Technology has always been seen as a tool that is used to make human life easier and more efficient. Though there are many more perspectives to see technology, the core purpose of manifesting a tool or applying scientific knowledge of increasing efficiency has remained the same. To put it in other words, we are creating technologies which are enhancing human tasks, which enable us in return to create even more efficient technologies.
This results in a cyclic development process (feedback loop). In this domain of development of human-technology feedback loop, synthetic biology has emerged from the 1960s; which is at the intersection of biology and engineering and involves various disciplines like genetic engineering, biotechnology, evolutionary biology, etc. It has been defined as “designing and constructing biological modules, biological systems, and biological machines for useful purposes (Nakano, Eckford, & Haraguchi,2013).” With time, this definition has evolved (debated) and also expanded to include the scope of “artificial design and engineering of biological systems and living organisms for purposes of improving applications for industry or biological research (Osbourn, O'Maille, Rosser, & Lindsey, 2012).”
The modern developments of synthetic biology which includes the artificial design of biological systems, combined with the development of electronics have led to the upbringing of a new culture in the world of synthetic biology, called Biohacking or DIY (do-it-yourself) biology. Biohacking is a culture of exploration of biology, where all sorts of people (professionals or non-professional in field of biology, who are just enthusiastic about biology/human body related experiments) get together to explore biology in small labs (mostly non-universities). They aim at the application of the IT hacks into the biological systems, mostly the human bodies (Spencer, 2014). This could mean implanting a NFC (Near Field Communication) chip in your hand to use your hand itself to pay or modelling tumor DNA and performing data analysis using software to understand whether a drug or treatment works or not.
There has been no formal definition of biohacking as it is an upcoming culture in synthetic biology, but there have been various activities categorized as biohacking. Dave Asprey, originally a computer security expert and now (considers himself) a biohacker, gives two approaches to work in this culture where you either work on biology outside of yourself (like make an amoeba glow) or you hack your own biology and gain access and control of body that you usually wouldn’t have access to. This culture of biohacking strives on its openness, where there is no peer review or publications in scientific journals, but knowledge sharing is done via blogs and open discussion forums (Bousted, 2008).
There have been strong proponents and opponents of the culture of biohacking’s existence itself. Some of the proponents of biohacking culture like Ron Shigeta who runs Berkeley Bio-labs (a biohacking site in Berkeley), where many to-be biologists gather to hack around frequently defines biohacking as “a freedom to explore biology, kind of like you would explore good fiction.” He believes that this freedom helps biohackers in following their own curiosity, and get to the bottom of the things they would want to understand. Drew Endy, professor of bioengineering at Stanford, who is also a biohacker, believes the hacking culture in general to be positive which aims at learning by building and studying results. Opponents of biohacking culture have labelled it as “criminal activities” stressing on no regards to ethical considerations in such a culture. They fear the potential safety risks like exposure of lethal microorganisms in environment due to a small experiment mistake (Marsh, 2015).
Biohackers have led to great contributions to medical field because of their entrepreneurial component which the research labs usually miss on. The examples have been development of coffee products by Dave Asprey (founder of Bulletproof) which helps a person to achieve high level performance. Another startup by biohackers has helped developing genetically modified food via concept like gene silencing to prevent food from rotting when exposed to air (Venkatraman, 2013). Also, biohackers have been working in security purposes like identifying and authenticating the user for any transaction. This has the potential to replace reviled passwords (Mimoso, 2015). Another aspect that biohacking has which is different from the professional laboratory setups for synthetic biology is the extent of information availability or openness, which gives it a benefit over these professional laboratory setups. For example, lowcost thermocyclers such as OpenPCR are created to make such technologies available to public and anyone can contribute to its design, making researches cost very cheap. Also, biohacking culture promotes a community learning environment in labs or online, and this helps in faster learnings for researchers.
Thus, completely opposing the field of biohacking due to potential safety risks would disrupt such innovations which contribute to development of humankind. But then, the potential risks which might even lead to a global catastrophe (like biohackers running amok with DNA modifications and developing programmable biological agents that might be used in a biological warfare) if not regulated, remains. So, the question arises that whether biohacking should be in the same state as it is existing today or should it be allowed to exist under firm regulations only? The common answer would be to take the midway stand that there should be a balance of both, but I propose that there needs to be firm regulations in place for any form of biohacking activity to flourish. It should be clear that putting biohacking under strict regulations does not mean banning biohacking, because biohacking have other aspects which exist even after regulations in place like the open community learning culture (which is not possible in professional labs where people are formally equipped with information and do not need such platforms in general). The following discussion over the scope of regulations, consequences and arguments over both a regulated and non-regulated field of biohacking would help in explaining my stand.
Regulations and its benefits
Before diving deeper into the answer over why there should be a regulated environment for biohacking, it should be understood that what defines such an environment in general in the field of synthetic biology. Hoffman et al. (2012) defines the “principles necessary for the effective assessment and oversight of the emerging field of synthetic biology” as precautionary principles, mandatory synthetic bio specific regulations, responsibility towards environment, public and worker safety, corporate accountability and right to information. The regulations have been divided on five various clusters for easier understanding (CDC, 2009; CDC, 2013; OSHA, 2011):
1) Regulatory bodies:
Assignment of a regulatory body: Regulation of the bio-labs is done at both federal and state level such that the government has the “ability to revoke the use of select agents, levy fines in the form of civil money penalties and imprison people who are not registered to possess select agents but do so anyway, or a registered person who transfers a select agent to an unregistered person.”
2) Laboratory and environmental safety:
Regular amendments to definition of the biosafety protocols (defining bio safety levels BSLs) and the lab safety levels based on the level of contamination present during the experiment (in labs). Once these levels are defined, the safety levels have to be implemented in the labs to prevent any form of leakage from the labs. All form of protective equipment should be available in the laboratory
3) Procedural safety:
Defining standard microbiological practices (a) personal: like washing hands, complete prohibition of eating, drinking, and smoking in laboratories, etc. (b) procedural: like minimum splashes or aerosols, decontamination of surfaces and (c) prerequisite checks: checking that all the safety provisions of the lab are working, etc.
4) Personnel safety:
Appropriate training of (trained staff) the performers and volunteers of the experiment and complete tests of their immunizations and infections before experimentations.
5) Information safety:
Clear regulations about which information is sharable (e.g. experiments results) and which information should be kept as hidden or protected (e.g. volunteer’s personal details).
Biohacking itself is a task related to biology which deals with experimentation with living beings and any task on a living organism need to be done with utmost care to prevent any negative consequences to the health of that being. This demands the need of clear regulations like the volunteer and the experimenter safety (personnel safety) regulations to prevent any type of harm to involved people. The biohacking experimentations can be done by the experimenters on themselves and thus there is high chance that the experimenter would not look into their own safety. In such a case, such regulations would help prevent any accidents.
It should be understood that a threat that biohacking has in itself is the inability to “undo” such hacks. “….when a hacker causes the digital reality in their computer to malfunction through tinkering, they can simply reboot and start again. It might not be so simple when hacking biology itself. This may be a flawed analogy, but it is probably something the new socio-ethics of syn-bio should address if serious mis-steps are to be avoided” (Maynard, 2008). In such an environment, if there is no button (regulation) to control the start of the process in case the hack is risky, the results can be devastating for not just one, but maybe many lives. The regulations like procedural safety checks like prerequisite checks (wearing gloves before the experiments, decontaminating surfaces after experiments) and laboratory safety level checks help prevent such mistakes.
As this culture has just emerged in recent decade, there has not been enough awareness till the jurisdiction level and due to the informal and dispersed research structure, there haven’t been any regulation possible to be set up yet. Also it has been questioned very well that “How do you establish a framework for socially and ethically responsible development when the person you need to reach is an adolescent teenager constructing new biological code in their basement” (Maynard, 2008)? In spite of these practical issues, this is the exact reason why there is an urgent need to start organizing the research setup and thus put up a formal process in place in this domain of research. A teenager if accidentally creates a biological replication code while working with harmful bacteria, who are we going to hold responsible for the catastrophe caused? These regulations like allocating regulatory bodies like governments, independent organizations, etc., clearly give this form of responsibilities to specific bodies preventing such issues. For example, a state government or a locally formed community organization overlooking the specific community activity can take up this responsibility. But this would only be possible in case there is some form of regulation structure which can allocate such a community run body in the first place.
On a bigger level (like national), these regulations cannot completely eliminate the threats of bioterrorism, or the threat of accessing someone’s body data without their consent (like implantation of RFID/ Radio frequency identification tag in a person to study their location, etc.), but these regulations can surely help in reducing them, for e.g. due to the fear of arrests or fines there might be a significant amount of control possible on such activities.
These regulations also help in standardizing (introduction of standard rules) and thus giving a stable form to the biohacking culture in itself. This homogeneity over the biohacking experiments helps ease and complement researchers on similar fields. Also, introducing regulations makes this field less risk-prone and thus young-minds start looking towards this like a more professional career, which increases their involvement and thus, contributions to this field. This in turn leads to breakthroughs, finally attracting more students. This is a strong feedback loop which only a regulated environment can ensure. Also, a regulated environment develops more trust for the customers of biohacking firms.
The existence of the research environment also emphasizes the need of the formal education for conducting such researches where a single mistake could take lives. Such decisions can only be responsibly handled by formally trained people. A formal education is based on a framework and questions the very requirement of a particular bio-hack making the subsequent decisions well grounded.
Also one of the argument against the regulation related to formal training, which is usually made by the DIY biologists have been that the formal education is not always required for learning things and anyone who is willing to learn can participate in exploring biology. It is right to argue that there have been exceptional minds who were dropouts and still turned out to deliver world’s greatest innovations. But, majority of the innovations and development in science come from formally educated students. Above all, the formal education gives credibility about what is being done has the least chances of going wrong (because the education system trains you so).
Questioning these benefits of a controlled research environment, one of the most pressing critic has been about the existence of regulations itself which are claimed to prohibit the freedom to work as per your wish. Research in itself prospers due to the freedom it gets, and thus it is ironical to ask for regulations in the field of research. But, we should understand that freedom if exercised equally by a bioterrorist and a person who is passionate about helping humankind through biohacking can lead to two completely different consequences. So, if one cannot identify who amongst us is the former, the system of regulation to control the freedom and minimize the risk of a bioterror attack needs to be in place. Also, it should be kept in mind that such regulations over research have the focus to enable or prosper the legit approach which would help humankind, rather than just restricting someone.
Resistance to regulations
The proponent of the biohacking freedom culture (or rather the opponents of the regulations in biohacking) are strongly resistant on introduction of any form of regulations to this biohacking environment. This is usually because they are pure preachers of freedom. What they look as the benefit of biohacking is not the benefit of the culture itself but rather the characteristic property of freedom which feels more comfortable than any forms of restrictions, and also prevents them from fast and immediate results (where freedom has more chances to deliver faster results).
Usually there is a reason given by the proponents of biohacking by giving an analogy of how well a garage-culture (culture of experimenting without anyone’s consent, usually done in garages and thus the name) like in Silicon Valley helped development of some of the best innovations in today’s world like Google and Apple. This free-spirited innovation culture assures crazy and at the same time unexpected innovations, some of which turns to be really helpful and breakthroughs for humankind. Thus the claim has been that limiting the progress of biotechnology in hackers’ community with regulations may slow down such innovations’ pace and thus may impact the development of humankind. But this is an out-of-place analogy, because if we look into the history of any form of life saving drugs or biological/medical innovations, we won’t be able to find a single innovation which came from such a culture. The reason is not because the biohacking culture didn’t exist back then, but the reason is that such innovations require a form of physical environment and professional experience which biohacking (garage)
culture lacks.
Also, the partially in-principle claims by these opponents of the regulations have been pointing to freedom too, for example as stated by Drew Endy (professor at Stanford and a biohacker), this hacking culture helps in learning something that you are curious about and implement them. This claim suggests that because of no form of professionalism or regulations, it is easier to learn and implement something you are curious about, which you wouldn’t have done in a regulated professional environment. This again talks about the benefits of the freedom and not the benefits or advantage of this environment to biohacking itself. So none of the claims help in showing that only such unregulated environments of biohacking can help get the benefits from the biohacking environment, and a regulated environment cannot achieve the same. Most importantly the myth/fear in mind of the opponents of the regulations is that regulations will completely shut down the biohacking culture need to be cleared because the benefits of biohacking can still be exercised, for the development of humankind, even in the presence of these regulations in place.
Conclusion (is it?)
The advancements in synthetic biology related to the artificial design of biology for industrial and medical purposes have helped to born a new culture of “biohacking” which combines entrepreneurship with synthetic biology and works on the principle of no form of regulations or controls and complete openness of research. Biohacking has huge potentials for enhancing human life by modifying the genes and curing illness, ease of gathering data over different types of treatments, and producing genetically modified foods, making humans more resistant to various bacterial illness, etc. Except for the direct medical benefits, there are various security benefits from biohacking’s entrepreneurial activities too. But, the openness of this culture possess
the safety risks, and to prevent the catastrophic potential consequences of non-regulation, there needs to be a strict regulation in place before any further activities take place in biohacking. As this regulation structure cannot be applied to just a few who might use biohacking as a weapon like in bioterrorism, this formal structure needs to be present for all and there cannot be a relaxation for such a system.
It can be clearly seen from the essay that there are various benefits of the regulations from the synthetic biology, if applied to biohacking in five main clusters (safety regulations): procedural, laboratory and environmental, personnel, regulatory body and informational safety. There are inherent issues in biohacking which makes it risky without regulations and then there are also the issues which are caused because people proposing the biohacking culture are adamant on any form of regulation introduced. The latter case usually happens due to the firm belief of these proponents towards freedom only and thus overshadowing the benefits of biohacking, which can be realized even in a regulated environment. Above all, it should be kept in mind that the regulations in place do not stop the benefits of biohacking like the promotion of a community culture to share information (for e.g. stack overflow platform, where coders help solve bugs), which is still a part of biohacking that remains even in a regulated environment. Thus there is no need to ban biohacking culture in itself, but regulate its aspects which exercises complete freedom in EVERY form. Thus, to conclude biohacking needs to have an urgent shift towards a regulated environment before any form of activities are promoted any more in this field.
