ArticleIRB
Reaping the Bounty of Publicly Available Clinical Trial Consent Forms.
Article in IRB. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers.
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
6 citing papers in PubMed.
- Availability of consent forms in ClinicalTrials.gov for industry-sponsored trials.Health affairs scholar · 2025Article
- Consent Form Reporting on ClinicalTrials.Gov, 2013-2023.JAMA network open · 2024Article
- Characterization of Informed Consent Forms Posted on ClinicalTrials.gov.JAMA network open · 2021Article
- Increasing diversity in research through dedicated language access services.Contemporary clinical trials · 2021Article
- 10-Year Update on Study Results Submitted to ClinicalTrials.gov.The New England journal of medicine · 2019Article
- New requirements for clinical trial transparency provide new opportunities for informatics research.Journal of the American Medical Informatics Association : JAMIA · 2019Article
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.
Funding
Abstract
Public access to clinical trial consent forms, beyond those individuals involved in reviewing, conducting, or participating in a trial, has been notoriously poor, resulting in missed opportunities for empirical analysis and improvement, among other benefits. However, recent changes to the Common Rule and policies governing ClinicalTrials.gov promise to make trial consent forms more accessible to the public, including prospective trial participants, other trialists and IRBs, and those seeking to study research consent. Analysis of publicly available consent forms can facilitate development of best practices, make the process of drafting consent forms more efficient, and provide insight into how well consent forms are satisfying their mission of protecting and promoting the autonomy of trial participants. Gaps in public access will remain even under the new policies, but we are on the cusp of an exciting new dataset that can contribute to addressing a perpetual challenge in research ethics: optimal informed consent.
Indexed as
Identifiers
29881132PMC5985974What 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.