Consent and clarification: duty and right to information in dentistry
Zilda Betânia Barbosa Medeiros de Farias, Márcia Maria Fonseca da Silveira, Richardson Silva, Rebeka Thiara Nascimento dos Santos, Ana Paula Veras Sobral
Revista Bioética, 2024
Abstract
Studies on informed patient consent in the field of dentistry are scarce and present divergences, highlighting the need to deepen knowledge about definitions, dynamics, normative acts, case law and limits of responsibility in the face of diverse factors and risks inherent to the profession. From a bibliographic review that included studies indexed in the SciELO and LILACS databases, as well as textbooks, this study aimed to define what is meant by a patient’s free and informed consent, distinguish different types and highlight the so-called “informed choice,” considering that the activity of the dental surgeon is classified as a service and is regulated by the 1988 Federal Constitution of Brazil, the Consumer Defense Code, the Civil Code and special laws. The aim is to see if it is possible to improve the process of obtaining informed consent from patients, transforming it into a process of informed choice that takes into account appropriately indicated treatments whose main purpose is health.
Obtaining Informed Consent in Veterinary Clinical Trials Mini Review
Obtaining Informed Consent in Veterinary Clinical Trials Mini Review
Carol Frederick
Frontiers in Veterinary Science, 11 June 2024
Abstract
In September 2023 the US Food and Drug Administration (FDA) released draft guidance for comment about how informed client consent for companion animal clinical trials should be obtained. This guidance has the potential to substantially change how informed consent documents are written and presented to clients in the veterinary community. It provides specifics not only about how to obtain informed consent from owners but also the timeframe within which consent should be obtained, the formatting and language in the consent forms, and details on elements that are required to be in these consent forms. These changes will involve additional efforts by investigators to ensure compliance yet might lead to increased owner compliance and higher enrollment in clinical studies with subsequent benefits for all.
Current Calls For Public Consultation
Current Calls For Public Consultation
We will selectively include calls for public consultation from multilateral agencies, governments, INGOs and other sources where there is a clear intersection with consent/assent. This might be obvious from the title of the draft guidance, regulations, etc., but more often, it will be a thematic area or topic – if properly addressed at all. If you would like to explore participation with our working group developing submissions for these calls, please contact us [david.r.curry@ge2p2global.org].
Global Consultation: First Draft Text of UNESCO Recommendation on Ethics of Neurotechnology
UNESCO – 10 June 2024, This survey remains available until 12 July 2024 (midnight Paris time)
Overview
UNESCO has embarked on a two-year process to elaborate the first global Recommendation on the ethics of neurotechnology. This Recommendation is expected to define shared values, principles, and ethical challenges as well as identify concrete policy actions to promote and strengthen an ethical development, deployment and use of neurotechnology worldwide.
The purpose of this questionnaire is to collect feedback from different actors bringing in different perspectives and points of views on the first version of a draft text of a Recommendation, elaborated by an Ad Hoc Expert Group (AHEG) during their first meeting at UNESCO HQ (Paris, 22-26 April 2024). This meeting will be followed by a second meeting (Paris, 26-30 August) to embed inputs received through a wide range of consultations, including inputs received through this online consultation.
Your participation will help enrich the first draft of the Recommendation with your views about how to harness the potential benefits of neurotechnology and mitigate the risks. The questionnaire is structured to provide you with the option to comment on the different parts of the text: definition and scope, approach, values principles and rights and policy actions.
To efficiently reply to this questionnaire, you are invited to consult the first draft of the Recommendation.]attached] For more information on UNESCO Social and Human Sciences Sector’s work on the Ethics of Neurotechnology, please visit our website.
Request for Information on Draft NIH Intramural Research Program Policy: Promoting Equity in Access Planning
Posted on May 21, 2024 Comments must be received by July 22, 2024
NIH is proposing to develop and implement a new policy within the NIH’s Intramural Research Program, the internal research arm of the agency. The policy would require organizations partnering with NIH through a patent licensing agreement that succeed in bringing certain products to market to submit a plan outlining steps they intend to take to promote patient access to any resulting drug, biologic, vaccine, or device. NIH seeks input on this draft policy and accompanying draft license agreement language that incorporates patient access in the commercialization process for NIH-owned inventions.
NIH will use the responses to this request for information to develop a final policy. Comments on the proposed policy must be submitted at: https://osp.od.nih.gov/comment-form-draft-nih-intramuralresearch-program-policy-promoting-equity-through-access-planning.
In addition, NIH will be hosting an informational webinar on the proposed policy on June 11, 2024. More information on the agenda and how to register will be provided shortly.
For additional context on the benefits of access planning, please see NIH’s 2023 Workshop on Transforming Discoveries into Products: Maximizing NIH’s Levers to Catalyze Technology Transfer. Questions may be sent to SciencePolicy@od.nih.gov.
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.
Center for Informed Consent Integrity 