Health Literacy and the IRB

Considering Literacy while Conducting Medical and Public Health Research: Informed Consent Procedures

By: Leeann Siegel

Most recently, I have been working with a community-based organization conducting research. I came to appreciate, first hand, some of the challenges posed by informed consent procedures.

Obtaining informed consent is a critical step in the ethical conduct of research involving human subjects and is mandated by both the Department of Health and Human Services and the Food and Drug Administration.1 However, for informed consent procedures to serve their intended purpose of empowering individuals to voluntarily decide whether or not they will participate in a study, potential research subjects must be presented with information they can understand and use in their decision-making processes.2 Unfortunately, as several studies have demonstrated, the language used in consent forms is often complex and written at a reading level that far exceeds the reading skills of many Americans, particularly the nearly 50% of U.S. adults who are estimated to have limited health literacy.3,4,5 In order to prevent literacy barriers from compromising the effectiveness of the informed consent procedures used in their studies, investigators conducting medical or public health research must consider the demands these procedures place on potential research subjects.

Many Institutional Review Boards (IRBs) provide guidance and template language to aid researchers in the development of easy-to-read consent documents. However, in a 2003 study Paasche-Orlow et al assessed the suggested text for consent documents provided by the IRBs of over 100 medical schools and found that, for the most part, these texts were written at an inappropriately high reading level that would not be suitable for a general audience. In fact, a substantial number of these IRBs provided sample text that significantly exceeded their own specified reading level standards.6 When the researchers repeated their study ten years later, they found that the average readability of template consent form language provided by medical school IRBs had improved only marginally. Furthermore, the additional content many consent forms were now required to include under the Health Insurance Portability and Accountability Act (HIPAA) was complex and written at a particularly high reading level, presenting an additional barrier to comprehension.7

Despite these findings, tools and resources do exist that can aid researchers in the development of consent documents that are suitable for populations with varying levels of literacy. Some of these are listed below.

Useful Tools and Resources:

Additionally, many recent studies have looked beyond the consent document to clarify other interventions that might prove effective in creating informed consent procedures that promote improved comprehension among potential participants. The two articles listed below summarize and discuss findings from this growing body of literature.

Modifying Informed Consent Procedures – Literature Reviews:

  • Tamariz L, Palacio A, Robert M, Marcus E. (2013). Improving the Informed Consent Process for Research Subjects with Low Literacy: A Systematic Review. Journal of General Internal Medicine, 28(1): 121-126.
  • Flory J, Emanuel E. (2004). Interventions to Improve Research Participants’ Understanding in Informed Consent for Research: A Systematic Review. JAMA, 292(13): 1593-1601.


References Cited:

  1. Code of Federal Regulations for the Protection of Human Subjects in Research, U.S. Department of Health and Human Services, 1998, 21 CFR Part 50 ( and 45 CFR Part 46 (
  2. Sugarman J, Paasche-Orlow M. (2006). Confirming comprehension of informed consent as a protection of human subjects. Journal of General Internal Medicine, 21(8): 898-899.
  3. Sudore R, Landefeld CS, Williams B, Barnes D, Lindquist K, Schillinger D. (2006). Use of a Modified Informed Consent Process among Vulnerable Patients: A Descriptive Study. Journal of General Internal Medicine, 21(8): 867-873.
  4. Paasche-Orlow M, Taylor H, Brancati F. (2003). Readability standards for informed-consent forms as compared with actual readability. New England Journal of Medicine, 348(8): 721-726.
  5. Rudd R. (2007). Health Literacy Skills of U.S. adults. American Journal of Health Behavior, 31(Suppl 1): S8-S18.
  6. Paasche-Orlow M, Taylor H, Brancati F. (2003). Readability standards for informed-consent forms as compared with actual readability. New England Journal of Medicine, 348(8): 721-726.
  7. Paasche-Orlow M, Brancati F, Taylor H, Jain S, Pandit A, Wolf S. (2013). Readability of Consent Form Templates: A Second Look. IRB: Ethics & Human Research, 35(4): 12-19.