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Length and Complexity of US and International HIV Consent Forms from Federal HIV Network Trials

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Abstract

BACKGROUND

Informed 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.

DESIGN

Consent 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.

RESULTS

One 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.

CONCLUSIONS

Consent 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.

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Acknowledgements

This study was funded by the grant from NIAID,1R21AI074005-01A1, Testing Modified Approaches to Informed Consent, as well as a personal research discretionary fund. The authors wish to thank Jessica Holzer, Jonathan Kagan, and Nandita Chopra for their assistance.

Conflicts of Interest

None disclosed.

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Authors and Affiliations

  1. Johns Hopkins Berman Institute of Bioethics, 1809 Ashland Ave., Baltimore, MD, 21205, USA

    Nancy E. Kass ScD, Lelia Chaisson BA, Holly A. Taylor PhD, MPH & Jennifer Lohse BA

  2. Johns Hopkins Bloomberg School of Public Health, 1809 Ashland Ave., Baltimore, MD, 21205, USA

    Lelia Chaisson BA, Holly A. Taylor PhD, MPH & Jennifer Lohse BA

Authors
  1. Nancy E. Kass ScD
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  2. Lelia Chaisson BA
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Correspondence to Nancy E. Kass ScD.

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Kass, N.E., Chaisson, L., Taylor, H.A. et al. Length and Complexity of US and International HIV Consent Forms from Federal HIV Network Trials. J GEN INTERN MED 26, 1324–1328 (2011). https://doi.org/10.1007/s11606-011-1778-6

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  • DOI: https://doi.org/10.1007/s11606-011-1778-6

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