Month: January 2025

Strengthening Informed Consent for Federal Research through Person-Centered Development and Administration

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Strengthening Informed Consent for Federal Research through Person-Centered Development and Administration
Research Report
Lauren Farrell, Mikaela Tajo, Elsa Falkenburger, Soumita Bose
Urban Institute, 26 December 2024
Summary
    In September 2021, the Office of Planning, Research, and Evaluation (OPRE) within the Administration for Children and Families (ACF) contracted with the Urban Institute to conduct the Advancing Contextual Analysis and Methods of Participant Engagement (CAMPE) project. The goal of the CAMPE project was to aid OPRE in better understanding, incorporating, and advancing equitable research practices in OPRE projects. To achieve this goal, the project was designed to support OPRE’s efforts to develop tools and guidance for applying an equity lens to research and evaluation projects in the federal context. A core focus of the project was on ways to better engage people who have lived experience with ACF programs as collaborators and partners in research and evaluation.

One key aspect of this work included developing and engaging a community advisory board (CAB) of individuals who have lived experience with ACF programs (Temporary Assistance for Needy Families, the Child Care and Development Fund, refugee resettlement, child welfare and foster care, and others) to get feedback and input on several OPRE documents and materials related to research processes. Urban recruited, onboarded, trained, and supported a 13-member CAB to review and comment on these materials. The CAMPE CAB reviewed multiple documents and processes within OPRE to advance the aim of more equitable research practices in OPRE projects. One OPRE process that the CAB reviewed was for informed consent.

The CAMPE CAB reviewed a sample OPRE study informed consent form, which includes the steps researchers take and the language they use to inform people of their rights, risks, and benefits when choosing whether to participate in a research study. This report contains the CAB’s recommendations on developing and implementing person-centered informed consent processes. A person-centered approach reflects an understanding of the perspective, position, and experience of the intended participant.

Women’s Experience of the Consent Process to Planned Caesarean Section and Its Surgical Risk: A Qualitative Study

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Women’s Experience of the Consent Process to Planned Caesarean Section and Its Surgical Risk: A Qualitative Study
Research Article
Malathy Nithiyananthan, Jacqueline Nicholls, Melissa Whitten, Katherine Maslowski, Anne Lanceley
British Journal of Obstetrics & Gynaecology, 25 December 2024
Open Access
Abstract
Objective
To explore how women appreciated the risks discussed within the consent process for planned caesarean section (CS).
Design
Exploratory qualitative interview study.
Setting
NHS Teaching Hospital in Central London.
Population
Women over the age of 18, English speaking, scheduled for a planned CS.
Methods
Semi-structured interviews were conducted before and after a woman’s CS. Eighteen women were recruited and interviewed prior to undergoing CS and 12 of these were interviewed following CS. Interviews were audio-recorded, transcribed and thematically analysed.
Main Outcome Measures
Themes generated from analysis of interviews exploring the experiences of women consenting to CS and specifically their awareness of postpartum haemorrhage (PPH), hysterectomy, organ damage and risk of placental abnormalities in future pregnancies.
Results
Two broad themes and four subthemes were identified (1) Untimely provision of risk information: (a) superficial risk discussions during the antenatal period and full risk disclosure on the day of surgery and (b) incompleteness absent or sparse risk disclosure prior to making the decision to undergo the CS, where women were unaware of specific risks and (2) Emotional overload: (a) fear of risks and (b) fear that a CS will be denied to them—women’s cognitive response and notably their emotional response to their situation limited their understanding of risks disclosed.
Conclusion
The consent process for planned CS was found to lack appropriate and full risk disclosure. Risk disclosure was ill-timed or deficient in facilitating women’s understanding of risks reflecting a consent process which does not meet legal and professional standards of informed consent.

ChatGPT in Dental Education: Enhancing Student Proficiency in Informed Consent

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ChatGPT in Dental Education: Enhancing Student Proficiency in Informed Consent
Short Communication
Les Kalman, Arman Danesh
Medical Science Educator, 22 January 2025
Abstract
There is a scarcity of research regarding how ChatGPT can be integrated in dental curricula to develop the understanding of students regarding informed consent. Our study implemented an educational exercise where D3 dental students compared ChatGPT-generated consent forms with professionally validated consent forms, qualitatively assessing the educational value that the chatbot provides in this setting. The findings of the present study encourage dental educators to acknowledge the importance of supervised learning in helping the next generations of dentists prepare for the safe use of AI technologies, such as ChatGPT, in their future practice.

Use of ChatGPT to Generate Informed Consent for Surgery in Urogynecology

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Use of ChatGPT to Generate Informed Consent for Surgery in Urogynecology
Emily S. Johnson, Eva K. Welch, Jacqueline Kikuchi, Heather Barbier, Christine M. Vaccaro, Felicia Balzano, Katherine L. Dengler
Urogynecology, 17 January 2025
Abstract
Importance
Use of the publicly available Large Language Model, Chat Generative Pre-trained Transformer (ChatGPT 3.5; OpenAI, 2022), is growing in health care despite varying accuracies.
Objective
The aim of this study was to assess the accuracy and readability of ChatGPT’s responses to questions encompassing surgical informed consent in urogynecology.
Study Design
Five fellowship-trained urogynecology attending physicians and 1 reconstructive female urologist evaluated ChatGPT’s responses to questions about 4 surgical procedures: (1) retropubic midurethral sling, (2) total vaginal hysterectomy, (3) uterosacral ligament suspension, and (4) sacrocolpopexy. Questions involved procedure descriptions, risks/benefits/alternatives, and additional resources. Responses were rated using the DISCERN tool, a 4-point accuracy scale, and the Flesch-Kinkaid Grade Level score.
Results
The median DISCERN tool overall rating was 3 (interquartile range [IQR], 3–4), indicating a moderate rating (“potentially important but not serious shortcomings”). Retropubic midurethral sling received the highest overall score (median, 4; IQR, 3–4), and uterosacral ligament suspension received the lowest (median, 3; IQR, 3–3). Using the 4-point accuracy scale, 44.0% of responses received a score of 4 (“correct and adequate”), 22.6% received a score of 3 (“correct but insufficient”), 29.8% received a score of 2 (“accurate and misleading information together”), and 3.6% received a score of 1 (“wrong or irrelevant answer”). ChatGPT performance was poor for discussion of benefits and alternatives for all surgical procedures, with some responses being inaccurate. The mean Flesch-Kinkaid Grade Level score for all responses was 17.5 (SD, 2.1), corresponding to a postgraduate reading level.
Conclusions
Overall, ChatGPT generated accurate responses to questions about surgical informed consent. However, it produced clearly false portions of responses, highlighting the need for a careful review of responses by qualified health care professionals.

The ethical implications of using children’s photographs in artificial intelligence: challenges and recommendations

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The ethical implications of using children’s photographs in artificial intelligence: challenges and recommendations
Original Research
Wael Badawy
AI and Ethics, 15 January 2025
Abstract
The rapid advancement of artificial intelligence (AI) technologies has brought to the forefront the ethical implications of using children’s photographs within these systems. This paper aims to explore the multifaceted ethical considerations surrounding the utilization of children’s images in AI, highlighting the need for a delicate balance between technological progress and the protection of children’s rights. We examine the challenges of obtaining informed consent, the risks associated with data security and misuse, the potential for bias and discrimination, and the psychological impacts on children whose images are used in AI applications. Through a critical analysis of existing legal frameworks and ethical guidelines, this study identifies gaps in the protection of children’s digital identities and proposes a set of ethical recommendations and best practices for the responsible use of children’s photographs in AI. By advocating for enhanced safeguards, transparency, and accountability, this paper contributes to the ongoing dialogue on ethical AI practices, underscoring the importance of prioritizing children’s privacy and well-being in the digital age.

Informed Consent in Educational AI Research Needs to Be Transparent, Flexible, and Dynamic

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Informed Consent in Educational AI Research Needs to Be Transparent, Flexible, and Dynamic
Commentary
Alexander Skulmowski
Mind, Brain, and Education, 5 January 2025
Open Access
Abstract
Generative artificial intelligence (AI) has become a major research trend in the fields of education and psychology. However, several risks posed by this technology concerning the cognitive and socio-emotional development of children and adolescents have been identified. While it would be highly useful to have a clear understanding of these potential negative effects, empirical results cannot be obtained without putting the participants of these studies in a situation that potentially endangers their development. Research fields such as the biomedical sciences utilize several measures to minimize risks, such as dose escalation and stopping rules. In addition, dynamic and flexible forms of informed consent could be adopted by our field to maximize transparency. By including methodological advancements and ethical developments in the psychological and educational research process, risks could be averted, and the ethical soundness of AI research involving children and adolescents could be maintained.

Developing Project-Specific Consent Documents: A Registered Report for a Multistep Approach Using LLMs

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Developing Project-Specific Consent Documents: A Registered Report for a Multistep Approach Using LLMs
Filipa Lopes, Carolina Trindade, Tânia Carvalho, Maria Strecht Almeida, Ana Sofia Carvalho
Drug Repurposing, 18 December 2024
Abstract
Within the scope of clinical trials, developing participant information sheets and informed consent forms is a complex task that demands clarity, precision, and compliance with regulatory standards. Developing these documents is crucial for ensuring that participants are fully informed about the research in which they are involved. However, the process is often time-consuming and resource-intensive. In this context, we present the development of a methodology enabling the use of Large Language Models to assist in the creation of information sheets and informed consent forms for clinical trials according to a predesigned template. This research is being conducted within the framework of the project REPO4EU (Precision drug REPurpOsing For EUrope and the world).

Enhancing patient engagement: the influence of an in-consult patient decision aid on shared decision-making for lung tumour radiation – protocol for the randomised trial ‘SDM Lung SBRT’

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Enhancing patient engagement: the influence of an in-consult patient decision aid on shared decision-making for lung tumour radiation – protocol for the randomised trial ‘SDM Lung SBRT’
Thomas Leth Fink, Torben Frøstrup Hansen, Charlotte Kristiansen, Torben Schjødt Hansen, Rune Slot Thing, Signe Timm, Karina Dahl Steffensen
BMJ Open: Randomized Controlled Trial, 20 January 2025; 15(1)
Abstract
Introduction
Patient engagement is continuously being promoted by patients as well as politicians and healthcare professionals. One way of increasing patient engagement is by using shared decision-making (SDM), which is a joint effort of clinicians and patients making decisions together. When planning stereotactic body radiation therapy (SBRT) for a lung tumour located close to the thoracic wall, there are conflicting interests between (1) delivering the highest possible dose to obtain local tumour control and (2) reducing the dose to the thoracic wall to decrease the risk of chest wall pain and rib fractures following treatment. The radiation oncologist often makes the choice of dose without any engagement of the patient. We believe that the patients should be engaged in such a decision. To explore this matter, we have designed a randomised trial, ‘SDM Lung SBRT’, for which we present our study protocol with a special focus on a patient decision aid (PtDA), which is being tested in this trial.
Methods and analysis
This study includes patients with a lung tumour located ≤1 cm from the thoracic wall. Patients are randomised to have the primary consultation with or without use of the PtDA. Treatment options are a radiation dose of either 66 Gray (Gy) in three fractions, 45 Gy in three fractions or no treatment. The primary outcome is patient engagement in decision-making measured by the validated observer-rated OPTION-12 score. Secondary outcomes are patient-reported outcomes, quality of life and side effects following treatment.
Ethics and dissemination
All patients give informed consent to participate. According to Danish legislation, ethical approval is not required for this study as studies using questionnaires, observations or other non-biological studies are not considered interventions according to the Committee Act. Results from this study will be presented at scientific meetings and published in English peer-reviewed journals.

Acceptability and effectiveness of a study information video in improving the research consent process for youth: a non-inferiority trial

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Acceptability and effectiveness of a study information video in improving the research consent process for youth: a non-inferiority trial
Original Research
Tinashe Cynthia Mwaturura, Victoria Simms, Ethel Dauya, Som Kumar Shrestha, Salmaan Ferrand, Talent Shavani, Chido Dziva Chikwari, Constance R S Mackworth-Young, Tsitsi Bandason, Constancia Mavodza, Mandikudza Tembo, Katharina Kranzer, Sarah Bernays, Rashida Abbas Ferra
BMJ Global Health, 19 January 2025
Open Access
Abstract
Introduction
Obtaining informed consent for research includes the use of information sheets, which are often long and may be difficult for participants to understand. We conducted a trial to investigate whether consent procedures using a study information video coupled with electronic consent were non-inferior to standard consent procedures using participant information sheets (PIS) among youth aged 18–24 years in Zimbabwe.
Methods
The trial was nested within an endline population-based survey for a cluster-randomised trial from October 2021 to June 2022. Randomisation of participants to video or paper-based consent was at household level. We assessed non-inferiority in comprehension of the study using a questionnaire. The video method was accepted as non-inferior to standard consent procedures if the 95% CIs of the mean difference did not fall below the prespecified margin of 1.98. Thematic analysis was conducted on brief qualitative discussions with randomly selected youth to explore the acceptability of video and PIS within consent methods.
Results
Overall, 921 participants were enrolled (54% female). The median age was 20 (IQR 18–24) years. The mean comprehension score was 25.4/30 in both arms. The mean difference in comprehension between arms was −0.02 (95% CI −0.51 to 0.47) showing non-inferiority of the intervention in comprehension of study information. Youth (N=90) described both consent methods as interactive and inclusive. Those in the video consent arm felt it was exciting and youth focused. The use of imagery to explain procedures strengthened the perceived trustworthiness of the research. However, the high volume of information in both arms reduced acceptability.
Conclusion
Comprehension of study information using an information video is non-inferior to a paper-based consent method. Using information videos for consent processes shows promise as a person-centred and context-sensitive approach to enhance the informed consent process and should be encouraged by ethics committees.

Examining Trust and Consent Models for Patient-Generated Health Data-sharing and Incentives

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Examining Trust and Consent Models for Patient-Generated Health Data-sharing and Incentives
Brian Thoms, Nathan Botts, Evren Eryilmaz
Proceedings of the 58th Hawaii International Conference on System Sciences, 7 January 2025
Abstract
This research explores mitigating factors that influence personal health information sharing as it relates to the adoption of personal health information systems (PHIS). We examine the willingness of online users to share specific types of health data, their general concerns about sharing their health data, and what incentives might exist to motivate health data-sharing in the future. Findings across 336 survey respondents identify an overall sense of concern towards online data-sharing and privacy policies, and yet a willingness to share information, including personal health data, and the potential for health incentives to affect their willingness to share various types of health data. The implications of this research will play an important role as organizations and individuals increasingly adopt personal health information systems. This research also addresses the need for established guidelines and frameworks that address patient privacy as more data is captured and stored within cloud computing environments.