Johns Hopkins Psychedelic Clergy Study Found to Have Multiple Counts of "Serious Non-Compliance" with Federal Human Subject Protections
Unauthorized donor involvement and unauthorized study team members "significantly compromised" human research protection program, per JHU, citing other concerns for participants' rights and welfare.
In August 2023, I became a whistleblower on a psychedelic clergy study at Johns Hopkins University after a number of issues around the trial environment and its goals disturbed me. After over six months of silence from Hopkins’ Center for Psychedelics and Consciousness Research, I sent a letter to the Johns Hopkins Medicine Institutional Review Board in March 2024.
After twelve more months of silence, on Friday, I received the following email from the Office of Human Subjects Research:
Text reprinted below:
“Dear Reverend Welker
We are writing in follow-up to your letter dated March 4, 2024 concerning JHM IRB protocol number: IRB00036973 - “Effects of Psilocybin-facilitated Experience on the Psychology and Effectiveness of Professional Leaders in Religion”.
The Johns Hopkins Medicine IRB (JHMIRB) reviewed the human subjects related concerns and concluded that the following events constituted serious non-compliance because they significantly compromised the integrity of the Organization’s human research protection program:
Engagement of two study team members whose research activities were not IRB reviewed and approved;
Failure to accurately report support sources; and
Failure of two people engaged in this research to disclose their conflicts of interest, including their role as study sponsors, to the IRB or to participants. Only one of the two conflicted individuals was added to the study team. This individual failed to disclose their role of sponsor of the research to the IRB and led the qualitative analysis.
Furthermore, the JHM IRB determined that using an external entity to transcribe data without IRB approval and appropriate agreements constituted serious non-compliance because it significantly compromised the rights and welfare of the participants.
The JHM IRB determined the following must be reported to all journals and disclosed in all publications where data related to this study may be published:
There were two unapproved study team members, one who was also a study sponsor, directly engaged in the research;
There was an additional approved study team member whose role as a sponsor of the study was not disclosed to the IRB and who directly led the qualitative analysis;
Conflicts of interest related to the two individuals who were engaged in the research and also served as study sponsors were not appropriately disclosed nor managed; and
The funding sponsorship for this study was not disclosed to the JHM IRB.
These determinations were reported to the FDA.
We take seriously concerns reported to us related to human subjects research and appreciate your report to our office. If you have any questions about the IRB’s determination, please feel free to contact me.”
The study's serious non-compliance events were in violation of the U.S. Department of Health and Human Services regulations governing human subjects research. Hopkins did not return a request for comment at the time of publication. I hope to soon share a longer post with more detailed thoughts around this.
-Joe