ArticleAnnals of intensive care2011
Protecting vulnerable research subjects in critical care trials: enhancing the informed consent process and recommendations for safeguards.
Article in Annals of intensive care, 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 20 papers, 1 of them a synthesis 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
20 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Participants' understanding of informed consent in clinical trials: A systematic review and updated meta-analysis.PloS one · 2024Pooled it
- Research Ethics Challenges, Controversies and Difficulties in Intensive Care Units-A Systematic Review of Theoretical Concepts.Nursing reports (Pavia, Italy) · 2025Review
- Informed consent: Navigating the bioethical complexities of clinical research.Bioinformation · 2025Article
- Patient vulnerability in stereotactic arrhythmia radioablation (STAR): a preliminary ethical appraisal from the STOPSTORM.eu consortium.Strahlentherapie und Onkologie : Organ der Deutschen Rontgengesellschaft ... [et al] · 2024Article
- Informed consent and trial prioritization for clinical studies during the COVID-19 pandemic. Stakeholder experiences and viewpoints.PloS one · 2024Article
- Learning from stakeholders to inform good practice guidance on consent to research in intensive care units: a mixed-methods study.BMJ open · 2022Article
- Four reasons why too many informed consents to clinical research are invalid: a critical analysis of current practices.BMJ open · 2022Review
- Challenges and proposed solutions in making clinical research on COVID-19 ethical: a status quo analysis across German research ethics committees.BMC medical ethics · 2021Article
- No research for the decisionally-impaired mentally ill: a view from Montenegro.BMC medical ethics · 2020Article
- A review of informed consent and how it has evolved to protect vulnerable participants in emergency care research.EFORT open reviews · 2020Article
- Action Ethnography of Community Reintegration for Veterans and Military Service Members With Traumatic Brain Injury: Protocol for a Mixed Methods Study.JMIR research protocols · 2019Article
- Informed consent for functional MRI research on comatose patients following severe brain injury: balancing the social benefits of research against patient autonomy.Journal of medical ethics · 2019Article
- An Alternative Consent Process for Minimal Risk Research in the ICU.Critical care medicine · 2017Article
- Exploring obstacles to critical care trials in the UK: A qualitative investigation.Journal of the Intensive Care Society · 2017Article
- Informed consent in paediatric critical care research--a South African perspective.BMC medical ethics · 2015Article
- Registration and design alterations of clinical trials in critical care: a cross-sectional observational study.Intensive care medicine · 2014Review
- End of life in the intensive care unit: should French law be adapted?Annals of intensive care · 2014Article
- ICU research: the impact of invasiveness on informed consent.Intensive care medicine · 2013Article
- Participants with schizophrenia retain the information necessary for informed consent during clinical trials.The Journal of clinical psychiatry · 2013Article
- [Enrolment of intensive care patients in clinical studies. Ethical, legal and organizational problems from an interdisciplinary point of view].Medizinische Klinik, Intensivmedizin und Notfallmedizin · 2013Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
1 author.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Although critically ill patients represent a vulnerable group of individuals, guidelines in research ethics assert that ethically acceptable research may proceed with such vulnerable subjects if additional safeguards are in place to minimize the risk of harm and exploitation. Such safeguards include the proper obtainment of informed consent that avoids the presence of the therapeutic misconception and the assessment of decisional capacity in critically ill patients recruited for research. Also discussed in this review are additional safeguards for such vulnerable subjects, as well as the issues involved with proxy consent. Heightened awareness to principles of ethics and provision of additional safeguards to enhance protections of vulnerable subjects would help to maintain the public trust in the research endeavor.
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.