ArticleDeveloping world bioethics2018
Consent for participating in clinical trials - Is it really informed?
Article in Developing world bioethics, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 14 papers, 2 of them syntheses that pooled it.
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
14 citing papers in PubMed, 2 syntheses or guidelines pooled it.
- Measuring and evaluating participant understanding of consent processes in clinical trials: a systematic review.Trials · 2026Pooled it
- Participants' understanding of informed consent in clinical trials: A systematic review and updated meta-analysis.PloS one · 2024Pooled it
- Video-Assisted Informed Consent in a Clinical Trial of Resuscitation of Extremely Preterm Infants: Lessons Learned.American journal of perinatology · 2024Trial
- Research on issues in the protection of clinical trial human subjects in China: a Delphi study.BMC medical ethics · 2025Article
- 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
- Researchers experience and views on participants' comprehension of informed consent in clinical trials in Malawi: a descriptive qualitative study.BMC medical ethics · 2024Article
- Comprehension of informed consent and voluntary participation in registration cohorts for phase IIb HIV vaccine trial in Dar Es Salaam, Tanzania: a qualitative descriptive study.BMC medical ethics · 2024Article
- Factors Associated with Burnout in Medical Staff: A Look Back at the Role of the COVID-19 Pandemic.Healthcare (Basel, Switzerland) · 2023Article
- Article
- Methodologic Considerations for Epigenomic Investigation of Preterm Birth in African American Women.Western journal of nursing research · 2022Article
- Patients' knowledge about their involvement in clinical trials. A non-randomized controlled trial.Frontiers in medicine · 2022Article
- Assessment of the appropriateness of the i-CONSENT guidelines recommendations for improving understanding of the informed consent process in clinical studies.BMC medical ethics · 2021Article
- Omega plate for the treatment of acetabular fractures involving the quadrilateral plate.Experimental and therapeutic medicine · 2021Article
- The significance of immune microenvironment in patients with endometriosis.Romanian journal of morphology and embryology = Revue roumaine de morphologie et embryologieArticle
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
5 authors.
Funding
Abstract
The article explores the challenges of ensuring voluntary and informed consent which is obtained from potential research subjects in the north-eastern part of Romania. This study is one of the first empirical papers of this nature in Romania. The study used a quantitative survey design using the adapted Quality of Informed Consent (QuIC) questionnaire. The target population consisted of 100 adult persons who voluntarily enrolled in clinical trials. The informed consent form must contain details regarding the potential risks and benefits, the aim of the clinical trial, study design, confidentiality, insurance and contact details in case of additional questions. Our study confirmed that although all required information was included in the ICF, few clinical trial participants truly understood it. We also found that the most important predictive factor for a good subjective and objective understanding of the clinical trial was the level of education. Our study suggests that researchers should consider putting more effort in order to help clinical trials participants achieve a better understanding of the informed consent. In this way they will ensure that participants' decision-making is meaningful and that their interests are protected.
Indexed as
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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.