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.