Informed consent documents: increasing comprehension by reducing reading level.

The purpose of the informed consent process is to ensure that potential volunteers for research studies are informed about risks and benefits so that they can make an informed decision before taking part in a study Written informed consent is critical for communicating such information in research where face-to-face communication is lacking. In the late 1970s, the U.S. Food and Drug Administration (FDA) and the Department of Health and Human Services (HHS) issued rules that required written informed consent to be obtained from individuals taking part in research regulated by or sponsored by these agencies. Clinical studies designed to determine the safety or efficacy of a new pharmaceutical product were the original focus of these rules. However, the concept of informed consent has been extended to other types of research, including psychological research as well as some types of consumer-related research. This last category involves product preference testing on products such as antibacterial shampoos and soaps, and over-the-counter drug products such as aspirin, etc. Product preference research plays an important part in the development of successful consumer products. Product preference testing is used to determine what attributes consumers want and to obtain their evaluations of various characteristics. In conducting medical research, psychological research, and some types of product preference research with healthy subjects, the FDA's Institutional Review Board (IRB) rules require that specific information be presented to potential subjects in the consent procedure. For example, subjects must be told about: (1) the purpose of the research; (2) any possible risks; (3) the benefits of participating; (4) other treatments available (when appropriate); (5) the confidentiality of records; (6) who to contact concerning questions or if complications arise; (7) the consequences of withdrawing from the study; and (8) voluntariness of their participation. Such specifications are useful. However, to be truly informed, this information must be presented in such a way that subjects are able to understand it clearly. Over the past 15 years much of the discussion in the literature relating to informed consent has centered on the informational requirements of informed consent. More recently; there has been some discussion and research on consent comprehension. In an extensive review of research reviewed by IRBs, Gray Cooke, and Tannenbaum found that over 77% of the 1526 consent forms evaluated had readability scores (using the Flesch Readability Yardstick) in the scholarly/academic or scientific/professional range. Other studies have also found that a high percentage of consent forms are written at college level or higher. Many potential research subjects or patients are not reading at a college level or higher, as a result, it is likely that they do not truly understand the procedure or research in which they are agreeing to participate. This concern has been supported indirectly by a number of studies showing that comprehension of consent form information increases with the education and vocabulary level of participants. In addition, other research has indicated poor recall and comprehension of key information presented in consent forms. However, few studies have directly compared the comprehension of consent forms written at different educational reading levels. In addition, very limited research on informed consent has been conducted in a consumer preference research context. Our research on informed consent comprehension was conducted as a result of questions raised by the Procter & Gamble IRB about the consent process. This IRB primarily reviews human testing conducted by Procter & Gamble on consumer products in the low risk category: The primary purpose of this research was to gain insight into the impact the informed consent reading level has on potential volunteer subjects’ comprehension of consent information and their concerns about participating. An additional goal of the study was to examine the impact of delaying for 15 minutes a subject's decision to participate after reading the consent form on both consent form comprehension and concerns about participating. The question was whether the 15 minute delay could affect potential subjects' comprehension of the information presented or their level of concern and thus, their willingness to participate in the research.