Artificial Intelligence and Informed Consent: an information science perspective on privacy policies and terms of use in major AI platforms
Conference Presentation
Jonas Ferrigolo Melo, Moises Rockembach
Artificial Intelligence in Library and Information Science: Exploring the Intersection, January 2025; Istanbul, Turkey
Abstract
This study examines how AI platforms incorporate the principles of informed consent (IC) concerning transparency, privacy, and user autonomy. The research aims to identify areas of convergence, divergence, and potential integration between the conceptual framework of IC in Information Science and the Privacy Policies of ChatGPT, Gemini, and Co-pilot. By analyzing these policies, the study explores how these platforms communicate data practices, ensure user control over personal information, and align with ethical standards of informed decision-making. The findings contribute to a broader understanding of AI governance and user rights in digital environments.
Month: February 2025
Analysis of informed consent forms of patients undergoing cancer genetic testing in the era of next-generation sequencing
Analysis of informed consent forms of patients undergoing cancer genetic testing in the era of next-generation sequencing
Research
Tina Kerševan, Tina Kogovšek, Ana Blatnik, Mateja Krajc
Hereditary Cancer in Clinical Practice, 21 February 2025
Open Access
Abstract
Background
The Department of Clinical Cancer Genetics at the Institute of Oncology Ljubljana offers genetic counselling and testing to cancer patients and their relatives. Before undergoing genetic testing, patients sign the informed consent form. In addition to giving consent for collection of biological material and genetic testing, patients decide about storage of biological material and participation in international databases. Furthermore, patients decide whether the information regarding their test results may be revealed to their blood relatives and whether they want to be informed about secondary findings.
Methods
Using the signed consent forms, we investigated the effect of selected factors on patients’ decisions. Using different statistical methods, we tried to determine the proportion of patients who opted for different items and the effect of gender, age and cancer diagnoses on their decisions.
Results
Nearly all (99.6%) patients, regardless of gender, age, and presence of oncological diagnosis, consented to the storage of their biological material, 98.4% of patients, regardless of gender, age, and presence of oncological diagnosis, wanted to be included in international databases in a pseudo-anonymised form, 98.8% of patients, irrespective of gender, age, and presence of oncological diagnosis, allowed blood relatives to see their results, and 98.4% of patients, irrespective of gender, age and presence of oncological diagnosis, wanted to know whether secondary findings were detected when genetic analysis of their biological material was performed. Men are, on average, more likely to consent but the difference between genders is not statistically significant. Patients without oncological disease were more likely to agree to be included in international databases than patients with a confirmed oncological diagnosis.
Conclusions
Our results show that the vast majority of patients were in favour of the options they were offered. Most importantly, the majority of them allow their genetic test results be revealed to their blood relatives when needed and would participate in international databases. Research in rare diseases, including rare cancer genetic predisposition syndromes, is crucial for optimal diagnostic, prevention and treatment options for patients with rare genetic disorders. The results are also important for refining the approach to pre-and post-test cancer genetic counselling.
New Online Consent Tool for Patients
New Online Consent Tool for Patients
Australian Genomics, 23 January 2025
Abstract
Informed consent is a critical component of genomic and genetic testing. It is a process whereby a patient agrees to undergo genomic testing in full knowledge of the potential risks, benefits and outcomes. It is therefore essential that they are given clear and transparent information to support their decision. A new interactive online tool developed by Australian Genomics provides easy and accessible information in bite-sized chunks to guide patients through the key concepts of genomic testing. It is designed to complement the updated genetic and genomic clinical consent package released by Australian Genomics earlier last year. “These consent materials are among the most popular resources we have produced,” said Project Lead Professor Julie McGaughran. “This is another step forward in our work to provide accurate and engaging material to help people better understand the often-complex process of genomic testing.” The tool is designed to provide key details upfront and then options for users to explore more information based on their interests.
Looking Beyond the IRB
Looking Beyond the IRB
Editorial
Quinn Waeiss, Margaret Levi, Leif Wenar, David Magnus
The American Journal of Bioethics, 29 January 2025
Excerpt
…Looking to the informed consent process to address group harms also brings serious complications. The first is defining the groups that could experience harm. Without careful thought to the identification of these groups, researchers run the risk of using social groups as inappropriate proxies for the groups actually under study—and those ultimately at risk of harm (Juengst Citation1998). Blanket calls for community engagement in data-centric research without careful consideration of the communities in question seems likely to reinforce the incorrect use of population descriptors in fields like genomics. Doerr and Meeder (Citation2025) highlight several additional complexities with appropriately demarcating groups in data-intensive research, including groups that researchers can analyze into existence. Even if groups are properly identified, we still need to consider the additional burdens placed on communities and their members through community engagement in the research process, and how burdens could compound if such engagement were mandatory…
Consideration and Disclosure of Group Risks in Genomics and Other Data-Centric Research: Does the Common Rule Need Revision?
Consideration and Disclosure of Group Risks in Genomics and Other Data-Centric Research: Does the Common Rule Need Revision?
Target Article
Carolyn Riley Chapman, Gwendolyn P. Quinn, Heini M. Natri, Courtney Berrios, Patrick Dwyer, Kellie Owens, Síofra Heratyf Birkbeck, Arthur L. Caplan
The American Journal of Bioethics, 2025
Abstract
Harms and risks to groups and third-parties can be significant in the context of research, particularly in data-centric studies involving genomic, artificial intelligence, and/or machine learning technologies. This article explores whether and how United States federal regulations should be adapted to better align with current ethical thinking and protect group interests. Three aspects of the Common Rule deserve attention and reconsideration with respect to group interests: institutional review board (IRB) assessment of the risks/benefits of research; disclosure requirements in the informed consent process; and criteria for waivers of informed consent. In accordance with respect for persons and communities, investigators and IRBs should systematically consider potential group harm when designing and reviewing protocols, respectively. Research participants should be informed about any potential group harm in the consent process. We call for additional public discussion, empirical research, and normative analysis on these issues to determine the right regulatory and policy path forward.
Beyond Individual Consent: The Hidden Crisis of Group Harm in the AI and Genomics Era
Beyond Individual Consent: The Hidden Crisis of Group Harm in the AI and Genomics Era
Open Peer Commentaries
Tony Yang
The American Journal of Bioethics, 29 January 2025
Excerpt
…Chapman and colleagues’ analysis highlights critical gaps in current regulatory frameworks, particularly around institutional review board (IRB) assessment of group risks, informed consent requirements, and criteria for consent waivers. Their work connects to and builds upon several themes identified in earlier work: the increasing salience of group risks in data-centric research, as highlighted by analyses of algorithmic harm and bias in big health data research (Obermeyer et al. Citation2019); the challenges of prospectively identifying group harms, emphasized in studies of genetic research with Indigenous communities (Garrison et al. Citation2019); and the limitations of individual-focused protections in addressing collective risks, a theme present across multiple analyses…
The Impact of Video Consent on Patient Satisfaction When Undergoing Percutaneous Nephrolithotomy: A Randomized Control Trial
The Impact of Video Consent on Patient Satisfaction When Undergoing Percutaneous Nephrolithotomy: A Randomized Control Trial
Kartik Sharma, Gautam Ram Choudhary, Shiv Charan Navriya, Jeena Raju Kudunthail, Deepak Prakash Bhirud, Mahendra Singh, Arjun Singh Sandhu
Société Internationale d’Urologie Journal, 12 February 2025
Abstract
Introduction
Consent-taking for surgery evolved from a historical paternalistic approach to informed consent in the mid-20th century. Modern healthcare models prioritize patient-centric care, and the use of multimedia tools may overcome challenges such as language barriers and complex medical surgical steps. This study evaluates the impact of an educational video on patient satisfaction for those undergoing percutaneous nephrolithotomy (PCNL), a procedure where explaining complexities verbally can be challenging.
Materials and Methods
A randomized control trial was conducted at a tertiary care center in India from July 2022 to April 2024. A total of 232 adult patients scheduled for PCNL were randomly assigned to a study group (Group A) or a control group (Group B). Group A viewed an educational video about PCNL, while Group B provided standard written consent. The video, presented in patients’ native languages, covered procedural details, potential outcomes, and post-operative care. Patient satisfaction was assessed using a 10-question questionnaire at discharge, with scores ranging from one (poor) to five (best). Statistical analysis was performed using SPSS software to compare outcomes between the two groups.
Results
The study found that Group A exhibited significantly higher satisfaction compared to Group B across all domains. Group A demonstrated a better understanding of the procedure, improved knowledge of post-operative care, reduced anxiety, and a greater awareness of potential complications. Specifically, the mean satisfaction scores for Group A were higher in understanding the procedure (13.15 vs. 10.00), post-operative care (8.46 vs. 6.84), and overall anxiety (8.65 vs. 6.96). The video also improved patients’ comprehension regarding potential complications and the need for further procedures. Complication rates and hospital stay durations were similar between both groups.
Discussion
The educational video significantly enhanced patient satisfaction and the understanding of PCNL. This multimedia approach provided a consistent, clear explanation of the procedure, which improved patient comprehension and reduced anxiety, irrespective of literacy levels. These findings support the integration of video-assisted consent in pre-operative education to enhance patient engagement and satisfaction.
Conclusions
The use of an educational video for consent in PCNL improves patient understanding and satisfaction. This method effectively complements traditional consent processes, providing a valuable tool for patient education in complex procedures.
Improving Endoscopy Room Efficiency: Evaluation of a Video as a Supplementary Tool for Informed Consent
Improving Endoscopy Room Efficiency: Evaluation of a Video as a Supplementary Tool for Informed Consent
A Kyei, O esenwa, C Tan, D Llovet, M Bernstein, B Mannino, L Cohen, N Griller, F Saibil, P Tartaro, E Yong, J Tinmouth
Journal of the Canadian Association of Gastroenterology, 10 February 2025
Abstract
Background
Endoscopy unit efficiency is critical because of the need to provide timely and quality care, despite limited resources. In previous work, obtaining informed consent negatively impacted efficiency. We developed a 3-minute animated video to facilitate the consent process, including describing colonoscopy, its purpose and potential risks/benefits.
Aims
1) Assess the ability of the video to support the informed consent process; 2) Determine the effectiveness of the video as a communication tool.
Methods
Using a critical case sample design with maximum variation, 12 participants completed pre- and post-colonoscopy 1:1 semi-structured interviews after viewing the video. Questions evaluated whether key components of informed consent were conveyed and assessed the video using principles of learner verification (attractiveness, usability, comprehension, impact on self-efficacy, acceptability). Interviews were recorded and transcribed. The data were coded inductively and deductively.
Results
Regarding components of informed consent, most participants understood the purpose and nature of a colonoscopy, but alternatives, including the right to refuse, were less effectively communicated. As a communication tool, the animations engaged participants and aided comprehension of complex material. The language was accessible, however, some participants found the video too fast and the font too small. Most participants found the video acceptable and characters relatable. Some identified information gaps included sedation level and procedure duration.
Conclusions
Endoscopy unit efficiency may be improved by providing consent information via video to patients scheduled for colonoscopy to supplement current approaches to informed consent. Our findings will inform revisions of the video and subsequent implementation into clinical practice.
How Inclusive Are Patient Decision Aids for People with Limited Health Literacy? An Analysis of Understandability Criteria and the Communication about Options and Probabilities
How Inclusive Are Patient Decision Aids for People with Limited Health Literacy? An Analysis of Understandability Criteria and the Communication about Options and Probabilities
Research Article
Romy Richter, Jesse Jansen, Josine van der Kraan, Wais Abbaspoor, Iris Bongaerts, Fleur Pouwels, Celine Vilters, Jany Rademakers, Trudy van der Weijden
Medical Decision Making, 14 December 2024
Abstract
Objective
Patient decision aids (PtDAs) can support shared decision making. We aimed to explore how inclusive PtDAs are for people with limited health literacy (LHL) by analyzing 1) the understandability of PtDAs using established criteria, 2) how options and probabilities of outcomes are communicated, and 3) the extent to which risk communication (RC) guidelines are followed.
Methods
In a descriptive document analysis, we analyzed Dutch PtDAs available in 2021 that met the International Patient Decision Aid Standards. We developed and pilot tested a data extraction form based on key RC and health literacy literature.
Results`
Most PtDAs (151/198) met most of the understandability criteria on layout (7–8 out of 8 items) such as font size but not on content aspects (121/198 PtDAs scored 5–7 out of 12 items) such as defining medical terms. Only 31 of 198 PtDAs used a short and simple sentence structure. Most PtDAs presented 2 to 4 treatment options. Many followed RC recommendations such as the use of numerical RC strategies such as percentages or natural frequencies (160/198) and visual formats such as icon arrays (91/198). Only 10 used neutral framing (10/198). When presented, uncertainty was presented verbally (134/198) or in ranges (58/198). Four PtDAs were co-created together with patients with LHL and used only verbal RC or no RC.
Conclusion
Most PtDAs met most of the understandability criteria on layout, but content aspects and adherence to RC strategies can be improved. Many PtDAs used long sentences and mostly verbal RC and are therefore likely to be inappropriate for patients with LHL. Further research is needed on PtDA characteristics and RC strategies suitable for people with LHL.
Highlights
- Despite meeting most criteria for understandability, many of the Dutch PtDAs use long sentences, which likely impede comprehension for patients with LHL.
- Most of the Dutch PtDAs follow established recommendations for risk communication, with room for improvement for some strategies such as framing and a clear reference to the time frame.
- Overall, more research is needed to tailor PtDAs to the needs of people with LHL.
Exploring Consent to Use Real-World Data in Lung Cancer Radiotherapy: Decision of a Citizens’ Jury for an ‘Informed Opt-Out’ Approach
Exploring Consent to Use Real-World Data in Lung Cancer Radiotherapy: Decision of a Citizens’ Jury for an ‘Informed Opt-Out’ Approach
Arbaz Kapadi, Hannah Turner-Uaandja, Rebecca Holley, Kate Wicks, Leila Hamrang, Brian Turner, Tjeerd van Staa, Catherine Bowden, Annie Keane, Gareth Price, Corinne Faivre-Finn, David French, Caroline Sanders, Søren Holm, Sarah Devaney
Health Care Analysis, 10 February 2025
Abstract
An emerging approach to complement randomised controlled trial (RCT) data in the development of radiotherapy treatments is to use routinely collected ‘real-world’ data (RWD). RWD is the data collected as standard-of-care about all patients during their usual cancer care pathway. Given the nature of this data, important questions remain about the permissibility and acceptability of using RWD in routine practice. We involved and engaged with patients, carers and the public in a two-day citizens’ jury to understand their views and obtain decisions regarding two key issues: (1) preferred approaches to consent for the use of RWD within the context of patients receiving radiotherapy for lung cancer in RAPID-RT and (2) how RWD use should be best communicated to patients. Individual views were polled using questionnaires at various stages of the jury, whilst group discussion activities prompted further dialogue about the rationale behind choices of consent. Key decisions obtained from the jury include: (1) an opt-out approach to consent for the use of RWD; (2) the opt-out approach to consent should be informed. Furthermore, it was advised that information and communication regarding the consent process and use of RWD should be accessible, clear and available in a variety of formats. It is important that the consent process for patient data use is underpinned by principles of autonomy and transparency with clear channels of communication between those asking for and giving consent. Moreover, the process of seeking consent from patients should be proportionate to the risks presented from their participation.
Center for Informed Consent Integrity 