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Psychedelic treatments for mental health conditions pose challenges for informed consent

Nature Medicine volume 29, pages 2167–2170 (2023)Cite this article

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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.

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Acknowledgements

We thank C. E. Fisher and J. Taborda da Gama for comments on an initial version of this manuscript. This work was supported by grant PTDC/MED-NEU/31331/2017 from the Fundação para a Ciência e Tecnologia to C.S., G.C. and A.J.O.-M. A.J.O.-M. received other grants from the Fundação para Ciência e Tecnologia (PTDC/SAU-NUT/3507/2021; PTDC/MED-NEU/1552/2021) and the Fundação para Ciência e Tecnologia and FEDER (PTDC/MED-NEU/30845/2017_LISBOA-01-0145-FEDER-030845; PTDC/MEC-PSQ/30302/2017_LISBOA-01-0145-FEDER-30302), a Starting Grant from the European Research Council (grant agreement no. 950357) and grants from the European Union’s Horizon 2020 research and innovation program (H2020‑SC1‑2017‑CNECT‑2‑777167‑ΒΟUNCE; H2020‑SC1‑DTH‑2019‑875358‑FAITH) and the European Joint Programme in Rare Diseases (Joint Translational Call 2019) through the Fundação para Ciência e Tecnologia (EJPRD/0001/2020).

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Authors and Affiliations

  1. Champalimaud Research and Clinical Centre, Champalimaud Foundation, Lisbon, Portugal

    Carolina Seybert, Gonçalo Cotovio & Albino J. Oliveira-Maia

  2. Instituto Universitário de Ciências Psicológicas, Sociais e da Vida (ISPA), Lisbon, Portugal

    Carolina Seybert

  3. NOVA Medical School, Faculdade de Ciências Médicas, NMS, FCM, Universidade NOVA de Lisboa, Lisbon, Portugal

    Gonçalo Cotovio & Albino J. Oliveira-Maia

  4. Department of Psychiatry and Mental Health, Centro Hospitalar de Lisboa Ocidental, Lisbon, Portugal

    Gonçalo Cotovio

  5. Faculty of Medicine, Universidade de Lisboa, Lisbon, Portugal

    Luís Madeira

  6. Portuguese Society of Psychiatry and Mental Health, Lisbon, Portugal

    Luís Madeira & Albino J. Oliveira-Maia

  7. National Council of Ethics for the Life Sciences, Lisbon, Portugal

    Luís Madeira & Miguel Ricou

  8. Center for Health Technology and Services Research (CINTESIS), Faculty of Medicine, Universidade do Porto, Porto, Portugal

    Miguel Ricou

  9. College of Clinical and Health Psychology, Portuguese Psychologists Association, Lisbon, Portugal

    Miguel Ricou

  10. Mental Health Department, Unidade Local de Saúde do Baixo Alentejo, Beja, Portugal

    Ana Matos Pires

  11. Comprehensive Health Research Centre (CHRC), NOVA Medical School, Universidade NOVA de Lisboa (NMS/UNL), Lisbon, Portugal

    Ana Matos Pires

  12. College of Psychiatry, Portuguese Medical Association, Lisbon, Portugal

    Ana Matos Pires

Authors
  1. Carolina Seybert
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  2. Gonçalo Cotovio
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  3. Luís Madeira
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  4. Miguel Ricou
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  5. Ana Matos Pires
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  6. Albino J. Oliveira-Maia
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Corresponding author

Correspondence to Albino J. Oliveira-Maia.

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Competing interests

C.S. received payment from the European Monitoring Centre for Drugs and Drug Addiction. A.M.P. received payment or honoraria from Janssen and Lundbeck and participated in advisory boards for Janssen and Angelini. A.J.O.-M. was the national coordinator for Portugal of trials for treatment-resistant depression of psilocybin, sponsored by Compass Pathways, Ltd (EudraCT number 2017-003288-36), and of esketamine, sponsored by Janssen-Cilag, Ltd (EudraCT NUMBER: 2019-002992-33); received payment or honoraria from MSD, Neurolite AG, Janssen and the European Monitoring Centre for Drugs and Drug Addiction; participated in advisory boards for Janssen and Angelini; and is the recipient of a grant from Schuhfried GmBH. The remaining authors declare no competing interests.

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Seybert, C., Cotovio, G., Madeira, L. et al. Psychedelic treatments for mental health conditions pose challenges for informed consent. Nat Med 29, 2167–2170 (2023). https://doi.org/10.1038/s41591-023-02378-5

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