Role and Complexities of Informed Consent in Vascular Surgery
Editorial
Himanshu Verma
Indian Journal of Vascular and Endovascular Surgery, January – March 2025; 12(1)
Open Access
Introduction
   Informed consent is a cornerstone of ethical medical practice, emphasizing the patient’s right to autonomy and the alignment of medical care with their values and preferences. Over the past century, this principle has evolved from a procedural formality to an essential process enabling shared decision-making (SDM). Patients now actively participate in treatment decisions, weighing the risks, benefits, and alternatives of interventions to ensure their choices reflect personal goals and priorities.
While patient comprehension remains a critical element of informed consent, studies reveal significant gaps in understanding.[4] Patients often struggle to recall or fully grasp essential details, including diagnoses, procedural risks, benefits, and alternatives.[5,6] Consequently, informed consent has transitioned from being a mere legal safeguard to an interactive dialog fostering patient engagement and trust.[7,8] This editorial explores the nuances of informed consent, particularly within the context of vascular surgery, where challenges are multifaceted and deeply rooted in both medical complexity and patient perception.

Broad consent in the emergency department: a cross sectional study
Research
Antje Fischer-Rosinský, Larissa Eienbröker, Martin Möckel, Frank Hanses, Felix Patricius Hans, Sebastian Wolfrum, Johannes Drepper, Philipp Heinrich, Anna Slagman
Archives of Public Health volume, 18 February 2025
Open access
Abstract
Background
The Medical Informatics Initiative (MII) introduced a broad consent form (MII-BC) encompassing clinical, insurance, and biomaterial data, along with re-contacting options. In the emergency department (ED), outpatient and inpatient patients of all illnesses and severity could be reached early in their treatment course. The BC-ED (Broad Consent in the Emergency Department) project uniquely investigated the implementation of MII-BC in EDs, exploring feasibility, selection bias and patients’ perceptions of voluntariness, information recall, motivation, and satisfaction.
Methods
The BC-ED project involving four university hospital EDs in Germany, is part of CODEX+ (Collaborative Data Exchange and Usage), an initiative within the Network University Medicine (NUM). To minimize selection bias, a systematic sampling approach (every 5th/30th patient) was applied, with patient recruitment and consent processes adapted to local conditions and therefore varying among sites. Data collection included patient questionnaires, surveys completed by study nurses, and routine clinical data. Analysis was conducted descriptively using SPSS.
Results
Of 1,138 patients approached, 553 (48.6%) were capable of giving consent. Of 353 patients who could not consent, primary reasons included language barriers (35.4%) and inability to grasp study details (21.5%). Of all eligible patients, 3.3% could not be contacted. Of 535 (47.0%) patients able to consent and contacted, 313 consented to the MII-BC. Resulting in a consent rate of 27.5% corresponding to the baseline population and 58.5% of those contacted. Motivations for consenting were general support for research (85.3%) and the desire to help future patients (78.2%). Patients generally reported a high level of understanding and satisfaction with the consent process, reporting comprehensive understanding of scientific data use (89.8%) and associated risks (82.2%). However, discrepancies were noted between consented options and patient recall.
Conclusions
This study is the first to investigate the implementation of the MII-BC in the challenging ED environment. With a consent rate of 27.5% total baseline population and 58.5% of those contacted, it demonstrates that patients were able and willing to participate in research. Reasons for non-consent were barriers like language and medical conditions. Strategies to address these barriers are crucial for inclusivity. Although patients generally understood the consent process, discrepancies in recall highlight the need for improved comprehension strategies.

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?
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
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
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
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.