Informed Consent in Psychedelic-Assisted Therapy
Book Chapter
Mazdak M. Bradberry, Paul S. Appelbaum, Natalie Gukasyan
Current Topics in Behavioral Neurosciences, 31 December 2024 [Springer]
Abstract
Humans have long used classical serotonergic psychedelics, such as psilocybin, for a variety of purposes. Entactogens, such as methylenedioxymethamphetamine (MDMA), emerged during the twentieth century and have likewise seen use in a broad range of settings. Interest has arisen in the use of classical psychedelics and entactogens, together termed “psychedelics,” for therapeutic purposes in Western clinical settings. Care in these settings is governed by standards for the communication and assumption of risk in the process of informed consent. Rigorous informed consent standards in psychedelic medicine are not only essential for quality care but also critical to the mitigation of risk, particularly in research settings and for vulnerable individuals. This chapter describes practical elements of informed consent in psychedelic therapy, with a focus on effective communication of the risks and potential benefits of classical psychedelic and entactogen treatments as they are currently understood.

Promoting trans patient autonomy in surgical preparation for phalloplasty and metoidioplasty: results from a community-based cross-sectional survey and implications for preoperative assessments
Research
Leo L. Rutherford, Elijah R. Castle, Noah Adams, Logan Berrian, Linden Jennings, Ayden Scheim, Aaron Devor, Nathan J. Lachowsky
BMC Medical Ethics, 31 December 2024
Open Access
Abstract
Background
Some transgender and nonbinary people undergo phalloplasty and/or metoidioplasty as part of their medical transition process. Across surgical disciplines, a variety of resources are used to assist patients who are preparing for surgeries, including educational materials, workshops, peer support, and lifestyle changes. For gender-affirming surgeries, patients undergoing assessments to discern whether they are ready to undergo the surgery, and to assist them in achieving preparedness when needed. Little research investigates what resources are useful in helping patients to feel prepared to undergo phalloplasty or metoidioplasty, and how assessments and resources can promote patient autonomy in the process. Respect for patient autonomy is one of the central tenets of ethical healthcare, yet historically, scholarship related to pre-surgical assessments for gender-affirming surgery has focused determining the ideal surgical candidate rather than respecting patient autonomy and ascertaining individual patient needs.
Methods
This study sought to fill this gap by utilizing data from PROGRESS (Patient-Reported Outcomes of Genital Reconstruction and Experiences of Surgical Satisfaction), a cross-sectional, community-based survey of trans and nonbinary adults from the United States of America and Canada who had undergone one or more of these surgeries.
Results
Results revealed most participants (86%, n = 186) felt prepared to undergo surgery, though the majority of our sample (53%, n = 105) did not find referral letter assessments to be helpful. Peer support such as online resources/blogs were rated as highly useful, along with surgical consults. In a multivariable logistic regression, higher perceived preparedness was associated with identifying as queer (inclusive of gay, bi and pansexual compared to being straight), and feeling that one’s assessment process was useful (as opposed to not useful). Type of assessment was not significantly associated with preparedness; therefore, what is most useful when preparing for surgery may vary across individuals.
Conclusion
Healthcare professionals who interact with preparing patients should develop new or utilize existing resources to assist patients in identifying their preparation needs and achieving preparedness. Our data supports assessments that center surgical care planning rather than assessing level of gender dysphoria. Future longitudinal research could further refine which assessment processes are most effective in helping patients who are preparing for these surgeries. Assessments should ensure that patients are appropriately prepared to undergo and recover from surgery through a robust process of informed consent.

Maternity Care Informed Consent Practices and Perspectives: A Qualitative Study at a Tertiary Maternity Unit
Sally Ely, Susanne Langer, Hans Peter Dietz, Ka Lai Shek
The Australian & New Zealand Journal of Obstetrics & Gynaecology, 30 December 2024
Abstract
Background
Although consent has long been accepted as necessary in maternity care, the concept of informed consent for planned vaginal birth has polarised maternity politics. The publication of the NSW Consent Manual outlines new standards of informed consent, signalling the need for examination of current maternity consent practices.
Aims
To examine informed consent and disclosure of material risks in birth in a prospective qualitative study of midwives and obstetricians.
Materials and methods
Qualitative study using semi-structured interviews to examine practices and perspectives of obstetricians and midwives.
Results
Twenty-two telephone interviews were concluded. Five sub-themes were identified: (1) non-compliance with the NSW Consent Manual, (2) risk communication/informed consent in maternity care, (3) consent practices in instrumental birth, (4) who should deliver risk information and when (5) barriers to change in consent practice (obstetricians only).
Conclusions
One hundred per cent of participants (18 obstetricians, 4 midwives) described risk communication/informed consent practices that were non-complaint with the standards set out in the 2020 NSW Consent Manual. Eighty-three per cent (15/18) of obstetricians reported that current hospital-wide maternity care practices in risk communication/informed consent are inadequate. Sixty-one per cent (11/18) of obstetricians specifically singled out informed consent practices regarding instrumental birth to be inadequate. Ninety-four per cent (17/18) of obstetricians believe that maternity care consent practices need to be improved. The results of this study indicate that material risks of vaginal birth, caesarean section and instrumental birth, are not routinely disclosed during antenatal courses. Urgent resources and structural change are required to uphold women’s legal right to bodily autonomy.

Ethics of the fiduciary relationship between patient and physician: the case of informed consent
Extended essay
Sophie Ludewigs, Jonas Narchi, Lukas Kiefer, Eva C Winkler
Journal of Medical Ethics, 23 December 2024
Abstract
This paper serves two purposes: first, the proposition of an ethical fiduciary theory that substantiates the often-cited assertion that the patient–physician relationship is fiduciary in nature; and second, the application of this theory to the case of informed consent. Patients’ decision-making preferences vary significantly. While some seek fully autonomous decision-making, others prefer to delegate parts of their decision. Therefore, we propose an ethical fiduciary theory that allows physician and patient to jointly determine the physician’s role on a spectrum from fiduciary as advisor to fiduciary as agent. Drawing on legal concepts of the fiduciary relationship and on phenomenological accounts of obligation by Lévinas and Løgstrup, our theory relies on the key attributes of trust, vulnerability and otherness. Finally, practical implications of this theory for the informed consent process are developed: we propose a preassessment of patients’ risk and value profiles as well as a restructuring of the oral consent interview and the written consent materials.

Reconsidering Consent on Brain Death Examination
Claire Hyunseo Lee
Intersect, 2024
Abstract
By medical definition, brain death refers to ”the irreversible loss of all functions of the brain” (Goila and Pawar, 2009, 8). Although brain death has been under US legislative approval since 1981, heightened legal disputes and criticism from bioethicists have brought renewed interest in brain death examination (Starr et al., 2024). Some individuals claim that the current protocol for conducting brain death examination has been developed incautiously, driven by an exaggeration of practical benefits without sufficient consideration of ethical implications. In light of these issues, we argue that performing brain death examination without consent is unethical. To support our assertion, we investigate the faulty application of implied consent, potential medical inaccuracies of the procedure, and the need to problematize taking epistemic authority as an absolute judgment. The danger of utilitarian bias and the dead donor rule are analyzed to refute primary rationales for conducting brain death examinations without consent. As a culmination of these findings, we proactively address how consent can be ethically obtained with respect to the affected patient and family. Ultimately, we argue that establishing a policy of consent will ensure that a patient’s autonomy and well-being are protected in an era of rapidly developing medical technology and policy.

Editor’s note: Intersect is the Stanford Journal of Science, Technology, and Society.

Perception of resident physicians about the informed consent form
Research
Cristiano Roberto Nakagawa, Gustavo Azevedo Pontes, Leide da Conceição Sanches, Elaine Rossi Ribeiro
Revista Bioética, 2024
Open Access
Abstract
The right to information about medical procedures is the basis of a good physician-patient relationship and, together with bioethical principles, ensures respect for patient autonomy. From this perspective, this descriptive research with a qualitative approach sought to understand the perception of resident physicians about the informed consent form. Data were collected using remote semi-structured individual interviews. Complying with the methodological criteria, the information obtained was classified into three categories: 1) perception, knowledge, and construction of the informed consent form for medical procedures; 2) social and legal function of the informed consent form; and 3) relevance of the patient’s capacity, temporality, and provision of the form to the patient. The importance of bioethics, legislation, and the preparation of medical consent in a practical and theoretical environment was highlighted to consolidate an adequate physician-patient relationship.

Consent to medical student teaching: an observational, cross-sectional study exploring the patient view
Research
Niki Newman, Fraser McKenzie, Jonathan M. Wells, Tim Wilkinson, John Dean, Matthew Doogue, Lutz Beckert
BMC Medical Education, 24 December 2024
Open Access
Abstract
Background
New Zealand guidelines stipulate that patient consent is obtained for medical student involvement in clinical care, however, patients’ preferences regarding consent for medical student teaching have not been widely explored. This study examined patient preferences for consent for medical student teaching with the aim to increase patient empowerment, to optimise care and to reflect societal expectations more accurately.
Method
Observational, semi-qualitative, cross-sectional study of in-patients. Each participant was presented with a series of nine hypothetical clinical scenarios and were allowed a limited number of responses. For each scenario the participants completed a short questionnaire about their preferences for consent. These included their preferred mode of consent (implicit, verbal or written), timing of consent, and who should take their consent. The analysis used descriptive statistics and ordinal logistic regression mixed models to investigate associations between patient characteristics and chosen mode of consent.
Results
There were 123 participants (50% male), median age was 64 years. Patients were admitted to either medical (69%), surgical (22%) or women’s health (9%). Increasing age was statistically significantly associated with a preference for verbal and implicit rather than written consent with the exception of ‘breaking bad news’ and ‘bedside teaching’. The majority of patients preferred verbal consent across all nine clinical scenarios (57–82%), including two surgical scenarios where verbal consent was preferred by 59%. Most patients preferred the supervising doctor to take consent, with no clear preference about the timing.
Conclusions
This study identifies the patient voice in the consent process for the involvement of medical students in clinical care. Although the patients’ views generally align with an existing national consensus statement, there is variability in the expectations of the patients suggesting flexibility in the consent process is still needed. The preference for older patients for verbal or implicit consent compared with younger patients for more invasive scenarios highlights the need for consideration of inter-generational differences. Most patients in this study were willing to contribute to student learning in all scenarios.

The German Medical Informatics Initiative Broad Consent in the Emergency Department: A Single Centre Prospective Observational Study to Assess Consenting Mode Dependent Success Rates
Felix Patricius Hans, Jan Kleinekort, Melanie Boerries, Alexandra Nieters, Gerhard Kindle, Micha Rautenberg, Laura Bühler, Gerda Weiser, Michael Clemens Röttger, Carolin Neufischer, Matthias Kühn, Julius Wehrle, Anna Christine Slagman, Antje Fischer-Rosinsky, Larissa Eienbröker, Frank Hanses, Gisbert Wilhelm Teepe, Hans-Jörg Busch, Leo Benning
JMIR Medical Informatics, 19 November 2024
Abstract
Background
The Broad Consent (BC) by the German Medical Informatics Initiative (MII) was developed to serve as a national blueprint for consenting patients for the use of routinely collected medical-, insurance- and contact data and biomaterials for research purposes, ensuring compliance with European General Data Protection Regulation (GDPR). Emergency departments (EDs) are characterized by a broad and unselected patient population that provides the opportunity to include patients from different demographic and socioeconomic groups, as well as from different disease groups. While also posing regulatory and ethical challenges, obtaining BC in an ED environment presents a promising opportunity to increase the availability of ED data for research.
Objective
This study aimed to evaluate the success rate of obtaining BC through different consenting approaches in a tertiary ED. The study also explored factors influencing consent and dropout rates.
Methods
A single-center prospective observational study was conducted in a German tertiary ED from September to December 2022. Patients were randomly selected (every 30th patient) and screened for eligibility to be informed about BC. Eligible patients were informed through one of three modalities: (a) directly in the ED, (b) during inpatient stay on the ward, or (c) via telephone after discharge. The primary outcome was the success rate of obtaining BC within 30 days of ED presentation. Secondary outcomes included analysis of potential influences on the success- and dropout rate concerning patient characteristics, information mode, and the interaction time applied for the information.
Results
Out of 11,842 ED visits in the study period, 419 patients were randomly screened for BC eligibility, with 151 meeting the inclusion criteria. Of these, 68 patients (45.0 %) consented to at least one BC module, while 24 (15.9 %) refused participation. The overall dropout rate was 39.1 %, with the highest dropout occurring in the telephone-based group (52.3 %) and lowest in the ED group (7.1 %). Patients who were informed face-to-face during the inpatient stay following their ED treatment had the highest consent rate (85.2 %), while those approached in the ED or by telephone consented in 69.2 %. Logistic regression analysis indicated that longer interaction time was significantly associated with higher consent rates, whereas female gender was associated with increased dropout rates. No significant differences were found between consenting and non-consenting groups concerning age, triage category, billing details (inpatient treatment), or diagnosis distribution.
Conclusions
Obtaining BC in an ED environment is feasible, and showed representative inclusion of the ED-population. However, discharge from the ED and female gender negatively influenced the odds of obtaining consent to the BC. Face-to-face interaction significantly improves consent rates and seems to be the most promising approach for consenting inpatients. Telephone-based approaches, conversely, resulted in higher dropout rates but equal consent rates as the direct consenting in the ED. The study highlights the need for tailored consent strategies, indicating a benefit to maintain staff in EDs and on wards to provide information on BC and obtain consent from eligible patients.

Ethical Concerns Regarding the Timing of Written Consent
Sean C. Wightman, Victoria Yin, Jacob S. Hershenhouse, Tsehay B. Abebe, Li Ding, Scott M. Atay, Takashi Harano, Anthony W. Kim, John N. Pagteilan, Abhineet Uppal, Baddr A. Shakhsheer
The Journal of Clinical Ethics, Winter 2024; 35(4)
Abstract
Objective
Thorough informed consent requires decision-making capacity, adequate information, lack of coercion, and an appropriate environment. Consent obtained in the preoperative area is hurried, limiting the quality of informed consent and the opportunity for patient reflection, characteristics inconsistent with patient-centered practice. The incidence of obtaining consent immediately prior to surgery is unknown.
Methods
Consecutive patients undergoing surgery at a single center between 1 June 2021 and 14 June 2021 were identified. Time between consent signature and operating room arrival time was measured. Three surgeons reviewed cases and categorized them as major or not major operations.
Results
78.7 percent (199/253) of patients arriving to the preoperative area the day of surgery signed written consent that day. 99.6 percent (248/249) of anesthesia consents were signed the day of surgery. Spanish as a primary language corelated significantly with consent signing on the day of surgery (p = .04). Race and distance traveled for surgery were not significantly associated with consent signing in the preoperative area. 79.3 percent (157/198) had consent signed within 90 minutes of arrival to the operating room. Among major outpatient cases, 77.8 percent (182/234) had consent signing in the preoperative area.
Conclusions
This demonstrates routine consent signing in the hurried preoperative setting, suggesting a potential source for improved informed consent. Additionally, language-based consenting disparities, specifically in Spanish, offer opportunity for improvement. The majority of consents were signed the day of surgery, in the preoperative area, and within 90 minutes prior to operating room start time. This offers an opportunity for improved patient-centered care.