Consent Comprehension in the 21st Century: What is Missing?
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Consent Comprehension in the 21st Century: What Is Missing?
Readability Mark Hochharser~ Consultant. PhD Golden Valley, Minnesota
Key Words Informed consent; Comprehension; Psychometrics; CorresPordeUce Address Mark Hochhauser. 3344 Scott Avenue North, Golden Vallev, MN 55422 (email: MakH38514 @aol.com).
Because federal regulations and ethical guideline emphasize the importance to subjects of understanding informed consent, many experimental interventions have been tested in hopes of improving subject comprehension. But most consent comprehension studies have not been psychometrically sound, producing inconsistent results because they are missing measurable definitions of comprehension, adequate validity and reliability, itandardized tesi adminis& tion, and scoring and interpretation issues-as well as the pmcticality of using such tests in clin-
IN T R 0 D U (T I0 N Four regulatory and ethical guidelines emphasize the need for prospective subjects to understand the informed consent process: 1. 1949-The Nuremburg Code: "The person involved.. . should have sufficient knowledge and comprehension of the elements of the subject matter involved as to enable him to make an understanding and enlightened decision." Available at: http://ohsr.od.nih.gov/guidelines/nuremberg .html. 2. 1979-Eklmont Report: "Even when some direct benefit to them is anticipated, the subjects should understand clearly the range of risk and the voluntary nature of participation. . . . Investigators are responsible for ascertaining that the subject has comprehended the information.. . . On occasion, it may be suitable to give some oral or written tests of comprehension." Available at: http://ohsr.od .nih.guidelines/Belmont.html. 3. 1981-Federal Regulations (45 CFR 46): "The information that is given to the subject or the representative shall be in language understandable to the subject or the representative." Available at: http://hhs.gov/ohrp/umansubjects/guidance/ 45cfr46.htm. 4. 2000-World Medical Association Declaration of Helsinki: "In any research on human beings, each potential subject must be adequately informed of
ical research settings. As proxy measures for comprehension, readability recommendations to write consent forms at a sixth-eighth grade reading level have not successjidly increased informed consent comprehension either The increasing complexity of clinical trials in the 21 st century may make it impossible to substantially improve comprehension tests unless researchers include those psychometric issues that have been large ignored and better understand what can and cannot be accomplished by naive readability recommendations.
the aims, methods, anticipated health benefits and potential hazards of the study and the discomfort it may entail.. . .After ensuring that the subject has understood the information, the physician should then obtain the subject's freely-given informed consent, preferably in writing." Available at: http://www.wma.net/e/policy/b3.htm.
But are these regulatory and ethical comprehension goals achievab
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