Monitoring Informed Consent Procedures: An Exploratory Record Review

Probably no aspect of the ethics of human research has received closer review by institutional review boards (IRBs) than that of informed consent. In a recent nationwide survey of IRB practices, modification of consent forms was found to be the most frequent substantive change requested of investigators.' However, this survey also found that IRBs were largely ineffective in improving the quality of consent procedures. IRB proposals for modification were largely limited to the content of consent forms. These modifications were found not to enhance either the completeness or the readability of the forms. One mechanism for upgrading the performance of IRBs in relation to informed consent would involve periodic IRB monitoring of the consent process. At present, most IRBs have no mechanism for monitoring the consent procedures they approve, nor do they generally require investigators to conduct internal consent audits. However, the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research recom-