Advance Consent for Interventional Radiology Procedures: Quality Improvement Project
Rohan Shankarghatta, Alexandra Garnett
The Physician, 17 February 2025
Abstract
Background
Advance consent is crucial for patients undergoing Interventional radiology (IR) procedures with potential serious harm. Two previous audits at our hospital revealed issues with obtaining consent before the day of the procedure, leading to the implementation of a consent clinic. Subsequently, a new electronic patient record (EPR) system was introduced. This third audit cycle assessed whether these changes improved the advance consent rates for vascular IR procedures.
Method
We retrospectively reviewed 53 patients who underwent vascular IR procedures in January 2023, noting whether each procedure was inpatient or outpatient, urgent or elective, and the procedure type. These results were compared with previous cycles to evaluate adherence to consent standards.
Results
Among the 53 patients, there was an even split between inpatient and outpatient procedures, as well as between urgent and elective procedures. 27 patients underwent lower limb angiogram/angioplasty, 19 had fistula work, and 7 underwent other procedures. 77% of patients consented in advance or had the consent process initiated beforehand.
Conclusion
An improvement in advance consent rates was noted compared to previous cycles (14% → 63% → 77%) following the implementation of consent clinics and the new EPR system. However, 33% of patients, primarily those undergoing fistula work, still consented on the day of the procedure. This audit highlights the benefit of the new EPR system and the need to continue consent clinics, emphasizing the importance of advance consent, especially for fistula procedures.
Is informed consent correctly obtained for vaccinations?
Is informed consent correctly obtained for vaccinations?
Dhriti Jagadish, Nathaniel Mamo, Felicia Pasadyn, Arthur Caplan
Human Vaccines & Immunotherapeutics, 16 February 2025
Abstract
Informed consent is an integral tenet of medical ethics. However, the United States lacks a standardized consent process for immunizations, with states and private companies instead reliant on Vaccine Information Statements (VISs) introduced by the 1986 National Childhood Vaccine Injury Act. VISs, rather than being developed with patient autonomy in mind, were a response to excessive vaccine injury litigation and resulting vaccine supply shortages. VISs do not provide meaningful information disclosures, with its producer – the Centers for Disease Control and Prevention – itself admitting that VISs should not be mistaken for informed consent forms. In its content, the VIS is too complex in its readability, does not situate immunization in a public health context, and does not present all alternatives. VIS delivery is also inadequate, with limited time given for patients to digest vaccine information and no documentation required to ensure that VISs were presented at all. Simply put, VISs do little to spark deliberation and increase vaccine confidence. This article recommends minor improvements to VIS content, delivery, and accountability mechanisms to ensure distribution. The authors argue that these patient-provider moments – for patients to better understand their health, the threat of disease, and the weight of their contribution to the public – should not be squandered.
Consent: risk assessment, risk communication and shared decision making
Consent: risk assessment, risk communication and shared decision making
Catherine Rimmer
Surgery, 10 February 2025
Abstract
The consent process is the foundation of the modern doctor–patient relationship, and can present a significant challenge to doctors. The consent process can be complex, and often involves the interaction of many different factors, including ethical and legal considerations. A shared decision-making process allows for full consideration of the treatment options available, and takes into account individual patients’ values and preferences. Ensuring that the patient is fully informed requires a thorough understanding of the risks of an intervention for that particular patient; therefore, individualized risk assessment is of fundamental importance. Using a combination of individual patient information, formal investigations and population data gives the most complete assessment of risk. Communicating that risk information to patients is key, and the doctor should always use clear language and avoid bias. The use of visual aids and information leaflets and the avoidance of vague language and complex statistical terms will all help the patient to develop a more complete understanding of the risks they face.
The impact of obtaining explicit informed consent for medical student participation in the pelvic examination under anesthesia: A qualitative interview study
The impact of obtaining explicit informed consent for medical student participation in the pelvic examination under anesthesia: A qualitative interview study
Hannah C Milad, Katie Watson, Patrick F Eucalitto, Ricky Hill, Alithia Zamantakis, Marlise Jeanne Pierre-Wright, Adaeze A Emeka, Susan Tsai, Susan Goldsmith, Magdy P Milad
International Journal of Gynaecology and Obstetrics, 4 February 2025
Abstract
Objective
To examine patient, physician, and operating room (OR) staff perceptions at an academic institution following the introduction of an explicit, written consent form for medical student participation in the pelvic examination under anesthesia (EUA).
Methods
The study was performed at one urban academic medical center between May 2021 and May 2023. Thirty-one individuals including patients, OR staff, and physicians were interviewed to better understand their perspectives regarding an initiative to explicitly consent patients for the student pelvic EUA. Northwestern University Institutional Review Board approval was obtained.
Results
Patients appreciated being asked to explicitly consent to or refuse the student pelvic EUA and having a dedicated consent form left them with a positive feeling about the hospital and their healthcare providers. OR staff and physicians agreed that the student pelvic EUA is necessary, and almost all supported an explicit consent form. Physicians did not find the additional consent form burdensome and noted only a modest decline in learning opportunities.
Conclusion
Patients and healthcare providers agreed that requiring explicit written consent for the student pelvic EUA respected patient autonomy, improved healthcare quality, and caused minimal disruption to medical education. Our data support the use of an explicit written consent form as standard practice.
Informed Consent in Pelvic Reconstructive Surgery: Patients’ Perspective of a Tertiary Service Process
Informed Consent in Pelvic Reconstructive Surgery: Patients’ Perspective of a Tertiary Service Process
Original Article
Vandna Verma, Hayser Medina Lucena, Ivilina Pandeva, Ashish Pradhan
International Urogynecology Journal, 31 January 2025
Abstract
Introduction and Hypothesis
Obtaining informed consent to surgery is essential for ethical, legal, and quality-care reasons. This study evaluates patients’ understanding, experience, and satisfaction with the informed consent process prior to pelvic reconstructive surgery.
Methods
A prospective study was conducted from April 2021 to April 2022, registered as a service evaluation project. It included all consenting women undergoing pelvic reconstructive surgery. A standardised questionnaire with closed and open-ended questions assessed patients’ experiences and decision-making evaluated using the Decisional Conflict Scale (DCS). Satisfaction was evaluated through a five-point Likert scale and a ten-point visual analogue scale (VAS) for response reliability.
Results
The study included 87 patients with a mean age of 61.4 years (SD 11.4). A significant 96.6% read the consent form thoroughly, 98% affirmed detailed explanations by staff, and 88.5% found the explanation clear. Although 83.9% considered the surgery details sufficient, 16.1% found the information overly detailed or too brief. Most patients (91.9%) felt that they had ample time to think before signing, and 75.9% deemed both oral and written information helpful. Only 13.8% preferred medical staff to decide for them, whereas 55.2% valued being included in decision making. Key factors influencing satisfaction were detailed procedure information (72.4%) and reading the consent form (51.7%). The mean DCS score was 7, indicating a high level of satisfaction. Overall, 85% were very satisfied or satisfied with the consent process, with 89.7% scoring 8–10 on the VAS scale.
Conclusions
A thorough consent process is associated with high patient satisfaction and facilitates shared decision making.
Informed Consent Challenges in Frail Surgical Patients
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.
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.
Center for Informed Consent Integrity 