ArticleJournal of empirical research on human research ethics : JERHRE2013
How IRBs view and make decisions about consent forms.
Article in Journal of empirical research on human research ethics : JERHRE, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 15 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
15 citing papers in PubMed.
- A randomized control trial of re-designed and shorter research informed consent forms to improve comprehension.Clinical trials (London, England) · 2026Trial
- Considerations for the Design of Informed Consent in Digital Health Research: Participant Perspectives.Journal of empirical research on human research ethics : JERHRE · 2024Article
- Standards of evidence for institutional review board decision-making.Accountability in research · 2021Article
- Motivation to participate and experiences of the informed consent process for randomized clinical trials in emergency obstetric care in Uganda.BMC medical ethics · 2021Article
- Researchers' views on, and experiences with, the requirement to obtain informed consent in research involving human participants: a qualitative study.BMC medical ethics · 2020Article
- Assessing Parent Decisions About Child Participation in a Behavioral Health Intervention Study and Utility of Informed Consent Forms.JAMA network open · 2020Article
- Genomics, Big Data, and Broad Consent: a New Ethics Frontier for Prevention Science.Prevention science : the official journal of the Society for Prevention Research · 2018Article
- DNA.Land is a framework to collect genomes and phenomes in the era of abundant genetic information.Nature genetics · 2018Article
- Perceived Risks and Benefits in a Text Message Study of Substance Abuse and Sexual Behavior.Ethics & behavior · 2018Article
- Ethical issues of informed consent in malaria research proposals submitted to a research ethics committee in Thailand: a retrospective document review.BMC medical ethics · 2017Article
- Therapeutic Misconception in Psychiatry Research: A Systematic Review.Clinical psychopharmacology and neuroscience : the official scientific journal of the Korean College of Neuropsychopharmacology · 2016Article
- Reading Level and Length of Written Research Consent Forms.Clinical and translational science · 2015Article
- How IRBs view and make decisions about social risks.Journal of empirical research on human research ethics : JERHRE · 2013Article
- Article
- Mandating Evidence-Based Informed Consent Practices: A Critical Engagement with IRB Leader Focus Group Findings.Ethics & human researchArticle
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
1 author.
Funding
Abstract
IRBs have been criticized for long and complicated consent forms, but how IRBs make decisions about these issues hasn't been examined. I contacted leaders of 60 IRBs, and interviewed IRB leaders from 34 (response rate = 55%), and 13 members and administrators. IRBs confront challenges and dilemmas regarding these documents: what and how much these forms should include (e.g., how "perfect" forms should be). While IRBs generally seek to decrease the length and complexity, institutions and industry funders often want these forms to be legal documents. IRBs may also "nitpick" these documents without realizing the costs. This study, the first to explore how IRBs view and make decisions about consent forms, suggests underlying tensions, ambiguities, and subjectivities that have important implications for future policy, practice, education, and research.
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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.