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.

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.

Is Specific Consent for Educational Sensitive Exams on Anesthetized Patients Necessary? Arguments for and Against From Canadian Medical Students
Original Article
Phoebe Friesen, Wan-Li Sun, Sarah Towle, Zoe Hyman-Levy
Journal of Surgical Education, March 2025; 82(3)
Abstract
Objective
Discussions related to the importance of seeking specific consent for sensitive (e.g., pelvic, rectal) exams performed on anesthetized patients by medical students have been growing. The perspectives of Canadian medical students on this topic have never been sought.
Design
An anonymous questionnaire related to experiences and beliefs regarding consent and sensitive exams under anesthesia (EUAs) within medical training was distributed to medical students across Canada.
Setting
Of 17 medical schools in Canada, 6 confirmed distribution, 8 schools expressed an intention to distribute but did not confirm whether distribution had occurred, and 3 did not share the questionnaire.
Participants
134 respondents answered at least 1 question. Canadian medical students who had begun clerkship or previous students enrolled within the last 5 years were eligible.
Results
Our data indicates that, of Canadian medical students surveyed, the majority (72%) believe that specific consent for educational sensitive EUAs is a moral requirement, while 20% are unsure, and 8% do not share this belief. Respondents offered a variety of reasons why specific consent is necessary, including patient rights, autonomy, respect, and integrity, as well as concerns related to nonconsensual exams being abusive or constituting assault. Some respondents noted that consent is already implied, is unnecessary because of clinical benefit, or requiring it could lead to missed educational opportunities, especially for male and/or racialized medical students.
Conclusion
These results indicate that while most respondents support specific consent for educational EUAs, confusion regarding the purpose of these exams and the moral basis of specific consent exists in training.

Informed Consent and Shared Decision-Making in Modern Medicine. Case-based Approach, Current Gaps and Practical Proposal
Giuseppe Tarantini, Chiara Fraccaro, Andrea Porzionato, Nicolas Van Mieghem, Hendrik Treede, Nicolas Shammas, Molly Szerlip, Vinod Thourani, Gino Gerosa, Alfredo Marchese, Giuseppe Speziale, Bertrand Ludes, Stephen Pollak, Peter Vanezis, Santo Davide Ferrara
The American Journal of Cardiology, 25 January 2025
Open Access
Abstract
Advances in personalized medicine and Systems Biology have introduced probabilistic models and error discovery to cardiovascular care, aiding disease prevention and procedural planning. However, clinical application faces cultural, technical, and methodological hurdles. Patient autonomy remains essential, with shared decision-making (SDM) gaining importance in managing complex cardiovascular treatment options. Effective SDM relies on collaboration between providers and patients, guided by P5 Medicine principles, which combine psycho-cognitive considerations with predictive, personalized, preventive, and participatory care. Here we propose a three-step methodological proposal for implementing SDM and enhancing consent acquisition in cardiovascular care. The approach emphasizes personalized patient engagement and the need for clear, comprehensive consent processes. It identifies and addresses significant gaps in current practices, including the complexity of consent language, information dispersion, and the specific needs of vulnerable populations. Issues of Medical Responsibility and/or Liability may raise in the case of absence of consent acquisition or invalid consent due to insufficient/incorrect information. The International Guidelines on Medico-Legal Methods of Ascertainment and Evaluation Criteria are reported. In conclusion, the paper proposes practical solutions, including the use of artificial intelligence (AI) to enhance decision-making and patient counseling, and strategies to ensure that consent processes are both thorough and legally sound and respectful to the individual’s autonomy.

Bridging gaps in surgical consent: an audit from the SNAPS department
Digital Poster
Alizay Rehman, Jennifer Billington, Simon Blackburn
BMJ Paediatrics Open, 17 January 2025
Open Access
Abstract
Introduction
Consent for surgical intervention involves providing patients and their families adequate information and time to make informed decision. An outpatient clinic appointment is crucial for sharing information about surgical diagnosis and necessary interventions. Our objective was to audit the consent process in the Specialist Neonatal and Paediatric Surgery (SNAPS) department at Great Ormond Street Hospital.
Method
The gold standards were consent guidelines by the Royal College of Surgeons, General Medical Council, and National Institute for Health and Care Excellence.1–3 Guidelines recommend taking consent in advance of surgery, such as in clinics, allowing patients ample time to make informed decisions. The consultation should share the following to meet guideline criteria: diagnosis, planned surgery, alternatives, risks, benefits, expected postoperative stay, preoperative instructions, and reading material, all documented in clinic letters. Patients’ notes (clinic letters, consent forms, date of surgery) were retrospectively assessed. During the implementation phase, consensus regarding guidelines was achieved across the surgical team. Smart phrases were created and shared for EPIC clinic letters, meeting guideline criteria, for common SNAPS surgical procedures, followed by a re-audit.
Results
Clinic letters of 70 patients were audited in first cycle. Only 27/70 (38.9%) letters met the criteria. 68/70 (97%) consents were signed on the day of surgery, 2/70 (3%) the day before, with 0/70 in clinic. The average duration between consultation and surgery was 5.39 months. The re-audit analysed 70 letters and demonstrated improvement of 11.1% with 35/70 (50%) letters meeting the criteria as per guidelines.
Conclusion
We demonstrated moderate improvement in surgical consultations by ensuring patients receive adequate information, in accordance with gold standards, with documented evidence in clinic letters. Further progress requires enhancing consent processes in clinics allowing sufficient time for patients to make decision, including consent guidelines in doctor inductions, access to smart phrases and re-auditing after some months.

Documentation of Consent in Appendicectomy: A Closed Loop Quality Improvement Project
Ismay Fabre, Kellie Bateman, Anil Ghosh
British Journal of Surgery, 17 January 2025
Abstract
Aim
The aim of this quality improvement project was to enhance documentation of informed consent for patients undergoing diagnostic laparoscopy and/or appendicectomy, ensuring compliance with legal standards and the Montgomery ruling.
Methods
Retrospective data were collected in an initial audit followed by two Plan-Do-Study-Act (PDSA) cycles from handwritten consent forms of adult patients listed for emergency diagnostic laparoscopy and/or appendicectomy. Data included: grade of consenting clinician, pre-operative imaging, and documentation of recognised risks, for example, conversion to open and drain insertion. Interventions implemented between cycles included providing EIDO leaflets on the surgical unit and teaching consent practices during induction.
Results
Data from 54 patients were analysed (Initial=18, Cycle1=15, Cycle2=21). Consent was performed by SHO’s in 38%-47%. Significant improvements were observed in documenting risks such as blood transfusion (0% to 71.4%), drain insertion (16.7% to 85.7%) and adhesions (38.9% to 76.2%). Documentation of risks such as damage to structures, bleeding and infection remained above 90% throughout. EIDO leaflet use increased from 11.1% to 80.0% within the first cycle but decreased (66.7%) in the second. Overall documentation of COVID risk decreased from 66.7% to 28.6%.
Conclusion
The initial cycle revealed poor documentation of risks, correlating with lack of informed consent. Subsequent PDSA cycles demonstrated significant improvement, particularly in recording recognised risks such as blood transfusion, drain insertion and adhesions. These improvements align with the Montgomery ruling, which requires detailed disclosure of risks to patients. Continued focus and further implementation of information leaflets/ digital resources is required to ensure consistent practice.

Survey of Clinical Specialties Performing Informed Consent for Endovascular Thrombectomy
Mbonde, A. A. Alsarah, B. Demaerschalk, A. A. Dmytriw, Q. J. Moyer, J. A. Hirsch, A. B. Singhal, T. M. Leslie‐Mazwi, N. S. Rost, A. B. Patel, M. J. Young, R. W. Regenhardt
Stroke: Vascular and Interventional Neurology, 15 January 2025
Open Access
Abstract
Introduction
Informed consent (IC) plays a central role in acute stroke care, especially endovascular thrombectomy (EVT). We investigated the clinical roles and medical specialties of individuals who obtain IC for EVT, aiming to provide insights for enhancing the process.
Methods
We conducted a survey from July to December 2023 among clinicians involved in acute stroke care. Utilizing Qualtrics, we disseminated a structured questionnaire through various national and international platforms. This analysis summarizes findings on the characteristics of those who obtain EVT IC at the respondents’ institution.
Results
Among 168 participants,71% were staff physicians, 70% practiced in the United States (US), and 70% were based at academic centers. The most common medical specialties obtaining EVT IC were neurology (77%), followed by neurosurgery (41%), radiology (30%) and emergency medicine (10%) (Table 1). Staff physician (61%) was the most common clinical role involved, followed by fellows (43%), residents (48%), and advanced practice providers (APP, 36%) (Table 2). Non‐US institutions were more likely to utilize a provider from neurology alone (50% vs. 31%, p=0.016) and staff physicians (76% vs. 54%, p=0.008), while US institutions were more likely to utilize providers from neurosurgery (51% vs. 18%, p<0.001), APPs (43 vs. 18%, p=0.002) and residents (56% vs. 28%, p=0.001). Non‐academic institutions more frequently used emergency medicine providers (25% vs. 5%, p<0.001) and APPs (50% vs. 31%, p=0.031), while academic institutions commonly utilized neurosurgery providers (48% vs. 18%, p=0.001), residents (59% vs. 13%, p<0.001) and fellows (52% vs. 18%, p<0.001).
Conclusion
This study highlights the diverse medical specialties and clinical roles of persons obtaining IC for EVT, with neurologists and staff physicians being the most frequently utilized. These variations likely reflect availability and capacity of certain providers in different settings. Future efforts to optimize the IC process should be multi‐disciplinary, with standardized content that addresses provider diversity.

Mixed methods study of the interfacility transfer system utilizing both patient-reported experiences and direct observation of the transfer consent process
L Stewart, D Bille, B Fields, L Kemper, C Pappa, E Orman, M Boustani, E Ramly, A Hybarger, A Watters, N Glober
The Joint Commission Journal on Quality and Patient Safety, 14 January 2025
Abstract
Background
Interfacility transfer is an integral component of the modern healthcare system. However, there are no commonly agreed-upon standards for interfacility processes or for patient engagement and shared decision-making in transfer, and little is known about their experience. This study used qualitative methods to better understand the patient and care partner experience with interfacility emergency department (ED)-to-ED transfer.
Methods
This mixed methods study used two distinct data sources: (1) semi-structured interviews of older adult patients and their care partners, performed at bedside in a large, tertiary care hospital (i.e., receiving facility) following interfacility transfer, and (2) direct observation of the transfer consent process at two community emergency departments (i.e., referring facilities) in the same health system.
Results
A total of 21 patients and 14 care partners were interviewed. We identified several common themes related to perceptions and experiences with interfacility transfer: (1) communication (e.g., perceived lack of agency), (2) logistics (e.g., wait times), (3) impacts on family (e.g., distance from home), (4) uncertainty about the bill (e.g., transfer-associated costs), and (5) quality of care (e.g., greater trust in tertiary care centers). We also conducted direct observations of the transfer consent process for 14 unique patient encounters. We observed considerable variability in practice patterns among sending clinicians and identified frequent patient-reported issues related to transfer logistics and effective communication, including distractions, lack of privacy, absence of support system, physical pain and/or psychological stress, preferred language, and health literacy.
Conclusions
These data suggest several potential areas for improvement in the care of patients requiring interfacility transfer, to increase engagement and allow patients and their care partners to make better-informed decisions most consistent with their goals of care.

Departmental practice on informed consent in radiotherapy departments: a UK evaluation
Marie Orr, Keeley Rosbottom
Journal of Radiotherapy in Practice, 9 January 2025
Abstract
Introduction
Valid and informed consent in healthcare is an ethical and legal requirement. This evaluation reports the practices within UK radiotherapy departments surrounding consent processes and therapeutic radiographer (TR) education. This article focuses on those patients who are considered to lack the capacity to consent.
Method
This service evaluation adopted a qualitative research design. Seventy-six radiotherapy department managers were sent the online survey: containing a combination of open, closed and free text questions relating to consent practices. Descriptive analysis using Microsoft Excel was performed; additional correlation analysis was attempted with Fisher’s exact test using Statistical Package for the Social Sciences.
Results
TRs from 39 radiotherapy departments (51%) completed the survey. Analysis of results demonstrated obtaining written consent before radiotherapy treatment was completed in all departments. Assessment methods used to determine capacity to consent varied across the departments. Responses identified 37 departments employ a different consent form for those considered to lack capacity. Thirty-eight departments have a policy surrounding consent; 16 departments reported no formal TR education in consent. Of the remaining 22 departments, 13 departments included lack of capacity within their education package.
Conclusion
To ensure best practice throughout the UK, is it recommended that radiotherapy departments review their consent processes to ensure they are in the best interests of the patient. It is recommended that TRs are familiar with their regulatory body standards and the ethical and legal issues surrounding consent; all departments should consider capacity and those considered to lack capacity within their education and training framework.