ArticleMedical devices (Auckland, N.Z.)2025
Enhancing Informed Consent Forms for Medical Devices: International Regulatory Guidance and Ethical Recommendations.
Article in Medical devices (Auckland, N.Z.), 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
1 citing paper in PubMed.
- Ethical and Linguistic Quality of Participant Information Sheets and Their Association with Recruitment Outcomes : An Empirical Bioethics Study of Clinical Trials.Journal of bioethical inquiry · 2026Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
4 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Many developers of medical devices face a new reality with the increasing demand for clinical evidence that is generated by clinical investigations. This affects biotechnology companies, start-ups and academic research centres. The participants' informed consent form (ICF), which includes the participant information sheet (PIS), is among the critical documents that are part of the clinical investigation. While many countries around the world follow the principles of good clinical practice (GCP), there are country-specific variations of the ICF requirements. In addition, many of the country guidelines are focused on medicinal products rather than medical devices. Clinical investigations involving medical devices have their unique challenges and need additional guidance to help developers improve the ICF and PIS content. This review provides information on the latest regulatory recommendations from Europe, USA and Asia regarding the content of the ICF and offers practical advice from professionals experienced in preparing ICFs. It also includes some ethical considerations that must be taken into account.
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What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.