making decisions because they are not easily comprehended, this failure constitutes an important deficit in the informed consent and permission process. In principle, investigators can compensate for some shortcomings in consent forms as they talk with people and explore their understanding of research participation. In reality, little is known about these conversations, including whether they can compensate for deficient consent forms. Although forms should not be the main focus of the consent and permission process, the exercise of developing a clear, readable, and informative consent document can contribute to the design and implementation of a clear, understandable, and constructive process for seeking informed consent or permission.
Research institutions and IRBs typically provide the same forms and related guidance for studies that involve adults making decisions about their own participation in research and for studies that have parents making decisions about their child’s participation. Study after study has found that the consent forms for medical treatment or research participation typically require high levels of education or, at least, levels of education higher than the average for key patient or study populations (e.g., low-income patients) (see, e.g., Ogloff and Otto, 1991; Rivera et al., 1992: Grossman et al., 1994; Hopper et al, 1995, 1998; Goldstein et al., 1996; and Paasche-Orlow et al., 2003). This is a serious problem given, that surveys suggest that more than one-fifth of adults in the United States have very limited literacy skills and that another quarter have seriously limited skills (Kirsch et al., 1993).
Consistent with other studies of consent forms for adults, one analysis of forms for the parents of prospective child participants in an array of biomedical research studies at a single hospital found that forms were written at the college-graduate level (Tarnowski et al., 1990). The researchers also found that forms had gotten longer but not more readable over a 10-year period.
Another study of institutional consent forms (for clinical care) and vaccine information pamphlets intended for parents reported that the forms generally required a reading level of 12th grade or above and the pamphlets required an 11th-grade reading level or higher (Davis et al., 1990). In reality, the inner-city parents at the investigators’ institution had a median reading level just below the seventh grade. A second study with the same lead author assessed educational materials from the American Academy of Pediatrics, the Centers for Disease Control and Prevention, and other sources. It found that parents at the outpatient pediatric clinic tested at a seventh- to eighth-grade reading level but that 80 percent of the educational materials required at least a 10th-grade reading level (Davis et al., 1994).
Unfortunately, efforts to make consent forms more readable have their limitations. The authors of one recent analysis of consent forms concluded,