Genetic modification is no longer just confined to the university laboratory. “Biohackers” are becoming more and more prevalent, working out of their garages or home laboratories, modifying the genome of human and bacteria alike. Some do this as a form of self-expression, others hope to take a stab at irradiating disease.
And it’s easy to do. With just a small amount of cash, they enter the biohacking world with very little technical know-how. Without regulation, some fear biohackers could cause major problems – like the release of a genetically modified bio-weapon or a human modification that is passed on from generation to generation. But can we even hope to regulate those who biohack from their garages?
Biohacking is easy to do. Anyone who wants to start modifying the genome in their garage can buy a DIY CRISPR kit for less than $200. There is a broad range of experimentation that can be done – from manipulating the genes of bacteria and yeast to self-experimentation. Some have performed genetic manipulation on themselves as a form of self-expression. Others want to attempt to improve their strength or come up with a treatment for diseases such as HIV or herpes. Unlike Europe, the United States does not regulate biohacking outside of licensed laboratories.
While still in high school, Keoni Gandall biohacked in his home laboratory. His recklessness got him kicked out of his science fair.
A team from the University of Alberta created an extinct relative of smallpox from scratch using biohacking. It showed the ease that someone could create a bio-weapon.
Things get particularly dangerous when these biohackers modify the germline. Germline modifications are not confined to the individual and can be passed from generation to generation. Such modifications may be impossible to stop and could cause terrifying problems if something goes wrong.
But not all biohacking is bad or irresponsible.
For example, every year the iGEM Foundation hosts the International Genetically Engineered Machine (iGEM) Competition. Students in this competition participate in synthetic biology, or biohacking, to build and design biological systems. But the ethical standards of the iGEM competition are high. Teams have to consider all facets of their projects, such as security, human practices, sustainability, and ethics. “iGEM often makes use of technologies right on the cutting edge of what’s feasible. That means that often regulators and oversight bodies haven’t had the chance to think about those technologies”, says Piers Millett, the iGEM Vice President for Safety and Security.
“Each project is reviewed for safety and security risks – making sure we do not cause harm to our community or the societies with which we interact,” Millett said in a personal communication.
The safety and security committee not only prohibits some activities, such as human experimentation or the release of pathogens, but also looks closely at certain activities, like those involving animals or anti-microbial resistance. Teams also receive awards for exemplary thought to ethical standards.
In a commentary in Science Magazine, Patricia Zettler, an Assistant Professor of Law at the Ohio State University Moritz College of Law, and collaborators recently talked about how biohacking can be regulated within the US without sacrificing scientific progress. They point out that DIY CRISPR kits fall within the FDA’s jurisdiction, but so far the FDA has not enforced any standards for biohackers. Many in the biohacking community are left confused about what they can and can’t do. “Given some biohackers’ continued confusion about FDA’s authority over their work, the agency might begin by clarifying the boundaries of its jurisdiction,” they say, “while seeking feedback from biohacking communities on how FDA could best exercise its authority in this space.”
“I hope there’s a real opportunity for regulators and biohacking communities to meaningfully engage with one another,” says Zettler in a personal communication. “Regulators don’t just police activities, they can also engage with communities.”