ReviewBMC medical ethics2016
Exceptions to the rule of informed consent for research with an intervention.
Review in BMC medical ethics, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 24 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
24 citing papers in PubMed, 2 syntheses or guidelines pooled it.
- Toward an Ethical Framework for the Text Mining of Social Media for Health Research: A Systematic Review.Frontiers in digital health · 2020Pooled it
- Meta-analysis of randomised controlled trials testing behavioural interventions to promote household action on climate change.Nature communications · 2019Pooled it
- Challenges and opportunities for conducting pre-hospital trauma trials: a behavioural investigation.Trials · 2023Trial
- Trial
- Trial
- Waiver of informed consent in clinical research: a summary of contemporary guidelines and a resource for researchers.BMJ open · 2025Review
- Public support for and concerns regarding pediatric dose optimization for seizures in emergency medical services: An exception from informed consent (EFIC) trial.Academic emergency medicine : official journal of the Society for Academic Emergency Medicine · 2024Article
- Ethics Committees: Structure, Roles, and Issues.Journal of Korean medical science · 2023Review
- Protocol for Deferral of Consent in Acute Stroke Trials.Neurology · 2023Article
- Application of positron emission tomography in psychiatry-methodological developments and future directions.Translational psychiatry · 2022Review
- Informed consent, genomic research and mental health: A integrative review.Nursing ethics · 2022Review
- Research Needs for Inpatient Management of Severe Alcohol Withdrawal Syndrome: An Official American Thoracic Society Research Statement.American journal of respiratory and critical care medicine · 2021Article
- Utility of procalcitonin in a medical intensive care unit in Croatia.Wiener klinische Wochenschrift · 2021Article
- What has changed after the COVID-19 pandemic in the publication process? A look-back to "Transfusion clinique et biologique".Transfusion clinique et biologique : journal de la Societe francaise de transfusion sanguine · 2021Article
- The TELE-DD project on treatment nonadherence in the population with type 2 diabetes and comorbid depression.Scientific reports · 2021Article
- Methodological challenges in conducting instrumentation research in non-communicative palliative care patients.Applied nursing research : ANR · 2020Article
- The Place for Religious Content in Clinical Ethics Consultations: A Reply to Janet Malek.HEC forum : an interdisciplinary journal on hospitals' ethical and legal issues · 2019Article
- Lessons from the Established Status Epilepticus Treatment Trial.Epilepsy & behavior : E&B · 2019Review
- A Formative Qualitative Study on the Acceptability of Deferred Consent in Adult Emergency Care Research in Malawi.Journal of empirical research on human research ethics : JERHRE · 2019Article
- Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
4 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundIn specific situations it may be necessary to make an exception to the general rule of informed consent for scientific research with an intervention. Earlier reviews only described subsets of arguments for exceptions to waive consent.
methodsHere, we provide a more extensive literature review of possible exceptions to the rule of informed consent and the accompanying arguments based on literature from 1997 onwards, using both Pubmed and PsycINFO in our search strategy.
resultsWe identified three main categories of arguments for the acceptability of a consent waiver: data validity and quality, major practical problems, and distress or confusion of participants. Approval by a medical ethical review board always needs to be obtained. Further, we provide examples of specific conditions under which consent waiving might be allowed, such as additional privacy protection measures.
conclusionsThe reasons legitimized by the authors of the papers in this overview can be used by researchers to form their own opinion about requesting an exception to the rule of informed consent for their own study. Importantly, rules and guidelines applicable in their country, institute and research field should be followed. Moreover, researchers should also take the conditions under which they feel an exception is legitimized under consideration. After discussions with relevant stakeholders, a formal request should be sent to an IRB.
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.