In 2017, an eccentric biotech CEO injected himself with a homemade herpes cure at a biohacking convention, the whole thing live streamed for the world to see. [1] What was perhaps previously only a fringe subculture in the science community immediately shot into the public eye. But what is biohacking, and how can it be treated lawfully?
Biohacking is traditionally defined as “the attempt to manipulate your brain and body in order to optimize performance, outside the realm of traditional medicine.”[2] This subculture encompasses a wide variety of people and aims: from the extremely health-conscious who wish to live to the age of 180 to those afflicted with a rare genetic condition and have become disillusioned with standard medical treatment. In its practice, biohacking can range from taking daily vitamin supplements, intermittent fasting, or meditating to completely changing the microbiome of one’s gut, implanting microchips in one’s body, and even selectively, artificially modifying one’s genome. While certainly overshadowed by events like the one that made the name famous, biohacking has provided incredible tools to increase the enjoyment of human life. For example, in 2018 a quadruple amputee had a microchip inserted under his skin in order to more easily perform daily tasks like opening doors. [3]
Arguably the most intriguing form of biohacking are procedures that involve the selective manipulation of the human genome. And while human genetic modification is still in its infancy – with examples of which, successful or unsuccessful, being few and far between – its future as a powerful technology should not be dismissed. As genetic modification technology is becoming a reality, its legality must be considered from an ethical perspective. Although home genetic editing kits may have the potential to cause harm and regulatory bodies should respect the principle of nonmaleficence (not doing harm), the adherence to the principle of autonomy, as described by the Principlist philosophy of Beauchamp and Childress, outweighs nonmaleficence and most prominently shapes the nature of the legality of genetic modification kits so as to fit an ethical criterion.
Autonomy, as defined as “self decision that is free from the controlling interference by others and from limitations that prevent meaningful choice”[4] is a fundamental principle of not only the American bioethical philosophy, but also of our national culture. Autonomy can be further broken down into three qualities: intentionality, understanding, and non-control. For genetic modification kits to be ethically made legal, they must support these aspects of autonomy in their consumers.
Acting with intentionality refers not so much to an action as much as it does the series of events and planning leading up to said action. For an action to be intentional, there must have been some thought or planning that led up to the decision to partake in the action. However, intentionality does not prevent undesired outcomes. An act can still be intentional even if its outcome was not what the agent wanted. This detail is significant, as it separates the principles of autonomy from nonmaleficence. Whereas the principle of nonmaleficence would primarily seek to minimize any and all harm, just because an act causes harm to an agent does not mean that the action has violated the principle of autonomy. Only if the agent had not been made aware of the possibility of harm when forming their plan of action could an act be considered unintentional and not respecting autonomy. Because of this, understanding could be considered a prerequisite for intentionality.
Understanding is simply the state of having adequate knowledge of an action they are going to undertake. This is obviously a vague and subjective criteria, and it can be difficult to determine where the threshold of understanding begins. However, we as a society have decided on actual thresholds of understanding that an individual is required before we can trust that they are acting autonomously in their actions. For example, passing a driver’s test is required before we grant driver’s licenses. Yes, an understanding of road laws is essential to driving safely and preventing harm to others (driver’s test also adheres to the principle of nonmaleficence), but driver’s tests also function to ensure that a potential driver is properly informed of the action in which they are going to participate. It would not be ethical to allow for a person to get behind the wheel of a car without properly understanding both the social contract they are agreeing to between themselves and other drivers and also the dangers of driving.
Lastly, non-control refers to the lack of controlling external influences on decision making. An act can only be autonomous, and an agent can only act autonomously, if their decisions are truly self-directed. Not all forms of external influence violate the principle of non-control (ensuring understanding could be considered an external influence), rather only influences that coerce or manipulate can strip an agent of autonomy. As it regards biohacking, the decision to genetically modify oneself must be sourced internally to the agent, and biohacking must not be used as a method of violating non-control, and therefore the autonomy, in others.
The criteria by which an action or an agent can be considered autonomous might be considered rigorous, and possibly even infringing on what some believe to be their freedom. However, ensuring people’s right to autonomy is not just allowing people to do whatever they want. Restrictions on “freedom” are in place to limit the influence of others on an individual’s decision and to ensure that an individual has a proper understanding of the action in which they are going to partake. Completely restricting access to genetic modification kits would completely violate the principle of autonomy, as it would deny people their right to self-directed actions and meaningful choice. However, legalizing genetic modification kits without any regulations or guidelines would also violate the principle of autonomy by not ensuring that intentionality, understanding, and non-control are respected.
One way that bioethicists have succinctly ensured autonomy in medical or regulatory settings is by emphasizing the notion of informed consent. If an agent is not given adequate information about a procedure or an act they are going to perform (i.e. the agent lacks understanding and/or intentionality), they cannot be considered as acting as autonomous agents (i.e. they are being unethically influenced and cannot give consent). Moreover, if an agent lacks the ability to develop understanding, intentionality, or resist control, they can be considered unable to give consent. An inability to give consent can be due to mental deficiencies, a vegetative state, or simply age. Children cannot be considered autonomous individuals because they can not be trusted to act with intentionality, understanding, and non-control. Buying alcohol for minors is illegal because we acknowledge that children are not developed enough to make autonomous decisions for themselves, and only a truly autonomous agent can understand the risks involved with and engage in a potentially harmful activity like alcohol consumption.
The concept of informed consent underlies the role of a regulatory agency like the FDA. Requiring clear labeling of nutritional information, side-effects of pharmaceuticals, and cancer warnings on cigarette packaging all aid in informing consumers of what exactly they are going to put in their bodies. Not only is this information essential to ensure intentionality and understanding, but it also helps prevent non-control; unequal access to information can create unhealthy, predatory relationships between those that have knowledge and those that don’t. A kit that could be used to edit one's genome must be held to the same standard of transparency. Not everyone has a Phd in molecular biology, and therefore the legality of the sale of technology that can edit human DNA for the masses is contingent on ensuring that the masses have the resources to act with intention, understanding, and non-control.
While an agency like the FDA is trying to respect the autonomy of the people it influences, it also has a moral obligation to prevent harm, or non-maleficence as it's called. While non-maleficence is generally used in the context of a medical professional preventing the harm that a treatment or experiment could cause to their patient, regulatory bodies should also be held to a similar standard of preventing the harm that genetic modification kits could produce. However, the difference between a doctor’s and a regulatory body’s obligation to non-maleficence is distinct. Whereas doctor’s must be required to not cause harm to their patients, regulatory bodies are not necessarily obligated to keep a consumer of a genetic modification kit from harming themselves. A regulatory body does have an obligation to non-maleficence when a consumer of the product they regulate is not acting as a truly autonomous agent. Like mentioned previously, this can be due to mental deficiencies, a vegetative state, and also ignorance. The role of a regulatory body, as it regards non-maleficence, is to ensure that individuals are not harming themselves because they lacked intentionality or understanding. If an individual is truly informed and able to consent to an action, which would mean they understand the risks involved, and the individual somehow harms themselves, then the regulatory body would not be morally responsible for this harm. Ensuring informed consent is not only vital to protecting consumers’ right to autonomy, but it also underlines a regulatory body’s responsibility to non-maleficence.
One could argue that a regulatory body’s responsibility to non-maleficence extends beyond just ensuring non-maleficence in non-autonomous individuals, and that the responsibility to non-maleficence of regulatory bodies should be held to the same standard as medical professionals (i.e. preventing all harm that a treatment could cause to a patient). Overarchingly, the difference between these two takes is deciding which bioethical principles takes precedence over the other: autonomy over non-maleficence or vice versa. In a case like this, where adhering to two bioethical principles might be contradictory, one should weigh and balance the weight of these two principles in the face of each other.
Instances where the responsibility to non-maleficence outweighs the responsibility to autonomy are referred to as paternalistic. In cases like these, a regulatory body would have the moral responsibility to intervene to prevent harm, even if it meant infringing on one’s right to autonomy. However, for intervention to occur, the following conditions must be met:
1. A patient is at risk of a significant, preventable harm or failure to receive a benefit.
2. The paternalistic action will probably prevent the harm or secure the benefit.
3. The intervention to prevent harm to or to secure a benefit for the patient probably outweighs the risks to the patient of the action taken.
4. There is no morally better alternative to the limitation of autonomy that will occur.
5. The least autonomy-restrictive alternative that will prevent the harm or secure the benefit is adopted. [4]
Regulatory bodies have a more difficult time in adhering to all of these conditions because they cannot act casuistically in their decision making. Regulatory bodies and lawmakers are making broad, generalized rules that should govern all consumers of a product objectively. While a physician might be able to determine that their patient “is at risk of a significant, preventable harm or failure to receive a benefit”, regulatory bodies can not say the same about a whole population. Since regulatory bodies can not as easily meet the conditions of justifying paternalism given the magnitude of their “patients,” it is only ethical for them to favor autonomy over non-maleficence and not justify acting paternalistically.
The potential for harm that genetic modification kits can yield does not necessarily necessitate their restriction. Yes, it is absolutely possible that rational, adult human beings could use genetic editing kits to harm themselves. However, rational, adult human beings drink alcohol, don’t wear sunscreen, and eat junk food all the time. All of these acts cause a great amount of harm to both the individual and society, yet the legality of these products and its respect for autonomy is weighed over the harm that they cause. That being said, it is also the responsibility of a regulatory body to mitigate as much harm as possible without violating autonomy. In the end though, autonomous agents ought to have the right to engage in the use of genetic modification technology, even with the potential for harm present. However, to actually meet the standard of autonomy that predicates their legality, strict rules must be in place that restrict genetic modification kits solely to individuals who act with intentionality, understanding, and non-control.
Sources:
Chen, Angela. “A Biohacker Injected Himself with a DIY Herpes Treatment in Front of a Live Audience.” The Verge. The Verge, February 5, 2018. https://www.theverge.com/2018/2/5/16973432/biohacking-aaron-traywick-ascendance-biomedical-health-diy-gene-therapy.
Samuel, Sigal. “How Biohackers Are Trying to Upgrade Their Brains, Their Bodies - and Human Nature.” Vox. Vox, June 25, 2019. https://www.vox.com/future-perfect/2019/6/25/18682583/biohacking-transhumanism-human-augmentation-genetic-engineering-crispr.
“Quadruple Amputee Has Microchip Implant to Unlock Doors.” BBC News. BBC, January 18, 2018. https://www.bbc.com/news/av/uk-england-dorset-42725099.
Beauchamp, Tom L., and James F. Childress. Principles of Biomedical Ethics. New York, NY: Oxford university press, 2019.