Evidence map›Paper›PMID 21748435›Full record

ArticleJournal of general internal medicine2011

Length and complexity of US and international HIV consent forms from federal HIV network trials.

Nancy E Kass, Lelia Chaisson, Holly A Taylor, Jennifer Lohse

Abstract readComparative Study
PubMed Full text at PMC Publisher
In one paragraph

Article in Journal of general internal medicine, 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 38 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
38citing papers in PubMed, 2 pooled it
–field-weighted citation impact
1 · What the graph read from it

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.

2 · The registry

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.

3 · Its place in the literature

Who cites it

38 citing papers in PubMed, 2 syntheses or guidelines pooled it.

  1. Pooled it
  2. Pooled it
  3. Trial
  4. Trial
  5. A randomized controlled trial of an electronic informed consent process.Journal of empirical research on human research ethics : JERHRE · 2014
    Trial
  6. Trial
  7. Trial
  8. Article
  9. Article
  10. Article
  11. Review
  12. Article
  13. Article
  14. Article
  15. Article
  16. Article
  17. Article
  18. Review
  19. Informing Informed Consent for HIV Research.Journal of empirical research on human research ethics : JERHRE · 2020
    Article
  20. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

4 authors.

Nancy E KassJohns Hopkins Berman Institute of Bioethics, Baltimore, MD 21205, USA. nkass@jhsph.edu
Lelia Chaisson
Holly A Taylor
Jennifer Lohse

Funding

Testing Modified Approaches to Informed ConsentR21AI074005 · NIAID · JOHNS HOPKINS UNIVERSITY · PI KASS, NANCY E · 2008 to 2010
$582k
NIAID NIH HHS 1R21AI074005-01A1NIAID NIH HHS R21 AI074005
6 · The paper itself

Abstract

backgroundInformed consent is required in most clinical research with humans. While federal regulations state consent information should be understandable to participants, concerns have been raised that consent forms are overly long and complex.

designConsent forms from 2006 HIV network trials sponsored by the National Institutes of Health (NIH), Division of AIDS (DAIDS), were analyzed for complexity and length. Comparisons were made between US and international sites, template and site forms, adult and pediatric trials, and trial type. How randomization and placebos were explained was examined as these are frequently misunderstood.

resultsOne hundred twenty-four consent forms (21 template and 103 site forms) were reviewed. Median readability was 9.2 grade level, although confidentiality sections were 12.35 median grade level. International sites' forms had lower readability than US forms (p = 0.025), template forms had lower readability than site forms (p = 0.046), and adult forms were less complex than pediatric (parent) forms (p < 0.0001). Median length of all forms was 22.4 pages; the 85 forms from adult studies had a median length of 27.4 pages. Sections describing randomization were a median length of 53 words.

conclusionsConsent forms are extremely long, exceeding recommendations for how much information readily can be processed. Networks should consider providing shorter consent templates, consistent with federal recommendations, given that sites' forms are based on these models. Further research should examine whether forms emphasizing key information (rather than providing details about all aspects of the research) improve understanding of research.

Indexed as

Clinical Trials as TopicHIV InfectionsInternationalityComprehensionEthics, ResearchHumansInformation ServicesInformed ConsentReadingResidence CharacteristicsStatistics as TopicTime FactorsUnited States

Identifiers

PMID21748435
PMCPMC3208469

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

None linked

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.