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 four 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.
KIE: The authors examined the effects of changes in federal regulations on the readability level and length of information sheets and consent forms used in biomedical and behavioral research in a Veterans Administration medical center from 1975 through 1982. Their findings suggest that consent documents continue to be too difficult for the average volunteer to comprehend, and that regulations designed to insure informed consent may have made it more difficult to obtain. Baker and Taub suggest further research on comprehension as distinct from recall, and on different, potentially promising informed consent procedures.