Researchers' Experiences with IRB Oversight of Psychedelic Research.
Logan Neitzke-Spruill, Jill Oliver Robinson, Alison B. Purcell, Dominic Sisti, Amy L. Mcguire, Holly Fernandez Lynch
Ethics & human research 2026 DOI: 10.1002/eahr.70033 (opens in new tab)
Study at a glance
AI-extracted from the abstract| Characteristics | Qualitative study Peer reviewed |
|---|---|
| Sample size | 20 |
| Population | US researchers who had been principal investigators on at least one research protocol involving psychedelics |
| Keywords | Investigator perspectives Psychedelics Research ethics Research oversight |
| Key findings | Investigators reported that IRBs raised standard concerns about safety, consent, legal issues, and data security, along with knowledge gaps about psychedelic risks and effects, yet all described their current IRB experiences as positive or neutral. Respondents often attributed this to cultivating strong IRB relationships and helping IRBs gain adequate knowledge. The authors caution that less experienced investigators and IRBs may face different outcomes. |
Abstract
Previous research raises concern that conservative institutional review board (IRB) approaches regarding stigmatized issues and vulnerable groups could similarly arise as an impediment to research with psychedelic drugs. We interviewed 20 US researchers who had been a principal investigator on at least one research protocol involving psychedelics about their experiences with IRB oversight and perspectives regarding what IRBs need to know. Respondents reported that their IRBs raised concern and asked questions about participant safety, consent, legal issues, and data security and confidentiality, typical domains for IRB consideration. They also mentioned several IRB knowledge gaps or misunderstandings about psychedelics, primarily about risks and safety, while emphasizing the importance of IRBs' understanding of psychedelic drug effects. Despite IRB concerns and misunderstandings, all study respondents ultimately reported positive or neutral current experiences with IRBs reviewing their protocols for research with psychedelics, which they often attributed to cultivating strong IRB relationships and helping IRBs achieve adequate knowledge about these types of studies. Although investigators in our study did not perceive their IRBs to be a significant barrier to research with psychedelics, less experienced investigators and IRBs may face different outcomes. As research with psychedelics continues to increase, both researchers and IRBs should be responsive to continued scientific developments and emergent best practices.