Readability of informed consent forms for research in a Veterans Administration medical center

Abstract

This study examined the effects of federal regulations on the readability and length of consent forms used in medical research from 1975 through 1982. Materials evaluated were 49 information sheets from 4 sample time periods and the 1975 and 1979 revisions of the Veterans Administration consent document. Flesch readability scores were at college level for both the consent documents and information sheets from all sample time periods. Thus, consent forms always may have been too difficult for typical volunteers to comprehend. Changes in length and content of the consent documents suggest that difficulty levels actually may have increased since 1975. Efforts to protect the rights of research subjects through federal regulations have resulted in presentation of appropriate information, but little progress has been made in ensuring that the information is comprehensible, understood and used.