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Informed Consent: A Monthly Review
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November 2024 :: Issue 71

In preparing this digest, we monitor a broad range of academic journals and utilize Google Scholar to search articles referencing  informed consent or assent. After careful consideration, a selection of these results appear in the digest. We also monitor other research, analysis, guidance and commentary beyond the academic literature globally, including calls for public consultation and symposia/conferences which address consent/assent in whole or in part. We recognize that some of the arguments presented in this edition may be controversial and may warrant closer scrutiny. We have elected to be generous in our inclusion with the goal of presentating of a wholistic landscape of informed consent literature as it is being published. We acknowledge that this scope yields an indicative and not an exhaustive digest product.

Informed Consent: A Monthly Review is a service of the Center for Informed Consent Integrity, a program of the GE2P2 Global Foundation. The Foundation is solely responsible for its content. Comments and suggestions should be directed to:

Editor
Paige Fitzsimmons, MA
Associate Director, Center for Informed Consent Integrity
GE2P2 Global Foundation
paige.fitzsimmons@ge2p2global.org

PDF Version: Center for Informed Consent Integrity – A Monthly Review_November 2024

Spotlight – Revised Declaration of Helsinki adopted by the global medical community, strengthening ethical standards in clinical research involving humans

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SPOTLIGHT

This month we have chosen to spotlight the recently revised Declaration of Helsinki and have provided the World Medical Association press release which positions the revision and how it was achieved below. We invite readers to review the full declaration as consent related issues are interwoven throughout, and we make special note of paragraphs 25-32 which deal with free and informed consent.

Revised Declaration of Helsinki adopted by the global medical community, strengthening ethical standards in clinical research involving humans
Press Release
World Medical Association, 21 October 2024
    The World Medical Association (WMA) has announced the adoption the 2024 Revision of the Declaration of Helsinki (DoH), the global reference for medical research involving human participants, at its General Assembly in Helsinki, Finland.

Newly inaugurated President of the WMA, Dr Ashok Philip said, “This landmark revision of the Declaration of Helsinki highlights the World Medical Association’s commitment to reinforcing the ethical principles that guide medical research involving human participants, to safeguard patient rights and to ensure the integrity of scientific studies.

“This was a mammoth revision process spanning 30 months, and the World Medical Association extends its heartfelt thanks to everyone who participated,” continued Dr Ashok Philip, President of the World Medical Association.

Under the leadership of Dr. Jack Resneck Jr., Chair of the WMA Declaration of Helsinki revision workgroup, the revision team concluded that some areas of the document had to be updated to ensure the Declaration’s continued relevance. The 2024 revision of the Declaration of Helsinki provides for increased protection for vulnerable populations, improved transparency in clinical trials, and stronger commitments to fairness and equity in research.

“Previously, the Declaration of Helsinki addressed WMA members and constituents. The new version of the Declaration says that as physicians, it’s part of our moral obligation to ensure that our patients and the participants in research are respected and treated with dignity,” said Dr Jack Resneck Jr.

“The revised Declaration of Helsinki calls on everybody involved in the research enterprise now to uphold those principles, whether they are individuals or teams or organizations across the medical research activity,” he continued.

Dr Resneck Jr. highlighted some new language in the sixth paragraph of the Declaration as important, saying, “To really address the theme of distributive and global justice, this change means that the Declaration of Helsinki calls on researchers to carefully consider how the benefits, the risks, the burdens of research are distributed.”

The substantive changes to the Declaration of Helsinki can be categorised in two areas:

  • Participant-centered inclusion, respect and protection, including recognition of participant vulnerability, calls for community engagement, pursuit of global justice, obtaining informed consent, and use of participant-centered language.
  • Research beneficence and value, including the pursuit of “individual and public health”, upholding scientific rigor and integrity, and considered distribution of benefits, risks and burdens.

More information

Advance Consent for Participation in Acute Stroke Trials: A Focus Group Study with People with Lived Experience of Stroke

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Advance Consent for Participation in Acute Stroke Trials: A Focus Group Study with People with Lived Experience of Stroke
Brief Communication
Ubong Udoh, Rena Seeger, Emma Cummings, Brian Dewar, Stuart Nicholls, Mark Fedyk, Sophia Gocan, Victoria Shepherd, Dar Dowlatshahi, Michel Shamy
The Canadian Journal of Neurological Sciences, 15 October 2024
Abstract
Advance consent could address many of the limitations traditional consenting methods pose to participation in acute stroke trials. We conducted a series of five focus groups with people with lived experience of stroke. Using an inductive thematic approach, two themes were developed: factors in favour of, and against, advance consent. Participants supported the idea of advance consent and highlighted trust, transparent communication and sufficient time as major factors that would positively affect their decision to provide advance consent. The results will be used to finalise a model of advance consent suitable for testing the feasibility in stroke prevention clinics.

Advance Consent for participation in Acute Stroke Trials (ACTION): protocol for a feasibility study

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Advance Consent for participation in Acute Stroke Trials (ACTION): protocol for a feasibility study
Ubong Udoh, Rena Seeger, Brian Dewar, Emma Cummings, Sophia Gocan, Stuart Nicholls, Mark Fedyk, Victoria Shepherd, Jeff Perry, Robert Fahed, Tim Ramsay, Jamie Brehaut, Michael D Hill, Alexandre Y Poppe, Bijoy K Menon, Richard H Swartz, Dar Dowlatshahi, Michel Shamy
Stroke and Vascular Neurology, 2 October 2024
Abstract
Introduction
Obtaining informed consent for research from patients in medical emergencies remains a challenge, particularly in acute stroke care as treatment must be administered quickly and patients often arrive in the hospital in a state of incapacitation. Adaptations to standard consenting approaches-such as the use of surrogate consent or deferral of consent-have significant limitations. This feasibility study aims to test a new consenting approach in acute stroke care that we call advance consent. Advance consent has the potential to render emergency trial enrolment faster, fairer and more transparent, leading to more generalisable results.
Methods and design
We will conduct a five-part study at The Ottawa Hospital, a quaternary care stroke centre: (1) administering questionnaires in the Ottawa Hospital Stroke Prevention Clinic that will examine patients’ perspectives on research participation and advance consent; (2) inviting participants to consent in advance to any or both currently enrolling acute stroke trials; (3) tracking patient enrolment into these trials over 1 year; (4) administering a follow up questionnaire to participants at 1 year and (5) administering a questionnaire to participating hospital staff in order to interrogate their experiences with advance consent. Outcomes include but are not limited to eligibility rate, recruitment rate, withdrawal rate and the proportion of patients whose advance consent results in trial enrolment.
Conclusion
This study will test the feasibility of enrolling patients at risk of stroke into acute stroke trials using advance consent.

Comparing ChatGPT vs. Surgeon-Generated Informed Consent Documentation for Plastic Surgery Procedures

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Comparing ChatGPT vs. Surgeon-Generated Informed Consent Documentation for Plastic Surgery Procedures
Ishan Patel, Anjali Om, Daniel Cuzzone, Gabriela Garcia Nores
Aesthetic Surgery Journal, 22 October 2024
Abstract
Background
Informed consent is a crucial requirement of a patient’s surgical care but can be a burdensome task. Artificial intelligence (AI) and machine learning language models may provide an alternative approach to writing detailed, readable consent forms in an efficient manner. No studies have assessed the accuracy and completeness of AI-generated consents for aesthetic plastic surgeries.
Objectives
This study aims to compare the length, reading level, accuracy, and completeness of informed consent forms that are AI chatbot (ChatGPT-4, OpenAI, San Francisco, CA)-generated versus plastic surgeon-generated for the most commonly performed aesthetic plastic surgeries.
Methods
This study is a cross-sectional design comparing informed consent forms created by the American Association of Plastic Surgeons (ASPS) with informed consent forms generated by ChatGPT-4 for the five most commonly performed plastic surgery procedures: liposuction, breast augmentation, abdominoplasty, breast lift, and blepharoplasty.
Results
The average word count of ChatGPT forms was lower than for the ASPS generated forms (1023 vs 2901, p=0.01). Average reading level for ChatGPT forms was also lower than ASPS forms (11.2 vs 12.5, p=0.02). There was no difference between accuracy and completeness scores for general descriptions of the surgery, risks, benefits, or alternatives. The mean overall impression score for ChatGPT consents was 2.33, whereas it was 2.23 for ASPS consent forms (p=0.18).
Conclusions
Our study demonstrates that informed consent forms generated by ChatGPT were significantly shorter and more readable than ASPS forms with no significant difference in completeness and accuracy.

Automated informed consent

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Automated informed consent
Research article
Adam John Andreotta, Björn Lundgren
Big Data & Society, 18 October 2024
Open access
Abstract
Online privacy policies or terms and conditions ideally provide users with information about how their personal data are being used. The reality is that very few users read them: they are long, often hard to understand, and ubiquitous. The average internet user cannot realistically read and understand all aspects that apply to them and thus give informed consent to the companies who use their personal data. In this article, we provide a basic overview of a solution to the problem. We suggest that software could allow users to delegate the consent process and consent could thus be automated. The article investigates the practical feasibility of this idea. After suggesting that it is feasible, we develop some normative issues that we believe should be addressed before automated consent is implemented.

Editor’s Note: We are concerned that the core argument being made in this article challenges the integrity of the informed consent process. 

Informed consent in the age of smart technologies

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Informed consent in the age of smart technologies
Jaana Leikas, Arja Halkoaho, Marinka Lanne
Finnish Journal of eHealth and eWelfare, 14 October 2024
Abstract
     Technology is increasingly being brought into the home care of older people. Digitalization is seen as an enabler for efficient and resource-saving operations. In the use of technology, informed consent is considered an ethical practice and part of a responsible home care service system. The aim of this article is to describe the problem of informed consent in situations where emerging technologies, such as artificial intelligence (AI) and mass data, are used as part of welfare services and home care for older people. The article discusses principles and ways to better integrate informed consent as an ethical practice into a responsible home care service system.

A qualitative study was carried out to gather the views of experts in the field of elderly care and ethics. A content analysis of a semi-structured focus group was used to explore perceptions of the changing nature of informed consent. According to our findings, the informed consent model requires updating. The key is to embrace the idea that consent is a living process designed to respect people’s autonomous choices and protect them from risk. If the nature of the use of the data collected from individuals changes significantly in the future, the consent should also be updated to reflect this change. This aspect is important because new technologies will change the nature of the collection and use of the data. Mass data collection combines multiple databases so that the resulting data can be used even far from the original purpose or context in which it was collected. Therefore, consent should always be tailored to the context, allowing sufficient time for the person seeking and giving consent to clarify the content of the consent. This process highlights the importance of understanding the agency of the consent giver.

Using Large Language Models to Create Patient Centered Consent Forms

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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.

Multi-Center Pilot Study to Assess Provider Experience with an Artificial Intelligence Multimedia Informed Consent Platform

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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

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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.