ReviewJournal of general internal medicine2016
Proposals to Conduct Randomized Controlled Trials Without Informed Consent: a Narrative Review.
Review in Journal of general internal medicine, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 24 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
24 citing papers in PubMed, 1 synthesis or guideline pooled it, 37 citations in OpenAlex.
- When is it impractical to ask informed consent? A systematic review.Clinical trials (London, England) · 2022Pooled it
- Trial
- Effect of Personalized Breast Cancer Risk Tool on Chemoprevention and Breast Imaging: ENGAGED-2 Trial.JNCI cancer spectrum · 2021Trial
- The adapted Zelen was a feasible design to trial exercise in myeloma survivors.Journal of clinical epidemiology · 2020Trial
- Feasibility and long-term efficacy of a proactive health program in the treatment of chronic back pain: a randomized controlled trial.BMC health services research · 2019Trial
- Trial
- Does Waiver of Informed Consent in Low-Risk Randomised Controlled Trials Improve Research Inclusion? Insights from a Review of the UK Health Research Authority Confidentiality Advisory Group Register.Journal of empirical research on human research ethics : JERHRE · 2026Review
- Informed consent, randomization, and blinding in neonatal resuscitation and immediate care trials.Resuscitation plus · 2026Article
- Article
- Optimizing clinical scientific research: the cohort intervention random sampling study with historical controls.Journal of comparative effectiveness research · 2025Article
- Evaluation of the effectiveness of osteopathic treatment on the mother-newborn dyad in the event of painful breastfeeding in a maternity hospital despite the application of all usual aids: randomized interventional trial in two parallel arms without blinding.Frontiers in nutrition · 2025Article
- Widely Integrated Services in Home (WISH) for homebound older adults: a study protocol for a randomized encouragement trial.BMC geriatrics · 2024Article
- Randomised trials conducted using cohorts: a scoping review.BMJ open · 2024Article
- Is There a Doctor in the House?The American journal of bioethics : AJOB · 2023Article
- Consent Requirements for Testing Health Policies: An Intercontinental Comparison of Expert Opinions.Journal of empirical research on human research ethics : JERHRE · 2022Article
- Article
- Citizens, Research Ethics Committee Members and Researchers' Attitude Toward Information and Consent for the Secondary Use of Health Data: Implications for Research Within Learning Health Systems.Journal of empirical research on human research ethics : JERHRE · 2021Article
- Clinical trials may be unethical in certain instances.International Journal of Cardiology. Hypertension · 2020Article
- Informed consent within a learning health system: A scoping review.Learning health systems · 2020Article
- Ethical Acceptability of Postrandomization Consent in Pragmatic Clinical Trials.JAMA network open · 2018Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
3 authors at 1 institution in 1 country.
Funding
Abstract
backgroundIndividual informed consent from all participants is required for most randomized clinical trials (RCTs). However, some exceptions-for example, emergency research-are widely accepted.
methodsThe literature on various approaches to randomization without consent (RWOC) has never been systematically reviewed. Our goal was to provide a survey and narrative synthesis of published proposals for RWOC. We focused on proposals to randomize at least some participants in a study without first obtaining consent to randomization. This definition included studies that omitted informed consent entirely, omitted informed consent for selected patients (e.g., the control group), obtained informed consent to research but not to randomization, or only obtained informed consent to randomization after random assignment had already occurred. It omitted oral and staged consent processes that still obtain consent to randomization from all participants before randomization occurs.
resultsWe identified ten different proposals for RWOC: two variants of cluster randomization, two variants of the Zelen design, consent to postponed information, two-stage randomized consent, cohort multiple RCT, emergency research, prompted optional randomization trials, and low-risk pragmatic RCTs without consent.
conclusionOf all designs discussed here, only cluster randomized designs and emergency research are routinely used, with the justification that informed consent is infeasible in those settings. Other designs have raised concerns that they do not appropriately respect patient autonomy. Recent proposals have emphasized the importance for RWOC of demonstrating such respect through systematic patient engagement, transparency, and accountability, potentially in the context of learning health care systems.
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.