ReviewGerman medical science : GMS e-journal2013
Aspects of vulnerable patients and informed consent in clinical trials.
Review in German medical science : GMS e-journal, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 16 papers.
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
16 citing papers in PubMed.
- Research on issues in the protection of clinical trial human subjects in China: a Delphi study.BMC medical ethics · 2025Article
- Evaluating the use of SPIRIT on participant retention in randomised trials: Challenges in reporting and implications for practice.PloS one · 2025Article
- Clinicians' experiences of obtaining informed consent for research and treatment: a nested qualitative study from Pakistan.BMC medical ethics · 2024Article
- Informed Consent in COVID-19-Research: An Ethical Analysis of Clinical Studies Performed during the Pandemic.Healthcare (Basel, Switzerland) · 2023Article
- Rethinking Benefits in Health Research, Reflections of an Ethics Committee.The Yale journal of biology and medicine · 2022Review
- Heterogeneity of national legislation and practice on clinical trials with vulnerable patients based on the EU Clinical Trials Directive by the example of adults permanently incapable of giving informed consent.German medical science : GMS e-journal · 2021Article
- Helping Them Decide: A Scoping Review of Interventions Used to Help Minors Understand the Concept and Process of Assent.Frontiers in pediatrics · 2020Article
- Consent for participating in clinical trials - Is it really informed?Developing world bioethics · 2018Article
- Factors Contributing to Exacerbating Vulnerabilities in Global Clinical Trials.Frontiers in pharmacology · 2017Article
- Article
- Novel Use of Hydroxyurea in an African Region With Malaria: Protocol for a Randomized Controlled Clinical Trial.JMIR research protocols · 2016Article
- Adolescents with substance use disorder and assent/consent: Empirical data on understanding biobank risks in genomic research.Drug and alcohol dependence · 2016Article
- Article
- A cross-sectional pilot study to investigate patient attitudes and perception regarding the use of real time digital recording of urological procedures for research and teaching purposes.Annals of medicine and surgery (2012) · 2015Article
- Autonomy and authority in medical futility.Journal of biomedical research · 2014Article
- Ensuring that informed consent is really an informed consent: Role of videography.Perspectives in clinical research · 2014Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
2 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
scopeTo discuss the rationale behind informed consent in clinical trials focusing on vulnerable patients from a European and German viewpoint.
methodsScientific literature search via PubMed, Medline, Google.
resultsVoluntary informed consent is the cornerstone of policies regulating clinical trials. To enroll a patient into a clinical trial without having obtained written and signed consent is to be considered as a serious issue in the conduct of a clinical trial. Development of ethical guidance for physicians started before Christ Era with the Hippocratic Oath. Main function of consent, as articulated in all guidelines developed for clinical research, is to facilitate an individual's freedom of choice, respect autonomy, and thus to ensure welfare of the participants in clinical trials. Minors are unable to provide legally binding informed consent, this issue is addressed through a combination of parental permission and minor's assent. Illiteracy is a critical problem that affects all corners of our earth; it has no boundaries and exists among every race and ethnicity, age group, and economic class. New strategies to improve communication with patients including the use of videotapes or animated cartoon illustrations could be taught. Finally the time with the potential participant seems to be the best way to improve understanding.
conclusionDiscovery of life saving and life enhancing new treatments requires partnership that is based on good communication and trust between patients and researchers, sponsors, ethics committees, authorities, lawyers and politicians so that vulnerable patients can benefit from the results of well controlled clinical trials.
Indexed as
Identifiers
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.