Using Large Language Models to Create Patient Centered Consent Forms
Beattie, S. Neufeld, D.X. Yang, C. Chukwuma, N.B. Desai, M. Dohopolski, S.B. Jiang
International Journal of Radiation Oncology, Biology, Physics, 1 October 2024
Abstract
Purpose/Objective(s)
Understanding informed consent forms, which outline the risks, costs, and procedures of clinical trials, presents a significant challenge for patients due to their complex language and length. Recognizing that such complexity can impede patient comprehension and decision-making, this study proposes the use of Large Language Models (LLMs) to distill these forms into concise, easy-to-understand cover pages. We hypothesize that we can significantly improve the readability of these forms using LLMs.
Materials/Methods
Five approved institutional clinical trial consent forms were assessed for their readability using SMOG and the Flesch-Kincaid Ease of Reading score using Python libraries. The documents were segmented and catalogued in a vector database to facilitate similarity searches. OpenAI’s GPT-4 API was prompted to extract information about costs, payments, contact information, eligibility criteria, treatments, duration, and requirements based on relevant information retrieved from the vector database. Furthermore, each prompt included instructions to respond at a 7th to 8th-grade reading level. The answers were collected, and their readability evaluated using the aforementioned metrics. Finally, the SMOG and Flesch-Kincaid readability scores were compared using a Wilcoxon signed-rank test.
Results
The original informed consent forms exhibited an average SMOG score of 16.74 (± 0.86), corresponding to a graduate reading level, and an average Flesch-Kincaid score of 12.93 (± 0.70), corresponding to an undergraduate reading level. Conversely, the LLM-generated information sheets exhibited an average SMOG score of 11.25 (± 0.50), corresponding to a high school reading level, and an average Flesch-Kincaid score of 8.15 (± 0.68), corresponding to an 8-9th grade reading level, demonstrating a significant reduction in reading level (p<0.05 for both SMOG and Flesh-Kincaid scores). Some LLM-generated information sheets were successful in adhering to a 7th to 8th-grade reading level, as denoted by a Flesch-Kincaid score < 8.
Conclusion
Our approach successfully simplified clinical trial consent forms using LLMs, reducing reading levels and making information more accessible. This approach could significantly enhance the transparency and comprehensibility of the clinical trial consent process, fostering a more patient-centric approach. Feedback from patients on LLM-generated information sheets could provide invaluable insights into the practicality and usefulness of this approach.
Year: 2024
Multi-Center Pilot Study to Assess Provider Experience with an Artificial Intelligence Multimedia Informed Consent Platform
Multi-Center Pilot Study to Assess Provider Experience with an Artificial Intelligence Multimedia Informed Consent Platform
Usman Latif, Timothy Deer, Sean Li
Neuromodulation: Technology at the Neural Interface, October 2024
Introduction
Informed consent is a keystone of medical care, involving a thorough discussion of the procedure, risks and benefits involved, and reasonable expectations for patients. 24% of malpractice suits in the field of spine surgery are attributable to insufficient informed consent. Numerous studies indicate that informed consent is frequently inadequate. Multimedia aids have been shown to enhance patient comprehension and satisfaction. This study assessed experience at multiple centers with a platform that delivers multimedia videos and utilizes artificial intelligence to ensure patients view the entire video while maintaining attention before signing a digital consent. A permanent videographic record of the patient viewing the video is created for the purpose of reducing malpractice exposure.
Editor’s Note: After assessing the observations and arguments made in this paper, we are reaching out to the corresponding authors for clarification.
Understanding and processing informed consent during data-intensive health research in sub-Saharan Africa: challenges and opportunities from a multilingual perspective
Understanding and processing informed consent during data-intensive health research in sub-Saharan Africa: challenges and opportunities from a multilingual perspective
Research article
Lillian Omutoko, George Rugare Chingarande, Marietjie Botes, Farayi Moyana, Shenuka Singh, Walter Jaoko, Esperança Sevene, Tiwonge K Mtande, Ama Kyerewaa Edwin, Limbanazo Matandika, Theresa Burgess, Keymanthri Moodley
Research Ethics, 26 September 2024
Open access
Abstract
Africa has a colonial past that renders it a linguistic melting pot, where language is not only important for communication but is inextricably related to cultural identity. In Africa, there are over 2000 languages that are still being used and spoken. Language diversity coupled with cultural diversity may affect the process of obtaining informed consent in data-intensive research. We explore some of the challenges and opportunities of multilingualism in handling informed consent in the context of data-intensive research. In multilingual contexts, as in most African countries, language is exceptionally central, and translation has potential cultural, social, historical, functional and scientific importance. However, it is recognised that terminological and translation activities may not always be cost-effective or feasible. We consider alternative mechanisms of harmonisation of data-related terminology and concepts in multilingual contexts, such as iconography, graphic elicitation and other multimedia formats of information sharing. The inclusion of visual or multimedia explanations in informed consent forms can improve comprehension, enhance information transfer and learning, reduce potential vulnerabilities associated with low literacy levels or the inability to interpret technical language associated with data-intensive research, build trust with participants and their communities, and promote autonomy of potential participants. We recognise that the inclusion of visual or multimedia content to facilitate information transfer is only one component of the informed consent process for data-intensive research. Research ethics committees (RECs) should be mindful of other key considerations and challenges of informed consent for data-intensive research in sub-Saharan Africa (SSA), and to explore whether these alternative forms of consent are ethical and effective in multilingual contexts.
Infrastructuring Readability: Framing and Overflowing in Writing Assistant Software for Biomedical Research Informed Consent Forms
Infrastructuring Readability: Framing and Overflowing in Writing Assistant Software for Biomedical Research Informed Consent Forms
Research article
Loïc Riom, Solène Gouilhers, Claudine Burton-Jeangros
Science, Technology, & Human Values, 8 October 2024
Open access
Abstract
This article analyzes the development process of a software solution designed to assist researchers in writing biomedical research–informed consent forms. Funded by a Swiss ethics committee, the purpose of the software is to enhance the readability of such documents to improve biomedical research participants’ understanding of the information disclosed therein and to reduce the editing work of research ethics committees. Drawing on an embedded ethnographic research, we show how concerns that emerge in ethics reviews shape ethics committee IT infrastructure and how, in turn, this infrastructure contributes to redefining research ethics. We demonstrate that while the software reinforces the biomedical framing of research ethics, it also generates unexpected overflows. By forming new collectives, this infrastructuring process furthers expertise on informed consent forms while giving rise to new areas of inquiry and redefining the issue of readability in biomedical research. Thus, we provide insights into the complex entanglements between research ethic, computer programs, and writing practices. We conclude by reflecting on the role played by our research team during the software’s development and outline proposals on how ethnographic methods can contribute to make research ethics review accountable.
Data professionals’ attitudes on data privacy, sharing, and consent in healthcare and research
Data professionals’ attitudes on data privacy, sharing, and consent in healthcare and research
Research Article
Katya Kaplow,Max Downey, Darren Stewart, Allan B. Massie, Jennifer D. Motter, Lauren Taylor, John Massarelli, Taylor Matalon, Carolyn Sidoti, Macey L. Levan, Brendan Parent
Digital Health, 22 October 2024
Open Access
Abstract
Objective
Individuals who work on health data systems and services are uniquely positioned to understand the risks of health data collection and use. We designed and conducted a survey assessing the perceptions of those who work with health data around health data consent, sharing, and privacy practices in healthcare and clinical research.
Methods
A 43-item online survey was distributed via a market research firm to individuals (18+) who work with health data in the United States from March to April 2023. Descriptive statistics were calculated for all variables. Associations with demographic variables were assessed using Pearson’s X2 tests and ordinal logistic regression.
Results
Most of our respondents (61.7%) reported that they would trust people to use their health data across various sectors, but more respondents trusted those working in academic medical research (86.5%) and healthcare offices (89.9%) compared to those working in industry (68.2%). Despite this reported trust, a strong majority believed that individuals should have complete control over their health data (97.3%), specific consent should be obtained for each use of their health data (92.0%), and that there should be higher standards of consent and privacy for health records data than other types of data (93.7%).
Conclusions
Based on our findings, we might infer that people who work with health data generally trust institutions across sectors to protect their health data. However, many would prefer to have complete control over who has access to their health data and how it is used. These insights should be explored further through qualitative studies.
Considerations for the Design of Informed Consent in Digital Health Research: Participant Perspectives
Considerations for the Design of Informed Consent in Digital Health Research: Participant Perspectives
Research article
Brian J. McInnis, Ramona Pindus, Daniah Kareem, Camille Nebeker
Journal of Empirical Research on Human Research Ethics, 14 October 2024
Abstract
The research team, prospective participants, and written materials all influence the success of the informed consent process. As digital health research becomes more prevalent, new challenges for successful informed consent are introduced. This exploratory research utilized a human centered design process in which 19 people were enrolled to participate in one of four online focus-groups. Participants discussed their experiences with informed consent, preferences for receiving study information and ideas about alternative consent approaches. Data were analyzed using qualitative methods. Six major themes and sixteen sub-themes were identified that included study information that prospective participants would like to receive, preferences for accessing information and a desire to connect with research team members. Specific to digital health, participants expressed a need to understand how the technologies worked and how the volume of granular personal information would be collected, stored, and shared.
Trust and Inclusion in Digital Health: The Need to Transform Consent
Trust and Inclusion in Digital Health: The Need to Transform Consent
Brief Communication
Celia Brightwell, Stefanie Brückner, Orit Halpern, Stephen Gilbert
Digital Society, October 2024
Open Access
Abstract
As health systems increasingly adopt digital solutions, such as remote monitoring and telemedicine, the use of health apps is becoming increasingly widespread. Meanwhile, data protection regulations and digital transformation initiatives are making the individual responsible for protecting their health data. In this brief communication, we focus on how the consent interface in a health app can impact trust and inclusion in digital health for privacy-sensitive people. As the consent interface determines how an individual’s health data can be used in medical research, it represents a critical point between the citizen’s right to informational self-determination and the potential public benefit of advances in medical science. We find that app developers’ interests in controlling access to health data may influence the design of the consent interface and undermine an individual’s ability to understand what they are consenting to. We describe how a standardized consent interface applied to health apps could foster a trusting relationship between individuals and the digital transformation of healthcare.
Biobank consent under the GDPR: are potential sample donors informed about all lawful uses of biobank data?
Biobank consent under the GDPR: are potential sample donors informed about all lawful uses of biobank data?
Emmi Kaaya
Medicine, Health Care and Philosophy, 8 October 2024
Abstract
This paper analyses the information disclosures in two biobank consent documents used by biobanks operating under the General Data Protection Regulation (GDPR). The aim of the analysis is to investigate how these documents inform potential sample donors about possible future uses of biobank data. The findings suggest that the consent documents provide potentially misleading information regarding the range of possible future uses of biobank data. Based on these information disclosures, potential sample donors may reasonably believe that the data can only be used for a narrowly defined range of research purposes. However, the range of lawful uses of the data is much broader and less clearly defined. Consent provided based on misleading information is not morally transformative, even if it were legally valid. To facilitate morally transformative biobank consent, this paper provides two recommendations for information disclosure to potential sample donors regarding future uses of biobank data: first, potential sample donors should be informed about the legal scope of consent; and second, they should be informed about the full range of lawful uses of biobank data.
Biobanking, digital health and privacy: the choices of 1410 volunteers and neurological patients regarding limitations on use of data and biological samples, return of results and sharing
Biobanking, digital health and privacy: the choices of 1410 volunteers and neurological patients regarding limitations on use of data and biological samples, return of results and sharing
Emilia Giannella, Josep Miquel Bauça, Simona Gabriella Di Santo, Stefano Brunelli, Elisabetta Costa, Sergio Di Fonzo, Francesca Romana Fusco, Antonio Perre, Valerio Pisani, Giorgia Presicce, Francesca Spanedda, Giorgio Scivoletto, Rita Formisano, Maria Grazia Grasso, Stefano Paolucci, Domenico De Angelis, Giulia Sancesario
BMC Medical Ethics, 27 September 2024
Open access
Abstract
Background
The growing diffusion of artificial intelligence, data science and digital health has highlighted the role of collection of data and biological samples, thus raising legal and ethical concerns regarding its use and dissemination. Further, the expansion of biobanking, from the basic collection of frozen specimens to the virtual biobanks of specimens and associated data that exist today, has given a revolutionary potential on healthcare systems, particularly in the field of neurological diseases, due to the inaccessibility of central nervous system and the need of non-invasive investigation approaches. Informed Consent (IC) is considered mandatory in all research studies and specimen collections, and must specifically take into account the ethical respect to the individuals to whom the used biological material and data belong.
Methods
We evaluated the attitudes of patients with neurological diseases (NP) and healthy volunteers (HV) towards the donation of biological samples to a biobank for future research studies on neurological diseases, and limitations on the use of data, related to the requirements set by the General Data Protection Regulation (GDPR). The study involved a total of 1454 subjects, including 502 HVs and 952 NPs, recruited at Santa Lucia Foundation IRCCS, Rome, from 2020 to 2024.
Results
We found that (i) almost all subjects agreed with the participation in biobanking (ii) and authorization to genetic studies (HV = 99.1%; NP = 98.3%); Regarding the return of results, (iii) we found a statistically significant difference between NP and HV, the latter preferring not to be informed of potential results (HV = 43%; NP = 11.3%; p < 0.0001); (iv) a small number limited the sharing inside European Union (EU) (HV = 4.6%; NP = 6.6%), whereas patients were more likely to refuse transfer outside EU (HV = 7.4%; NP = 10.7% p = 0.05); (v) nearly all patients agreed with the use of additional health data from EMR for research purposes (98.9%).
Conclusions
Consent for the donation of material for research purposes is crucial for biobanking and biomedical research studies that use biological material of human origin. Here, we have shown that choices regarding participation in a neurological biobank can be different between HVs and NPs, even if the benefit for research and scientific progress is recognized. NP have a strong interest in being informed of possible results but limit sharing of samples, highlighting a perception of greater individual or relative benefit, while HV prefer a wide dissemination and sharing of data but not to have the return of the results, favoring a possible benefit for society and knowledge. The results underline the need to carefully manage biological material and data collected in biobanks, in compliance with the GDPR and the specific requests of donors.
Public Perspectives on Consent for and Governance of Biobanking in Japan
Public Perspectives on Consent for and Governance of Biobanking in Japan
Research Article
Masanori Oikawa, Yoshiyuki Takimoto
Journal of Empirical Research on Human Research Ethics, 27 September 2024
Abstract
Through strengthened biobank governance, broad consent has been widely accepted as a means to replace donors’ discretion based on the information of individual research protocols. Trust and other ethical and social notions, such as reciprocity and solidarity, are key concepts that support biobank governance. The types of allowed broad consent are several; however, they remain unclear, and whether these ethical and social notions are associated with public attitudes toward the consent model is not fully understood. This quantitative study examined two hypotheses: narrower and limited broad consent are more accepted by the public, and acceptance rates for broad consent increase with established measures related to biobank governance. This analysis supported both hypotheses, implying that the limited type of broad consent should be considered an important option, and that a specific type of governance is critical in promoting trust, reciprocity, and solidarity between biobanks and the public.
Center for Informed Consent Integrity 