Design and implementation of community consultation for research conducted under exception from informed consent regulations for the PreVent and the PreVent 2 trials: Changes over time and during the COVID-19 pandemic
Research article
Tom Gugel, Karen Adams, Madelon Baranoski, N David Yanez, Michael Kampp, Tesheia Johnson, Ani Aydin, Elaine C Fajardo, Emily Sharp, Aartee Potnis, Chanel Johnson, Miriam M Treggiari
Clinical Trials, 27 April 2024
Abstract
Introduction
Emergency clinical research has played an important role in improving outcomes for acutely ill patients. This is due in part to regulatory measures that allow Exception From Informed Consent (EFIC) trials. The Food and Drug Administration (FDA) requires sponsor-investigators to engage in community consultation and public disclosure activities prior to initiating an Exception From Informed Consent trial. Various approaches to community consultation and public disclosure have been described and adapted to local contexts and Institutional Review Board (IRB) interpretations. The COVID-19 pandemic has precluded the ability to engage local communities through direct, in-person public venues, requiring research teams to find alternative ways to inform communities about emergency research.
Methods
The PreVent and PreVent 2 studies were two Exception From Informed Consent trials of emergency endotracheal intubation, conducted in one geographic location for the PreVent Study and in two geographic locations for the PreVent 2 Study. During the period of the two studies, there was a substantial shift in the methodological approach spanning across the periods before and after the pandemic from telephone, to in-person, to virtual settings.
Results
During the 10 years of implementation of Exception From Informed Consent activities for the two PreVent trials, there was overall favorable public support for the concept of Exception From Informed Consent trials and for the importance of emergency clinical research. Community concerns were few and also did not differ much by method of contact. Attendance was higher with the implementation of virtual technology to reach members of the community, and overall feedback was more positive compared with telephone contacts or in-person events. However, the proportion of survey responses received after completion of the remote, live event was substantially lower, with a greater proportion of respondents having higher education levels. This suggests less active engagement after completion of the synchronous activity and potentially higher selection bias among respondents. Importantly, we found that engagement with local community leaders was a key component to develop appropriate plans to connect with the public.
Conclusion
The PreVent experience illustrated operational advantages and disadvantages to community consultation conducted primarily by telephone, in-person events, or online activities. Approaches to enhance community acceptance included partnering with community leaders to optimize the communication strategies and trust building with the involvement of Institutional Review Board representatives during community meetings. Researchers might need to pivot from in-person planning to virtual techniques while maintaining the ability to engage with the public with two-way communication approaches. Due to less active engagement, and potential for selection bias in the responders, further research is needed to address the costs and benefits of virtual community consultation and public disclosure activities compared to in-person events.
Scoping review and thematic analysis of informed consent in humanitarian emergencies
Scoping review and thematic analysis of informed consent in humanitarian emergencies
Research
Benjamin Thomson, S. Mehta, C. Robinson
BMC Medical Ethics, 20 November 2024
Open access
Abstract
Background
To identify and to summarize challenges related to the informed consent process for research completed during humanitarian emergencies.
Methods
Using relevant search terms, a search of 5 databases was completed, without language, date, or study type restriction. Studies were screened for inclusion, with eligible studies being those that were relevant to the informed consent process for research studies completed in humanitarian emergencies. A Grounded Theory Analysis was completed to identify themes and subthemes.
Results
Review identified 30 relevant studies. We identified 11 challenges (lack of trust, therapeutic misconception, reduced capacity, security and privacy concerns, harmful research, power differential, literacy, language/local and cultural context, researcher burden and re-evaluation of ongoing trials) and 7 strategies (engage local research communities, use alternative to standard written consent process, modify traditional process of research ethics board review, dynamic consent, training of research staff, mandating transparency of commercial interests, and mandating reporting of informed consent process in all publications) to confront the challenges. These challenges and strategies were unique to the informed consent process in research conducted during humanitarian emergencies.
Conclusions
This scoping review identified an evidence-based guide for researchers and research ethics boards to perform ethical informed consent procedures in humanitarian emergencies.
Emergency Verbal Consent for Intrapartum Research: A Grounded Theory Study
Emergency Verbal Consent for Intrapartum Research: A Grounded Theory Study
Research Article
Carol Bedwell, Wendy Taylor, Caroline Cunningham, Andrew D. Weeks, Dame Tina Lavender
BJOG: An International Journal of Obstetrics & Gynaecology, 7 November 2024
Open Access
Abstract
Objective
To understand the experiences of women, birth partners and health professionals of verbal followed by retrospective written consent in a prospective cohort study of a device to manage postpartum haemorrhage (PPH).
Design
Grounded Theory.
Setting
Tertiary facility in North-West England, UK.
Sample
We used purposive and theoretical sampling to recruit 51 participants; 12 women, 12 birth partners, 16 obstetricians and 11 midwives.
Methods
Semi-structured interviews were conducted, using a topic guide for focus, until data saturation was achieved. Data were analysed using framework analysis technique.
Results
Most women wanted sufficient information to make a decision at the time of the event, rather than in advance, and preferred not to be overwhelmed with detail. A key factor in making the decision to participate was a positive and trusting relationship with the attending obstetrician. Obtaining consent for research in emergencies was viewed by obstetricians as requiring a different approach and more challenging than consent for standard procedures in an emergency.
Conclusions
This is one of the first studies to explore verbal followed by retrospective written consent processes with women, clinicians and observers. This was acceptable to all, however information needs to be appropriate, and those discussing consent require adequate training.
Enhancing patient understanding in obstetrics: The role of generative AI in simplifying informed consent for labor induction with oxytocin
Enhancing patient understanding in obstetrics: The role of generative AI in simplifying informed consent for labor induction with oxytocin
Amos Grünebaum, Joachim Dudenhausen, Frank A. Chervenak
Journal of Perinatal Medicine, 30 October 2024
Abstract
Informed consent is a cornerstone of ethical medical practice, particularly in obstetrics where procedures like labor induction carry significant risks and require clear patient understanding. Despite legal mandates for patient materials to be accessible, many consent forms remain too complex, resulting in patient confusion and dissatisfaction. This study explores the use of Generative Artificial Intelligence (GAI) to simplify informed consent for labor induction with oxytocin, ensuring content is both medically accurate and comprehensible at an 8th-grade readability level. GAI-generated consent forms streamline the process, automatically tailoring content to meet readability standards while retaining essential details such as the procedure’s nature, risks, benefits, and alternatives. Through iterative prompts and expert refinement, the AI produces clear, patient-friendly language that bridges the gap between medical jargon and patient comprehension. Flesch Reading Ease scores show improved readability, meeting recommended levels for health literacy. GAI has the potential to revolutionize healthcare communication by enhancing patient understanding, promoting shared decision-making, and improving satisfaction with the consent process. However, human oversight remains critical to ensure that AI-generated content adheres to legal and ethical standards. This case study demonstrates that GAI can be an effective tool in creating accessible, standardized, yet personalized consent documents, contributing to better-informed patients and potentially reducing malpractice claims.
Evaluating AI-Generated informed consent documents in oral surgery: A comparative study of ChatGPT-4, Bard gemini advanced, and human-written consents
Evaluating AI-Generated informed consent documents in oral surgery: A comparative study of ChatGPT-4, Bard gemini advanced, and human-written consents
Luigi Angelo Vaira, Jerome R. Lechien, Antonino Maniaci, Giuseppe Tanda, Vincenzo Abbate, Fabiana Allevi, Antonio Arena, Giada Anna Beltramini, Michela Bergonzani, Alessandro Remigio Bolzoni, Salvatore Crimi, Andrea Frosolini, Guido Gabriele, Fabio Maglitto, Miguel Mayo-Yáñez, Ludovica Orrù, Marzia Petrocelli, Resi Pucci, Alberto Maria Saibene, Stefania Troise, Giacomo De Riu
Journal of Cranio-Maxillofacial Surgery, 26 October 2024
Open Access
Abstract
This study evaluates the quality and readability of informed consent documents generated by AI platforms ChatGPT-4 and Bard Gemini Advanced compared to those written by a first-year oral surgery resident for common oral surgery procedures. The evaluation, conducted by 18 experienced oral and maxillofacial surgeons, assessed consents for accuracy, completeness, readability, and overall quality.
ChatGPT-4 consistently outperformed both Bard and human-written consents. ChatGPT-4 consents had a median accuracy score of 4 [IQR 4-4], compared to Bard’s 3 [IQR 3–4] and human’s 4 [IQR 3–4]. Completeness scores were higher for ChatGPT-4 (4 [IQR 4–5]) than Bard (3 [IQR 3–4]) and human (4 [IQR 3–4]). Readability was also superior for ChatGPT-4, with a median score of 4 [IQR 4–5] compared to Bard and human consents, both at 4 [IQR 4-4] and 4 [IQR 3–4], respectively. The Gunning Fog Index for ChatGPT-4 was 17.2 [IQR 16.5–18.2], better than Bard’s 23.1 [IQR 20.5–24.7] and the human consents’ 20 [IQR 19.2–20.9].
Overall, ChatGPT-4’s consents received the highest quality ratings, underscoring AI’s potential in enhancing patient communication and the informed consent process. The study suggests AI can reduce misinformation risks and improve patient understanding, but continuous evaluation, oversight, and patient feedback integration are crucial to ensure the effectiveness and appropriateness of AI-generated content in clinical practice.
Impact of Informative Videos on Proxy Consent by Parents for Pediatric Surgery: A Randomized Controlled Trial
Impact of Informative Videos on Proxy Consent by Parents for Pediatric Surgery: A Randomized Controlled Trial
Original Article
Shreyas Dudhani, Bindey Kumar, Amit Kumar Sinha, Amit Kumar, Rashi Rashi, Gaurav Shandilya
Journal of Indian Association of Pediatric Surgeons, November–December 2024; 29(6) pp 573-578
Abstract
Background
Consent is never truly exercised in children as parents act as their proxy and often do not understand the advantages, disadvantages, risks, and benefits of the procedure. Their high anxiety state is mirrored in the child, leading to slower recovery. Hence, this study was designed to understand if an intervention can impact the effect of consent on parents’ anxiety, satisfaction, and knowledge.
Methodology
A two-arm, parallel design, randomized controlled trial was conducted from March 2020 to March 2022 to analyze the effect of an educational video in comparison to an informational leaflet in parents giving proxy consents for various listed pediatric surgical procedures.
Results
Parents in the video group had a higher mean knowledge score (6.97 vs. 6.77, P = 0.40), comparable satisfaction scores (27.45 vs. 27.58, P = 0.88), and statistically insignificant difference between anxiety scores. We noted highest score of satisfaction (28.5/40) in the parents educated up to High School level or less. Knowledge scores were lowest in pelvic-ureteric junction obstruction (5.1/10) patients.
Conclusions
Our study done over a period of 2 years included a variety of diagnoses, and the videos and information leaflets were self-designed. It showed comparable anxiety, knowledge, or satisfaction in parents. Studies with more participants would be needed to take this research forward.
Comprehensive consent in urology using decision aids, leaflets, videos and newer technologies: empowering patient choice and shared decision-making
Comprehensive consent in urology using decision aids, leaflets, videos and newer technologies: empowering patient choice and shared decision-making
Review article
Carlotta Nedbal, Nithesh Naik, Niall Davis, Sanjeev Madaan, Theodoros Tokas, Giovanni Cacciamani, Eugenio Ventimiglia, Robert M. Geraghty, Dmitry Enikeev, Bhaskar K. Somani
Therapeutic Advances in Urology, 23 November 2024
Open access
Abstract
In this paper, we explore the usage of decision aids, patient information leaflets (PILs), videos, social media and modern technology to empower patients and enable shared decision-making (SDM). It explores the role of enhanced consent processes in urology. A re-evaluation of the conventional consent process is required towards more patient-centred care and SDM, which prioritises patient education and understanding of their medical conditions and treatment pathways. The use of decision aids, such as multimedia resources and PILs, is crucial in enhancing patients’ understanding, level of satisfaction, quality of life and healthcare utilisation. New tools are opening exciting possibilities for patient education and information distribution, such as Chat Generative Pre-Trained Transformer (ChatGPT). The effectiveness of ChatGPT in comparison to well-established PILs is still up for debate, despite the fact that it makes information easily accessible. Improving patients’ involvement, understanding and engagement in SDM procedures relies heavily on decision aids, PILs and current technological integration. Patients and healthcare practitioners should work together in accordance with the principles of SDM, which include considering patients’ values, backgrounds, priorities and preferences when making treatment decisions. The emphasis on patient-centred care has prompted a re-evaluation of traditional consent processes in urology, with more emphasis on the shared decision-making process. Several informative aids are currently available as reported in the literature, ranging from 3D models, multimedia presentations and virtual reality (VR) devices. While the costs of these tools might be substantial, the advantages of adopting such informative resources are unmistakable. Social media and platforms such as patient–physician blogs are increasingly popular sources of medical information. Urologists should embrace these platforms to enhance patient engagement and the quality of information provided. Despite recent progress, there remains significant room for improvement in patient education and engagement which is achievable via concerted efforts of a wider medical community.
Short-Form Video Informed Consent Compared With Written Consent for Adolescents and Young Adults: Randomized Experiment
Short-Form Video Informed Consent Compared With Written Consent for Adolescents and Young Adults: Randomized Experiment
Aliyyat Afolabi, Elaine Cheung, Joanne Chen Lyu, Pamela M Ling
JMIR Formative Research, 22 November 2024
Abstract
Background
Adolescents and young adults have the highest prevalence of e-cigarette use (“vaping”), but they are difficult to enroll in health research studies. Previous studies have found that video consent can improve comprehension and make informed consent procedures more accessible, but the videos in previous studies are much longer than videos on contemporary social media platforms that are popular among young people.
Objective
This study aimed to examine the effectiveness of a short-form (90-second) video consent compared with a standard written consent for a vaping cessation study for adolescents and young adults.
Methods
We conducted a web-based experiment with 435 adolescents and young adults (aged 13-24 years) recruited by a web-based survey research provider. Each participant was randomly assigned to view either a short-form video consent or a written consent form describing a behavioral study of a social media–based vaping cessation program. Participants completed a postexposure survey measuring three outcomes: (1) comprehension of the consent information, (2) satisfaction with the consent process, and (3) willingness to participate in the described study. Independent sample 2-tailed t tests and chi-square tests were conducted to compare the outcomes between the 2 groups.
Results
In total, 435 cases comprised the final analytic sample (video: n=215, 49.4%; written: n=220, 50.6%). There was no significant difference in characteristics between the 2 groups (all P>.05). Participants who watched the short-form video completed the consent review and postconsent survey process in less time (average 4.5 minutes) than those in the written consent group (5.1 minutes). A total of 83.2% (179/215) of the participants in the video consent condition reported satisfaction with the overall consent process compared with 76.3% (168/220) in the written consent condition (P=.047). There was no difference in the ability to complete consent unassisted and satisfaction with the amount of time between study conditions. There was no difference in the composite measure of overall comprehension, although in individual measures, participants who watched the short-form video consent performed better in 4 measures of comprehension about risk, privacy, and procedures, while participants who read the written document consent had better comprehension of 2 measures of study procedures. There was no difference between the groups in willingness to participate in the described study.
Conclusions
Short-form informed consent videos had similar comprehension and satisfaction with the consent procedure among adolescents and young adults. Short-form informed consent videos may be a feasible and acceptable alternative to the standard written consent process, although video and written consent forms have different strengths with respect to comprehension. Because they match how young people consume media, short-form videos may be particularly well suited for adolescents and young adults participating in research.
Virtual reality for patient informed consent in skull base tumors and intracranial vascular pathologies: A pilot study
Virtual reality for patient informed consent in skull base tumors and intracranial vascular pathologies: A pilot study
Research
Emilia Westarp, Attill Saemann, Marek Zelechovski, Balazs Faludi, Philippe Cattin, Jehuda Soleman, Raphael Guzman
Acta Neurochirurgica, 15 November 2024
Open Access
Abstract
Purpose
With the growing demand for shared decision-making and patient-centered care, optimal informed consent (IC) has gained relevance. Virtual reality (VR) has seen significant technological advancements, and its medical applications currently include surgical planning and medical education. This pilot study investigates the feasibility of VR-enhanced informed consent (VR-IC) in neurosurgery to improve preoperative IC and patient satisfaction.
Methods
We included patients aged 18 to 75 years who were scheduled for skull base meningioma or brain aneurysm surgery between May and December 2023. Exclusion criteria were visual/auditory impairments and severe cognitive/psychiatric disorders. Patients received standard IC followed by VR-IC using patient-specific VR models of their pathology. After an initial demonstration by the surgeon, the patients used the VR station independently. A questionnaire with 18 questions on a 5-point Likert scale assessed the subjective impression of VR-IC.
Results
Ten patients participated in the study, with six (60%) undergoing aneurysm clipping and four (40%) undergoing skull base meningioma resection. The mean age of the participants was 58 years (± 15, range 27 to 75 years), with four female patients (40%). Patients overall rated the VR-informed consent (VR-IC) positively with a mean of 4.22 (± 0.84). There was a better understanding of their pathology (mean 4.30 ± 0.92) and the planned procedure (mean 3.95 ± 1.04). Trust in the surgeon was rated with a mean of 3.47 (± 0.94). Only minimal side effects from the VR experience including dizziness or discomfort were noted (mean 4.60 ± 0.22). None of the participants dropped out of the study.
Conclusion
VR-enhanced informed consent is feasible and improves patient understanding and satisfaction without significant side effects. These findings will guide the planning of a randomized controlled trial to validate the benefits of VR-IC in neurosurgery further.
Demonstrating the Electronic Consent Process for Emergency Surgical Patients
Demonstrating the Electronic Consent Process for Emergency Surgical Patients
David Fellows, Giles Bond-Smith
Cureus, 25 October 2024
Abstract
Introduction
Patient consent for surgery is a vital part of the surgical pathway from both a patient safety and medicolegal point of view. Improvement in documenting the full consent process in the electronic patient record (EPR), alongside the standard completion of the paper consent form in a surgical emergency unit (SEU), to comply with the Montgomery ruling of informed consent, has become of paramount importance. The aim of this project was to improve the documentation of the full consent process by creating an electronic template that was easy for the consenting clinician to use and provided a robust record of the bespoke consent process for the individual patient.
Methods
In July 2020, clinicians in the SEU were asked to begin documenting the patient’s consent process in the EPR. The number of documented electronic consent processes (ECPs) of patients who underwent emergency general surgery during a two-week period was then captured between October and November 2020. The second cycle involved creating a single consent template, allowing the ECP to be easily documented in one template for all the common emergency surgery operations. All clinicians who were responsible for surgical consenting were asked to use the electronic template as part of the consent process. The rate of electronic consent was recorded over a second two-week period, six months later, in May 2021.
Results
From the first cycle, 78 patients were identified as undergoing emergency surgery, of which 13% (N=10) had an electronic entry regarding the consent process fully documented and personalised to the patient. From the second cycle, 64 patients were identified. The rate of documented ECPs increased to 77% (N=49).
Conclusion
This project has successfully improved the electronic demonstration of a consent process, bespoke to the individual, in accordance with the Montgomery ruling, by implementing an easy-to-use template on EPR. This is a significant step towards full digital consent in the future.
Center for Informed Consent Integrity 