Can an electronic signature instead of a handwritten signature be used to document informed consent?
Yes, a written consent, which may be an electronic version, must be given to and signed by the subjects or the subjects’ legally authorized representatives, unless the IRB waives the requirement to obtain informed consent [45 CFR 46.116(d)] or the IRB waives the requirement to obtain a signed consent form [45 CFR 46.117(c)]. In addition, some form of the informed consent document must be made available to the subjects or the subjects’ legally authorized representatives in a format that they can retain. For example, subjects or the subjects’ legally authorized representatives may be provided a hard copy of the signed consent form. Further, a secure system that provides encrypted identifiable signatures must be used when obtaining electronic or digital signatures.
