Parallel-access compounds: unregulated availability as a consideration in research ethics

Some investigational drugs, such as ketamine, psychedelics, and cannabis, exist simultaneously in regulated clinical trials and unregulated street or online markets, where they are accessible without clinician oversight. The authors propose the term "parallel-access compounds" for this category and argue that research ethics should formally recognize these substances. Non-psychoactive examples also exist, like retatrutide, an investigational weight-loss drug that has been illicitly manufactured and sold despite being intended only for trial participants.

Study at a glance

Abstract

Some investigational compounds exist in both regulated clinical pipelines and unregulated street or online markets. Ketamine, psychedelics and cannabis are all under active clinical investigation while remaining accessible, in unregulated form, through illicit channels without clinician oversight. We propose the term parallel-access compounds for this category and argue that it deserves recognition in research ethics (see box 1). The most familiar examples are psychoactive, but non-psychoactive examples also exist: retatrutide, an investigational triple hormone-receptor agonist meant to be available only to trial participants, has nonetheless been illicitly manufactured and sold as a weight-loss drug.1