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.

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

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 and ethics committee involvement in case reports and case series: cross-sectional meta-research study

Research

Matea Valešić, Marta Čivljak, Livia Puljak

BMC Medical Ethics, 19 May 2025

Open Access

Abstract

Background

Although the research should guarantee the protection of privacy and personal data, case reports and case series frequently lack the involvement of the ethics board and informed consent that includes the required information. This study aimed to analyze the reporting about informed consent and ethics committees in case reports and case series.

Methods

This cross-sectional meta-research study analyzed case reports and case series published in 2021, indexed in PubMed, and available as open-access articles. Extracted variables included authorship details, country, journal name, number of cases, and documentation of informed consent and ethics committee approval.

Results

This study analyzed 2053 case reports and case series. Most articles (86%) reported a single case. Statements about informed consent were reported in 79% of cases. Informed consent was primarily obtained from patients (74%). Statements about an ethics committee were reported in 46% of articles. In 24% of articles, it was reported that approval was obtained from an ethics committee. Case reports were significantly more likely to include a statement on informed consent than case series. On the contrary, case series were significantly more likely to report ethics committee statements than case reports.

Conclusion

The findings reveal inconsistencies in ethics reporting, with 46% of articles mentioning ethics committee involvement and varying justifications for exemption. While 79% of articles reported informed consent, further improvements in transparency and standardization are needed. Clear guidelines on ethical approval requirements and consent documentation should be established to enhance the quality and ethical rigor of case reports.

Editor’s note: The authors refer to cases as the following in the article: “Case studies, case reports, and case series are descriptive studies that illustrate innovative, unusual, or atypical features found in patients in clinical practice.”

Patient perception of consent processes for epidural analgesia in induction of labour: a qualitative study

Danna Nitzani, Jacqueline Nicholls, Katherine Maslowski, Robert Craig, Sohail Bampoe, Melissa Whitten, Anne Lanceley

Anaesthesia, 12 May 2025

Abstract

Introduction

Women undergoing induction of labour often utilise epidural analgesia. Obtaining consent for labour epidural presents a unique challenge for the obstetric anaesthetist, who must comply with the legal standards of consent. This study explores how women perceive the consent process for epidural analgesia during induction of labour.

Methods

This was a qualitative, single-centre, interview-based study. Fourteen women who received an epidural for labour analgesia were interviewed using a semi-structured interview guide. Data were analysed using thematic analysis.

Results

Four themes described women’s experience of the consent process. Understanding alternatives, risks and benefits; for example, time constraints hindering the effective communication of information around epidural analgesia, including alternative analgesic options. Timing of information; for example, the value of information was diminished by pain, fatigue and the imminence of the procedure. Timing of consent; for example, physiological and psychological demands of labour negatively impacted patients’ ability to engage with the consent process. Anaesthetists’ assessment of patient understanding; for example, confirmation of patient understanding by anaesthetists was lacking.

Discussion

Women’s experiences of the consent process for induction of labour suggest that in the context of the pain and exhaustion of labour, inadequate and untimely information provision and dialogue between women and their anaesthetists can undermine the implementation of lawful consent.

Investigating the Level of Awareness Regarding Informed Consent Among the Post-Operative Patients in Surgical Ward

Faiza Shoaib, Amir Sultan, Noshaba Faiz, Samin Rani

Journal of Medical & Health Sciences Review, 10 May 2025

Abstract

Background

The concept of informed consent is an important aspect of biomedical ethics, which is obtained in written form, but in some cases, it may be verbal, especially for non-invasive and relatively non-risky interventions. The study was conducted with the aim of evaluating the level of awareness among post-operative patients regarding informed consent.

Methodology

The study design was cross-sectional descriptive and was conducted in the surgical ward of a tertiary care hospital in Swat, Pakistan from December 2023 to January 2024. The sample size of the study was 180 using the purposive sampling technique, while a valid and reliable questionnaire was used for data collection. Descriptive statistics were used through SPSS 22.0. The study was approved by an ethical review committee, and informed consent was obtained from every respondent.

Results

The finding reveals that the majority of the participants were female 112 (55.7%), the age group 36–45 years was 75 (37.3%), and people belonged to village 189 (94%). The maximum number of patients level of awareness was good (58%), while the remaining 42% had a poor level of awareness. The majority of the patients know the type of surgery 181 (90%), alternative treatment to the surgery 123 (61.2%), number of hours to be nothing per oral (NPO) 190 (94.5%), time of surgery 197 (98%), and overall satisfaction regarding informed consent 201 (100%).

Conclusion

The study found that patients lack awareness about the surgeon, procedure process, advantages and disadvantages, procedure importance, anesthesia type, and complications, highlighting the need for enough information regarding their procedure.

Informed Consent: A Monthly Review
_________________

May 2025 :: Issue 77

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_May 2025

Informed Consent: A Monthly Review
_________________

April 2025 :: Issue 76

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_April 2025

Is consent to psychological interventions less important than consent to bodily interventions?
Lisa Forsberg, Thomas Douglas, Julian Savulescu
The Philosophical Quarterly, 27 February 2025
Abstract
It is standardly accepted that medical interventions can be permissibly administered to a patient who has decision-making capacity only when she has given her valid consent to the intervention. However, this requirement for valid medical consent is much less frequently discussed in relation to psychological interventions (‘PIs’) than it is in relation to bodily interventions (‘BIs’). Moreover, legal and professional consent requirements in respect of PIs are laxer than the analogous requirements in respect of BIs. One possible justification for these differences appeals to the Differential Importance View—the view that it is presumptively morally less important to obtain explicitly given valid consent for PIs than for BIs. In this article, we argue against the Differential Importance View by considering and rejecting three possible justifications for it. These invoke differences between PIs and BIs with respect to implicit consent, risk, and wrongfulness.