmissible to humans – was a Dutch experiment, funded by the US National Institutes of Health. The Netherlands has been at the forefront of GOF discussions and published a substantial report in late 2013 on risk assessment of GOF and other dual-use research experiments. Germany has come out with a substantial report on how to put in place adequate oversight of GOF and other dual-use biosecurity-relevant work. Other countries have been vocal in the debate, too. The United Kingdom held an open and inclusive debate on GOF research at its Royal Society in April 2012. At their most recent meeting in December 2014, bioweapons experts and disarmament diplomats of the 173 Biological Weapons Convention member states agreed that GOF work could have uses contrary to the treaty. The BWC will continue to review developments in the field in future meetings. Switzerland has been particularly active in this context, pushing the risk versus benefit debate.

An international set of Asilomar-type conferences must urgently be convened to agree in principle that there may be some life science research that should not be permitted because the risks far outweigh the benefits, and to develop a common understanding of where the red lines should be drawn. Some of the key lessons from the original 1975 Asilomar meeting were that the areas of concern must not be restricted, the complexity of arguments must not be reduced, and the representation of different perspectives at the table must be enlarged. Different perceptions of the problem will lead to different conclusions about what an appropriate regulatory framework should look like. For instance, had there been wider representation at Asilomar, the recombinant DNA regulations might also have extended to apply to the military and commercial sectors, and not been limited to those in receipt of NIH funds. Legislation rather than controlling the purse strings could have been the vehicle of regulatory control. These lessons all underscore the importance of an open, inclusive debate that also extends into the decision-making process.

The White House is to be commended for putting the funding pause in place last October and launching the year-long deliberative process. While the immediate aim might not be to develop international policy, GOF is inherently a global issue and the debate needs a globally representative group. Provision must be made for robust, broad and deep public engagement and harnessing the views of civil society.

There is more at stake than just a certain set of experiments or the degree of freedom of research. There will be further loss of public trust in scientists and in the institution of science itself if it appears that decisions about such exceptionally risky projects are taken without substantial, genuine involvement by the public and wider civil society. The United States is the only country with the convening power to make an international set of revamped, trust-building Asilomar-type meetings happen. Stepping in was admirable, but now is the time to step up.

Filippa Lentzos is Senior Research Fellow, Department of Social Science, Health & Medicine, King’s College London. Koos van der Bruggen is an independent biosecurity expert and former adviser for biosecurity to the Royal Netherlands Academy of Arts & Sciences. Kathryn Nixdorff is Professor Emeritus, Department of Microbiology & Genetics, Darmstadt University of Technology.