Modifying Informed Consent to Help Address Functional Unmasking in Psychedelic Clinical Trials
Special Communication
Michelle Matvey, D. Parker Kelley, Ellen R. Bradley, Winston Chiong, Aoife O’Donovan, Josh Woolley
JAMA Psychiatry, 8 January 2025
Abstract
Importance
There is unprecedented clinician, industry, and patient interest in the therapeutic development of psychedelic drugs. This is due to a combination of promising clinical trial results, positive media coverage, and the lack of novel pharmacologic treatments for psychiatric disorders in recent decades. However, the field faces a key methodological challenge: masking participants to treatment conditions in psychedelic clinical trials has been largely unsuccessful.
Objective
When participants can tell whether they received active drug or placebo, their responses to clinical assessments, questionnaires, and even their functional imaging and biological data can be influenced by preconceptions about treatment effects. Positive patient expectancies combined with ineffective masking may skew outcomes and inflate effect sizes. This complicates efforts to determine the safety and efficacy of psychedelic drugs. Here, we explore a method to help address this problem: modifying informed consent to obscure information about the study design.
Evidence Review
We reviewed all contemporary (2000-2024) clinical trials of psychedelic or methylenedioxymethamphetamine (MDMA) therapy and corresponded with the investigators to compile information on the use of modifications to informed consent in these studies.
Findings
Modifying informed consent to obscure details of the study design has been implemented in several psychedelic clinical trials and may offer a way to strengthen masking. However, this approach poses significant ethical risks. We examine examples of modifications used in the psychedelic literature, discuss the current regulatory landscape, and suggest strategies to mitigate risks associated with modified informed consent.
Conclusions and Relevance
Incorporating modified informed consent in future psychedelic clinical trials may improve interpretability and impact, but this has not been explicitly tested. Modifications to informed consent may not be appropriate in all cases, and risks to participants should be minimized by implementing appropriate guardrails.

Informed Consent in dementia research: how Public Involvement can contribute to addressing “old” and “new” challenges Provisionally accepted
Ana Diaz-Ponce, Cindy Birck, Angela Bradshaw, Jean Georges, Daphne Lamirel, Soraya Moradi-Bachiller, Dianne Gove
Frontiers in Dementia, 2025
Abstract
Informed consent is a critical ethical requirement in research, ensuring the protection of participants’ rights and promoting their well-being and autonomy. However, in dementia research, this process becomes particularly complex due to cognitive impairments and fluctuating capacity. While substantial work has been done to address these challenges, much of the literature on informed consent in dementia research has been shaped by the perspectives of researchers and healthcare professionals, with less focus on those with lived experience. This paper provides an overview of the perspectives of people with dementia and their carers resulting from Public Involvement activities organised by Alzheimer Europe. It builds on Alzheimer Europe’s previous work with the European Working Group of People with Dementia and draws on discussions held during a face-to-face meeting about Participant Informed Consent forms and processes used in two specific European projects. We highlight views and key concerns raised by people with lived experience regarding the informed consent process, including barriers and facilitators. In addition to ensuring understandability, the discussions emphasised the importance of promoting respect and autonomy, ensuring that the values and interests of people with lived experience remain central throughout the research process. This paper contributes to the ongoing dialogue on improving informed consent practices in dementia research, highlighting the need for continuous involvement and the inclusion of people with lived experience in shaping consent practices to address both old and emerging challenges (i.e. new types of research such as artificial intelligence and data sharing/re-use) in dementia research.

The practice of electroconvulsive therapy without patient consent: a French naturalistic study
Original Article
Chevalier, S. Lespagnol, J. Charron, L. Cheval, S. Bulteau, A. Sauvaget, A. Laurin
Ethics, Medicine and Public Health, 2025
Abstract
Introduction
Free and informed consent is essential in care, though it may be impossible to obtain in psychiatry due to the impairment of discernment caused by mental illness. In this context, the law authorizes coerced care, including electroconvulsive therapy (ECT), a highly effective treatment that can at least partially restore discernment. However, the practice of ECT without consent is poorly documented, as is the question of reassessing consent during ECT. We need to take stock of the situation in order to improve practices.
Method
We conducted a monocentric observational retrospective chart-based study at Nantes University Hospital (France) involving 162 patients treated by ECT between 2018 and 2022.
Results
Our results showed that 36% of patients were treated by ECT without their consent, but with the agreement of a close relative (32% spouse, 31% child). ECT without the patient’s consent was mainly carried out in patients hospitalized under restraint, with a manic or mixed state, suffering from a catatonic or dementia syndrome. Despite an efficacy rate of 97%, only 3% of patients regularized their consent at the end of the ECT course. Surprisingly, 21 patients were treated with ECT without their consent, with the agreement of a third party, while in open hospitalization, and 26 patients were treated with ECT with their consent while in restricted hospitalization.

Exploring consent as an aesthetic experience through applied theatre with people living with dementia
Karoline Dalby, Lilli Mittner, Rikke Gürgens Gjærum
Nordic Journal of Art & Research, 31 December 2024
Abstract
    The process of giving or obtaining consent is typically seen as a series of language-based actions, either documented on a written form or communicated verbally. However, both methods can present challenges when engaging with individuals living with dementia. This paper explores how to understand consent as an aesthetic experience through applied theatre practices.

We draw on data from 12 applied theatre sessions in a residential care home in Northern Norway (2019–2021). The study design was practice led and situated in everyday-life practices at the care home. Through writing field stories collectively, based on a mixture of notes, video recordings, and embodied experiences, we analysed how people gave their consent to engaging in creative activities beyond using spoken and written language.

We find consent in four key elements that play a major role when we work co-creatively with people living with dementia:1) trust; 2) attunement; 3) sensibility; and 4) mutuality. Consent as an aesthetic experience is thus highly embodied, processual, and relational.

Our paper is written within an emerging discourse of relational perspectives in dementia research. It promotes the perception of people living with dementia as creative citizens who can equally contribute to art and research.

Facing the new diagnostic and treatment options of Alzheimer’s disease: The necessity of informed consent
Jonas Karneboge, Julia Haberstroh, Katharina Geschke, Julia Perry, Katrin Radenbach, Frank Jessen, Ayda Rostamzadeh
Alzheimer’s & Dementia, 30 December 2024
Abstract
With advances in biomarker-based detection of Alzheimer’s disease (AD) and new treatment options with disease-modifying treatments (DMTs), we are heading toward a new conceptualization of diagnostics and therapy in the early stages of AD. Yet consensus guidelines on best clinical practices in predictive AD diagnostics are still developing. Currently, there is a knowledge gap regarding counseling and disclosure practices in early symptomatic disease stages, its implications for dementia risk estimation, and DMTs with associated risks and benefits. The crucial feature is the capacity of patients with (mild) cognitive impairment, eligible for DMTs, to consent. This perspective aims to (1) discuss the current challenges in assessing capacity to consent and (2) highlight the importance of a supported (informed) decision-making process. Measures to facilitate informed decision-making of patients constitute an ethical approach to enhancing the quality of care in this evolving therapeutic landscape.
Highlights
This perspective: Explores biomarker-based early symptomatic AD detection and the implications for patient care. Emphasizes supported decision-making in DMTs for MCI and dementia patients. Discusses the need for standardized tools to assess the capacity to consent. Aligns diagnostic and treatment approaches with ethical care standards. Enhances patient autonomy in the evolving AD therapeutic landscape.

Obtaining Informed Consent of Vulnerable Populations for Participating in Social and Education Sciences Research
Karen S. Voytecki, Gregory L. Hassler
International Conference on Social and Education Sciences, 17-20 October 2024; Chicago, USA
Abstract
Obtaining informed consent is the foundation of ethics in clinical research involving human participants. Individuals who provide informed consent acknowledge they understand all aspects of the research including the nature of the study, the risks and benefits of participation, the participant’s rights, study procedures, research duration, confidentiality, and voluntariness. The process of obtaining informed consent from research study participants contains legal and ethical procedures. The “Common Rule” identifies “vulnerable subjects” for research purposes as “children, prisoners, individuals with impaired decision-making capacity, or economically or educational disadvantaged persons.” This social and education sciences research article explores a pragmatic approach for Institutional Review Boards (“IRBs”) to review research protocols involving individuals with disabilities and/or those who are educationally-disadvantaged as study participants. Consideration is also given to Universal Design for Learning (UDL) principles in relation to appropriate and effective accessibility options to IRB materials. As a direct result, a process is formed for obtaining informed consent of vulnerable participants in social and education sciences research.