Informed consent research on subjects' understanding needed "desperately," HHS' Ellis says.
This article was originally published in The Gray Sheet
INFORMED CONSENT PROCESS RESEARCH "DESPERATELY NEEDED" to determine the degree to which research participants understand the consent forms they sign, Gary Ellis, director of the HHS Office of Protection from Research Risks, said Oct. 19 in Boston. Speaking at a Tufts University School of Medicine-sponsored Public Responsibility in Medicine & Research conference, Ellis stated: "The specificity of the federal regulatory language that has endured through many years and the enthusiasm with which we all adhere to it all belie the fact that little empirical work exists to document the degree of understanding achieved by research participants."
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