In Search of Informed Consent Improvement

For years now, clinical research professionals across a variety of disciplines—from government- and industry-funded research sponsor professionals to investigative site staff, bio-ethicists, and IRB members—have spoken passionately about the need for improvements in the informed consent process. Numerous initiatives have been implemented, including those utilizing multimedia technologies, those simplifying and streamlining consent form language, and those modifying approaches to communicating and educating study volunteers. Despite all of these well-intentioned initiatives, however, little has been done to fundamentally and sustainably improve the informed consent process.

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