Psychedelic treatments for mental health conditions pose challenges for informed consent
Comment
Carolina Seybert, Gonçalo Cotovio, Luís Madeira, Miguel Ricou, Ana Matos Pires, Albino J. Oliveira-Maia
Nature Medicine, 14 June 2023
Excerpt
Enhanced informed consent procedures are needed for patients treated with psychedelics such as psilocybin and MDMA, due to effects that include an altered state of consciousness and vulnerability to suggestion.
In past years, clinical trials with psychedelic substances have been conducted to find alternative treatments for hard-to-treat mental health conditions such as treatment-resistant depression1, cancer-related depression and anxiety symptoms2 and post-traumatic stress disorder3. Clinical research has advanced under the regulation of national ethical and medication authorities for clinical trials, much as for any study testing a new intervention. Indeed, recent research on psychedelics has been conducted under the protected conditions of clinical trials, following international guidelines. However, psychedelic treatments present unique ethical and regulatory challenges that may not have been fully addressed within the traditional structures of clinical trial regulation4. These challenges need to be addressed before these substances are approved for use in general clinical practice…
Center for Informed Consent Integrity 