Length and Complexity of US and International HIV Consent Forms from Federal HIV Network Trials
- 174 Downloads
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.
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.
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.
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.
KEY WORDSinformed consent HIV clinical trials
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
- 1.National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. The Belmont Report: Ethical principles and guidelines for the protection of human subjects of research. 1979. (Accessed May 26, 2011 at http://ohsr.od.nih.gov/guidelines/belmont.html)
- 2.World Medical Association. Declaration of Helsinki: Ethical Principles for Medical Research Involving Human Subjects. 2000. (Accessed May 26, 2011at http://ohsr.od.nih.gov/guidelines/helsinki.html)
- 3.Faden RR, Beauchamp TL. A History and Theory of Informed Consent. New York: Oxford University Press; 1986.Google Scholar
- 4.Office of Human Subjects Research, National Institutes of Health. Guidelines for Writing Informed Consent Documents. 2006. (Accessed May 26, 2011at http://ohsr.od.nih.gov/info/sheet6.html)
- 6.Informed Consent Working Group, National Cancer Institute (NCI), Office of Human Research Protections, US Food and Drug Administration. Recommendations for the Development of Informed Consent Documents for Cancer Clinical Trials. 1998. (Accessed May 26, 2011at http://www.cancer.gov/clinicaltrials/education/simplification-of-informed-consent-docs/page2)
- 15.Leroy T, Christophe V, Penel N, et al. Factual understanding of randomized clinical trials: a multicenter case-control study in cancer patients. Invest New Drugs 2009. doi: 10.1007/s10637-009-9315-8.
- 23.Kripalanni S, Bengtzen R, Henderson LE, et al. Clinical research in low-literacy populations: using teach-back to assess comprehension of informed consent and privacy information. IRB. 2008;30(2):13–9.Google Scholar
- 26.UNESCO Institute for Statistics. National literacy rates for youths and adults. (Accessed May 26, 2011 at http://stats.uis.unesco.org/unesco/TableViewer/tableView.aspx?ReportId=210)
- 27.European Medicines Agency. ICH Topic E6 (R1) Guideline for Good Clinical Practice. 2002. (Accessed May 26, 2011 at http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500002874.pdf)
- 29.Schnelbach S, Wyatt C. Tameri Guide for Writers: How Many Words? (Last accessed May 26, 2011 at http://www.tameri.com/format/wordcounts.html)