ArticleAnnals of translational medicine2017
Ethical challenges involved in obtaining consent for research from patients hospitalized in the intensive care unit.
Article in Annals of translational medicine, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 26 papers.
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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.
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Who cites it
26 citing papers in PubMed.
- A Randomized Controlled Trial of Behavioral Nudges to Improve Enrollment in Critical Care Trials.Annals of the American Thoracic Society · 2020Trial
- Review
- Levosimendan in Cardiac Arrest (LeiCA): Protocol for a Randomized, Double-Blind, Phase II Clinical Trial.Acta anaesthesiologica Scandinavica · 2026Article
- Understanding how the informed consent process influences the decision to participate in an adaptive platform trial: A scoping review.PloS one · 2026Article
- Bioethics training needs assessment for HIV research in vulnerable populations: a survey of trainees at college of health sciences, Makerere university.BMC medical ethics · 2025Article
- The implementation and evaluation of a family-led novel intervention for delirium prevention and management in adult critically ill patients: A mixed-methods pilot study.Nursing in critical care · 2025Article
- Research Ethics Challenges, Controversies and Difficulties in Intensive Care Units-A Systematic Review of Theoretical Concepts.Nursing reports (Pavia, Italy) · 2025Review
- Co-designing and pilot-testing an infographic to support the consent process in an adaptive platform trial for adults in ICU with community-acquired pneumonia or COVID-19: a mixed methods study within a trial (SWAT).Research involvement and engagement · 2025Article
- Review
- Informed consent: Navigating the bioethical complexities of clinical research.Bioinformation · 2025Article
- Ethics of non-therapeutic research on imminently dying patients in the intensive care unit.Journal of medical ethics · 2023Article
- Co-designing and pilot testing an infographic to support patients/families through the REMAP-CAP consent process: a mixed-methods study protocol.Pilot and feasibility studies · 2023Article
- Article
- Patient Information and Consent for Care in the Intensive Care Unit.Healthcare (Basel, Switzerland) · 2023Review
- Rationale and design of a randomized controlled clinical trial; Titration of Oxygen Levels (TOOL) during mechanical ventilation.Contemporary clinical trials · 2022Article
- Challenges in the conduct of randomised controlled trials in cardiogenic shock complicating acute myocardial infarction.Journal of geriatric cardiology : JGC · 2022Article
- What does coercion in intensive care mean for patients and their relatives? A thematic qualitative study.BMC medical ethics · 2022Article
- Ethical Considerations in Clinical Trials for Disorders of Consciousness.Brain sciences · 2022Article
- Ethical challenges of nurses related COVID-19 pandemic in inpatient wards: An integrative review.Ethics, medicine, and public health · 2021Review
- Recall of clinical trial participation and attrition rates in survivors of acute respiratory distress syndrome.Journal of critical care · 2021Article
Corrections and comments
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Authors and funding
4 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Clinical research remains a vital contributor to medical knowledge, and is an established and integral part of the practice of medicine worldwide. Respect for patient autonomy and ethical principles dictate that informed consent must be obtained from subjects before they can be enrolled into clinical research, yet these conditions may be difficult to apply in real practice in the intensive care unit (ICU). A number of factors serve to complexify the consent process in critically ill patients, notably decisional incapacity of the patient due to illness or sedation. Obtaining consent for research from a designated proxy or family member, commonly termed a "surrogate decision maker" (SDM) may be difficult, since SDMs dealing with the emotional, psychological and logistic impact of a sudden hospitalisation of their loved-one are not always receptive to the idea of research or emotionally equipped to reflect rationally on the opportunities being proposed to them. In addition, time constraints and workload pressures on the attending physician may render consent opportunities unfeasible, and the resulting loss of eligible patients could represent a bias in clinical trials, or limit the generalizability of their results. Alternative procedures such as deferred or waived consent have been used in the past and may be suitable alternatives in certain conditions, provided appropriate approval from institutional review boards (IRBs) can be obtained, in accordance with existing legislation. Some of the main questions inherent to the conduct of clinical research in critically ill patients are discussed in this review.
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