Agency and power in research: some thoughts about informed consent forms

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Agency and power in research: some thoughts about informed consent forms
Claudia Barcellos Rezendea
Saúde e Sociedade, 2023
Open Access
Abstract
This article discusses some premises that constitute informed consent forms, assuming they should not be taken for granted. I argue that the use of informed consent forms should be understood within a research relationship, which is always an intersubjective relation between two or more socially positioned individuals. I develop these reflection based on my recent experiences of anthropological research on pregnancy and birth, during which I used an informed consent form in two stages but not in an intermediary phase, which was dedicated to focus on kinship relations during pregnancy more than the bodily experience itself. Thus, by comparing these three situations, I examine their particularities in obtaining consent, discussing agency, power, and ethics in social research.

Editor’s note: This is a Portuguese language publication. Saúde e Sociedade is a publication of  the University of São Paulo.

The Need to Consider Context: A Systematic Review of Factors Involved in the Consent Process for Genetic Tests from the Perspective of Patients

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The Need to Consider Context: A Systematic Review of Factors Involved in the Consent Process for Genetic Tests from the Perspective of Patients
Research Article
Frédéric Coulombe, Anne-Marie Laberge
AJOB Empirical Bioethics, 8 January 2024
Abstract
Background
Informed consent for genetic tests is a well-established practice. It should be based on good quality information and in keeping with the patient’s values. Existing informed consent assessment tools assess knowledge and values. Nevertheless, there is no consensus on what specific elements need to be discussed or considered in the consent process for genetic tests.
Methods
We performed a systematic review to identify all factors involved in the decision-making and consent process about genetic testing, from the perspective of patients. Through public databases, we identified studies reporting factors that influence the decision to accept or decline genetic testing. Studies were included if they reported the perspective of patients or at-risk individuals. All articles were thematically coded.
Results
1989 articles were reviewed: 70 met inclusion criteria and 12 additional articles were identified through the references of included studies. Coding of the 82 articles led to the identification of 45 factors involved in decision-making and consent, which were initially divided into three domains: in favor of, against or with an undetermined influence on genetic testing. Each factor was also divided into three subdomains relating to the informed choice concept: knowledge, values or other. The factors in the “other” subdomain were all related to the context of testing (e.g. timing, cost, influence of family members, etc), and were present in all three domains.
Conclusions
We describe the network of factors contributing to decision-making and consent process and identify the context of genetic testing as a third component to influence this process. Future studies should consider the evaluation of contextual factors as an important and relevant component of the consent and decision-making process about genetic tests. Based on these results, we plan to develop and test a more comprehensive tool to assess informed consent for genetic testing.

Patient Perspectives on Data Sharing

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Patient Perspectives on Data Sharing
Book Chapter
Louise C. Druedahl, Sofia Kälvemark Sporrong
The Law and Ethics of Data Sharing in Health Sciences, 20 December 2023 [Springer]
Open Access
Abstract
Data sharing is key for artificial intelligence and for future healthcare systems, but the perspectives of patients are seldom included in the larger debates of how, when, and what data to share. This chapter provides an overview of research on patient perspectives on data sharing and associated aspects, including patients’ motivations, concerns, and views on privacy and conditions for sharing. Moreover, these perspectives are put into the evolving context of informed consent and today’s European context of the General Data Protection Regulation (GDPR) and Data Governance Act (DGA). Overall, there seems to be a discrepancy between the patients’ perspective on data sharing and the reality in which their data are to be shared. The current patient views are researched within relatively ‘local’ contexts, where the patient would consent to collecting data for primary use and on patients’ preferences regarding consent and what they see as barriers and motivators for data sharing. However, the reality of data use is moving towards re-use of data for secondary purposes and a context of more altruistic consent such as the DGA. Questions remain regarding how patients perceive sharing and the role of their data in the larger governance of data; seemingly, patient views are lost in the wider debate of innovation and jurisdictional competitiveness. Ensuring that patients’ voices are heard is essential for public acceptance of data sharing, and thus for inclusiveness and equity of results and innovations originating from patients’ shared data.

Informed Consent to Psychedelic-Assisted Psychotherapy: Ethical Considerations

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Informed Consent to Psychedelic-Assisted Psychotherapy: Ethical Considerations
Research Article
Andrew Lee, Daniel Rosenbaum, Daniel Z. Buchman
The Canadian Journal of Psychiatry, 17 January 2024
Excerpt
…Given that psychedelics can induce powerful nonordinary states of consciousness and increase suggestibility, challenges surrounding the informed consent process in [Psychedelic-Assisted Psychotherapy] PAP have begun to receive attention. For example, Smith and Sisti suggest that a process of “enhanced consent” be undertaken prior to PAP, characterized by special attention to the shifts in personality and values that can follow a psychedelic experience, the possible mental health side effects of psychedelics, and the possible use of therapeutic touch during treatment. However, Jacobs argues that owing to the particular effects of psychedelics—namely, mystical and ego-dissolution experiences which can occur acutely after administration and longer-term shifts in identity and values—the typical standards for informed consent may not be feasible.

Issues of capacity and consent during the psychedelic experience have received less attention. Individuals using psychedelics often experience profound acute changes to their sensorium along with alterations in mood, detachment from the body, and distortions of their sense of self, time, and reality. Consequently, it may be difficult for patients to appreciate the risks and benefits of terminating the session during the psychedelic experience. It may also be difficult for observers to predict or interpret the internal process and distress of patients during sessions, as their observable behaviour may not be representative of their inner experience…

Informed consent for capacity assessment

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Informed consent for capacity assessment
Shaun T. O’Keeffe, Mary Donnelly
International Journal of Law and Psychiatry, January–February 2024
Abstract
In this paper we examine the role of informed consent to capacity assessment, focussing primarily on the two jurisdictions of England and Wales, and Ireland. We argue that in both jurisdictions, a capacity assessment should be regarded as a distinct intervention, separate from the ‘original’ intervention at issue, and that specific informed consent to the assessment should generally be sought in advance. As part of this, we consider what information should be provided so as to ensure informed consent. Having established a baseline requirement for informed consent, we also recognise that informed consent to assessment will not always be possible, either because the person is unable to understand the information about assessment or because the person refuses to be assessed and so, in the final part of the article, we explore how to proceed when informed consent is either not possible or not forthcoming, including an analysis of the implications of the statutory presumption of capacity.

Capacity to consent to treatment in severe eating disorders

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Capacity to consent to treatment in severe eating disorders
Research Article
Giovanna Parmigiani, Lorenzo Tarsitani, Fabiano Grassi, Gabriele Mandarelli, Stefano Ferracuti
International Review of Psychiatry, 12 January 2024
Abstract
Eating disorders represent a disabling, deadly and costly condition, whose principal treatment is constituted by weigh restoration and psychotherapy. Partial or total refuse of treatment is very common, leading some authors to question their decision-making capacity (DMC) to consent to treatment. However, very few studies have investigated treatment DMC, leading to contrasting results. Forty-five women were enrolled at the Psychiatric and Eating Disorders Unit of the University Hospital Policlinico Umberto I of Rome. Psychiatric symptoms severity (Brief Psychiatric Rating Scale Expanded, BPRS-E), treatment DMC (MacArthur Competence Assessment Tool for Treatment, MacCAT-T), depressive symptoms (Hamilton Depression Rating Scale, HAM-D), anxiety symptoms (Hamilton Anxiety Rating Scale, HAM-A), symptoms and psychological characteristics of eating disorders (Eating Disorder Inventory, EDI-3) and Metacognitive beliefs (Metacognitions Questionnaire 30, MCQ-30) were assessed. Sixty-seven percent of the total sample showed low treatment DMC; specifically, 70.4% of patients affected by Anorexia Nervosa, 72.7% of patients affected by Bulimia Nervosa, and 42.9% of patients affected by Binge Eating Disorder. Specific psychopathological symptoms enhance or hamper patients’ decisional capacities. Clinicians should be aware of the risk of impaired DMC in this vulnerable group of patients and pay attention at those factors suggesting the need of an in-depth evaluation.

Comparing Anxiety Levels and Pain Scores for Video-assisted and Traditional Informed Consent in Extracorporeal Shockwave Lithotripsy: A Prospective, Randomised, Controlled Study

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Comparing Anxiety Levels and Pain Scores for Video-assisted and Traditional Informed Consent in Extracorporeal Shockwave Lithotripsy: A Prospective, Randomised, Controlled Study
Nurul Zubaidah Shahul Hameed, Devindran Manoharan, Lee Say Bob, Susan Woo
Asian Journal of Research and Reports in Urology, 23 January 2024
Abstract
Aims
Traditionally, informed consent involves verbal and/or written material provided to the patient by a treating clinician. Multimedia interventions improve patients’ knowledge and understanding during the informed consent process. This study aimed to compare pre-procedural anxiety levels and pain scores between educational video-assisted informed consent and traditional informed consent for extracorporeal shockwave lithotripsy (ESWL) at our centre.
Study Design
This was a prospective, randomised, controlled study conducted at two centres.
Place and Duration of Study
The study was conducted in two Urology centre Department of Urology, Penang General Hospital and Department of Urology, Hospital Kuala Lumpur between 15th May 2022 and 15th October 2022.
Methodology
The study group consisted of all adult patients undergoing ESWL in both centres. A video presentation explaining the ESWL procedure was developed in two languages, and group allocation was randomised using a computer-based random number generator. Anxiety levels were assessed using the Amsterdam Preoperative Anxiety and Information Scale (APAIS) questionnaire, visual analogue scale, and numerical rating scale used to collect data on pain scores.
Results
A total of 54 respondents, with a predominance of male patients (57.4%) and the majority of patients having completed secondary school education (53.7%). In comparing the two groups, the video-assisted respondents exhibited significantly lower anxiety scores regarding the procedure than those in the traditional group (p< 0.05). However, there were no statistically significant differences between the groups in terms of pain scores, both pre- and post-procedural.
Conclusion
Video-assisted informed consent can reduce procedure-related patient anxiety levels before ESWL; however, there was no difference in pain scores between the two consent methods. patients.

Practicing care-full scholarship: Exploring the use of ‘visual informed consent’ in a study of motherhood, health and agroecology in Coventry, UK

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Practicing care-full scholarship: Exploring the use of ‘visual informed consent’ in a study of motherhood, health and agroecology in Coventry, UK
Research Article
Mai Abbas, Alex Franklin, Stefanie Lemke, Chiara Tornaghi
Qualitative Research, 10 January 2024
Open Access
Abstract
The demand for alternative methods of providing informed consent is increasing, especially in research with marginalised (or illiterate) research participants. This article discusses the co-creation of a visual informed consent (VIC), in collaboration with an artist. The VIC was inspired by the experience of obtaining informed consent from a group of migrant women with limited English proficiency, in empirical research undertaken on agroecology and health in Coventry, UK. Reflecting further on its creation and wider utility, this article explores the inner values that might guide researchers and lead to the co-creation of care-full tools that meet the needs of research participants. Specifically, this includes, reflecting on the iterative process of developing a VIC and using an ethics of care as a primary conceptual framework. Findings reveal that participants’ understanding of ethical issues is facilitated using visual illustrations. It is argued that the creation of a VIC requires the researcher to be attentive to the embodied nature of research practice and guided by an ethics of care. A conceptual framework that integrates care and embodiment is presented, with the intention that it may further support the development of care-full research by others.

Ethical and legal challenges of medical AI on informed consent: China as an example

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Ethical and legal challenges of medical AI on informed consent: China as an example
Wang Y, Ma Z
Developing World Bioethics, 19 January 2024
Abstract
The escalating integration of Artificial Intelligence (AI) in clinical settings carries profound implications for the doctrine of informed consent, presenting challenges that necessitate immediate attention. China, in its advancement in the deployment of medical AI, is proactively engaging in the formulation of legal and ethical regulations. This paper takes China as an example to undertake a theoretical examination rooted in the principles of medical ethics and legal norms, analyzing informed consent and medical AI through relevant literature data. The study reveals that medical AI poses fundamental challenges to the accuracy, adequacy, and objectivity of information disclosed by doctors, alongside impacting patient competency and willingness to give consent. To enhance adherence to informed consent rules in the context of medical AI, this paper advocates for a shift towards a patient-centric information disclosure standard, the restructuring of medical liability rules, the augmentation of professional training, and the advancement of public understanding through educational initiatives.

Using ChatGPT to Facilitate Truly Informed Medical Consent

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Using ChatGPT to Facilitate Truly Informed Medical Consent
Fatima N. Mirza, Oliver Y. Tang, Ian D. Connolly, Hael A. Abdulrazeq, Rachel K. Lim, G. Dean Roye, Cedric Priebe, Cheryl Chandler, Tiffany J. Libby, Michael W. Groff, John H. Shin, Albert E. Telfeian, Curtis E. Doberstein, Wael F. Asaad, Ziya L. Gokaslan, James Zou, Rohaid Ali
New England Journal of Medicine AI, 10 January 2024
Abstract
Informed consent is integral to the practice of medicine. Most informed consent documents are written at a reading level that surpasses the reading comprehension level of the average American. Large language models, a type of artificial intelligence (AI) with the ability to summarize and revise content, present a novel opportunity to make the language used in consent forms more accessible to the average American and thus, improve the quality of informed consent. In this study, we present the experience of the largest health care system in the state of Rhode Island in implementing AI to improve the readability of informed consent documents, highlighting one tangible application for emerging AI in the clinical setting.