Biohacking is a Do-It-Yourself movement that encourages experimenting with biotechnology tools to find ways to improve one’s health and enhance one’s natural capabilities, and many in the movement advocate for the democratization of scientific tools so that everyone can participate in such scientific discovery. However, some biohackers take their experimentation to the extreme, and not all of them seem to understand the responsibility and risks associated with the scientific methods they employ. As a result, tension between the biohacking community and the professional science community has grown as biohacking continues to increase in popularity. Though the biohacking movement makes salient points about the way ethical precautions and regulation slow innovation, this paper explores the need for codes of ethics governing the pursuit of scientific discovery and how biohackers and traditional, trained scientists can reach common ground.
Biohacking is a Do-It-Yourself movement that encourages experimenting with biotechnology tools to find ways to improve one’s health and enhance one’s natural capabilities . It involves a mindset that parallels engineering: rather than accepting deficient aspects of our biology or health, why not use science to find ways to “hack” these aspects and improve them ? For this reason, prominent biohacking groups advocate for the “democratization” and “decentralization” of scientific knowledge and tools from the research institutions they were originally created in, for easy access and use by all . Those who embrace the title of “biohacker” range from average people working in garages to scientists trained in academic research labs who engage in non-workplace-supported research projects on the side . In fact, a documentary series called DIYSect highlights how some scientists are tempted to engage in DIY biohacking as an “alternative pathway to whatever research [they] want to pursue” both to “escape the bureaucracy that comes with academia” and to “reinvigorate their passion for biology” . Biohackers are excited about the power that science and technology provide to help achieve their end goals. But while biohackers cite their frustrations with traditional rules and regulations as their motivation for working outside of them, the crucial question is whether they recognize the associated responsibility and risks that come along with that power. As the biohacking movement continues to grow, so does the clear tension between this “counterculture” community and the traditional “mainstream” scientific community . This paper will explore relevant ethical considerations for each group and make a proposal on how to reach a common ground of mutual benefit.
“Do-it-yourself” or DIY refers to the action of conducting projects without the help that would usually be required from a professional or expert. Using DIY “hacks,” the average person can take it upon themselves to improve their life, expand their skill set, become engaged with new hobbies, or save money. Once reserved for home repair or fun design projects, the DIY mindset is now used by the steadily growing biohacking movement to pursue a new field: optimizing personal health. At a mild level, biohacking means making lifestyle changes based on some internet research and following science-backed methods such as exercising more, trying new diets, or starting to meditate. However, more advanced efforts in DIY biology and biotechnology are being made possible by the decreasing costs of professional scientific tools used for powerful techniques such as DNA sequencing and synthesis .
On the extreme end of the spectrum, some biohackers called “grinders” leverage biotechnology tools and methods in order to fuel transhumanism: the movement to enhance the abilities and characteristics of human beings beyond their natural limits . Grinders shape how biohacking is represented in the mainstream media by pursuing dangerous, shock-worthy projects in which they implant technologies into their bodies and use themselves as test subjects for the results of gene-editing research. For example, with the goal of enhancing his muscles, prominent biohacker and former NASA researcher Josiah Zayner edited DNA with CRISPR technology and injected himself with it on a social media livestream . In an interview about the fallout from this experiment, Zayner explained how he aims to combine science and social activism through biohacking in order to achieve two goals: (1) show people the accessibility of scientific knowledge and tools and (2) advance the development of helpful medical technologies past the frustratingly slow rate of traditional “academic and medical science” . However, no matter the reasoning behind them, the more extreme ends of biohacking are reckless because of their potential for tampering with the unknown. This is especially true as grinders pursue stunts like injecting themselves with younger blood to stop aging, performing fecal transplants to experiment with microbiome engineering, and genetically modifying their own DNA . Even Zayner is now worried that his biohacking attempts have inspired other grinders to perform even more dangerous experiments such as injecting an untested HIV treatment on a livestream and ingesting a purified virus in an attempt to test a gene therapy for lactose intolerance .
But what about the more moderate branches of DIY biologists, such as those who aim to improve the lives of those suffering from disease by working to produce treatments quicker than a company that complies with federal regulations could? Biohackers on both ends of the spectrum are commonly motivated by frustrations with the bureaucratic pace of translating current scientific breakthroughs and discoveries into life-saving products . For instance, biohacking also encompasses diabetes patients who hack into their own insulin pumps to tune the delivery of insulin closer to their personalized disease physiology . The Open Insulin Project is an example of a coalition of biohackers aiming to improve diabetes care by bypassing existing regulatory blockades and performing research themselves . An ethical objective to save more lives like that of the Open Insulin Project seems more defendable in terms of an “end justifies the means” argument than the goals of biohackers who purposefully test boundaries that the scientific community has reached consensus on. However, complex ethical implications still exist even for biohacking in pursuit of saving lives, and they must be considered.
For the scientific community, acting in an ethical manner means conducting research and using tools according to strict regulations and safety measures. When the biohacking community purposefully breaks away from such precautions and uses scientific tools in unauthorized and possibly unintended ways, how can the tension between these two groups be resolved? In “Ethics in an Exponentially Changing World,” Viterbi School of Engineering Dean Yannis Yortsos explores the multi-faceted considerations that influence the way society should respond to the growing complexity of how humans interact with technology . Separating tools themselves from the morally-characterized decision-making process that humans employ when making these tools into “useful” objects, Yortsos defines “useful” as leveraging phenomena to achieve a goal . He suggests that acceptable uses for tools fall within the intersection of smart, legal, and ethical domains . The more extreme branches of biohacking, which purposefully aim to be provocative and push boundaries with their use of tools, pose a clear risk to society due to the unpredictable consequences of their actions. Thus, these extreme uses of biotechnology tools can be justifiably restrained with legal actions, as exemplified by a law passed in California to restrict the sale of DIY genetic engineering kits. Legislators took this sensible action to prevent “safety mishaps by amateur users” after listening to the “many in the scientific community [who] have sounded the alarm” about the “negative consequences” CRISPR technology can have outside of research institutions .
Nevertheless, how the scientific community should respond to less overtly extreme biohacking endeavors remains in question. Trained scientists and engineers might make the determination that those who practice biohacking are moving outside the “smart” domain by conducting research in a risky manner with inadequate materials and a disregard for proper training. However, is this reason enough to write off biohackers as risks to society and deem their calls for the democratization of scientific tools ridiculous? Should legislative and regulatory bodies such as state governments or the FDA take further action to either label all biohacking efforts as illegal or necessitate that they be subjected to oversight? It is important to consider if these kinds of responses aimed at delegitimizing and admonishing biohackers will actually mitigate the risk they pose and lead to increased safety; as some biohackers have warned, it is possible that this dismissive response will merely push the movement underground and eliminate the possibility of any oversight .
Biohackers challenge what the traditional scientific community considers to be ethical and acceptable uses of scientific tools. Rather than dismissing this challenge, what if the traditional community took this as an opportunity to re-examine and then adjust or defend its current definition of how “ethical” scientific research must be carried out? Arguments made in support of biohacking will be presented below to allow for consideration of the potential ethical intentions behind using biohacking as an alternative avenue to traditional routes, such as developing life-saving treatments in a faster and cheaper manner. However, it is still legitimate for trained scientists to critique biohacking movements as unethical or dangerous due to the lack of safety and risk management involved. Consequently, these critiques will be explored to stress to any readers who are considering or actively involved in biohacking that any seemingly sound arguments in support of biohacking do not outweigh the dangers associated with this independent path. Furthermore, it will be demonstrated that trained engineers have common ground with certain moderate groups of biohackers, and it is possible to lead biohackers down an ethical path that is safe for both them and the public and that could potentially benefit research institutions as well.
Considering Common Ground
Let’s begin by considering the merits of biohacking and the important conversations that it sparks. It was previously mentioned that biohackers are driven by certain frustrations with the way the scientific and regulatory community operates. The criticisms that biohackers have about mainstream progress are worthy of discussion, especially due to similar frustrations having been acknowledged from within the traditional scientific community. The following paragraphs describe three specific frustrations that have been expressed.
First, it takes too long to get a potentially or even proven life-saving device or medication to market . In 2016, U.S. regulatory pathways caused medical device approval to take an average of three to seven years and new drug approval an average of twelve years . In “The FDA Approval Process for Medical Devices: an Inherently Flawed System or a Valuable Pathway for Innovation?” Dr. Kyle M. Fargen and his co-authors point out that “the price of innovation is monumental for those invested in advancing medicine through cutting edge technologies” . This strongly worded commentary piece was written in 2013 by researchers in the traditional scientific community to express discontent with the rate of progress achieved by the conventional medical device approval process. Furthermore, its publication in a scholarly journal, the Journal of Neurointerventional Surgery, demonstrates that the professionals who reviewed and approved this article for publication agreed that this was a conversation worth having. Currently, companies will sometimes not pursue certain innovative technologies due to the excessive amount of money and time they would have to invest to navigate the complex regulatory landscape and get their product to market. Even back in 2013, there was a push to “streamline the lengthy FDA approval process” by device manufacturers who worried that “the USA [would] lose its ability to compete globally due to the excessive costs and delays in obtaining FDA approval” .
Second, medical devices and medicines manufactured through traditional means can be absurdly expensive due to the “complex intellectual property and regulatory landscape” of the US . This is part of the case made by the previously mentioned Open Insulin Project, a collaborative effort among DIY biologists working in community labs around the world, which aims to find alternative, less expensive ways to produce insulin . Cheaper methods of production would be possible if manufacturers were allowed to make generic versions of insulin or if manufacturing could be done on a smaller scale at hospitals or pharmacies; however, it is difficult to implement these methods with current intellectual property and regulatory barriers. Thus, the most promising route to achieving the Open Insulin Project’s goal is to develop and publicize an “open protocol for insulin manufacturing” to encourage patients to engage in biohacking and make cheaper “home-brewed” insulin for their own use .
Third, professional research and development does not focus on rare diseases because they are not as profitable for companies. In a 2018 publication discussing the future of rare diseases research, the International Rare Diseases Research Consortium (IRDiRC) presented the startling statistic that 94% of rare diseases still do not have an FDA-approved treatment . It was also found that even when treatments are available, “serious inequalities remain with regard to patient access to effective treatments” .However, the approach to drug development for rare diseases is receiving more recognition as an “economically viable strategy for biopharma R&D” due to the benefits offered by the US Orphan Drug Act . Furthermore, the FDA does have the Humanitarian Use Device (HUD) pathway for products that address medical conditions with fewer than 8,000 annual cases . This pathway removes some of the regulatory barriers in traditional FDA approval pathways by only requiring that the probable benefit of an HUD outweigh its risks and exempting companies from performing extensive clinical trials in order to prove the effectiveness of the device .
Each of these frustrations holds merit and motivates people to turn to biohacking rather than following the existing routes of research and development. On the one hand, just because their reasons hold merit, this does not necessarily justify biohackers disregarding legal practices followed by the scientific community. On the other hand, just because biohackers are not experimenting within established rules, this does not create automatic grounds for dismissal. It might be more worthwhile for the two communities to stand in solidarity on commonly identified issues and work together to find solutions that follow a path that lies somewhere between complete disregard of the rules and blind faith in existing regulations.
Is a Biohacking Code of Ethics Enough to Ensure Ethical Practice?
A discussion is needed on whether biohacking is unethical or dangerous even for more moderate biohackers who are not undergoing “young blood” transfusions or giving themselves fecal transplants. Most biohackers themselves would likely agree that extreme examples of grinders are unethical or at the very least push the boundaries of what seems acceptable. For example, founded in 2008, DIYbio is a group that describes itself as “an institution for the Do-It-Yourself Biologist” with the mission of “establishing a vibrant, productive, and safe community” . DIYbio, like other established biohacking groups, considers itself to be a civilized community and follows its own code of ethics formed through a process of collaborative deliberation in 2011. The DIYbio code of ethics for North America consists of the following values: “open access, transparency, education (of the public about biotechnology and their possibilities), safety, environment, peaceful purposes, and tinkering” . Even though some biohacking groups like DIYbio have ethical intentions and established codes of ethics, moderate biohacking is still dangerous for three main reasons.
First, even with biohacking groups, there are limited ways to monitor group members and enforce ethical standards. This can be illustrated by considering the way Genspace, an organized biohacking community, operates. Genspace was established in 2010 as “the world’s first community-based biotechnology laboratory” and provides its members with “safety training and access to scientific equipment and expertise” based on a paid subscription service . Genspace follows CDC Biosafety Level 1 guidelines and reviews proposed individual projects before approving access to their facilities . However, these facility safety measures do not ensure that Genspace’s members implement proper safety measures, as approved members have 24/7 access to the lab space . Furthermore, even if biohackers say that they follow a code of ethics, individuals who perform research at home use biotechnology tools obtained through a secondhand method such as eBay, so their practice is not dependent on a supervisor monitoring them for ethical violations. In contrast, effective and concrete ways exist to enforce codes of ethics for groups within the professional scientific community, such as for each engineering profession. Engineers and scientists who are employed in academia or industry are dependent upon their employers for access to biotechnology tools and journals and can be punished for ethical violations with fines, demotions, or dismissal, which results in total loss of access to the tools.
Second, the biohacking code of ethics seems to be biased towards the goals of the biohacking movement; arguably, it provides a false sense of safety and ethical underpinning for the right to access innovative tools and be considered on an equal level as professionals. Since codes of ethics are documents that attempt to outline “ethical” behavior for a specific group, these codes can be inherently biased depending on who the stakeholders are and what definitions of “ethical” behavior best suit their goals. Furthermore, there are concerns about the ethical integrity of research conducted by a biohacker who acts as both the researcher and the research subject, two roles that can naturally pose conflicts of interest . Thus, the existence of a biohacking code of ethics cannot be cited as objective proof that giving moderate biohackers access to powerful tools is not dangerous or unethical. When it comes to widening access to biotechnology tools that can impact public health and potentially redefine what it means to be human, the top priority stakeholder should be the general public, not self-interested biohackers. Thus, the Biomedical Engineering Society Code of Ethics is more impartially posed to safeguard public health, safety, and welfare as opposed to the DIYbio code, which seems to position the interests of biohackers as the top priority .
Third, the value of “tinkering” highlighted on the DIYbio code of ethics reveals the difference in approach to powerful biotechnology tools between biohackers and professional scientists who follow the rigorous process of the scientific method. For biohackers with no training or familiarity with the scientific method or other guiding research principles, “tinkering” is the preferred phrase to describe the process of trial and error as they use advanced technologies under conditions that were most likely never intended by the original creators of these technologies . This innocuous term is more familiarly associated with scenarios like “fiddling” around with a broken TV remote to figure out how to fix it‒not working with tools that can genetically modify DNA, the fabric of what makes us human. “Tinkering” is not necessarily an appropriate word to associate with safe and responsible use of this power. Commonly, the public finds it desirable for people in positions of power, whether political or scientific, to have a certain level of expertise in using the tools central to their field. Thus, it seems counterintuitive that biohacking movements, which advocate for removing the barrier of expertise for tool access, are growing in popularity.
Exclusion Based on Expertise and Accordance with Professional Institution Guidelines: Elitist or Reasonable?
The more people have access to a technology, the more likely it is to be harnessed for goals that greatly diverge from the original intent. This naturally leads to questions: What should the prerequisites be for those who have access to powerful technology? What determines a “bad” user? Yortsos suggests that “bad actors” are ones who act against the public good. Engineering codes of ethics like the National Society of Professional Engineers (NSPE) Code and the Biomedical Engineering Society Code also echo the priority of placing public health, safety, and welfare first [19, 20]. In order to place the public good above all, users of biotechnology must possess a level of technical excellence in the field as well as awareness of the risk and “social implications” of this technology . As has been previously discussed, it is too risky and thus unethical for biohackers to conduct projects on their own outside the realms of regulation or limitations applied to the professional scientific community. This is because ethics involves issues of safety and carefully considering, weighing, and preparing for all the possible risks that could occur when introducing a product to the market for public use.
The ethical rationale for the current quality and regulatory processes is best understood by engineers as “preventative ethics” to safeguard against disasters and “professional misconduct” . Engineers have studied and have practical experience dealing with disasters that were the result of rushed efforts to introduce scientific breakthroughs and tools into society. A biomedical engineering education, for instance, highlights the fundamental importance of abiding by ethical standards and managing risk to prevent medical devices from failing and causing harm to patients. Unlike independent biohackers working at home or in community spaces on a project for themselves, engineers are held responsible for the consequences of their inventions, whether positive or negative, and thus must follow codes that employ “preventative ethics.”
Furthermore, user error can occur with these important scientific tools. For example, a surgeon implanting a medical device could make a mistake or ignore certain instructions, resulting in the device failing not because it wasn’t manufactured or designed properly, but because the user made a mistake. User error is a large issue, because for all the careful time, effort, money, and planning funneled into a tool by engineers to account for all possible risks involved, they cannot control the actions or ethical code of the end user. If independent biohackers work with scientific tools in their own environment, they often do not have the training required to use these tools and thus could use them improperly and expose themselves and others to safety hazards or break certain moral boundaries. Academia and industry professionals can decide on ethical standards not to cross; they can be held accountable for failing to adhere to them. Independent biohackers, whether amateurs or trained scientists, can disregard professional standards and cross these lines without thinking twice. This is a danger that can never be fully mitigated. Thus, it is not unethical to deny access to biotechnology tools based on lack of expertise or compliance with appropriate protocols; rather, it is making a smart, informed decision to ensure that those who can handle powerful tools will use them responsibly.
While moderate biohackers bring up valid frustrations about how ethical precautions can slow down the rate of innovation in the medical field, these points do not justify a right for average citizens to access these biotechnology tools and bypass these precautions. Conforming to ethical codes is not the easy or simple choice, but if biohackers want to engage with technology that has the power to blur these ethical lines, they must be willing to contend with the associated difficulties. There are other ways for citizens who want to get involved in scientific research to do so without sparking such complex ethical debates and creating a high potential for dangerous outcomes. If those interested in the applications of biotechnology are not able to spend the time, effort, and money required to obtain a professional degree and research experience, they can assist professionals with research areas such as data collection and recruitment of human subjects, for example .
One significant takeaway is that more conversations should occur between biohackers and professional scientists and engineers in order to share insight from both groups on current issues within the scientific community. Instead of reacting harshly and forcing biohacking movements underground, it is better to open a dialogue and learn from the biohacking community. Biohackers leverage scientific research and tools created by engineers to achieve their own interests and place their objectives into larger conversations on what makes a scientist and who should have access to scientific tools. Similarly, engineers can leverage the phenomenon of biohacking to hold difficult conversations regarding the rate of progress that the current systems allow. Furthermore, more professional involvement rather than mere oversight of the biohacking community can be useful to increase the safety measures that biohackers use . To practice ethical actions and decision-making when using powerful biotechnology tools, everyone‒including biohackers‒must follow safety protocols.
One way to mitigate the danger of biohackers using advanced tools without necessary experience is to support the creation of more collaborative spaces like Genspace in which average citizens can be trained to use these tools and monitored for compliance with safety protocols. Admittedly, this sort of collaboration would give rise to new ethical considerations. For example, it is possible that not all citizen biohackers would agree to be trained by professionals, especially biohackers who adopt a populist viewpoint and see scientists and engineers as the “elite,” looking down on them and denying them a right. Furthermore, trained professionals have no ethical obligation to teach citizens, and for those who are willing, a new code of ethics must be created to determine the responsibilities of engineers and scientists in transferring such powerful knowledge to the general public. Despite the new implications to consider, this arrangement would allow the aspirations of biohackers to be recognized by professionals and give those citizens the opportunity to further progress towards life-saving technologies. At the same time, this would allow professionals to receive diverse insight on their research from members of the patient population their research attempts to target.
Overall, the future of biotechnology and biohacking remains malleable. Freeman Dyson, the so-called “patron saint” of biohackers, imagines a world where biotechnology has been “domestic[ated]” similar to the “domestication” of computers, which progressed from a few giant machines in “elite” academic labs to a variety of tech found even in the most remote, impoverished places on Earth . He envisions biotechnology becoming so “user-friendly” that kids play with “biotech games” . Although this vision may seem fantastical, some extreme biohackers are intent on making it a reality. However, there are endless checkpoints along the way where the ethics of this domestication should be pondered and deliberated. Today, the scientific community can start by engaging in conversation with moderate biohackers to shape safer, more ethical outcomes through the use of DIY biotechnology.
By Lindsey Marks, Viterbi School of Engineering, University of Southern California
About the Author
At the time of writing this paper, Lindsey was a junior studying biomedical engineering with a mechanical emphasis.
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