ArticleBMC medical ethics2021
Assessment of the appropriateness of the i-CONSENT guidelines recommendations for improving understanding of the informed consent process in clinical studies.
Article in BMC medical ethics, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 12 papers.
What it found
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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
12 citing papers in PubMed.
- Recruiting and Consenting Decentralized Clinical Trial Participants-Learnings from the Trials@Home RADIAL Proof-of-Concept Trial.Clinical pharmacology and therapeutics · 2025Trial
- Addressing the Key Challenges of Decentralized Clinical Trials in Europe: Multistakeholder Perspective Delphi Study.Journal of medical Internet research · 2026Article
- SWOT analysis of decentralised clinical trials from an ethical, legal, regulatory and operational perspective.BMC medical ethics · 2026Article
- Consent beyond the written form: Implications for ketamine trials in the Philippines.Therapeutic advances in psychopharmacology · 2026Article
- Digital Informed Consent/Assent in Clinical Trials Among Pregnant Women, Minors, and Adults: Multicountry Cross-Sectional Evaluation of Comprehension and Satisfaction.JMIR human factors · 2025Article
- The Ethics of Decentralized Clinical Trials and Informed Consent: Taking Technologies' Soft Impacts into Account.Health care analysis : HCA : journal of health philosophy and policy · 2025Article
- Potential role of ChatGPT in simplifying and improving informed consent forms for vaccination: a pilot study conducted in Italy.BMJ health & care informatics · 2025Article
- Article
- Evolution of informed consent in research: From the Hippocratic Oath to the tailored consent.Open research Europe · 2024Article
- Improving oncology first-in-human and Window of opportunity informed consent forms through participant feedback.BMC medical ethics · 2023Article
- Co-creation of information materials within the assent process: From theory to practice.Health expectations : an international journal of public participation in health care and health policy · 2023Article
- Keys to improving the informed consent process in research: Highlights of the i-CONSENT project.Health expectations : an international journal of public participation in health care and health policy · 2022Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
3 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundThe H2020 i-CONSENT project has developed a set of guidelines that offer ethical recommendations and practical tools aimed at making the informed consent process in clinical studies more comprehensive, tailored, and inclusive. An analysis of the appropriateness of some of its novel recommendations was carried out by a group of experts representing different stakeholders.
methodsAn adaptation of the RAND/UCLA Appropriateness Method was used to assess the level of agreement on the recommendations among 14 representatives of different stakeholders, including patients, regulators, investigators, ethics experts, and the pharmaceutical industry. The process included two rounds of rating and a virtual meeting.
resultsFifty-three recommendations were evaluated. After the first round, 34 recommendations were judged "appropriate"; 19 were judged "uncertain"; and none was judged "inappropriate". After the second round, 9 "uncertains" changed to "appropriate". All recommendations rated medians of 6.5-9 on a 1-9 scale (1 = "extremely inappropriate", 5 = "uncertain", 9 = "extremely appropriate"). The sections "General recommendations" and "Gender perspective during the consent process for clinical studies" showed the highest "uncertainty" rating. The four keys to improving the understanding of the ICP in clinical studies are to: (1) consider consent a two-way continuous interaction that begins at the first contact with the potential participant and continues until the end of the study; (2) improve investigators' communication skills; (3) co-create the information; and (4) use a layered approach, including information to compensate for the potential participant's possible lack of health literacy and a glossary of terms.
conclusionsThe RAND/UCLA method has demonstrated validity for assessing the appropriateness of recommendations in ethical guidelines. The recommendations of the i-CONSENT guidelines were mostly judged "appropriate" by all stakeholders involved in the informed consent process.
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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 Socratic graph.