Modifying Informed Consent to Help Address Functional Unmasking in Psychedelic Clinical Trials.
JAMA psychiatry March 1, 2025 Michelle Matvey, D Parker Kelley, Ellen R Bradley et al. 12 citations
In psychedelic clinical trials, participants often cannot be masked to whether they received the active drug or placebo, because the drug's effects are so noticeable. This can bias outcomes because participants' expectations influence their responses. One proposed solution is to modify the informed consent process to obscure some details of the study design, which has been used in several recent trials. However, this approach raises serious ethical concerns. The authors review the use of such modifications in trials from 2000 to 2024, discuss the regulatory landscape, and suggest ways to reduce risks. They conclude that modified consent may improve trial interpretability but has not been explicitly tested and may not be appropriate in all cases.