Standardization of written informed consent forms to improve patient care, a quality improvement project
Jaweria Akram, Madeha Khalid, Rawand Abdelnaser Jebril, Isra Saleh Alsheikh, Amina Bougaila, Esha Subhash, Muhammed Zahid
BMJ Open Quality, 23 April 2025
Open Access
Abstract
Background
Informed consent taken by inadequately explaining the procedure to the patient or patient representative, along with incomplete documentation of the process, can have ethical, legal and administrative implications. We conducted a baseline survey from the patient’s representative admitted to the Acute Medical Assessment Unit (AMAU), Hamad General Hospital (HGH) [Doha, Qatar], and their representatives to assess the level of satisfaction and understanding with the current informed consent taking process for thoracocentesis, ascitic tapping, lumbar puncture, blood, and blood product transfusion. It showed only 64% were satisfied. We conducted a Quality Improvement project to standardize the process of taking informed consent for the above-mentioned procedures in order to improve patient satisfaction from 64% to 80% by December 2021 by providing them with individualized informed consent forms along with patient information template in their preferred language.
Methods
A thorough process mapping showed different factors that can lead to inadequate informed consent. We introduced the use of individualized informed consent forms for each above-mentioned procedure with the already printed complications along with patient information template in their preferred language with pictorial presentation of the procedure. Ten Plan/Do/Study/Act (PDSA) cycles were conducted with each cycle lasting four weeks. Before each cycle, the quality team conducted extensive training sessions for the residents and nurses. Different reinforcements were provided with each cycle to ensure the utilization of the interventions.
Results
After 10 PDSA cycles, the level of satisfaction with the process of taking informed consent improved from 64% to 94%.
Conclusion
A standardized informed consent form, along with a patient information template written in their preferred language, improves patients’ understanding to make a well-informed decision and therefore improves their satisfaction with the process, acting as a marker of quality improvement.

Legal Implication in Utilizing Automated Robots: A Written Informed Consent Form Proposal
Maria Teresa Contaldo, Sonia Triggiani, Giacomo Vignati, Daniele Bracchi, Gianpaolo Carrafiello
International Journal of Medical Robotics and Computer Assisted Surgery, 22 April 2025
Abstract
Background
Robotic systems enhance physicians’ capabilities by replicating hand movements in real‐time, ensuring precise control and a quick return to conventional procedures if patient safety is compromised. Physicians performing robot‐assisted procedures bear ultimate responsibility, sharing potential liability with manufacturers for malfunctions.
Methods
This study, conducted by a transdisciplinary team of interventional radiologists and a legal expert, evaluates the integration of robotic systems in interventional radiology through a comprehensive literature review, addressing potential legal contingencies.
Results
This paper aims to define liability in this context and examines how workflows and doctor‐patient relationships might be reshaped: patients must be informed about treatment options, including details about robot‐assisted procedures and associated risks.
Conclusions
These systems could significantly impact interventional radiology practice. A dedicated informed consent process is necessary to ensure clear communication and protect the decision‐making process and patient‐centred care; thereby, an informed consent is proposed to comprehensively address these needs.

Informed Consent Practices for Publication of Patient Images in Dermatology Journals
Toluwani Taiwo, Bianca Obiakor, Sarah McClung, Kanade Shinkai
JMIR Dermatology, 18 April 2025
Introduction
Clinical images play an important role in informing clinical care and education in dermatology. Standardized informed consent for publishing patient images is an important concern regarding patient privacy, especially given increasing avenues for dissemination (eg. online publication and social media). Protecting patient privacy is a critical aim for dermatologists, as publishing images with potentially identifiable features is often necessary. Establishing trust between dermatologists and patients is imperative when complete anonymity cannot be guaranteed. Clear guidelines and thorough consent practices can ensure that authors are accountable for upholding patients’ privacy and are transparent when obtaining photo consent, thereby empowering patients to make informed decisions about sharing their images. This study assesses current informed consent practices in image publication for top dermatology journals, examining author-facing guidelines and patient consent forms.

Rethinking the Burden of Traditional Informed Consent Prior to Prenatal Genetic Screening
Megan Allyse, Kirsten Riggan, Natasha Bonhomme, Marsha Michie
Hastings Center Report, 17 April 2025
Abstract
The ethics literature and professional guidelines call for extensive discussions prior to prescreening consent to prenatal cell-free DNA screening to, theoretically, allow patients to make decisions that match their values and goals of care. Most patients, however, actively avoid in-depth moral deliberation when consenting to prenatal screening and then receive a screen-negative result, suggesting that an information-heavy process is irrelevant for average-risk pregnancies. In addition, extensive information-based consent procedures are not feasible in many resource-limited contexts. Meanwhile, patients and families with screen-positive results frequently report minimal support following screening, resulting in long-term distress and suboptimal outcomes. We argue for a fundamental shift to an approach we call “just-in-time consent”: identifying the essential information for values-based decisions prior to screening while relocating resources and moral deliberation to when families receive screen-positive results. This model both ensures that patients and families receive support when they most need it and maintains high standards for the ethical provision of prenatal genetic screening.

Editor’s Note: We recognise that the “just-in-time consent” model proposed in this article could be very problematic. We will be examining this further in our Center for Informed Consent Integrity work.

Challenges in Obtaining Informed Consent for Endovascular Thrombectomy in Acute Stroke: A Survey of Providers
Ali Alsarah, Amir Mbonde, Adam Dmytriw, Joshua Hirshch, Aneesh Singhal, Thabele Leslie-Mazwi, Anna Bonkhoff, Natalia Rost, Aman Patel, Michael Young, Robert Regenhardt
Neurology, 8 April 2025
Abstract
Objective
To identify challenges that providers face when obtaining informed consent (IC) for endovascular thrombectomy (EVT).
Background
IC is viewed as integral to medical practice and clinical research, particularly when procedures are involved. However, the process can be fraught with significant challenges, especially for time sensitive emergency treatments such as EVT.
Design/Methods
Healthcare providers involved in acute stroke care were surveyed from July to December 2023. The questionnaire was created using Qualtrics and distributed via institutional networks, professional societies including the American Academy of Neurology and StrokeNet, and social media.
Results
Among 391 total respondents, 74% were staff physicians, predominantly from the United States (70%) and employed at academic medical centers (76%). The mean duration in clinical practice was 13.1 ±10.6 years. When asked how often there was uncertainty regarding the optimal approach to IC for EVT, responses stated: “never” (35%), “sometimes” (52%), “often” (9%), and “always” (4%). Respondents answered “no” (21%), “yes” (56%), or “unsure” (23%), when asked if their institutions had policies around IC for EVT. Furthermore, 83% stated they never received training at their institutions on the topic. In free-text responses about perceived challenges to IC for EVT, several key themes emerged: time constraints in emergency settings (40%), lack of patient capacity (20%), availability of surrogates/family (15%), communication barriers (10%), institutional practices/policies (10%), and legal/ethical considerations (5%). Respondents stated: “time is brain,” “seems excessive like consent for CPR,” “overly ambitious to provide EVT even outside of guidelines,” “wildly different physician opinions,” and “patients are unusually incapacitated.”
Conclusions
This study underscores the provider uncertainty, lack of specific training, and challenges associated with obtaining IC for EVT in acute stroke care. To address these specific challenges, there is a critical need for standardized training, protocols, and guidelines that can be applied across varied geographical regions and multidisciplinary environments.

The role of the enrolling clinician in emergency research conducted under an exception from informed consent
Katherine Sahan, Ethan Cowan & Mark Sheehan
Theoretical Medicine and Bioethics, 1 April 2025
Open Access
Abstract
The Exception from Informed Consent (EFIC) permits patient enrolment into therapeutic emergency research where obtaining informed consent is challenging. Yet this fails to resolve a core ethical conflict in the research and has generated controversy. This is because existing justification and practice has relied on applying EFIC per study—a wholesale permission to enroll irrespective of circumstance—instead of per patient. Our novel justification for enrolment centers on applying EFIC per patient, which empowers the enrolling clinician to judge whether to enroll patients with an Exception. This contrasts with the idea that clinician judgment is surplus to the judgements already made by institutions in deciding the research may proceed. Instead, we show that enrolling clinician’s judgment is ethically significant and should not be overlooked: attending to this strengthens the research ethically and reduces controversy. There should be a bigger role for the clinician in the research enrolment space.

An Iterative Model of Informed Consent: A Trauma-Informed Approach to Consent in Gender-Affirming Surgery
Elijah R. Castle, Rey L. Daigle, Andres Cazares, Nathan Levitt, Augustus Klein
Transgender Health, 31 March 2025
Abstract
Discourse regarding informed consent in trans health care generally addresses overarching interventions (hormones, surgery) and not specific details of these interventions (who will be involved, what kind of and where touch is required), which threatens patient autonomy and bodily agency and reinforces power imbalances inherent in health care. Pelvic care has made the case for a trauma-informed approach to informed consent, which offers a strategy to discuss these specific details and mitigate such threats. In this article, we provide guidance for how clinicians working in gender-affirming surgery can implement a trauma-informed approach to informed consent through an iterative model of informed consent.

Editor’s Note: The article states that “Principles of trauma-informed care stipulate that the clinician should seek consent for each part of the exam and, importantly, that the patient can stop the exam at any time.”

Feasibility, comprehension and applicability of broad consent in the emergency department: an exploratory mixed-methods study
Extended essay
Larissa Eienbröker, Antje Fischer-Rosinský, Martin Möckel, Frank Hanses, Felix Patricius Hans, Sebastian Wolfrum, Johannes Drepper, Daniela Krüger, Philipp Heinrich, Liane Schenk, Anna Slagman
Journal of Medical Ethics, 26 March 2025
Abstract
Background
The German Medical Informatics Initiative (MII) introduced a standardised Broad Consent (BC) form encompassing medical data, insurance data, contact information and biomaterials for health data research. This study assesses the feasibility of MII-BC in emergency departments (EDs), examining patient understanding and identifying implementation facilitators and barriers. Recommendations for implementation of MII-BC in EDs will be derived.
Methods
Mixed-method data were collected in EDs of four German university hospitals (UHs) using pseudonymised participant observation with a focus on patient perspective and surveys from patients. Data included MII-BC acceptance rates, patient understanding, motivation to consent and implementation facilitators and barriers. Quantitative data were analysed descriptively; qualitative data underwent content analysis with deductive–inductive category formation.
Results
The exploratory study involved 12 participant observations from four tertiary UHs, surfacing five key themes: (1) MII-BC patient information in the ED, (2) facilitators and (3) barriers in obtaining MII-BC in the ED, (4) patient perspectives on MII-BC and (5) recommendations for implementing MII-BC in EDs. Survey results (n=225) showed that most patients (89.8%) demonstrated high understanding of MII-BC patient information. Facilitators include empathetic engagement, clear communication and encouragement for questions. Hindering factors include estimating study time frames, ambient noises and study procedure interruptions. Adequate resources, such as trained staff and suitable premises, are crucial.
Conclusion
Implementing MII-BC in the ED is feasible with appropriate resources, though ED-specific challenges must be addressed. Successful MII-BC implementation in EDs hinges on ensuring access to comprehensible information materials, transparent communication and a calm recruitment environment.

Valid and Informed Consent in Orthopaedic Surgery: A Multicentre, Regional Service Evaluation of Current UK Practice
R Mills, M Sohail, H Sadique, O Adebayo, K Shanmuganathan, G Mamarelis, S Ali, A Sanalla, F Acquaah, A Ali, S Subhash, M Archunan, S Janjua, O Toma, V Matera, A Al-Sukaini, G Hourston, J Barwell, A Adeyeye, A Genena, M Lebe, S Towell, Ch Chan, A MacDowell, P Novak, W Khan, F Bhatti, A Iqbal, H Fawi, J Patel, M Begum, I Marciulynaite, N De Reock, R Tansey, S Hussein, Z Elgheriany, R Munni, T Sandhu, J Rahman, M Popescu, M Loeffler
Georgian Medical News, January 2025
Abstract
Background
In recent years, there has been increasing focus upon tailoring the consent process to reflect patients’ individual needs and concerns. Meanwhile, clinical litigation costs for ‘failure to warn’ as part of ‘informed consent’ remain staggeringly high. We aimed to investigate the validity of the patient consent process in elective lower limb arthroplasty surgery regionally, with a view to ascertaining how it could be improved.
Methods
Regional data across the East of England was collected retrospectively from seven hospital trusts (fifty data sets per hospital) in 2021 and analyzed against predetermined criteria. Data analyzed included operation notes, patient records and clinic letters.
Results
A total of 165 elective knee and 173 elective hip replacement cases were included in the final analysis. Capacity criteria (defined as the ability to understand, retain, weigh up and communicate a decision) were fulfilled in 11.6% of hip and 13.9% of knee replacement surgeries, despite Consent Form 1 (a form commonly used in England to consent adults, deemed to have capacity, for surgical procedures) being completed in 94.8% and 88.5% of these same cases. Procedure-specific consent was obtained in 74.0% and 72.1% of cases, respectively, whilst ‘Type’ and ‘Brand’ of implant were rarely consented for. Alternative treatment options were offered in 67.1% of hips and 62.1% of knee cases. Separate consent clinics were offered in 55.5% of hip and 57.6% of knee cases.
Conclusions
This study demonstrates that there is room for improvement within the current consent process. We propose digitalization, utilizing interactive multimedia and audio-visual demonstrations to explain surgical procedures, as a dynamic and versatile adjunct to the consent process.

Informed Consent Regarding Risk of Stroke from Cervical Spine Manipulation: A Narrative Review
Steven Brown, James J. Lehman
Journal of the International Academy of Neuromusculoskeletal Medicine, 2025
Open Access
Abstract
Objective
Although the incidence of stroke following cervical spine manipulation (CSM) is low, the potential outcomes are serious. The objective of this study was to perform a narrative review to assess whether informed consent to the risk of stroke from CSM is recommended by chiropractic researchers and practice guidelines.
Methods
An electronic literature search was conducted in February 2025 using PubMed, Google Scholar, and the Index to Chiropractic Literature, covering 1989 to March 2025. Search terms included chiropractic, cervical spine manipulation, stroke, informed consent, and risk. English language peer reviewed studies by chiropractic physicians, along with practice guidelines written in whole or in part by chiropractic physicians, were considered.
Results
There was unanimous support for informed consent to the risk of stroke from CSM in the results. We identified two practice guidelines, two case control studies, three narrative reviews, and one case series authored by chiropractic physicians that recommend such informed consent. We did not find any peer reviewed studies that argued against such informed consent.
Conclusions
Informed consent to the risk of stroke from CSM is recommended by practice guidelines and chiropractic researchers. This lends weight to the view that such informed consent is the standard of care for the chiropractic profession.