Exploring the Readability of Consent Forms in Human Research in the United States Air Force

摘要

Informed consent documents used in human subject research within the United States Air Force appear increasingly complex and lengthy based on the level of risk, or potential harm to a human research subject, and are rife with both medical and legal terminology. It becomes difficult to discern whether the intent of consent forms is to inform the patient or protect the researcher and organization from litigation. A literature review highlighted two observations: (1) consistently, every article published about consent forms concluded that these documents were too complex for the lay person; and (2) there is a gap in the literature concerning the readability of consent forms in military protocols. Using a 1997 study conducted by Mader and Playe (n = 94) as a foundation, this study evaluated the readability of consent forms (n = 21) in human research performed within the U.S. Air Force. Studying the effects of 10 dependent variables based on 2 levels of risk (minimal risk and greater than minimal risk), the author found significance across 3 of 10 variables with Air Force consent forms (p <.01). The validity of the study was strengthened by similarities with the results of Mader and Playe (1997). The results demonstrate that the readability of consent forms within the U.S. Air Force is too complex for the average reader. A readability standard of the sixth grade level is difficult to meet, but such a standard would better serve the interests of participants in human subject research because it would allow them to understand the methods, risks, benefits, and alternatives of the research. The Nuremburg Code (1947), the Belmont Report (1976), and the Declaration of Helsinki (1964/2000) demand that the rights of individual patients and human research subjects be placed above scientific and societal goals. The author argues that when subjects of studies cannot understand the contents of a consent form, their autonomy is not respected.