US Institutional Review Board Perspectives Regarding Psychedelic Research

Abstract

Background:

Institutional review boards (IRBs) are gatekeepers of psychedelic research, deciding whether and under what conditions it may proceed. Yet IRB understanding, attitudes, perspectives, and concerns regarding psychedelics and psychedelic research have not previously been studied. These factors are important to assessing whether US IRBs are likely to be over- or underprotective of psychedelic research participants and to helping psychedelic investigators address key IRB concerns.

Methods:

A total of 529 current IRB chairs were invited to participate in an electronic survey conducted in October–November 2024. The sample included chairs at US organizations affiliated with psychedelic studies registered on ClinicalTrials.gov, the top 100 NIH-funded organizations, and organizations in states with more and less favorable psychedelic policies; IRB chairs affiliated with the Department of Veterans Affairs and two commercial IRBs were also included. Survey domains included psychedelic experience, understanding and attitudes about psychedelics, confidence reviewing psychedelic protocols, concern about aspects of psychedelic administration research compared to other research, views on risks associated with psychedelic administration research, perspectives on participant protections, and resource needs.

Results:

Overall, 212 IRB chairs completed at least 80% of the survey (42.7% response rate), a third of whom (34.9%) reported professional experience with psychedelics. Participants often reported lacking knowledge about psychedelic risks/benefits (35–51%) and selected neutral responses to questions examining their attitudes about psychedelics (35–47%). Most (61–78%) reported similar confidence reviewing psychedelic and nonpsychedelic protocols. Many IRB chairs (33–53%) reported heightened concern about psychedelic administration research, including legal, employment, and other social risks, expectations of benefit leading to bias, participant safety, consent challenges, and inclusion of vulnerable populations; about half (47.2%) reported heightened institutional risk compared to other research. Most agreed with requiring extensive monitoring of psychedelic administration sessions (82.9%) but expressed wide-ranging views on other protections.

Conclusions:

Rather than reflecting a broadly conservative approach to psychedelic research, IRB chairs often expressed a neutral attitude toward psychedelics alongside some uncertainty, while noting concerns that align with unsettled issues in the field. Gaps in IRB knowledge regarding psychedelic risks/benefits can be addressed in research protocols, while the field must continue to work toward consensus on best practices for participant protection.