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
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
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
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.
Social Media, Informed Consent, and the Harm Principle
Social Media, Informed Consent, and the Harm Principle
Charles Foster
Philosophies, 11 January 2025
Open Access
Abstract
This article examines whether social media users can validly consent to their own use of social media. It argues that, whether or not social media use is analogous to public health interventions, there is an obligation to provide users with information about risks and benefits, and absent that provision, there is no valid consent. Many or most users, in any event, do not have the capacity to consent, according to the criteria for capacity articulated in the ‘four abilities’ model: the ability to express a choice, the ability to understand the facts pertinent to the decision in question, the ability of a subject to believe that the information applies to them, and the ability to reason—in the sense of being able to consider and weigh (with reference to the patient’s own concerns, circumstances, and values) the main possible outcomes of the decision to opt for the intervention and the decision to opt not to undergo it. Even if an individual social media user is capacitous according to these criteria, many will fail to be judged capacitous if (as it is argued should be the case), a further criterion, identified by Jennifer Hawkins must be satisfied, namely that the individual can look after their own interests at least as well as most other people can. It follows from this consideration that not only can regulation of social media (in the form of a ban) be justified under Mill’s harm principle, but that non-regulation cannot be justified.
“Knowledge was clearly associated with education” epistemic positioning in the context of informed choice: a scoping review and secondary qualitative analysis
“Knowledge was clearly associated with education” epistemic positioning in the context of informed choice: a scoping review and secondary qualitative analysis
Research
Niamh Ireland-Blake, Fiona Cram, Kevin Dew, Sondra Bacharach, Jeanne Snelling, Peter Stone, Christina Buchanan, Sara Filoche
BMC Medical Ethics, 9 January 2025
Open Access
Abstract
Background
Being able to measure informed choice represents a mechanism for service evaluation to monitor whether informed choice is achieved in practice. Approaches to measuring informed choice to date have been based in the biomedical hegemony. Overlooked is the effect of epistemic positioning, that is, how people are positioned as credible knowers in relation to knowledge tested as being relevant for informed choice.
Aims
To identify and describe studies that have measured informed choice in the context of prenatal screening and to describe epistemic positioning of pregnant people in these studies.
Methods
Online databases to identify papers published from 2005 to 2021. The PRISMA-ScR checklist guided data collection, analysis and reporting. Secondary analysis that considered hermeneutics (e.g., knowledge that was tested, study design) and testimony (e.g., population descriptors) developed a priori.
Findings
Twenty-nine studies explored the measurement of informed choice. None reported that pregnant people were involved in the design of the study. Two studies reported pregnant people had some involvement in the design of the measurement. Knowledge tested for informed choice included technical aspects of screening, conditions screened and mathematical concepts. Twenty-seven studies attributed informed choice to population descriptors (e.g., race/ethnicity, age, education). Population descriptors were reified as characteristics of epistemic credibility for informed choice obtained. For example, when compared to a high school qualification, a tertiary qualification was a statistically significant characteristic of informed choice. When compared by race, white people were found to be significantly more likely to make an informed choice. Additional demographic descriptors such as age, language spoken, faith and previous pregnancies were used to further explain differences for informed choice obtained. Explanations about underlying assumptions of population descriptors were infrequent.
Conclusion
Using population descriptors in the biomedical hegemony as explanatory variables for informed choice can position (groups of) people as more, or less, epistemically credible. Such positioning could perpetuate epistemic injustices in practice leading to inequitable access to healthcare. To better uphold (pregnant) people as credible knowers population descriptors should instead be contextual (and contextualising) variables. For example, as indicators of social privilege. Further, making room for ways of knowing that go beyond the biomedical hegemony requires the development of epistemically just ‘measures’ through intentional, inclusive design.
Consent-driven, semi-automated data collection during birth and newborn resuscitation: Insights from the NewbornTime study
Consent-driven, semi-automated data collection during birth and newborn resuscitation: Insights from the NewbornTime study
Sara Brunner, Anders Johannessen, Jorge García-Torres, Ferhat Özgur Catak, Øyvind Meinich-Bache, Siren Rettedal, Kjersti Engan
medRxiv, 17 January 2025
Abstract
Accurate observations at birth and during newborn resuscitation are fundamental for quality improvement initiatives and research. However, manual data collection methods often lack consistency and objectivity, are not scalable, and may raise privacy concerns. The NewbornTime project aims to develop an AI system that generates accurate timelines from birth and newborn resuscitation events by automated video recording and processing, providing a source of objective and consistent data. This work aims to describe the implementation of the data collection system that is necessary to support the project’s purpose.
Videos were recorded using thermal cameras in labor rooms and thermal and visual light cameras in resuscitation rooms. Consent from mothers were obtained before birth, and healthcare providers were given the option to delete videos by opting out. The video collection process was designed to minimize interference with ongoing treatment and not impose unnecessary burden on healthcare providers. Videos have been collected at Stavanger University Hospital since November 2021. By July 31st 2024, 645 thermal videos of birth and 186 visual light videos of resuscitation have been collected. Data collection and development and implementation of AI systems is still ongoing.
The utilization of automated data collection and AI video processing around birth may allow for consistent and enhanced documentation, quality improvement initiatives, and research opportunities on sequence, timing and duration of treatment activities during acute events, with less efforts needed for capturing data and improved privacy for participants.
Informed Consent: A Monthly Review
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January 2025 :: Issue 73
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_January 2025
Spotlight
To start the new year, we have highlighted an article which broadens our thinking to informed consent at a population level. In the Public Health Ethics article Collective Consent to Xenotransplantation: A Critical Appraisal Bobier et al. discuss the need to go beyond surveying trends in public attitudes surrounding novel technologies which have the potential to impact the planet on a large scale and actively obtain collective consent for xenotransplantation procedures.
[Extract]
“…solid organ xenotransplantation… involves the transplantation of a genetically engineered porcine organ into a human recipient (Carrier et al., 2022; Fischer and Schnieke, 2022). There is concern, however, that a novel zoonotic disease could be transmitted from the source organ to the human recipient, then from the recipient to others. Theoretically, this could result in an epidemic or pandemic (Fishman, 2022; Thom et al., 2024).
Given the novelty of xenotransplantation and the theoretical potential to cause significant harm, it has been the stated position of the World Health Organization (WHO) since 2008 that any xenotransplantation regulatory system must include ethical assessments that involve the public (WHO, 2008). Public engagement regarding novel medical technology promotes important (i) ethical, (ii) transparent and (iii) inclusive practices (Hurst and Cooper, 2024). However, some have gone further and argued that something more than the assessment of public viewpoints is needed. It has been argued that collective consent is required in addition to the due diligence of researchers and oversight organizations, such as the US Food and Drug Administration…
While the authors conclude that collective consent is not required in this case to proceed ethically, we have highlighted this article because it engages population level thinking, and is a useful example of a niche area in the informed consent landscape.
Collective Consent to Xenotransplantation: A Critical Appraisal
Christopher Bobier, Adam Omelianchuk, Daniel Rodger, Daniel J Hurst
Public Health Ethics, 12 December 2024
Abstract
Solid organ xenotransplantation may have the potential to help address the shortage of organs for transplantation. There is concern, however, that a novel zoonotic disease could be transmitted from the source organ to the human recipient, and then from the recipient to others. Theoretically, this could result in an epidemic or pandemic. Because of this potential risk, it has been argued that collective consent is required. Our goal is to critically evaluate the claim that collective consent is necessary for xenotransplantation to be ethically permissible. We argue that collective consent is not required and highlight the important roles of public engagement and due diligence in xenotransplant research moving forward.
Navigating the consent river: questions to consider before waiving consent requirements in pragmatic cluster randomised trials
Navigating the consent river: questions to consider before waiving consent requirements in pragmatic cluster randomised trials
Cory E Goldstein, Monica Taljaard, Stephanie N Dixon, Charles Weijer
Journal of Medical Ethics, 18 December 2024
Open Access
Abstract
The robust design and conduct of pragmatic cluster randomised trials may be in tension with the ethical requirement to obtain written informed consent from prospective research participants. In our experience, researchers tend to focus on whether a waiver of consent is appropriate for their studies. However, pragmatic cluster randomised trials raise other important questions that have direct implications for determining when an alteration or waiver of consent is permissible. To assist those involved in the design, conduct and review of pragmatic cluster randomised trials, we outline four critical questions to consider: (1) What is the nature of the intervention being evaluated? (2) Is the choice to use cluster randomisation justified? (3) Can the risk of recruitment bias be addressed? and (4) Is an alteration or waiver of consent appropriately justified? We recommend that researchers and research ethics committees conduct a stepwise analysis of a planned cluster randomised trial using these questions. To illustrate the application of this stepwise analysis, we use three pragmatic cluster randomised trials in the haemodialysis setting as case studies.
Center for Informed Consent Integrity 