Informed Consent: A Monthly Review
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June 2024 :: Issue 66

This digest aggregates and distills key content addressing informed consent from a broad spectrum of peer-reviewed journals and grey literature, and from various practice domains and organization types including international agencies, INGOs, governments, academic and research institutions, consortiums and collaborations, foundations, and commercial organizations. 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_June 2024 

Spotlight Section

This month we would like to spotlight two articles focused on the applications of artificial intelligence technologies in healthcare. In an article in Machine Learning and Knowledge Extraction – Evaluation of AI ChatBots for the Creation of Patient-Informed Consent Sheets – Raimann et al. assessed the ability of large language models (LLMs) to generate information sheets for six basic anesthesiologic procedures.The authors found that that the three LLMs tested fulfilled less than 50% of the predetermined requirements for a satisfactory and compliant information sheet. They also found that the descriptions of key elements such as risks and documentation regarding consultation varied. The authors assess that LLMs have “clear limitations” in generating patient information sheets.

Park addresses the patient perspective on AI use in healthcare provision in the Digital Health article – Patient perspectives on informed consent for medical AI: A web-based experiment. Through this work Park adds a new voice to the debate about whether, when using LLMs as a decision aid, healthcare providers ought to disclose this to the patients. It was found that patients trust second opinions from other physicians more than an AI diagnosis, but as the risk level increased for procedures, as did the importance of AI generated information. This study found the disclosure of AI use in diagnosis to be necessary from a patient perspective.

The Center for Informed Consent Integrity is exploring use of ChatGPT 4.0 to analyze the informed consent landscape, specifically how the 60+ editions of this digest might function as a specific content base for inquiry. We have encountered some limitations given our purpose, albeit different than those found by the authors below. We will continue to explore generative AI to strengthen our work and keep our readers updated.

Evaluation of AI ChatBots for the Creation of Patient-Informed Consent Sheets
Florian Jürgen Raimann, Vanessa Neef, Marie Charlotte Hennighausen, Kai Zacharowski, Armin Niklas Flinspach
Machine Learning and Knowledge Extraction, 24 May 2024
Abstract
Introduction
Large language models (LLMs), such as ChatGPT, are a topic of major public interest, and their potential benefits and threats are a subject of discussion. The potential contribution of these models to health care is widely discussed. However, few studies to date have examined LLMs. For example, the potential use of LLMs in (individualized) informed consent remains unclear.
Methods
We analyzed the performance of the LLMs ChatGPT 3.5, ChatGPT 4.0, and Gemini with regard to their ability to create an information sheet for six basic anesthesiologic procedures in response to corresponding questions. We performed multiple attempts to create forms for anesthesia and analyzed the results checklists based on existing standard sheets.
Results
None of the LLMs tested were able to create a legally compliant information sheet for any basic anesthesiologic procedure. Overall, fewer than one-third of the risks, procedural descriptions, and preparations listed were covered by the LLMs.
Conclusions
There are clear limitations of current LLMs in terms of practical application. Advantages in the generation of patient-adapted risk stratification within individual informed consent forms are not available at the moment, although the potential for further development is difficult to predict. 

Patient perspectives on informed consent for medical AI: A web-based experiment
Hai Jin Park
Digital Health, 30 April 2024
Abstract
Objective
Despite the increasing use of AI applications as a clinical decision support tool in healthcare, patients are often unaware of their use in the physician’s decision-making process. This study aims to determine whether doctors should disclose the use of AI tools in diagnosis and what kind of information should be provided.
Methods
A survey experiment with 1000 respondents in South Korea was conducted to estimate the patients’ perceived importance of information regarding the use of an AI tool in diagnosis in deciding whether to receive the treatment.
Results
The study found that the use of an AI tool increases the perceived importance of information related to its use, compared with when a physician consults with a human radiologist. Information regarding the AI tool when AI is used was perceived by participants either as more important than or similar to the regularly disclosed information regarding short-term effects when AI is not used. Further analysis revealed that gender, age, and income have a statistically significant effect on the perceived importance of every piece of AI information.
Conclusions
This study supports the disclosure of AI use in diagnosis during the informed consent process. However, the disclosure should be tailored to the individual patient’s needs, as patient preferences for information regarding AI use vary across gender, age and income levels. It is recommended that ethical guidelines be developed for informed consent when using AI in diagnoses that go beyond mere legal requirements.

 

The Ethics of Decentralized Clinical Trials and Informed Consent: Taking Technologies’ Soft Impacts into Account

The Ethics of Decentralized Clinical Trials and Informed Consent: Taking Technologies’ Soft Impacts into Account
Original Article
Tessa I. van Rijssel, Ghislaine J. M. W. van Thiel, Johannes J. M. van Delden
Health Care Analysis, 19 May 2024
Open Access
Abstract
Decentralized clinical trials (DCTs) have the potential to advance the conduct of clinical trials, but raise several ethical issues, including obtaining valid informed consent. The debate on the ethical issues resulting from digitalization is predominantly focused on direct risks relating to, for example, data protection, safety, and data quality. We submit however, that a broader view on ethical aspects of DCTs is needed to touch upon the new challenges that come with the DCT practice. Digitalization has impacts that go beyond its direct purposes, by shaping behaviors, experiences, social relations, and values. We examine four elements of the informed consent procedure that are affected by DCTs, while taking these soft impacts of technologies into account: (i) informing participants and testing understanding, (ii) freedoms in relation to responsibilities and burdens, (iii) trust in participant-researcher relations, and (iv) impacts on the concept of privacy. Our analysis reveals that a broad view is key for optimal conduct of DCTs. In addition, it provides insight into the ethical impacts of DCTs on informed consent. Technologies such as DCTs potentially have profound impacts which are not immediately addressed by the existing regulatory frameworks, but nonetheless important to recognize. These findings can guide future practices of DCTs to foster the important values of clinical research in this novel approach for conducting clinical trials.

When describing harms and benefits to potential trial participants, participant information leaflets are inadequate

When describing harms and benefits to potential trial participants, participant information leaflets are inadequate
Research
Laura Cuddihy, Jeremy Howick, Ellen Murphy, Frances Shiely
Trials, 1 May 2024
Open Access
Abstract
Background
Providing informed consent for trials requires providing trial participants with comprehensive information about the trial, including information about potential risks and benefits. It is required by the ethical principle of respecting patient autonomy. Our study examines the variation in the way information about potential trial benefits and harms is shared in participant information leaflets (PILs).
Methods
A total of 214 PILs and informed consent forms from clinical trials units (CTUs) and Clinical Research Facilities (CRFs) in Ireland and the UK were assessed by two authors independently, to check the extent to which they adhered to seven recently developed principles. Discrepancies were resolved by a third.
Results
Usage of the seven principles varied widely between PILs regardless of the intended recipient or trial type. None of the PILs used more than four principles, and some (4%) used none. Twenty-seven per cent of PILs presented information about all known potential harms, whereas 45% presented information on all known potential benefits. Some PILs did not provide any potential harms or potential benefits (8%). There was variation in the information contained in adult and children PILs and across disease areas.
Conclusion
Significant variation exists in how potential trial benefits and harms are described to potential trial participants in PILs in our sample. Usage of the seven principles of good practice will promote consistency, ensure informed ethical decision-making and invoke trust and transparency. In the long term, a standardised PIL template is needed.

Editor’s note: The seven principles as described in the abstract appear in Table 2 in the paper.

What Is “Key Information”? Consideration of the Reasons People Do or Do Not Take Part in Research

What Is “Key Information”? Consideration of the Reasons People Do or Do Not Take Part in Research
Article
Kara Berwanger, Jon F. Merz
Ethics & Human Research, 17 April 2024
Abstract
We performed a qualitative review of 50 consent forms posted on Clinicaltrials.gov, examining the content of key information sections. We found that key information disclosures are typically focused on procedures, risks, potential benefits, and alternatives. Drawing upon reviews of the large literature examining the reasons people do or do not take part in research, we propose that these disclosures should be based more directly on what we know to be the real reasons why people choose to take part or refuse participation. We propose key information language for consideration by researchers and institutional review boards.

Translating “medicalese”: The case of informed consent forms

Translating “medicalese”: The case of informed consent forms
Raluca Chereji
Medical Writing, March 2024; 33(1) pp 44–47
Abstract
Informed consent forms (ICFs) are documents used in clinical research to inform prospective participants about – and obtain their consent for – partaking in a clinical trial. Evidence suggests that ICFs may not be fit for purpose because their linguistic and textual features exceed the comprehensibility needs of their non-expert target audience. These issues also impact medical translators who translate ICFs for prospective participants of international trials. This article discusses some of the main challenges of translating ICFs, such as specialised terminology and jargon, lexico-syntactic complexity, and text length, and argues for increased training and collaboration to mitigate these difficulties in medical translation.

Who to engage in HIV vaccine trial benefit-sharing negotiations? An empirical proposition of a framework

Who to engage in HIV vaccine trial benefit-sharing negotiations? An empirical proposition of a framework
Research
Godwin Pancras, Mangi Ezekiel, Erasto Mbugi, Jon F. Merz
BMC Medical Ethics, 14 May 2024
Open access
Abstract
Background
A morally sound framework for benefit-sharing is crucial to minimize research exploitation for research conducted in developing countries. However, in practice, it remains uncertain which stakeholders should be involved in the decision-making process regarding benefit-sharing and what the implications might be. Therefore the study aimed to empirically propose a framework for benefit-sharing negotiations in research by taking HIV vaccine trials as a case.
Methods
The study was conducted in Tanzania using a case study design and qualitative approaches. Data were collected using in-depth interviews (IDI) and focus group discussions (FGD). A total of 37 study participants were selected purposively comprising institutional review board (IRB) members, researchers, community advisory board (CAB) members, a policymaker, and HIV/AIDS advocates. Deductive and inductive thematic analysis approaches were deployed to analyze collected data with the aid of MAXQDA version 20.4.0 software.
Results
The findings indicate a triangular relationship between the research community, researched community and intermediaries. However, the relationship ought to take into consideration the timing of negotiations, the level of understanding between parties and the phase of the clinical trial. The proposed framework operationalize partnership interactions in community-based participatory research.
Conclusion
In the context of this study, the suggested framework incorporates the research community, the community being researched, and intermediary parties. The framework would guarantee well-informed and inclusive decision-making regarding benefit-sharing in HIV vaccine trials and other health-related research conducted in resource-limited settings.

Upholding Informed Consent: Experiences of Note –Taking without Audio Recording of in-Depth Individual Interviews in a Qualitative Study on the Implementation of the Pregnancy ReEntry Policy in Zambia

Upholding Informed Consent: Experiences of Note –Taking without Audio Recording of in-Depth Individual Interviews in a Qualitative Study on the Implementation of the Pregnancy ReEntry Policy in Zambia
Namakau Kakanda-Sinkala
International Journal Of Multidisciplinary Research And Analysis, 5 May 2024
Abstract
The context of the research study needs to determine the data recording method to be used in order to ensure that no harm is done to the participants. In-depth individual Interviews (IDIs) is one of the main data collecting strategy used in qualitative research on sensitive topics such as teenage pregnancy. Audio recording in capturing data during IDIs is a common practice. However, audio recording of IDIs should be done in the context of informed consent. The objective of this paper is to elaborate on how note-taking was used to capture data within the context of informed consent. The research design was multiplecohort Case studies involving Chongwe district plus national stakeholders of the Pregnancy Re-entry policy in Zambia. Semistructured interviews were conducted with hundred (100) participants from different cohorts of stakeholders using note-taking to capture the data. Ninety percent (90%) of the interviews involved physical note-taking with 10 % being electronic notes. The results are that note-taking increased the interview time but it afforded the interviewer the opportunity to probe further as the data was being collected. The major disadvantage with note –taking is that it reduces the pace of data collection as time has to be dedicated to consolidating the notes and memory recall of information shared. The conclusion drawn is that upholding informed consent in research is key, therefore the capturing of data during IDIs should be guided by what best upholds the rights of the participants. Therefore, note-taking offers an alternative to audio recording.

The participant’s voice: crowdsourced and undergraduate participants’ views toward ethics consent guidelines

The participant’s voice: crowdsourced and undergraduate participants’ views toward ethics consent guidelines
Research Article
Nadine S. J. Stirling, Melanie K. T. Takarangi
Ethics & Behavior, 28 April 2024
Abstract
The informed consent process presents challenges for psychological trauma research (e.g. Institutional Review Board [IRB] apprehension). While previous research documents researcher and IRB-member perspectives on these challenges, participant views remain absent. Thus, using a mixed-methods approach, we investigated participant views on consent guidelines in two convenience samples: crowdsourced (N = 268) and undergraduate (N = 265) participants. We also examined whether trauma-exposure influenced participant views. Overall, participants were satisfied with current guidelines, providing minor feedback and ethical reminders for researchers. Moreover, participant views for consent were similar irrespective of trauma-exposure. Our study has implications for IRBs and psychological researchers.

Comparing Attitudes Toward Different Consent Mediums: Semistructured Qualitative Study

Comparing Attitudes Toward Different Consent Mediums: Semistructured Qualitative Study
Xengie Doan, Arianna Rossi, Marietjie Botes,  Annika Selzer
JMIR Human Factors, 30 April 2024
Abstract
Background
As consent for data sharing evolves with the digital age, plain-text consent is not the only format in which information can be presented. However, designing a good consent form is highly challenging. The addition of graphics, video, and other mediums to use can vary widely in effectiveness; and improper use can be detrimental to users.
Objective
This study aims to explore the expectations and experiences of adults toward consent given in infographic, video, text, newsletter, and comic forms in a health data sharing scenario to better understand the appropriateness of different mediums and identify elements of each medium that most affect engagement with the content.
Methods
We designed mock consent forms in infographic, video, text, newsletter, and comic versions. Semistructured interviews were conducted with adults who were interviewed about their expectations for consent and were then shown each consent medium and asked about engaging elements across mediums, preferences for consent mediums, and the value of document quality criteria. We transcribed and qualitatively co-coded to identify themes and perform analyses.
Results
We interviewed 24 users and identified different thematic archetypes based on participant goals, such as the Trust Seeker, who considered their own understanding and trust in organizations when making decisions. The infographic was ranked first for enhancing understanding, prioritizing information, and maintaining the proper audience fit for serious consent in health data sharing scenarios. In addition, specific elements such as structure, step-by-step organization, and readability were preferred engaging elements.
Conclusions
We identified archetypes to better understand user needs and elements that can be targeted to enhance user engagement with consent forms; this can help inform the design of more effective consent in the future. Overall, preferences for mediums are highly contextual, and more research should be done.