Publisher’s Note:
Readers will encounter a pause in the regular publication of Informed Consent: A Monthly Review as our Editor, Paige Fitzsimmons, begins a planned academic leave.
Author: paigefitzsimmons
Informed Consent: A Monthly Review
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June 2025 :: Issue 78
In preparing this digest, we monitor a broad range of academic journals and utilize Google Scholar to search articles referencing informed consent or assent. After careful consideration, a selection of these results appear in the digest. We also monitor other research, analysis, guidance and commentary beyond the academic literature globally, including calls for public consultation and symposia/conferences which address consent/assent in whole or in part. We recognize that some of the arguments presented in this edition may be controversial and may warrant closer scrutiny. We have elected to be generous in our inclusion with the goal of presentating of a wholistic landscape of informed consent literature as it is being published. We acknowledge that this scope yields an indicative and not an exhaustive digest product.
Informed Consent: A Monthly Review is a service of the Center for Informed Consent Integrity, a program of the GE2P2 Global Foundation. The Foundation is solely responsible for its content. Comments and suggestions should be directed to:
Editor
Paige Fitzsimmons, MA
Associate Director, Center for Informed Consent Integrity
GE2P2 Global Foundation
paige.fitzsimmons@ge2p2global.org
PDF Version: Center for Informed Consent Integrity – A Monthly Review_June 2025
Optimizing Informed Consent—A Call to Action
Optimizing Informed Consent—A Call to Action
Viewpoint
Nancy E. Kass, Ann Meeker-O’Connell, Stephanie R. Morain, Matthew A. Crane
JAMA Health Forum, 2 May 2025; 6(5)
Excerpt
People who volunteer to participate in clinical trials regulated by the US Food and Drug Administration (FDA) play an integral role in advancing scientific knowledge about medical products. These clinical trials are intended to generate reliable evidence that informs product development and, ultimately, patient care—an essential task given the vast gap in evidence for clinical care.1 When implementing clinical research, investigators should provide information about a planned trial to potential participants in a clear, comprehensible way, both out of respect for the individuals who consider volunteering and so that those individuals can make informed decisions about whether they wish to volunteer.
…, we intend to identify additional ways to improve how the research community designs and obtains informed consent, in partnership with potential research participants, researchers, and others in the clinical trial and clinical practice communities… We also plan to continue supporting the research community in applying recommendations from our guidance or appropriate alternative approaches to improve informed consent, including through future demonstration projects that provide examples of clear, understandable, and informative consent documents and processes. Finally, given the multiregional nature of clinical trials, we are working with global partners—in partnership with the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use—to promote the comprehensibility and brevity of informed consent. We hope that a strategic and collaborative focus on informed consent will help to fulfill this fundamental ethical commitment to potential research participants.
Contemporary human rights violations in female sterilization care: legal and ethical considerations when coerced patients do consent
Liana Woskie, Mindy Jane Roseman
Monash Bioethics Review, 13 May 2025
Open Access
Abstract
In this piece we examine three forms of coercive or otherwise involuntary care that can occur with patient consent. To do so, we examine: (1) uninformed consent, (2) contingency-based consent and (3) constrained-market consent, amongst female sterilization patients. While there is broad recognition that “coercion” in sterilization care can manifest beyond instances of overt force and clarity on what constitutes coercion within clinical care, this has not translated to accountability. The current practice of identifying coercion through discrete civil cases may facilitate a narrow understanding of its contemporary prevalence; one that does not align with definitions of coercion supported by international human rights entities. We use three acute, and widely recognized, examples—hysterectomies in ICE detention facilities, India’s sterilization camp deaths and birth control quotas for Uyghur women—as an entry point to highlight less overt contemporary forms of coercive sterilization care, pairing each example with data that explores prevalence at a broader population level. These data suggest less visible forms of coercion may persist relatively unchallenged—raising the ethical case for a functional approach to the measurement of coercion. In turn, we argue the relevant question may not be “when is coercion ethically justified in public health,” but rather, why is coercion already the status quo?
Informed Consent Documents from Psychedelic Clinical Trials: A Descriptive Ethical Analysis
Informed Consent Documents from Psychedelic Clinical Trials: A Descriptive Ethical Analysis
Katherine Cheung, Caleigh Propes, Marianna Graziosi, Kyle Patch, David B. Yaden
AJOB Empirical Bioethics, May 2025
Abstract
Background
Classic psychedelics, such as psilocybin and LSD, evoke certain kinds of altered states of consciousness. Specific features of the experience, such as its allegedly ineffable nature, have been discussed as posing challenges to the informed consent process. A growing call for tailored informed consent documents (ICDs) in the psychedelic bioethics literature raises the question of how closely ICDs used in contemporary psychedelic trials reflect the concrete suggestions and proposals offered by psychedelic bioethicists.
Methods
In this article, we review ICDs from psilocybin clinical trials in the United States. Using a content analysis approach, we provide a systematic qualitative description of the ICDs which comprise our final sample (N=28; 28 clinical trials across 13 unique sites). Coders demonstrated good reliability (κ=.683).
Results
Qualitative analyses revealed that most of the coding aligned with expectations based upon the psychedelics bioethics literature, such as the emphasis on Mental Health Risks and Physical Risks in ICDs. Notably, psychedelic-specific codes (e.g., Inef ability, Therapeutic Touch) did not appear as frequently in ICDs.
Conclusions
Scholars in psychedelic bioethics have called for the inclusion of a variety of potential risks and benefits in ICDs. It will be important to continue debating which elements are worth including in ICDs such that potential research participants are presented with the most salient factors relevant to their decision about joining a study. We provide a table of best practices applied by our sample of ICDs.
Informed Consent in Qualitative Research: Lessons on Relationality from a Technologically Dense Classroom
Book Chapter
Fride Haram Klykken
Reframing Qualitative Research Ethics, 20 May 2025 [Emerald Publishing Limited]
Abstract
This chapter examines the challenges that informed consent poses in qualitative research. Drawing on examples from a video ethnography in a technologically rich classroom in Norway, this chapter highlights limitations of the current emphasis on anticipatory approaches to informed consent. I explore how a nuanced processual understanding of informed consent can be added to these established procedures so as to navigate the intricate dynamics of conducting ethical research in a relationally constituted world. This chapter illustrates how, from a relationally situated approach, explicit and implicit negotiations of informed consent can be incorporated throughout the research process. Informed by sociomaterial and material feminist theories, this chapter reflects on the iterative and material effects of contemporary informed consent practices. Encouraging a rethinking of the role of informed consent within qualitative research, I argue that engaging in informed consent practices is not only about formal procedures or written agreements but also entails a continuous relational negotiation that needs attention throughout the research process. In conclusion, I advocate that institutions and researchers should advance responsible research ethics by acknowledging ethical complexity, promoting trust, and building diverse and responsive ethical resource networks.
From black box to clarity: Strategies for effective AI informed consent in healthcare
From black box to clarity: Strategies for effective AI informed consent in healthcare
Research paper
Chau, M.G. Rahman, T. Debnath
Artificial Intelligence in Medicine, 24 May 2025
Abstract
Background
Informed consent is fundamental to ethical medical practice, ensuring that patients understand the procedures they undergo, the associated risks, and available alternatives. The advent of artificial intelligence (AI) in healthcare, particularly in diagnostics, introduces complexities that traditional informed consent forms do not adequately address. AI technologies, such as image analysis and decision-support systems, offer significant benefits but also raise ethical, legal, and practical concerns regarding patient information and autonomy.
Main body
The integration of AI in healthcare diagnostics necessitates a re-evaluation of current informed consent practices to ensure that patients are fully aware of AI’s role, capabilities, and limitations in their care. Existing standards, such as those in the UK’s National Health Service and the US, highlight the need for transparency and patient understanding but often fall short when applied to AI. The “black box” phenomenon, where the inner workings of AI systems are not transparent, poses a significant challenge. This lack of transparency can lead to over-reliance or distrust in AI tools by clinicians and patients alike. Additionally, the current informed consent process often fails to provide detailed explanations about AI algorithms, the data they use, and inherent biases. There is also a notable gap in the training and education of healthcare professionals on AI technologies, which impacts their ability to communicate effectively with patients. Ethical and legal considerations, including data privacy and algorithmic fairness, are frequently inadequately addressed in consent forms. Furthermore, integrating AI into clinical workflows presents practical challenges that require careful planning and robust support systems.
Conclusion
This review proposes strategies for redesigning informed consent forms. These include using plain language, visual aids, and personalised information to improve patient understanding and trust. Implementing continuous monitoring and feedback mechanisms can ensure the ongoing effectiveness of these forms. Future research should focus on developing comprehensive regulatory frameworks and enhancing communication techniques to convey complex AI concepts to patients. By improving informed consent practices, we can uphold ethical standards, foster patient trust, and support the responsible integration of AI in healthcare, ultimately benefiting both patients and healthcare providers.
“Does Black Box AI In Medicine Compromise Informed Consent?”
“Does Black Box AI In Medicine Compromise Informed Consent?”
Research Article
Samuel Director
Philosophy & Technology, 13 May 2025
Open Access
Abstract
Recently, there has been a large push for the use of artificial intelligence in medical settings. The promise of artificial intelligence (AI) in medicine is considerable, but its moral implications are insufficiently examined. If AI is used in medical diagnosis and treatment, it may pose a substantial problem for informed consent. The short version of the problem is this: medical AI will likely surpass human doctors in accuracy, meaning that patients have a prudential reason to prefer treatment from an AI. However, given the black box problem, medical AI cannot explain to patients how it makes decisions, yet such an explanation seems to be required by informed consent. Thus, it seems that doing what is best for patients (treatment via AI), even if patients want to permit this, might be prohibited by medicine’s commitment to informed consent. Conflicts between beneficence and autonomy are not new, but medical AI poses a novel version of this conflict, because this problem is one in which even if the patient says they want to use their autonomy to receive better care, the commitment to autonomy (via informed consent) seems to block them from doing so. Given this dilemma, should we abandon informed consent, or should we not use medical AI? My thesis is that we can have our cake and eat it too; we can use opaque AI in clinical medicine and retain our commitment to informed consent, although it may require revising our understanding of informed consent. Specifically, it will require us to distinguish between two levels of consent (higher-order and first-order consent).
Ethical approval and informed consent in mental health research: a scoping review
Ethical approval and informed consent in mental health research: a scoping review
Leona Cilar Budler, Gregor Stiglic
AI and Society, 1 May 2025
Abstract
Although there is a wide range of scientific papers introducing artificial intelligence techniques in the mental health field, there is a lack of literature assessing the reporting of ethical concerns in such studies. In addition, it is not yet known whether the authors seek ethical approval or informed consent while performing such research. This study aimed to investigate the extent to which studies in the mental health domain that utilize chatbots either ignore or incompletely disclose patient consent and ethical approval from the responsible review boards. A scoping literature search was performed in PsychARTICLES, PubMed, and Web of Science using both MeSH terms and free-text keywords. Following PRISMA-ScR guidelines, we also contacted study authors to verify missing information about ethical approval or informed consent, enhancing the transparency and rigor of our analysis. Among the 27 studies reviewed, 13 reported obtaining ethical approval, and 16 reported collecting informed consent. The remaining studies did not provide such information. These findings underscore the ethical complexities surrounding AI in mental health, especially regarding the collection, storage, and use of sensitive patient data. There is a correlation between sample size and the acquisition of ethical approval, particularly in studies published in journals with low-impact factors. Future research should investigate the role of journal policies in influencing ethical practices. In addition, training programs could be developed to educate researchers on the importance of ethics, particularly in studies with smaller sample sizes.
Whose Reality? Consent Boundaries and Free Speech Arguments in the Politics of Generative AI
Whose Reality? Consent Boundaries and Free Speech Arguments in the Politics of Generative AI
Sara Concetta Santoriello
Politikon: The IAPSS Journal of Political Science, 28 April 2025
Abstract
Generative AI enables creation of increasingly realistic deepfakes that challenge content authenticity assessment. This research examines how anti-woke opinion leaders frame deepfake technology within broader cultural discourse. Through narrative analysis of statements and media between 2018 and 2024, we identify significant inconsistencies in these figures’ approaches to consent and bodily autonomy. While championing unrestricted speech when deepfakes target women, minorities, or political opponents, these commentators often advocate for regulation when personally affected. This selective application of principles reveals how deepfake technology disproportionately impacts minoritized groups while reinforcing existing power hierarchies. The research exposes fundamental tensions within anti-woke discourse between freedom of expression and protection from exploitation. Ultimately, deepfakes serve as a lens through which to understand broader ideological inconsistencies around technological governance, highlighting the urgent need for consent-based approaches to synthetic media regulation.
Center for Informed Consent Integrity 