Do-it-yourself (DIY) treatments and “biohacking” become more feasible by the day. What can and should policymakers do as medical innovation is further democratized?

Biohacking usually conjures up images of a rogue, amateur scientist in his dark basement attempting to create a supervirus that he can unleash on the world out of pure spite. What is actually happening in the biohacking community is quite different.

Biohackerspaces offering access to scientific equipment, classes, advisors, and space to experiment and learn, all under rigorous safety standards, are the norm for this community. Meanwhile, parents and volunteers are working together to create custom 3D-printed orthoses to aid children with limb deficiencies, or to help children with cerebral palsy walk comfortably and without the aid of crutches. Other parents have come together and shared knowledge and open source code to create DIY insulin remote monitoring and delivery devices for their diabetic children.

On the fringe, there are reports of more controversial self-experimentation, as when biochemist Josiah Zayner injected himself with a DNA cocktail to bulk up his muscles. While rare, such experiments do pose certain risks, and have prompted calls to examine whether those who do them, and the biohacker community at large, ought to be regulated more heavily.

Recently, Science published an article exploring these very topics. The authors recognize that regulation of biohacking takes two forms: government regulation and private regulation.

Contrary to the popular narrative, biohackers do not operate in the “wild west.” These amateur scientists are subject to a number of laws and regulations, principally those administered by the Food and Drug Administration (FDA). While the agency has taken small steps into this arena, it has yet to vigorously assert its power. The authors recommend the FDA focus on its “community engagement” role, rather than piling on “new or more powerful regulations.” Specifically, this includes “education, warning, and standard setting.”

Previously, we have praised the success of FDA education campaigns and multistakeholder governance efforts as a smart way to address certain public health risks. For example, the “Real Cost” campaign, designed to make adolescents aware of the dangers of cigarette smoking, had enormous success. The agency’s 2009 Strategic Plan for Risk Communication as well as its 2011 report on Communicating Risks and Benefits: An Evidence-Based User's Guide, also offer excellent risk education guidelines that could be expanded to cover biohacking and citizen-based science.

Additionally, the agency has pursued a new, innovative form of governance that invites participation from regulated actors and other stakeholders in order to respond to the increasing speed of medical technological development. This includes “soft law” approaches like public workshops, guidance documents, and developing industry-wide best practices. Adopting such approaches in the context of biohacking could promote buy-in from the community and actually entice those would-be participants who are concerned about the legal grey zone that currently exists.

The Science authors also recognize the place of private regulation. The biohacking community is already sensitive to safety and ethics. Many of the biohackerspaces have their own strict safety standards. In 2011, representatives from these biohackerspaces drafted a code of ethics emphasizing values like transparency, innovation, and safety. In fact, Dr. Todd Kuiken, a scholar at North Carolina State University, has written that, when it comes to safety issues, the biohacker community is “arguably ahead of the scientific establishment.”

In addition to acknowledging the safety and ethical restrictions already adopted by biohackers, the Science article recommends using patent law and tort mechanisms to further curtail dangerous experiments.

For example, the institutions that own the patents to systems like the genome-editing system CRISPR can license these tools to individuals or biohackerspaces under strict agreements that prohibit certain uses. The Broad Institute at Harvard University has licensed CRISPR to Bayer with an agreement that prohibits Bayer from using it for tobacco research or germline editing.

Various common law remedies and consumer protection laws can also provide ex post relief to individuals harmed by biohackers. Threats of legal action also supply a powerful incentive not to undertake potentially dangerous experiments without adequate knowledge and skill.

While the steps outlined above may be prudent precautions, it is important to remember both the likelihood of harm and the potential for positive good of biohacking. There are institutional and technical limits on the damage that biohackers are able to affect. Focusing too much regulatory and enforcement energy on this community would be expensive and unnecessary. Additionally, biohacking offers educational benefits for students and citizen scientists who do not have access to the expensive, traditional avenue of university and institutional labs.

Government and the scientific community ought to temper their expectations and demands of this community to a level that is in line with the actual risks. As the Science article concludes, “striving for perfect compliance comes with substantial burdens, including throttling the development of new technologies, expending scarce enforcement resources, and facing political backlash.”

Social pressures and public shaming can also help constrain worst practices. For example, Dr. He Jiankui’s controversial recent genome-editing experiments on Chinese twins resulted in a global backlash and almost-universal condemnation. The episode served as a powerful warning to others who might try to rashly follow in his footsteps without considering ethical considerations and widely-accepted safety guidelines.

As we argued in a previous essay, to be most productive, regulators should focus on awareness-building efforts while simultaneously providing space for ongoing experimentation—both with innovations and new governance mechanisms for them. Giving in to the doomsayers worried about extreme hypotheticals will only stifle a promising community helping to cultivate tomorrow’s scientists, doctors, and potentially life-saving innovations.

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