Month: November 2023

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Informed Consent: A Monthly Review
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November 2023 :: Issue 59

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_November 2023 Continue reading →

Upcoming Calls For Public Consultation      

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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 This might be obvious from the title of the draft guidance, regulations, etc., but more often, it will be a thematic area or topic – if properly addressed at all.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].

 Call for input on the right to access and take part in scientific progress
Issued by Special Rapporteur in the field of cultural rights, UNHCHR
Deadline: 13 November 2023
Purpose: To inform the upcoming report of the Special Rapporteur to the Human Rights Council to be presented in March 2024
Key questions and types of input/comments sought via the questionnaire (Word):
English | Français | Español
[Excerpt]
…Participation in science

  1. How is the right of every person to participate in scientific progress and in decisions concerning its direction understood and implemented? What are the challenges? How are lack of representativeness of marginalized groups and inequalities in participation addressed?
  2. How is ‘citizen science’ (ordinary people doing science) understood in your country? Is it considered important, and what measures have been put in place to support it, particularly in terms of access to information and data, and participation in decision-making? What are the challenges? Please provide an example.
  3. To what extent are indigenous sciences and alternative sciences acknowledged, supported and included in policy decision-making? How is the conversation ensured between science and other kinds of knowledge?What are the limits to the right of every person to take part in scientific progress and in decisions concerning its direction and for which purposes? Please provide examples if any.

  

Request for Information (RFI): Inviting Comments and Suggestions on Opportunities and Challenges for the Collection, Use, and Sharing of Real-World Data (RWD) Including Electronic Health Records, for National Institutes of Health (NIH) Supported Biomedical and Behavioral Research
U.S. National Institutes of Health on 09/28/2023. 
Responses must be received by December 14, 2023
Background
   Researchers are increasingly using data collected in real-world settings to augment traditional research studies, as well as develop more effective treatments and interventions for patients. These “real-world data (RWD)”, defined by the U.S. Food and Drug Administration, are data relating to patient health status and/or the delivery of health care routinely collected from a variety of sources. Examples of RWD include data derived from electronic health records, medical claims data, data from product or disease registries, and data gathered from other sources (such as digital health technologies) that can inform on health status. While these data hold tremendous promise for biomedical and behavioral research, they can be collected from a variety of sources through multiple mechanisms, creating challenges for researchers and questions for those whose data are being shared.
   Importantly, NIH is committed to ensuring participant privacy and autonomy are protected in all NIH-supported research. As NIH establishes health-related research data platforms that include access to RWD, NIH continues to prioritize maximizing data access while upholding participant preferences regarding the collection and use of their data…
Information Requested
NIH is requesting public comment on the use of RWD for NIH-supported biomedical and behavioral research, including opportunities for leveraging the benefits of RWD and strategies for its responsible use. NIH also seeks to better understand community perspectives on the potential value and constraints—including scientific, administrative, legal, business, and bioethical—for the increased use of RWD in biomedical and behavioral research.

Spotlight Articles

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Generative AI – and LLMs [Large Language Models] which drive it – are receiving extensive (and appropriate) attention in the media, in regulatory contexts and in the academic literature. We feature here two articles which explore some of the intersections between generative AI and consent. The first, by Decker et al., explores how LLMs might be employed to potentially enhance ICF readability, improve articulation of risks, and “ease documentation burden for physicians.”  The second, by Litt et al., also explores improvements in readability through aggregating ICFs posted with oncology clinical trials registered on clinicaltrials.gov and then applying a generative AI tool generate more useful consent content. We anticipate a good deal more activity exploring how generative AI can contribute to consent content, effectiveness and integrity.

Large Language Model−Based Chatbot vs Surgeon-Generated Informed Consent Documentation for Common Procedures
Original Investigation Surgery
Hannah Decker, Karen Trang, Joel Ramirez, Alexis Colley, Logan Pierce, Melissa Coleman, Tasce Bongiovanni, Genevieve B. Melton, Elizabeth Wick
JAMA Network Open, 9 October 2023; 6(10)
Abstract
Importance
Informed consent is a critical component of patient care before invasive procedures, yet it is frequently inadequate. Electronic consent forms have the potential to facilitate patient comprehension if they provide information that is readable, accurate, and complete; it is not known if large language model (LLM)-based chatbots may improve informed consent documentation by generating accurate and complete information that is easily understood by patients.
Objective
To compare the readability, accuracy, and completeness of LLM-based chatbot- vs surgeon-generated information on the risks, benefits, and alternatives (RBAs) of common surgical procedures.
Design, Setting, and Participants
This cross-sectional study compared randomly selected surgeon-generated RBAs used in signed electronic consent forms at an academic referral center in San Francisco with LLM-based chatbot-generated (ChatGPT-3.5, OpenAI) RBAs for 6 surgical procedures (colectomy, coronary artery bypass graft, laparoscopic cholecystectomy, inguinal hernia repair, knee arthroplasty, and spinal fusion).
Main Outcomes and Measures
Readability was measured using previously validated scales (Flesh-Kincaid grade level, Gunning Fog index, the Simple Measure of Gobbledygook, and the Coleman-Liau index). Scores range from 0 to greater than 20 to indicate the years of education required to understand a text. Accuracy and completeness were assessed using a rubric developed with recommendations from LeapFrog, the Joint Commission, and the American College of Surgeons. Both composite and RBA subgroup scores were compared.
Results
The total sample consisted of 36 RBAs, with 1 RBA generated by the LLM-based chatbot and 5 RBAs generated by a surgeon for each of the 6 surgical procedures. The mean (SD) readability score for the LLM-based chatbot RBAs was 12.9 (2.0) vs 15.7 (4.0) for surgeon-generated RBAs (P = .10). The mean (SD) composite completeness and accuracy score was lower for surgeons’ RBAs at 1.6 (0.5) than for LLM-based chatbot RBAs at 2.2 (0.4) (P < .001). The LLM-based chatbot scores were higher than the surgeon-generated scores for descriptions of the benefits of surgery (2.3 [0.7] vs 1.4 [0.7]; P < .001) and alternatives to surgery (2.7 [0.5] vs 1.4 [0.7]; P < .001). There was no significant difference in chatbot vs surgeon RBA scores for risks of surgery (1.7 [0.5] vs 1.7 [0.4]; P = .38).
Conclusions and Relevance
The findings of this cross-sectional study suggest that despite not being perfect, LLM-based chatbots have the potential to enhance informed consent documentation. If an LLM were embedded in electronic health records in a manner compliant with the Health Insurance Portability and Accountability Act, it could be used to provide personalized risk information while easing documentation burden for physicians.

Improving clinical trial consent form readability through artificial intelligence
Conference Presentation – ASCO Quality Care Symposium 2023
Henry Kazunaru Litt, Emma Greenstreet Akman, Dame Idossa, Narjust Florez, Ana I. Velazquez Manana
JCO Oncology Practice – Health Care Access, Equity, and Disparities, 26 October 2023; 18(11)suppl
Abstract
Background
High literacy levels are needed to understand oncology clinical trial (CT) informed consent forms (ICF), which represents a barrier to enrollment of older adults and diverse populations. ChatGPT-4 is an artificial intelligence chatbot that responds to user prompts and can summarize large amounts of text. We tested whether ChatGPT-4 could simplify CT information from ICFs.
Methods
On May 22, 2023, we searched clinicaltrials.gov for interventional, therapeutic, NIH-funded, CTs involving adults with the 14 most prevalent cancer types. Only CTs with available study protocols that were currently recruiting, “enrolling by invitation”, and “active not recruiting” were included. Trials that were diagnostic, preventative, or supportive were excluded. Publicly available ICFs from the resulting CTs were downloaded and analyzed. Using the ChatGPT-4 plugin askyourpdf.com, we asked ChatGPT-4 to review each ICF and answer 8 questions recommended by the NCCN for patients considering a CT in a 6th grade literacy level. Our prompt included the following 8 questions: “1) What are the treatments used in the clinical trial? 2) Has the treatment been used for other types of cancer? 3) What are the risks and benefits of this treatment? 4) What side effects should I expect and how will they be managed? 5) How long will I be in the clinical trial? 6) Will I be able to get other treatment if this doesn’t work? 7) How will you know if the treatment is working? 8) Will the clinical trial cost me anything?” Reading level (readability) was assessed for both the ICFs and ChatGPT-4’s question responses using the validated Flesch-Kincaid (FK), Gunning Fog (GF), and SMOG indices using the online Readable App. Data was summarized with descriptive statistics and t-test was used to compare text reading levels between ICFs and ChatGPT-4’s answers.
Results
Our search yielded 83 therapeutic oncology CTs, of which 70 had publicly available ICFs. ChatGPT-4 successfully analyzed 66 of the 70 ICFs (94.3%). The mean text reading levels of its answers were 6.2 (95% CI: 5.9-6.5), 8.6 (95% CI: 8.2-8.9), and 9.2 (95% CI: 8.9-9.4) based on FK, GF, and SMOG indices, respectively. Of 70 ICFs, 54 (77.1%) contained text that could be evaluated for readability analysis and were included in the analysis. The mean text reading levels was 7.9 (95% CI: 7.7-8.1), 9.3 (95% CI: 9.1-9.6), and 10.5 (95% CI: 10.2-10.8) based on FK, GF, and SMOG indices, respectively. ChatGPT-4’s text responses had a significantly lower reading level compared to ICFs text for all three readability indices (FK: p<0.01, GF: p=0.02, SMOG: p<0.01).
Conclusions
ChatGPT-4 presented key information from oncology CT ICFs at a 6th to 9th grade reading level, which was significantly lower than the original ICFs. While further studies are needed to assess ChatGPT-4’s accuracy, this study shows its potential as tool for improving patients’ understanding of oncology CTs.

uConsent: Addressing the gap in measuring understanding of informed consent in clinical research

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uConsent: Addressing the gap in measuring understanding of informed consent in clinical research
Richard F. Ittenbach, J. William Gaynor, Jenny M. Dorich, Nancy B. Burnham, Guixia Huang, Madisen T. Harvey, Jeremy J. Corsmo
Clinical and Translational Science, 12 October 2023
Abstract
The purpose of this study was to establish the technical merit, feasibility, and generalizability of a new measure of understanding of informed consent for use with clinical research participants. A total of 109 teens/young adults at a large, pediatric medical center completed the consenting process of a hypothetical biobanking study. Data were analyzed using a combination of classical and modern theory analytic methods to produce a final set of 19 items referred to as the uConsent scale. A requirement of the scale was that each item mapped directly onto one or more of the Basic Elements of Informed Consent from the 2018 Final Rule. Descriptive statistics were computed for each item as well as the scale as a whole. Partial credit (Rasch) logistic modeling was then used to generate difficulty/endorsability estimates for each item. The final, 19- item uConsent scale was derived using inferential methods to yield a set of items that ranged across difficulty levels (−3.02 to 3.10 logits) with a range of point- measure correlations (0.12 to 0.50), within- range item-  and model- fit statistics, varying item types mapped to both Bloom’s Taxonomy of Learning and required regulatory components of the 2018 Final Rule. Median coverage rate for the uConsent scale was 95% for the 25 randomly selected studies from ClinicalTrials.gov. The uConsent scale may be used as an effective measure of informed consent when measuring and documenting participant understanding in clinical research studies today.

Risk to Research Non-Participants: Ethical Dimensions of Protecting Bystanders in Xenotransplantation Clinical Trials

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Risk to Research Non-Participants: Ethical Dimensions of Protecting Bystanders in Xenotransplantation Clinical Trials
Conference Presentation – IPITA-IXA-CTRMA 2023 Joint Congress Abstracts
Daniel Hurst, Luz Padilla, Daniel Rodger, Tamar Schiff, David KC Cooper
Transplantation, October 2023
Abstract
Introduction
Ethical issues regarding clinical xenotransplantation have been described for decades with most of the issues centering on animal welfare, the risks posed to the recipient, and the potential public health risks. Much less attention has been given to thinking through ethical issues for those who may care for xenograft recipients (e.g., caregivers, family members), especially when the recipient returns home. These caregivers or bystanders, due to their close interaction with the xenotransplantation recipient, face potential exposure to a xenozoonotic disease, with implications regarding informed consent for that risk, and whether or not such bystanders should be regularly monitored for infection, as is proposed for recipients.
Methods
This presentation raises concerns for the risks to bystanders in xenotransplantation which we believe have not been adequately addressed in the literature to date. We will propose several options for how bystanders should be informed of, and consented for, the risks of close contact with a xenotransplant recipient. The benefits and pitfalls of each potential option are explored.
Results
We conclude that only the xenograft recipient needs to provide their informed consent to the xenotransplantation and agree to lifelong (or long-term) monitoring. As no legal enforcement mechanism currently exists for requiring recipients to be monitored without evidence of infectious disease, such monitoring could only be strongly encouraged and agreed to at the point of xenotransplantation, but not required. In addition, we argue that the xenograft recipient, prior to xenotransplantation, should provide a list of members of the same household/close contacts for record keeping and future possible contact tracing. We propose at a minimum that all members listed should be provided with an information sheet or assent form that contains the basic elements of the informed consent form but does not require a signature or other declaration of agreement. This approach seeks to balance ethical concerns, namely the potential risks posed to bystanders and how strong a duty this creates to protect them and support their right to choose how or if they contiue to interact with the potential xenograft recipient, with the recipient’s reasonable right to patient privacy.
Conclusion
This presentation discusses a significant concern related to xenotransplantation, made increasingly pressing by the possibility of forthcoming clinical trials. By the end of the presentation, the audience will better understand the bystander risk, differing modes of mitigating that risk, and why it is important to foster dialogue and develop policy on this issue.

Encouraging greater empowerment for adolescents in consent procedures in social science research and policy projects

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Encouraging greater empowerment for adolescents in consent procedures in social science research and policy projects
Oddrun Samdal, Isabelle Budin-Ljøsne, Ellen Haug, Trond Helland, Lina Kjostarova‐Unkovska, Claire Bouillon, Christian Bröer, Maria Corell, Alina Cosma, Dorothy Currie, Charli Eriksson, Rosemarie Felder‐Puig, Tania Gaspar, Curt Hagquist, Janetta Harbron, Atle Jaastad, Colette Norena Kelly, Cécile Knai, Dorota Kleszczewska, Bjarte Birkeland Kysnes, Nanna Lien, Aleksandra Luszczynska, Gerben Moerman, Concepción Moreno-Maldonado, Saoirse NicGabhainn, Iveta Pudule, Jelena Gudelj Rakic, Ana Rito, Alfred Mestad Rønnestad, Madeleine Ulstein, Harry Rutter, Knut-Inge Klepp
Obesity Reviews, September 2023
Open Access
Abstract
The United Nations Convention on the Rights of the Child emphasizes the importance of allowing children and adolescents to influence decisions that are important to them following their age and maturity. This paper explores the principles, practices, and implications around using parental versus child/adolescent consent when participating in social science research and policy development. Experiences from two studies are presented: The Confronting Obesity: Co‐creating policy with youth (CO‐CREATE) and the Health Behaviour in School‐aged Children (HBSC) study, a World Health Organization (WHO) Collaborative Cross‐National study. Although parental consent may be an important gatekeeper for protecting children and adolescents from potentially harmful research participation, it may also be considered an obstacle to the empowerment of children and adolescents in case they want to share their views and experiences directly. This paper argues that evaluation of possible harm should be left to ethics committees and that, if no harm related to the research participation processes is identified and the project has a clear perspective on collaborating with the target group, adolescents from the age of 12 years should be granted the legal capacity to give consent to participate in the research project. Collaboration with adolescents in the development of the research project is encouraged.

‘It’s a nightmare’: informed consent in paediatric genome-wide sequencing. A qualitative expert interview study from Germany and Switzerland

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‘It’s a nightmare’: informed consent in paediatric genome-wide sequencing. A qualitative expert interview study from Germany and Switzerland
Johanna Eichinger, Bettina Zimmermann, Bernice Elger, Stuart McLennan, Isabel Filges, Insa Koné
European Journal of Human Genetics, 29 September 2023
Open Access
Abstract
The use of genome-wide sequencing (GWS) in paediatrics has added complexity to informed consent (IC) and pretest counselling because of the vast number and interpretation of potential findings, and their implications. However, empirical data from continental Europe on these issues remains limited. This study therefore aimed to explore the experiences and views of medical geneticists working with children in Germany and Switzerland regarding the challenges of obtaining valid IC in paediatric GWS. Qualitative interviews with 20 medical geneticists were analysed employing reflexive thematic analysis. In the interviews, many medical geneticists questioned the validity of parents’ IC due to the enormous amount of relevant information given and the variety and complexity of the possible test outcomes. Key barriers identified included familial implications, administrative challenges and struggles with non-directiveness. Medical geneticists’ suggestions for improvement included increasing the number of genetics professionals and better information material, which is crucial as GWS becomes a diagnostic standard in the early care pathways of children. An adjustment of aspirations from still existing ideal of traditional fully IC to appropriate IC seems to be needed. Such a more realistic and ethically sound adaptation of the requirements for IC can lead to better ‘informedness’ and improve the validity of the consent. This might also help reduce the moral distress for the medical geneticists involved.

The Social Contract for Health and Wellness Data Sharing Needs a Trusted Standardized Consent

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The Social Contract for Health and Wellness Data Sharing Needs a Trusted Standardized Consent
Brief Report
Stefanie Brückner, Toralf Kirsten, Peter Schwarz, Fabienne Cotte, Michael Tsesis, Stephen Gilbert
Mayo Clinic Proceedings: Digital Health, December 2023; 1(4) pp 527-533
Open Access
Abstract
The rise of health and wellness applications has led to a new category of citizen-generated health data, which are collected through sensors and user inputs. As more parameters are measured over longer time periods, these data will gradually become more important for disease prediction, care, and research than classical clinic-generated health data. Policymakers now recognize the potential of both data types in initiatives such as the European Health Data Space, which aims to enable data sharing for patient care and research at scale. Although it could be argued that clinic-generated data come from public-funded health systems and should therefore be sharable, after depersonalization, for public service, this argument extends poorly to data from wearables and applications. We propose a new approach for standardized health consent, both broad and dynamic, to overcome consent fatigue and engage citizens in data sharing.

Specific measures for data-intensive health research without consent: a systematic review of soft law instruments and academic literature

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Specific measures for data-intensive health research without consent: a systematic review of soft law instruments and academic literature
Review Article
Julie-Anne R. Smit, Menno Mostert, Rieke van der Graaf, Diederick E. Grobbee, Johannes J. M. van Delden
European Journal of Human Genetics, 17 October 2023
Open Access
Abstract
It is a common misunderstanding of current European data protection law that when consent is not being used as lawful basis, the processing of personal data is prohibited. Article 9(2)(j) of the European General Data Protection Regulation (GDPR) permits Member States to establish a legal basis in national law that allows for the processing of personal data for scientific research purposes without consent. However, the European legislator has formulated this “research exemption” as an opening clause, rendering the GDPR not specific as to what measures exactly are required to comply with the research exemption. This may have significant implications for both the protection of personal data and the advancement of data-intensive health research. We performed a systematic review of relevant soft law instruments and academic literature to identify what measures are mentioned in those documents. Our analysis resulted in the identification of four overarching themes of suggested measures: organizational measures; technical measures; oversight and review mechanisms; and public engagement and participation. Some of the suggested measures do not substantially contribute to the clarification of the GDPR’s “suitable and specific measures” requirement because they remain vague or broad in nature and encompass all types of data processing. However, the themes oversight and review mechanisms and public engagement and participation provide valuable insights which can be put to practice. Nevertheless, further clarification of the measures and safeguards that should be installed when invoking the research exemption remains necessary.

Toward Consent in Molecular HIV Surveillance? Perspectives of Critical Stakeholders

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Toward Consent in Molecular HIV Surveillance? Perspectives of Critical Stakeholders
Research Article
Stephen Molldrem, Anthony K J Smith, Vishnu Subrahmanyam
AJOB Empirical Bioethics, 28 September 2023
Abstract
Background
The emergence of molecular HIV surveillance (MHS) and cluster detection and response (CDR) programs as key features of the United States (US) HIV strategy since 2018 has caused major controversies. HIV surveillance programs that re-use individuals’ routinely collected clinical HIV data do not require consent on the basis that the public benefit of these programs outweighs individuals’ rights to opt out. However, criticisms of MHS/CDR have questioned whether expanded uses of HIV genetic sequence data for prevention reach beyond traditional public health ethics frameworks. This study aimed to explore views on consent within MHS/CDR among critical stakeholders.
Methods
In 2021 we interviewed 26 US HIV stakeholders who identified as being critical or concerned about the rollout of MHS/CDR. Stakeholders included participants belonging to networks of people living with HIV, other advocates, academics, and public health professionals. This analysis focused on identifying the range of positions among critical and concerned stakeholders on consent affordances, opt-outs, how to best inform people living with HIV about how data about them are used in public health programs, and related ethical issues.
Results
Participants were broadly supportive of introducing some forms of consent into MHS/CDR. However, they differed on the specifics of implementing consent. While some participants did not support introducing consent affordances, all supported the idea that people living with HIV should be informed about how HIV surveillance and prevention is conducted and how individuals’ data are used.
Conclusions
MHS/CDR has caused sustained controversy. Among critical stakeholders, consent is generally desirable but contested, although the right for people living with HIV to be informed was centrally supported. In an era of big data-driven public health interventions and routine uses of HIV genetic sequence data in surveillance and prevention, CDC and other agencies should revisit public health ethics frameworks and consider the possibility of consent processes.