ArticleAnnals of internal medicine2011
Analysis of informed consent document utilization in a minimal-risk genetic study.
Article in Annals of internal medicine, 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 12 papers, 2 of them syntheses that pooled it.
What it found
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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
12 citing papers in PubMed, 2 syntheses or guidelines pooled it.
- Genetic variants in PLG, LPA, and SIGLEC 14 as well as smoking contribute to plasma plasminogen levels.Blood · 2014Pooled it
- Linkage analysis identifies a locus for plasma von Willebrand factor undetected by genome-wide association.Proceedings of the National Academy of Sciences of the United States of America · 2013Pooled it
- Genome-wide association and linkage analysis of histidine-rich glycoprotein identifies common variants associated with plasma histidine-rich glycoprotein concentrations.Research and practice in thrombosis and haemostasis · 2025Article
- Antithrombin, Protein C, and Protein S: Genome and Transcriptome-Wide Association Studies Identify 7 Novel Loci Regulating Plasma Levels.Arteriosclerosis, thrombosis, and vascular biology · 2023Article
- Making a Traditional Spine Surgery Clinic Telemedicine-Ready in the "New Normal" of Coronavirus Disease 2019.Asian spine journal · 2021Article
- Assessing Parent Decisions About Child Participation in a Behavioral Health Intervention Study and Utility of Informed Consent Forms.JAMA network open · 2020Article
- Replacing Paper Informed Consent with Electronic Informed Consent for Research in Academic Medical Centers: A Scoping Review.AMIA Joint Summits on Translational Science proceedings. AMIA Joint Summits on Translational Science · 2020Article
- Genetic variants inBlood advances · 2017Article
- Online Education and e-Consent for GeneScreen, a Preventive Genomic Screening Study.Public health genomics · 2017Article
- Genome-wide studies of von Willebrand factor propeptide identify loci contributing to variation in propeptide levels and von Willebrand factor clearance.Journal of thrombosis and haemostasis : JTH · 2016Article
- Experiences with obtaining informed consent for genomic sequencing.American journal of medical genetics. Part A · 2015Article
- Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
7 authors.
Funding
Abstract
backgroundThe signed informed consent document certifies that the process of informed consent has taken place and provides research participants with comprehensive information about their role in the study. Despite efforts to optimize the informed consent document, only limited data are available about the actual use of consent documents by participants in biomedical research.
objectiveTo examine the use of online consent documents in a minimal-risk genetic study.
designProspective sibling cohort enrolled as part of a genetic study of hematologic and common human traits.
settingUniversity of Michigan Campus, Ann Arbor, Michigan.
participantsVolunteer sample of healthy persons with 1 or more eligible siblings aged 14 to 35 years. Enrollment was through targeted e-mail to student lists. A total of 1209 persons completed the study. MEASUREMENTS: Time taken by participants to review a 2833-word online consent document before indicating consent and identification of a masked hyperlink near the end of the document.
resultsThe minimum predicted reading time was 566 seconds. The median time to consent was 53 seconds. A total of 23% of participants consented within 10 seconds, and 93% of participants consented in less than the minimum predicted reading time. A total of 2.5% of participants identified the masked hyperlink. LIMITATION: The online consent process was not observed directly by study investigators, and some participants may have viewed the consent document more than once.
conclusionFew research participants thoroughly read the consent document before agreeing to participate in this genetic study. These data suggest that current informed consent documents, particularly for low-risk studies, may no longer serve the intended purpose of protecting human participants, and the role of these documents should be reassessed. PRIMARY FUNDING SOURCE: National Institutes of Health.
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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.