Genetic engineering of pathogens and synthetic genomics (the ability to create synthetic viruses) are a reality. Dual use research of concern (DURC), sometimes referred to as “gain of function research” (GOF) is research intended to benefit humankind, but which can also cause harm, either through laboratory accidents or deliberate release.(1) The controversy exploded in 2011 when two groups announced their intention to publish their methods for engineering of avian influenza H5N1 to make it transmissible to humans. The scientific community was polarized, with opponents arguing that the benefits of such research were minimal and potential risks too great. Proponents argued for scientific freedom, and for the potential benefits of this work.

At the time the US was one of the few countries to have a body tasked with deliberating on such issues, the National Science Advisory Board on Biosecurity.  After a brief moratorium on such research, the  NSABB allowed publication of these two papers, making methods for engineering of avian influenza to make it transmissible in humans, publicly available. The flood gates were open, and many DURC studies were published, including one which engineered the virus which caused the 1918 pandemic.(2) At a scientific conference, I recently heard someone describe the ease with which anyone could genetically engineer an avian influenza virus.  And methods to do so are publicly and freely available.  Following ongoing concerns, in 2014 the US government suspended funding for DURC, and commissioned a review of risks and benefits. The review is yet to deliver its findings, and the NSABB has been heavily lobbied to relax it’s restrictions and allow DURC to proceed.(3)

However, the US is one of the few countries to even have such a body, yet medical research is global. DURC can be done anywhere in the world. The larger issue is the remit of national governance bodies, when research in one country can harm people globally, due to the contagion and spread of infectious diseases.  A lab accident or deliberate release of an engineered pathogen in one country can affect other countries within weeks, and people who were never informed nor consented to the research could be harmed by it. This is a new frontier of ethics, one which we have not had to confront prior to 2011. (4)

What then of biohacking, the latest trend worldwide in the name of “democratization of science”. This movement involves establishment of community labs, open to the public to conduct experiment themselves. (5)  Such labs include Genspace in New York, Biofoundry in Sydney, BioCurious in San Francisco and La Paillasse in Paris.(6)  New technologies such as CRISPR, a method for editing DNA, have revolutionized the ability to edit DNA and made genetic engioneering widely accessible and possible in citizen biohacker labs.(7) Whilst biohackers espouse lofty ideals, such as “the democratization of science”(5) and making science open to anyone in the community, it is underpinned by the assumption that rigor and high level training is not required in science, that anyone can and should walk in and conduct experiments randomly, and that this is somehow desirable. Whilst breakthroughs in science have been made by people without formal training or minimal training,(8) on the whole this is an exception, not the rule.  The more important consideration is safety and regulation. Biohacker labs such as Biofoundry are subject to regulations and currently operating at PC1 level(9), but the practical ability to regulate and monitor activities in such labs is untested.  It is also unclear whether such labs will be subject to medical research ethics regulation, as is all research which occurs in universities and other institutions. It appears to me, biohacking labs can completely bypass the need for ethics approvals, which then risks unethical research being conducted.  “Democratisation of science” is a very real trend occurring globally of not just open access publication but open access conduct of science, without the strict ethical and technical regulation which traditional research experiments are subject to. The flip side of the “democratization” of science, is the escalation of biosecurity threats and the ability to engineer such threats freely without sanctions, which will become harder to monitor and regulate. As I have argued in a recent paper, using simple probability theory, when a method for harm is publicly available (along with the means to easily do such experiments), the probability of such methods being used for nefarious purposes are close to 1.(1) It would be naïve to believe otherwise. The other major risk of open access DURC and public labs is the risk of a lab accident or mishap. There were four in the US alone in 2014, involving Ebola, anthrax, smallpox and avian influenza in leading facilities of the CDC and NIH.(1) In medical research, to run a lab in a university or research institute takes years, often a decade or more, of scientific training, qualifications, and experience, and such facilities are led by very senior professionals with extensive expertise. If such world class facilities can have mishaps,(10) what of the biohacker labs, run by students, recent graduates and lay people with far less experience and expertise, and not subject to the same rigour and scrutiny? And of course, the latest trend in DIY labs and labs-in-a-box means the proliferation of illegal labs is a real threat. We do not even have systematic mechanisms to search for and identify illegal labs.

I have previously argued that from a medical ethics perspective, it is unethical to conduct research which has the potential to harm entire populations, without informing those populations of the risk and seeking their consent. This is the fundamental principle underpinning modern medical ethics today but has been entirely ignored in the conduct of DURC.(4)  The debate has been largely in the scientific community, with the rights of scientists and biohackers being the predominant discourse, and the public in general has not been meaningfully informed or engaged.  What would people think, if they fully understood the implications of DURC, DIY labs, and the revolutionary new technology available today? Every potential benefit has a countering risk, and the risks have not been considered adequately, while the benefits have been trumpeted. Even the NSABB review has limited potential to mitigate risk, when DURC is so easily conducted anywhere in the world, in any setting, and when infections can spread worldwide. We are lacking in adequate mechanisms for global governance and regulation of DURC, which poses a major risk to biosecurity.