Biosomething

"On reading," by Simon Wain-Hobson, is a weekly discussion of scientific papers and news articles around gain of function research in virology.

Since January 2024, Dr. Wain-Hobson has written weekly essays for Biosafety Now discussing risky research in virology. You can read his entire series here.

Sunset over the memorial flame to COVID victims with the Palacio de Cibeles, Madrid in the background

On Reading Ethical criteria for self-identifying societal risk associated with dangerous gain-of-function research by Patricia Delarosa, C. Matthew Sharkey and Kristjan Hollo. mSphere 2025; 10:e0060725

A possible turning point for research governance in the life sciences by David R. Gillum. mSphere 2025; 10:e0040725

Catholic bishops remind political leaders that nuclear weapons are immoral, by John Wester. Bulletin of the Atomic Scientists, December 14, 2025

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Coming across ‘ethical’ and ‘dangerous gain-of-function research’ in a journal of the American Society of Microbiology, an old friend, made it a must read.

By way of introduction, we’re reminded that the Executive Order (EO) on dangerous gain-of-function research (DGOF) “could cause significant societal consequences” or SSCs as the authors like to call them. Yep, that’s what it was all about. We’ll use the full version throughout as abbreviations allow the reader to forget what is at stake. Apparently, this is a new criterion that has not been included in previous institutional research oversight policies. Not having served on any such body it seems odd to an outsider that the institutions didn’t have the big picture already in their remit. Might this be because nobody ever considered the possibility of catastrophic risks emanating from a research lab? What cloud were they on?

They transpose ethical principles from the Belmont report upon which US policy on human subjects in clinical settings is based: …protecting them from harm but also by making efforts to secure their well-being.” It further elaborates that “[t]he obligations of beneficence affect both individual investigators and society at large, because they extend both to particular research projects and to the entire enterprise of research. Investigators and members of their institutions are obliged to give forethought to the maximization of benefits and the reduction of risk that might occur from the research investigation.

The big picture is society at large. Good, but then why did nobody on any of these institutional review boards or within the NIH see way before 2025 that there were no benefits to the DGOF work on bird flu viruses in the first place? After all, everyone agrees that the risks can go as high as sparking a pandemic. A sloth would have moved by now. Not so administrations.

Nonetheless, the authors note that The consideration of “longer-term benefits and risks” by the NSABB [US National Science Advisory Board for Biosecurity] was heavily focused on scientific advancements as the primary societal consideration, whereas the risks of the pathogen’s escaping containment were not central to their approach given existing biosafety policies and required containment practices. The line is NSABB didn’t have risk culture at their fingertips and so couldn’t handle analysis of work that could cause significant societal consequences. Certainly, the NSABB was composed mainly of university professors and not biosafety experts.

If correct this means is that the Kawaoka and Fouchier papers were published without any consideration of the bigger picture. Catastrophic risk went completely under the radar.

Yet the burning question for these university professors on the NSABB was could this risky work even deliver on the promises? If yes, then move to the difficult issue of benefits versus risks. Yet despite being of no value, Nature and Science published the papers. It was rammed down our throats because the NIH wanted it so. The irrelevance of these papers has been borne out over the following decade while their lead authors have changed their minds.

Next, do no harm is so obvious that it should be the base line. It should not need explaining or defending, especially as the authors cite the InterAcademy Panel statement on Biosecurity where the first principle - first, do no harm - pertains to scientists (Do no Harm 1).

Fortunately, post COVID things have changed. The dire societal consequences seen during the COVID-19 pandemic - in terms of human life and economic, educational, and social opportunities lost - should inform the consideration of SSC when assessing DGoF research; the COVID-19 experience frames the EO’s requirement for review of SSC as an ethical assessment review process… The assessment of SSC is founded on the assumption that biocontainment strategies may conceivably fail. Which they do. Occasionally. We’ve known this for ages. Emphasis added by the way.

Yet earlier in the paper the authors mentioned that the Biden era policy on the review and funding of research similar to DGoF called for an ethics review, whose criteria included non-maleficence, beneficence, justice, respect for persons, scientific freedom, and responsible stewardship. So it’s not clear what’s new. Perhaps the word ‘society’ wasn’t explicitly used, although this should have been obvious. Lots of words signifying little useful.

Opening the review aperture to apply the reasonably anticipated research effects to all pathogens and toxins shifts the review process from an agent- to outcome-focused assessment, which is more appropriate for the review and oversight of enhanced agents whose transmissibility or virulence may be enhanced in a manner not previously studied, especially given emerging capabilities in biodesign. Absolutely. But again, this was obvious years ago, indeed from 2012 and even 2005 following the resurrection of the Spanish flu virus.

The EO identifies SSC - an ethical assessment of anticipated benefits and potential bad outcomes - as the final filter to stratify and prioritize risks within the pool of potential DGoF research. This says the same thing albeit more succinctly. This leads to Clear SSC assessment criteria - grounded in ethical considerations - are fundamental to public transparency and the creation of trust between the life sciences research enterprise and the public.

Phew, they finally got to the essential albeit 13 years late. From the get-go, engineering novel human viruses by whatever means posed ethical problems. It’s amazing that bioethicists were not clear on this from day one. Well day two if day one was a Sunday. IMHO they have underperformed, tracking the discussion rather than educating, or dare it be said, helping virologists.

Now if you detected, perhaps a tiny trace of irk in the above, the second paper starts with unanchored rhetoric. While intended to strengthen biosafety and biosecurity, the EO introduces vague definitions… Researchers, biosafety professionals, and institutions are left with a biosecurity policy vacuum after this EO, which is creating uncertainty across the scientific enterprise. Disagree. Nonsense in fact.

The EO rescinded the 2024 United States Government Policy for Oversight of Dual Use Research of Concern and Pathogens with Enhanced Pandemic Potential (2024 DURC/PEPP policy), and charged the Office of Science and Technology Policy (OSTP) with issuing a replacement policy within 120 days. While very detailed, the 2024 policy document wasn’t very good and didn’t get to grips with dangerous GOF research (US DURC policy). Here too the word ethics was used but the narrative moved on. The EO cut through that Gordian knot. Correct, the OSTP hasn’t issued a replacement policy within 120 days.

This obviously leaves the powers that be to sort things out. Dr. Gillum claims that this leaves federal agencies, research institutions, and investigators without clear guidance or guardrails for conducting life sciences research. But wait a minute. Which is the lesser evil? Leaving virologists without clear guidance or allowing dangerous GOF research to continue, which the author admits could result in “significant societal consequences.” Unequivocally the latter. On top of which, virologists are not stupid. They spotted the EO on day 1 – a Monday as it happens - and will fall in line and be as careful as ever.

Yet without clear guidance or guardrails for conducting life sciences research is a false argument. Virologists know how to handle Ebola and Marburg viruses. There is no way they will expose themselves to infection if they can help it. They too have family and friends.

Virologists need institutional support such as labs and equipment, up to date training for there is always a non-zero risk of getting infected (LAIs). They don’t need bosses or science administrators to encourage them to work on dangerous GOF research that cannot answer questions about emergence and pandemics.

Dr. Gillum should cut them some slack and stop the dramatization. But he can’t. There follow a series of statements which if taken at face value indicate a baffling and confused situation in US biosafety. For example, this moment demands more than a routine regulatory update: it calls for a fundamentally different paradigm in which biosecurity governance is handled in a transparent, scientifically grounded, and operationally feasible manner, and responsive to current and emerging biotechnological threats.

Or the EO was not a surprise. U.S. biosafety and biosecurity governance has long been marked by fragmented oversight, inconsistent terminology, and regulatory frameworks that struggled to keep pace with scientific advancement.

Who underperformed? Yet Dr. Gillum says nothing about DGOF, the dilemma of pursuing needless research that creates catastrophic risks. From the point of view of protecting lab staff, it’s a no brainer. Yet he can’t even say that. He uses the EO to talk up his concerns. This is not good enough from a PhD and biosafety professional with 30 years under his belt.

The piece closes with the EO has created a disruption but also an opportunity. In its urgency, the EO reflects a broader recognition that our current oversight system is ill-equipped to handle modern bioscience challenges. Again, if so, then how come the powers that be maintained an oversight system [that] is ill-equipped to handle modern bioscience challenges? Science administrations should surely first set the rules and revise them as necessary; second, finance the best projects to roll back microbes and disease. Requiring that no harm is done in areas where risks arise and protecting staff seems to be obvious. Part of the job.

Whether bioethics has much to say here is a point that has baffled this writer since 2012. The answers are so obvious that biosomething arguments seem superfluous.

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Recently John Wester, the Archbishop of Santa Fe, reminded us that In 2019, Pope Francis elevated the Catholic Church beyond conditional acceptance of so-called deterrence. He declared that the mere possession of nuclear weapons is immoral.

Wester added that the 2021 Treaty on the Prohibition of Nuclear Weapons does nothing more than ban nuclear weapons, just like previous treaties that enjoyed universal support banned biological and chemical weapons, which are also weapons of mass destruction.

Let’s use a little logic: the mere possession of biological and chemical weapons of mass destruction is immoral.

Logically, as the results of dangerous GOF research by academic scientists are indistinguishable from biological weapons developed by the military, they are weapons of mass destruction.

Logically, their possession by any academic lab is therefore immoral.

Logically, publication of the papers describing these novel biological weapons was immoral. Albeit a post hoc symbol, the NIH could call for the retraction of the papers on dangerous GOF engineered bird flu viruses. Alas, the recipes for making them will always be available.

Logically, stocks of these viruses should be destroyed.

Despite the above, research on dangerous GOF pathogens is not prohibited. Anywhere. It is suspended in the US.

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Asides

• Can others confirm or deny Dr. Gillum’s concerns about US biosafety?

• Could biosafety officers from other nations reassure us that they are on a par with the US which, from On reading’s perspective, doesn’t seem to be the case?

• The Executive Order was issued without clammer from bioethicists.

• If yours truly had written such weak science manuscripts as the first two, he’d have been blasted by the reviewers.

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Simon Wain-Hobson is an emeritus professor at the Institute Pasteur, Paris, from which he retired in 2021. He and his colleagues were the first to sequence the genome of HIV, and Wain-Hobson has published more than 230 papers on virology and cancer.