Informed Consent Challenges in Frail Surgical Patients
Book Chapter
Alessandro Feola, Antonietta Porzio, Mariavictoria De Simone, Omero Pinto, Graziamaria Corbi, Carlo Pietro Campobasso
The Frail Surgical Patient, 28 January 2025 [Springer]
Abstract
Informed consent is an essential aspect of medical ethics and the foundation of patient-centered healthcare. It represents the principles of autonomy, self-determination, dignity, and patient rights. Physicians are responsible for acquiring informed consent or dissent before conducting any medical procedure and should provide comprehensive information about potential benefits, risks, and alternatives while also encouraging patient participation in their care whenever possible. The historical evolution of informed consent has led to a new definition of the doctor-patient relationship, shifting from a paternalistic approach to one that valorizes the individual’s decision-making capacity and will. For many years, the definition of “frailty” has not been uniform: several authors consider frailty as a condition where an inadequate response to stress and a high risk of adverse outcomes, such as the onset of disabilities, illnesses, institutionalization, or mortality. Frail surgical patients encounter unique ethical and legal challenges due to their increased vulnerability. Because of their cognitive limitations, physical disabilities, and comorbidities, these patients may face complex decisions about surgical procedures. Their limited capacity to comprehend the risks, advantages, and alternatives related to surgical intervention may compromise their ability to make informed choices. To ensure the best possible outcomes, healthcare providers should conduct a preoperative frailty assessment, implement perioperative management with a multidisciplinary approach, and reduce the risk of future complications to improve postoperative care. Informed consent in frail surgical patients is a challenging aspect of medical practice that requires a patient-centered approach based on adequate information and respect for patient autonomy. Healthcare professionals must ensure that patients and their caregivers are adequately informed and supported during the decision-making process and that all discussions related to informed consent are thoroughly documented.
Month: February 2025
EXPRESS: Beyond Opt-Out: How Presumed-Consent Language Shapes Persuasion
EXPRESS: Beyond Opt-Out: How Presumed-Consent Language Shapes Persuasion
Research article
Romain Cadario, Jenny Zimmermann, Bram Van den Bergh
Journal of Marketing, 16 February 2025
Abstract
When using opt-out (vs. opt-in) policies, choice architects presume that people consent, rather than explicitly asking them to state their consent. While opt-out policies often increase compliance, they are also associated with managerial issues such as ethical considerations, legal regulations, limited public support, and increased no-show rates. This research demonstrates that choice architects can also establish presumed-consent through the language they use, holding the opt-in policy constant. Seven studies in various health domains indicate that presumed-consent language (e.g., “a vaccine was arranged for you”) rather than explicit-consent language (e.g., “you can choose to get a vaccine”) increases persuasion (i.e., behavioral intentions, actual behaviors). This effect occurs through perceived endorsement: Decision makers infer through the presumed-consent language that the desired health behavior (e.g., vaccination) is the recommended course of action. Furthermore, this research examines the proposed endorsement process under various conditions. When product tangibility is low (e.g., a flu shot), the effectiveness of presumed-consent language stems primarily from perceived endorsement rather than psychological ownership or perceived ease. In contrast, when product tangibility is high (e.g., a sunscreen lotion), the effect stems primarily from psychological ownership rather than perceived endorsement or perceived ease.
Informed Consent, Autonomy, False Beliefs, and Ignorance
Informed Consent, Autonomy, False Beliefs, and Ignorance
James Stacey Taylor
Social Philosophy and Policy, 6 February 2025
Abstract
It is widely believed that health policy should take care to ensure that persons are informed about the expected risks as well as the anticipated advantages of medical procedures. This is often justified by a concern for the moral value of personal autonomy, as it is widely believed that to the extent that a person makes decisions on the basis of false beliefs or ignorance her autonomy with respect to them is compromised. This essay argues against this widespread claim. A person’s autonomy with respect to her decisions will not be compromised by either ignorance or false beliefs. However, it does not follow that there is no reason to provide persons with the opportunity to have access to the available information relevant to their decisions concerning their medical treatment. The epistemic requirements for a person to give her consent to her treatment are more stringent than those that must be met for her to be autonomous with respect to her consent. Consent, not autonomy, can be undermined by ignorance or false belief. It is a concern for consent, not a concern for autonomy, that justifies providing people with information about their prospective medical procedures.
Pragmatic Clinical Research, Informed Consent, and Clinical Equipoise
Pragmatic Clinical Research, Informed Consent, and Clinical Equipoise
Lynn A. Jansen
Social Philosophy and Policy, 6 February 2025
Abstract
There is a growing movement within contemporary medical ethics to blur the boundaries between clinical medicine and clinical research. Some writers now argue that the research-practice distinction is outdated and the importance of distinguishing between research and medicine is no longer as pressing as it once was or seemed to be. Instead, we are now urged to view the health-care system as a dynamic “learning health-care system” in which research components are embedded within standard clinical care. This essay defends the ethical significance of the research-practice distinction while acknowledging the reality and usefulness of integrated health care. A key claim that this essay advances is that the principle of clinical equipoise, which has largely been rejected by research ethicists, can be reinterpreted and repurposed to help distinguish medical practices that call for more demanding forms of informed consent from those that do not.
A pilot study to explore utility of electronic informed consent in a low- income setting; the case of a Controlled human infection study in Blantyre, Malawi
A pilot study to explore utility of electronic informed consent in a low- income setting; the case of a Controlled human infection study in Blantyre, Malawi
Clara Ngoliwa, Chikondi Chakwiya, Joel Gondwe, Edna Nsomba, Vitumbiko Nkhoma, Modesta Reuben, Linda Chantunga, Pemphero Liwonde, Edward Mangani, Evaristar Kudowa, Lumbani Makhaza, Neema Toto, Tiferanji Sochera, Tarsizio Chikaonda, Ben Morton, Marc Y.R. Henrion, Dingase Dula, Stephen B. Gordon, Anthony E. Chirwa
Wellcome Open Research, 5 February 2025
Abstract
Background
Electronic informed consent can improve accuracy, workflow, and overall patient experience in clinical research but has not been used in Malawi, owing to uncertainty about availability, utility, patient data security and technical support.
Objectives
We aimed to explore the utility of electronic consent (e-consent) in an ongoing human infection study in Blantyre, Malawi.
Methods
The approved paper consent forms were digitized using Open Data Kit (ODK). Following participant information giving by the research staff, healthy literate adult participants with no audio-visual impairments completed a self-administered e-consent and provided an electronic signature. We dual-consented participants by both paper-based and electronic-consenting. Signed e-consent forms were uploaded to a secure study server. Utility of e-consenting was observed by participation rate, user-friendliness, documentation error rate, and staff perception of the overall consenting process.
Results
All 109 participants offered e-consenting accepted participation. E-consenting was user-friendly, had no identifiable documentation errors as compared to 43.1% (n 47/109) error rate with paper-based consenting, and ensured data safety, and unravelled areas for consideration. Challenges with e-consenting included difficult digitization of ethics stamped documents, as well as present but infrequent delays of retrieval of e-consent forms.
Conclusion
E-consenting is feasible, has a utility benefit in a controlled human infection study in Malawi; a low-income country, and can supplement paper-based consenting. Its usefulness can improve the consenting process in research conducted in such settings. Additionally, success of e-consenting requires a careful consideration.
Integrating a conceptual consent permission model from the informed consent ontology for software application execution
Integrating a conceptual consent permission model from the informed consent ontology for software application execution
Muhammad “Tuan” Amith, Yongqun He, Elise Smith, Marceline Harris, Frank Manion, Cui Tao
MedRxiv, 2 February 2025
Abstract
We developed a simulated process to show a software implementation to facilitate an approach to integrate the Informed Consent Ontology, a reference ontology of informed consent information, to express implicit description and implement conceptual permission from informed consent life cycle. An early study introduced an experimental method to use Semantic Web Rule Language (SWRL) to describe and represent permissions to computational deduce more information from the Informed Consent Ontology (ICO), demonstrated by the use of the All of Us informed consent documents. We show how incomplete information in informed consent documents can be elucidated using a computational model of permissions toward health information technology that integrates ontologies. Future goals entail applying our computational approach for specific sub-domains of the informed consent life cycle, specifically for vaccine informed consent.
GA4GH Policy Brief: children’s data protection and genomic research (part 2: consent and lawful bases)
GA4GH Policy Brief: children’s data protection and genomic research (part 2: consent and lawful bases)
Global Alliance for Genomics and Health, 4 February 2025
Abstract
Following discussion of general considerations related to protection of children’s genomic and health data, part two of this two-part Policy Brief further explores considerations with respect to consent and lawful bases under the General Data Protection Regulation (GDPR). This two-part Policy Brief is published as part of the GA4GH Health Data Sharing, Privacy, and Regulatory Forum’s work to explore laws and regulations that have an impact on genomic and related health data sharing. The GA4GH Health Data Sharing, Privacy, and Regulatory Forum publishes Policy Briefs to explore laws and regulations that have an impact on genomic and related health data sharing. Following discussion of general considerations related to protection of children’s genomic and health data, published on 23 January, part two of this two-part Policy Brief, by Michael J. S. Beauvais, further explores considerations with respect to consent and lawful bases under the General Data Protection Regulation (GDPR).