Consent for research requires participants to understand medical and scientific information that may be complex and unfamiliar. Participants need to make decisions that may involve considerable uncertainty (research, by definition, is designed to create new knowledge). Participants may be unaware of the general features of research (for example, that a given activity may not provide direct benefit). For these reasons, the Belmont Report indicated that consent for research requires a level of understanding above and beyond standard medical care.1
Consent for research is particularly challenging for those with low health literacy, who are disproportionately represented in the population served by public health. Reports by the Institute of Medicine (IOM), the Agency for Healthcare Research and Quality (AHRQ), the American Medical Association (AMA) and the Department of Education (DOE) on health literacy indicate that many people in the United States lack basic health literacy.2
For example, as many as 50% of adults in America are not able to reliably and consistently determine the right dose of cold medicine for a child (Paasche-Orlow, et al, 2003). Thus, it is reasonable to assume that many people would have trouble reading and understanding informed consent forms for treatment or research. Individuals with limited literacy come from all segments of society, but are disproportionately represented in populations served by public health. Many patients seen by the Florida Department of Health do not speak English as their first language. The majority of patients seen by the Florida Department of Health are recipients of some type of financial assistance programs such as Medicaid, Women, Infants, and Children, or Florida’s KidCare Program. According to the most recent National Assessment of Adult Literacy, which includes an assessment of health literacy, about 30% of Medicaid recipients have below basic health literacy.
There is extensive literature documenting that consent forms are too difficult for most people in the United States to read and understand (Sugarman et al, 1999). For example, a recent study of recommended consent templates from US medical schools indicated that the average readability level of the forms was about 10th grade level, and that the language provided by schools exceeded the schools own guidelines for readability in most cases. Schools that had been subject to oversight by the Office of Human Research Protections had improved readability of consent forms (Paasche-Orlow, et al, 2003).
Because of low health literacy in the US and Florida, and because consent forms are often too complex, the Ethics and Human Research Protection Program in the Office of Public Health Research at the Florida Department of Health is taking steps to help researchers improve the readability and understandability of consent documents and educational materials for research participants. "Readability" refers to reading difficulty presented by a particular text. Although readability is not the same as comprehension, improving readability influences the willingness of participants to read and try to understand material. Improving readability of the consent form helps improve the process of informed consent. The Office of Public Health Research reviews reading level as part of our administrative review of applications for Institutional Review Board and informs IRB members of the reading level of informed consent forms.
Readability of research consent forms can be assessed using popular word processing programs, including Microsoft Word. There are a variety of scales that can be used to assess readability. The DOH IRB uses the Flesch–Kincaid readability tests to asses understanding
Researchers should design consent documents and educational materials for a 6th to 8th grade reading level. Paasche-Orlow et al’s federally funded study reviewed the issue of research consent readability, and provides a helpful table illustrating sample consent language written at various grade levels. (Paasche-Orlow, et al, 2003).
Readability involves the length of the consent as well as the way the document is written. There is no “simple formula” to create a more readable consent. Use the examples below to see how similar ideas can be conveyed using different reading levels. The National Cancer Institute has resources on improving informed consent at http://www.cancer.gov/clinicaltrials/understanding/simplification-of-informed-consent-docs/
Also, consider the following general suggestions:
• Replace complex words with simpler words.
• Change compound sentences (multiple thoughts connected with “and”, “but”, “so”, “because”) into two or more short sentences.
• Change passive voice to active voice (change “a sample will be drawn” changed to “We will take a sample”).
• Use simple declarative statements where possible.
Researchers should assess the research population and include consent documents and study documents in languages other than English as appropriate. The level of understanding in the primary language may be greater than in those for whom English is a second language. Consent documents not written in English should be designed to be readable at the 6th-8th grade level.
Researchers can easily find out what languages are spoken in your jurisdiction, and to what extent, by using a free language map tool provided by the Modern Language Association. You also can rank the languages and break down the data into two age groups.
The link is www.mla.org/census_data.
Access the page, then use the box on the left side, entitled, “Entire US, State, or County.” From the pull-down box, "Select type,” choose “county.” From the pull-down box, “Select a State,” select “New York.” From the pull-down box, “Select a county,” choose your county. The chart shows what languages are spoken and the total number of people who speak each language. The same information is available by city, town or ZIP Code.
The State of Florida's Plain Language site: http://www.plainlanguage.gov
The Centers for Disease Control and Prevention has links to additional information, including suggestions for writing for low-literacy populations, at http://www.cdc.gov/dhdsp/CDCynergy_training/Content/phase4/phase4step3resources.htm
National Cancer Institute, Improving Informed Consent
http://www.cancer.gov/clinicaltrials/understanding/simplification-of-informed-consent-docs/
The 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. Washington: 1979. Additional information, and the Report itself are available at: http://www.hhs.gov/ohrp/belmontArchive.html
Berkman N, DeWalt D, Pignone M, et al. Literacy and Health Outcomes. Summary, Evidence Report/Technology Assessment No. 87(Prepared by RTI International - University of North Carolina Evdence-Based Practice Center under Contract No. 290-02-0016). Rockville, Md: Agency for Healthcare Research and Quality; 2004. AHRQ
Nielson-Bohlman L, Panzer A, Kindig D, eds. Health Literacy: A Prescription to End Confusion. Washington, DC: National Academies Press; 2004.
Paasche-Orlow, MK, Taylor, HA, and Brancati, FL. "Readability Standards for Informed-Consent Forms as Compared With Actual Readability." New England Journal of Medicine 348, no. 8 (2003): 721-26.
Sugarman, J, McCrory, DC, Powell, D, Krasny, A, Adams, B, Ball, E, and Cassell, C. "Empirical Research on Informed Consent. An Annotated Bibliography." Hastings Cent Rep 29, no. 1 (1999): S1-42.
1. The Belmont Report reviews a number of standards for informed consent in medicine, and finds each of them inadequate for research: “One standard frequently invoked in medical practice, namely the information commonly provided by practitioners in the field or in the locale, is inadequate since research takes place precisely when a common understanding does not exist. Another standard, currently popular in malpractice law, requires the practitioner to reveal the information that reasonable persons would wish to know in order to make a decision regarding their care. This, too, seems insufficient since the research subject, being in essence a volunteer, may wish to know considerably more about risks gratuitously undertaken than do patients who deliver themselves into the hand of a clinician for needed care. It may be that a standard of "the reasonable volunteer" should be proposed: the extent and nature of information should be such that persons, knowing that the procedure is neither necessary for their care nor perhaps fully understood, can decide whether they wish to participate in the furthering of knowledge. Even when some direct benefit to them is anticipated, the subjects should understand clearly the range of risk and the voluntary nature of participation.” The 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. Washington: 1979. Additional information, and the Report itself are available at: http://www.hhs.gov/ohrp/belmontArchive.html
2. Health literacy means: The degree to which individuals have the capacity to obtain, process, and understand basic health information and services needed to make appropriate health decisions.(HHS 2000 and Institute of Medicine 2004)