ArticleClinical trials (London, England)2018
Just-in-time consent: The ethical case for an alternative to traditional informed consent in randomized trials comparing an experimental intervention with usual care.
Article in Clinical trials (London, England), 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 19 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
19 citing papers in PubMed.
- Transperineal Versus Transrectal Magnetic Resonance Imaging-targeted and Systematic Prostate Biopsy to Prevent Infectious Complications: The PREVENT Randomized Trial.European urology · 2024Trial
- A brief mind-body intervention to reduce pain and anxiety during prostate needle biopsy: a clinically integrated randomized controlled trial with 2-staged consent.Urologic oncology · 2023Trial
- A randomized comparison of two-stage versus traditional one-stage consent for a low-stakes randomized trial.Clinical trials (London, England) · 2023Trial
- Pilot randomised controlled trial of a brief mindfulness-based intervention for those with persistent pain.Journal of behavioral medicine · 2019Trial
- Nephron Sparing Treatment (NEST) for small renal masses: understanding patients' and clinicians' experiences of a cohort-embedded randomised control trial.Pilot and feasibility studies · 2026Article
- Article
- Successful completion of large, low-cost randomized cancer trials at an academic cancer center.Clinical trials (London, England) · 2025Article
- Randomised trials conducted using cohorts: a scoping review.BMJ open · 2024Article
- Ethical Considerations Regarding Psychedelics for Clinical Pain Research.Journal of pain research · 2024Review
- EORTC 2238 "De-Escalate": a pragmatic trial to revisit intermittent androgen deprivation therapy in the era of new androgen receptor pathway inhibitors.Frontiers in oncology · 2024Article
- Pragmatic Comparative Effectiveness Trials and Learning Health Systems in Pain Medicine: Opportunities and Challenges.Anesthesiology clinics · 2023Review
- Protocol of a multicentre randomised controlled trial assessing transperineal prostate biopsy to reduce infectiouscomplications.BMJ open · 2023Article
- Participants' informed consent in adaptive, platform drug trials in hospitalized COVID-19 patients: Not all approaches are ethically acceptable.European journal of internal medicine · 2022Article
- An Ethics Checklist for Digital Health Research in Psychiatry: Viewpoint.Journal of medical Internet research · 2022Article
- Patient accrual and understanding of informed consent in a two-stage consent design.Clinical trials (London, England) · 2021Article
- Ethical Acceptability of Postrandomization Consent in Pragmatic Clinical Trials.JAMA network open · 2018Article
- Innovative approaches to informed consent for randomized clinical trials: Identifying the ethical challenges.Clinical trials (London, England) · 2018Article
- TwiC or treat? Are trials within cohorts ethically defensible?Clinical trials (London, England) · 2018Article
- Ethics and practice of Trials within Cohorts: An emerging pragmatic trial design.Clinical trials (London, England) · 2018Article
Corrections and comments
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Authors and funding
4 authors.
Funding
Abstract
Informed consent for randomized trials often causes significant and persistent anxiety, distress and confusion to patients. Where an experimental treatment is compared to a standard care control, much of this burden is potentially avoidable in the control group. We propose a "just-in-time" consent in which consent discussions take place in two stages: an initial consent to research from all participants and a later specific consent to randomized treatment only from those assigned to the experimental intervention. All patients are first approached and informed about research procedures, such as questionnaires or tests. They are also informed that they might be randomly selected to receive an experimental treatment and that, if selected, they can learn more about the treatment and decide whether or not to accept it at that time. After randomization, control patients undergo standard clinical consent whereas patients randomized to the experimental procedure undergo a second consent discussion. Analysis would be by intent-to-treat, which protects the trial from selection bias, although not from poor acceptance of experimental treatment. The advantages of just-in-time consent stem from the fact that only patients randomized to the experimental treatment are subject to a discussion of that intervention. We hypothesize that this will reduce much of the patient's burden associated with the consent process, such as decisional anxiety, confusion and information overload. We recommend well-controlled studies to compare just-in-time and traditional consent, with endpoints to include characteristics of participants, distress and anxiety and participants' understanding of research procedures.
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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.