Comprehension of Informed Consent for Research: Issues and Directions for Future Study

Abstract

policy to protect the rights of human subjects participating in biomedical and behavioral research,' and each individual investigator bore responsibility for this process. Although the informal procedure appeared, on the surface, to be adequate, a growing body of reports of serious abuses and infringements on the basic human rights of subjects'-5 led to the development of increasingly specific requirements for presentation of written information and for signed documentation of voluntary informed consent.