Should biohackers be regulated? Depends on your definition of ‘biohackers’

Alex Pearlman
5 min readOct 4, 2021

New guidelines for stem cell and gene therapies miss the mark

This story was originally published in Sex, Drugs, and Biotech in May 2021.

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Newly released guidelines from an international stem cell advisory group say that biohackers who want to treat themselves with at-home kits should be better regulated.

The International Society for Stem Cell Research (ISSCR) Guidelines have been used by lawmakers, ethicists, and scientists around the world since 2006 for advice on how to manage emerging science like stem cells, embryo research, and gene therapies.

The fourth and latest update to the influential guidelines suggests, in addition to controversial new advice about embryo research, that biohacking using cell and gene therapy in humans should be “limited to settings with an appropriate level of regulatory oversight to ensure their safe and responsible use.”

This is the first time the ISSCR guidelines has mentioned biohackers, but because biohacking has no clear definition, no oversight mechanism, and largely exists in a legal grey area in the US and elsewhere, this is impossible. Additionally, the guidelines do not accurately explain “biohacking,” an oversight of the nuance of the landscape that could be problematic for the global Community Bio movement.

What’s the issue?

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Alex Pearlman

Reporter. Bioethicist. Publishing on the intersection of ethics and policy with emerging science and tech.