The Changing Face of Informed Consent

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the-changing-face-of-informed-consent

Informed consent for a research study brings to mind a paper document with a handwritten signature completed at a clinical research site. However, the paper, ink, and clinical site are not necessary. Sufficient information to enable a participant to make an informed decision can be provided electronically, either on-site (when the investigator and the participant are at the same location) or remotely.

We believe that freeing informed consent and clinical trials from the fetters of paper forms and physical clinical sites has the potential to improve the informed consent process, expand participation, and reduce the costs of trials. E-consent and Internet-based trials should also be studied with the goals of improving their performance and increasing the confidence of patients, investigators, and regulatory authorities in these new methods.

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