Most consent forms fail to make informed patients

Attention to readability and health literacy is critical for informed consent forms. But most consent forms marketed by commercial laboratories aren't given the attention they deserve.

It is widely acknowledged by groups such as the National Institute of Health that patient education literature should be written at a sixth to eighth grade reading level.1-7 Writing patient education materials within these reading levels optimizes a patient’s health literacy. It is prudent to assess the readability of patient education materials provided by a commercial laboratory before use in medical practice.

We assessed the readability of 18 consent forms obtained from nine laboratories using a software package called Readable.

What did we find?

  • Most consent forms do not meet basic standards for patient education.
  • Readability metrics for Progenity show it is possible to write consent forms at an inclusive reading level.
  • These results indicate that most laboratories do not give adequate attention to readability and health literacy when creating patient consent forms for genetic testing.


This research was shared with the 2020 American College of Medical Genetics (ACMG) Annual Clinical Genetics Meeting, Digital Edition.

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  1. National Institutes of Health. How to Write Easy to Read Health Materials. National Library of Medicine Web site. Available at: Accessed Feb 1, 2009.
  2. Centers for Disease Control and Prevention Web site. Scientific and Technical Information Simply Put. Available at: Accessed Jan 9, 2020.
  3. Nielsen-Bohlman L, et al.. Health Literacy: A Prescription to End Confusion. Washington, DC: Institute of Medicine, National Academies Press; 2004.
  4. Cotugna N, et al. Evaluation of literacy level of patient education pages in health-related journals. J Community Health. 2005;30:213–219.
  5. Weiss BD. Health Literacy: A Manual for Clinicians. Chicago, IL: American Medical Association, American Medical Foundation; 2003.
  6. Weiss BD, et al. Illiteracy among Medicaid recipients and its relationship to health care costs. J Health Care Poor Under-served. 1994;5:99–111.
  7. Badarudeen S, Sabharwal S. Assessing readability of patient education materials: current role in orthopaedics. Clinical Orthopaedics and Related Research. 2010 Oct;468(10):2572-2580.
  8. Latimer et al. Consent forms marketed by commercial laboratories vary in readability. Poster presented at the 2020 ACMG Annual Clinical Genetics Meeting, Digital Edition.