The Informed Consent Form: Document Development and Evaluation
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THE INFORMED CONSENT FORM: DOCUMENT DEVELOPMENT AND EVALUATION MARKHOCHHAUSER, PHD Golden Valley, Minnesota
The informed consentprocess can be viewed as a sales presentation, with the consent form serving as the written advertisement for the drug research. So viewed, drug companies can use basic document design, layout and typography principles from advertising, as well as strategies from the “plain English ” movement both to improve recruiting strategies and enhance participant understanding. This article evaluated 12 consent forms for investigational drug studies submitted to a Minnesota hospital institutional review board. Consent form text characteristics were compared to recommendations from the National Cancer Institute. Computer analyses judged the consent forms as difficult to read at a grade 13 to 14 reading level; forms included too many uncommon words, too many words per sentence, and too few active voice sentences, giving a “poor” overall style rating. The 12 forms did not always meet good principles of document design in terms of typeface, paragraph justifcation, and words per line. Several strategies for testing the consent form and reader comprehension were suggested. Key Words: Readability; Informed consent; Document design; Plain English
INTRODUCTION I N SOME WAYS, clinical drug research is a service that research participants can choose to buy-or not buy. Some participants (consumers) may benefit from buying a product (a new drug); many researchers (salespeople) will be paid for each subject they recruit. As a result, some consent forms are beginning to include statements about researcher compensation so that prospective participants can assess the financial aspects of the research project, including possible financial conflicts of interest. So viewed, the consent process can be thought of as a sales presentation, with the consent form being the written advertisement Reprint address: Mark Hochhauser, PhD, 3344 Scott Avenue North, Golden Valley, MN 55422.
for the research. From that perspective, why should drug companies not use basic document design (1) and layout and typography principles (2,3) from advertising, as well as strategies from the “plain English” movement to improve both participant recruitment efforts as well as participant understanding of the research project? One review found 14% to 44% refusal rates (4) although the reasons for such refusals are not clear. In October 1998, the National Cancer Institute (NCI) ( 5 ) published recommendations for developing informed consent documents for cancer clinical trials. Appendix 3 of that document is a checklist that can help ensure the development of easy-to-read consent forms. Unfortunately, the checklist is very brief, and does not include examples or explanations for any of the over 30 recommendations for text and graphic items.
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Mark Hochhauser
METHODS The researcher is a member of the Institutional Review Commi
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