Re-Consent Practices in Biobanks in Japan: Current Status and Stakeholder Perspectives
Research Article
Hiroko Terui-Kohbata, Hiyori Ueda, Masayuki Yoshida
Research Square, 13 May 2025
Abstract
Pediatric research in rare diseases relies on sharing biological specimens, clinical data, and analytical information among researchers. Re-consent is essential in longitudinal biobank (BB) research to ensure that pediatric participants remain informed and willing to continue. However, the issue of re-consent—obtaining consent once as participants reach adulthood—remains a significant ethical concern. This study examined the current practices of re-consent acquisition in Japanese BBs and explores stakeholder opinions regarding genomic data sharing. A survey of 41 BBs revealed that only 25% of those handling pediatric samples obtained re-consent, all via written informed consent. Although 71% of respondents recognized the necessity of re-consent, the methods used to obtain it varied. Stakeholders identified ethical and logistical challenges, including privacy concerns and administrative burden. Various re-consent methods were suggested, with preferences depending on feasibility and ethical considerations. The findings highlight the need for policy discussions to balance data-sharing benefits with participant rights and privacy protection in pediatric genomic research. Determining optimal re-consent methods requires continued stakeholder engagement, including research participants and the public.

Ethics and consent in randomized clinical trial integrity: A scoping systematic review
Authorea, 6 May 2025
Mohamad Alaa Elsuity, Furqan Ahmad Butt, Khalid Saeed Khan, Mohamed Fawzy, Manuel Martín-Díaz, Javier Perez Rojas, Patrick FW Chien, María Núñez-Núñez, Mosab M Rashwan, Aurora Bueno-Cavanillas
Abstract
Background
Research ethics committee approval and informed consent are fundamental to the integrity of randomized clinical trials (RCTs), the strongest possible evidence source for informing clinical decision-making.
Objectives
This scoping systematic review aimed to collate and synthesize available evidence on research ethics and consent aspects related to research integrity standards in RCTs. Prospective registration (https://osf.io/gxryb).
Search Strategy and selection criteria
We searched PubMed and Scopus databases from January 2018 to August 2023, using combinations of terms related to research ethics, approval, and informed consent. We included full academic articles relevant to the scope of the review without language restriction, including primary research articles, systematic reviews, scoping reviews, and narrative reviews.
Data collection and analysis
Two teams of four reviewers independently assessed the full text to select articles and extract data, performing the tasks independently and any disagreements were resolved through arbitration. A descriptive synthesis of the included articles main characteristics and findings were performed.
Results
69 articles were selected, covering RCT-related ethics and consent issues in 141 countries, including 89 (63%) low or middle-income ones. The extracted data fell into nine domains: general issues (30 articles; 43%), journals’ instructions and policies (one article; 1.4%), research institutions and funders’ policies (three articles; 4.3%), ethics committee regulations (five articles; 7.2%), ethics committee evaluation and approval (12 articles; 17%), informed consent and related procedures (six articles; 8.7%), monitoring of trials for compliance (three articles; 4.3%), post-publication concerns on ethics and consent (five articles; 7.2%), and recommendations for future research (four articles; 5.8%).
Conclusions
The key areas include standardization of ethics committee approval processes and enhancement of informed consent procedures. There were notable deficiencies in trial registration and reporting concerning ethics and consent. The observed variability in ethics and consent practices across RCTs globally needs to be addressed through an international expert consensus.

The ethics of simplification: Balancing patient autonomy, comprehension, and accuracy in AI-generated radiology reports
Research Article
Hong-Seon Lee, Seung-Hyun Song, Chaeri Park, Jeongrok Seo, Won Hwa Kim, Jaeil Kim, Sungjun Kim, Kyunghwa Han, Young Han Lee
Research Square, 2 May 2025
Abstract
Background
Large language models (LLMs) such as GPT-4 are increasingly used to simplify radiology reports and improve patient comprehension. However, excessive simplification may undermine informed consent and autonomy by compromising clinical accuracy. This study investigates the ethical implications of readability thresholds in AI-generated radiology reports, identifying the minimum reading level at which clinical accuracy is preserved.
Methods
We retrospectively analyzed 500 computed tomography and magnetic resonance imaging reports from a tertiary hospital. Each report was transformed into 17 versions (reading grade levels 1–17) using GPT-4 Turbo. Readability metrics and word counts were calculated for each version. Clinical accuracy was evaluated using radiologist assessments and PubMed-BERTScore. We identified the first grade level at which a statistically significant decline in accuracy occurred, determining the lowest level that preserved both accuracy and readability. We further assessed potential clinical consequences in reports simplified to the 7th-grade level.
Results
Readability scores showed strong correlation with prompted reading levels (r = 0.80–0.84). Accuracy remained stable across grades 13–11 but declined significantly below grade 11. At the 7th-grade level, 20% of reports contained inaccuracies with potential to alter patient management, primarily due to omission, incorrect conversion, or inappropriate generalization. The 11th-grade level emerged as the current lower bound for preserving accuracy in LLM-generated radiology reports.
Conclusions
Our findings highlight an ethical tension between improving readability and maintaining clinical accuracy. While 7th-grade readability remains an ethical ideal, current AI tools cannot reliably produce accurate reports below the 11th-grade level. Ethical implementation of AI-generated reporting should include layered communication strategies and model transparency to safeguard patient autonomy and comprehension.

Feasibility of a Study Within a Trial to evaluate a decision support intervention for families deciding about research on behalf of adults lacking capacity to consent (CONSULT SWAT)
Victoria Shepherd, Kim Smallman, Fiona Wood, Katie Gillies, Adam Martin, Maria Moore, Stacy Todd, Kerenza Hood
Research Square, 22 April 2025
Abstract
Background
Trials involving adults who lack capacity to consent can be challenging, partly due to the involvement of ‘proxy’ decision-makers. This is usually a family member, who advises the researchers about the person’s wishes. Families can find decision making difficult and some experience a decisional burden. Following the development of a decision aid for family members making trial participation decisions, we are conducting a mixed-methods randomised Study Within a Trial (SWAT) to evaluate its (cost-)effectiveness. This paper reports the feasibility stage conducted in one host study to inform the delivery of the main SWAT.
Methods
Family members approached to act as a consultee for the host study were randomised 1:1 to receive the decision aid booklet alongside standard study information (intervention), or standard information plus a blank notebook (control), and asked to complete the CONCORD scale (Combined Scale for Proxy Informed Consent Decisions) questions about their experience and take part in a semi-structured interview. Acceptability of the SWAT was assessed through recruitment rates, data completeness, and qualitatively through interviews with family members and research staff. Interviews were analysed using a rapid qualitative approach.
Results
In total, 92 family members were randomised to the SWAT and 16 completed the CONCORD scale. Interviews were conducted with consultees (n=4), and host study staff (n=3) who also provided resource use data. Mean CONCORD scores were higher in the control group (94.5 on a 100-point scale) compared with the intervention group (87.5), indicating higher decision quality, Differences in time staff spent with consultees were small. Key themes identified included 1) setting up the SWAT and balancing priorities with the host study, 2) differences when recruiting consultees to a SWAT, 3) feasibility and acceptability of the SWAT, 4) challenges of measuring decision quality, 5) views and experiences of the decision support intervention.
Conclusion
The CONSULT SWAT is feasible, but changes to study processes are needed in advance of the main SWAT. The small number of trials involving participants lacking capacity limits opportunities for developing the evidence-base. Recruitment of host trials continues, with a focus on evaluating the intervention in a broad range of populations and settings.

InformGen: An AI Copilot for Accurate and Compliant Clinical Research Consent Document Generation
Zifeng Wang, Junyi Gao, Benjamin Danek, Brandon Theodorou, Ruba Shaik, Shivashankar Thati, Seunghyun Won, Jimeng Sun
arXiv, 2 April 2025
Open Access
Abstract
Leveraging large language models (LLMs) to generate high-stakes documents, such as informed consent forms (ICFs), remains a significant challenge due to the extreme need for regulatory compliance and factual accuracy. Here, we present InformGen, an LLMdriven copilot for accurate and compliant ICF drafting by optimized knowledge document parsing and content generation, with humans in the loop. We further construct a benchmark dataset comprising protocols and ICFs from 900 clinical trials. Experimental results demonstrate that InformGen achieves near 100% compliance with 18 core regulatory rules derived from FDA guidelines, outperforming a vanilla GPT-4o model by up to 30%. Additionally, a user study with five annotators shows that InformGen, when integrated with manual intervention, attains over 90% factual accuracy, significantly surpassing the vanilla GPT-4o model’s 57%-82%. Crucially, InformGen ensures traceability by providing inline citations to source protocols, enabling easy verification and maintaining the highest standards of factual integrity.

Co-designing the consent process of critical care trials with patients and the public: Project protocol
Timo Tolppa, Arishay Hussaini, Vrindha Pari, Nikhat Ahmed, Arjen Dondorp, Shehla Farooq, Madiha Hashmi, Monaza Khan, Adnan Masood, Saima Saleem, Zahyd Shuja, Marianne Vidler, Shahnaz Zaman, Srinivas Murthy
Wellcome Open Research, 31 March 2025
Abstract
Background
Informed consent processes in critical care trials can be overwhelming for patients and their families as decisions about participation need to be made under distressing circumstances. Existing consent processes have been developed for and by White Western populations, making them less relevant for racialized groups from low- and middle-income countries. One solution is involving patients, their relatives and members of the public from diverse backgrounds in co-designing informed consent processes.
Methods
This project aims to co-design the consent materials and processes for two ongoing critical care trials with an existing Patient and Public Involvement and Engagement group at Ziauddin University in Pakistan. Using experience-based co-design and participatory action research, the process will follow six stages for each trial: (i) Introduction to trial and consent, (ii) Review of existing materials, (iii) Process mapping & recommendations, (iv) Creation of new materials, (v) Vetting, and (vi) Finalization. The final two steps involve collaboration with clinicians, trial teams, sponsors, and members of ethics review boards.
Expected Outcomes
The co-design process will produce new consent materials, aligned with patient and substitute decision-maker needs, that can be implemented to improve the conduct of two active trials. Deliverables include an informed consent process map, recommendations for revising consent materials, and guidelines on patient-centred formats. Additionally, training patient and public members in co-design will build capacity and enable the group to contribute to the design of consent processes of future trials.
Conclusion
Collaboration between patients, researchers and the public has the potential to promote ethical conduct of critical care trials in Pakistan and elsewhere by supporting patient-centered informed decision-making. This co-design process represents the first step towards achieving this goal, with future work evaluating the impact of the new consent materials and processes on trial enrolment rates, participant diversity and consent experiences.

Data sharing in child and adolescent psychiatry research: Key challenges (and some potential solutions)
Case Study
Beth Oakley, Alexandra Lautarescu, Tony Charman, Christopher Chatham, Eva Loth, Christian Beckmann, Thomas Bourgeron, Florence Campana, Rosie Holt, Eliza Eaton, Pierre Violland, Katrien Van den Bosch, Siofra Heraty, Scott Wagers, Jan Buitelaar, Declan Murphy, Amy Goodwin, Emily Jones
Open Research Europe, 31 March 2025
Open Access
Abstract
Background
The field of biomedical research is entering a new era, in which public data sharing is increasingly the norm. There are many advantages of embracing data sharing initiatives, including tackling the replication crisis through enhanced transparency and publication of null findings, facilitating global collaborations to accelerate research progress, enhancing cost-effectiveness by reducing duplication of efforts, and making scientific advances more accessible to the public. However, there are also several crucial ethical and logistical challenges that must be addressed to maximise the benefits of data sharing and minimise risks. The potential, and increasingly recognised, risks of unregulated data sharing (e.g., data reidentification, misuse, and lack of representativeness due to variability in who agrees to share data) have also been exemplified by high profile data breaches and directly clash with efforts to make research more robust, accessible, and global.
Methods/Results
Here, we narratively outline current challenges for data sharing from the perspective of child and adolescent psychiatry, one area where they may be particularly acute. For example, child and early adolescent research often requires caregivers to consent on behalf of a minor – increasing the responsibility of researchers to consider how the science of today may evolve into the future (when those individuals are no longer minors). We use data from our research consortium Autism Innovative Medicines Study – 2 – Trials (AIMS-2-TRIALS; https://www.aims-2-trials.eu/) to illustrate the points raised in this perspective piece.
Conclusions
We also propose some potential solutions to begin to address current challenges for data sharing, focusing on key priorities, including shared control of data curation between researcher and participant communities and equity of access by research groups to the tools and resources needed to conduct responsible and sustainable data sharing.

Improving shared decision‑making between paediatric haematologists, children with sickle cell disease and their parents: an observational post-intervention study
Ricardo Orlando Wijngaarde, Samantha C. Gouw, Dirk T. Ubbink
Research Square, 31 March 2025
Abstract
Background
Children with sickle cell disease (SCD) suffer from a chronic disease that can lead to serious co-morbidity and impacts their quality of life. During the course of their disease, a variety of health-related decisions need to be made for and by SCD-patients, depending on their age and health status, together with their parents and paediatric haematology clinicians. Shared decision-making (SDM) may improve health outcomes of chronically ill children but is still not commonly applied. We assessed the level of SDM among paediatric haematologists after the introduction of SDM-interventions.
Methods
An observational post-intervention study was conducted in a paediatric outpatient clinic of a university hospital. After an SDM consultation training of the three paediatric haematologists and introduction of SDM-supporting tools for both paediatricians and (parents of) patients with SCD, two evaluators independently and objectively analysed the level of patient involvement in decision-making from audio-recordings of the consultations using the OPTION-5 instrument. SDM-Q-9 and SDM-Q-Doc questionnaires were used to measure the level of SDM as perceived by patients/parents and paediatricians, respectively. Scores were expressed as a percentage, ranging from 0% (no SDM observed) to 100% (exemplary level of SDM).
Results
Participants were 9 female and 9 male patients between 3 months and 17 years old, with a mean age of 7.6 years (SD 5.5). Eighteen consultations (six per paediatrician) in which a decision was to be made about SCD treatment options were analysed. Median OPTION-5 score was 50 (Interquartile Range [IQR] 40–65%). Median SDM-Q-9 and SDM-Q-Doc scores were 73% (IQR 52.2–91) and 62.2% (IQR 55.6–71.1), respectively.
Conclusion
After the introduction of SDM training and tools, paediatric haematologists reached a moderately good level of SDM. This level had doubled as compared to the baseline level, as assessed in a previous study.

A pilot study to explore utility of electronic informed consent in a low- income setting; the case of a Controlled human infection study in Blantyre, Malawi
Clara Ngoliwa, Chikondi Chakwiya, Joel Gondwe, Edna Nsomba, Vitumbiko Nkhoma, Modesta Reuben, Linda Chantunga, Pemphero Liwonde, Edward Mangani, Evaristar Kudowa, Lumbani Makhaza, Neema Toto, Tiferanji Sochera, Tarsizio Chikaonda, Ben Morton, Marc Y.R. Henrion, Dingase Dula, Stephen B. Gordon, Anthony E. Chirwa
Wellcome Open Research, 5 February 2025
Abstract
Background
Electronic informed consent can improve accuracy, workflow, and overall patient experience in clinical research but has not been used in Malawi, owing to uncertainty about availability, utility, patient data security and technical support.
Objectives
We aimed to explore the utility of electronic consent (e-consent) in an ongoing human infection study in Blantyre, Malawi.
Methods
The approved paper consent forms were digitized using Open Data Kit (ODK). Following participant information giving by the research staff, healthy literate adult participants with no audio-visual impairments completed a self-administered e-consent and provided an electronic signature. We dual-consented participants by both paper-based and electronic-consenting. Signed e-consent forms were uploaded to a secure study server. Utility of e-consenting was observed by participation rate, user-friendliness, documentation error rate, and staff perception of the overall consenting process.
Results
All 109 participants offered e-consenting accepted participation. E-consenting was user-friendly, had no identifiable documentation errors as compared to 43.1% (n 47/109) error rate with paper-based consenting, and ensured data safety, and unravelled areas for consideration. Challenges with e-consenting included difficult digitization of ethics stamped documents, as well as present but infrequent delays of retrieval of e-consent forms.
Conclusion
E-consenting is feasible, has a utility benefit in a controlled human infection study in Malawi; a low-income country, and can supplement paper-based consenting. Its usefulness can improve the consenting process in research conducted in such settings. Additionally, success of e-consenting requires a careful consideration.

Integrating a conceptual consent permission model from the informed consent ontology for software application execution
Muhammad “Tuan” Amith, Yongqun He, Elise Smith, Marceline Harris, Frank Manion, Cui Tao
MedRxiv, 2 February 2025
Abstract
We developed a simulated process to show a software implementation to facilitate an approach to integrate the Informed Consent Ontology, a reference ontology of informed consent information, to express implicit description and implement conceptual permission from informed consent life cycle. An early study introduced an experimental method to use Semantic Web Rule Language (SWRL) to describe and represent permissions to computational deduce more information from the Informed Consent Ontology (ICO), demonstrated by the use of the All of Us informed consent documents. We show how incomplete information in informed consent documents can be elucidated using a computational model of permissions toward health information technology that integrates ontologies. Future goals entail applying our computational approach for specific sub-domains of the informed consent life cycle, specifically for vaccine informed consent.