ArticleClinical trials (London, England)2021
Details of risk-benefit communication in informed consent documents for phase I/II trials.
Article in Clinical trials (London, England), 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 10 papers, 1 of them a synthesis that pooled it.
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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
10 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Early-Phase Clinical Trials of Bio-Artificial Organ Technology: A Systematic Review of Ethical Issues.Transplant international : official journal of the European Society for Organ Transplantation · 2022Pooled it
- Very Low Uptake in Workplace Semen Analysis Research: Formative Web-Based Cross-Sectional Follow-Up Survey Distinguishing Employees With Self-Reported Unawareness From Aware Nonparticipants.JMIR formative research · 2026Article
- Informed consent and risk communication challenges in antimicrobial clinical trials: a scoping review.BMJ open · 2024Article
- Reporting of surrogate endpoints in randomised controlled trial reports (CONSORT-Surrogate): extension checklist with explanation and elaboration.BMJ (Clinical research ed.) · 2024Article
- Reporting of surrogate endpoints in randomised controlled trial protocols (SPIRIT-Surrogate): extension checklist with explanation and elaboration.BMJ (Clinical research ed.) · 2024Article
- Improving oncology first-in-human and Window of opportunity informed consent forms through participant feedback.BMC medical ethics · 2023Article
- Empirical studies on how ethical recommendations are translated into practice: a cross-section study on scope and study objectives.BMC medical ethics · 2023Article
- [Transparency in clinical research: What contribution does the new EU Regulation 536/2014 make?]Bundesgesundheitsblatt, Gesundheitsforschung, Gesundheitsschutz · 2023Review
- States of Uncertainty, Risk-Benefit Assessment and Early Clinical Research: A Conceptual Investigation.Science and engineering ethics · 2022Article
- Four reasons why too many informed consents to clinical research are invalid: a critical analysis of current practices.BMJ open · 2022Review
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Authors and funding
4 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundInformed consent documents for clinical studies should disclose all reasonably foreseeable risks and benefits. Little guidance exists on how to navigate the complexities of risk-benefit communication, especially in early clinical research. Practice-oriented development of such guidance should be informed by evidence on what and how details of risks and benefits are currently communicated.
methodWe surveyed the responsible parties of phase I/II trials registered in ClinicalTrials.gov that started 2007 or later and completed between 2012 and 2016 to sample informed consent documents from a broad spectrum of early phase clinical trials. Based on an assessment matrix, we qualitatively and quantitatively assessed the informed consent documents for details of risk-benefit communication.
resultsThe risk-benefit communication in the 172 informed consent documents differed substantially in several regards. The outcome, extent, and likelihood of health risks, for example, were described in 83%, 32%, and 63% of the informed consent documents. Only 45% of informed consent documents specified the outcome of mentioned health benefits, and the extent and likelihood of health benefits were never specified. From those informed consent documents reporting risk likelihoods, only 57% added frequency numbers to words such as "common" or "rare," and even in these cases, we found strong variations for presented frequency ranges. Substantial heterogeneity also exists for how informed consent documents communicate other risk and benefit types and related safeguards.
conclusionOur study points to several shortcomings and heterogeneities in how informed consent documents communicate risks and benefits to potential research participants. Health risks, for example, should be specified with frequency numbers, and health benefits should be specified at least by mentioning their outcomes. Further demand for research and policy development is needed to harmonize risk-benefit communication and to clarify ways to specify the likelihood of health benefits.
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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.