Can an electronic signature be used to document consent or parental permission?
Yes, under certain circumstances. First, the investigator and the IRB need to be aware of relevant laws pertaining to electronic signatures in the jurisdiction where the research is going to be conducted. Unless the IRB waives the requirement for the investigator to obtain a signed consent or permission form based on the HHS regulations at 45 CFR 46.117(c), a written consent or permission form, which may be an electronic version, must be given to and signed by the subjects or the subjects’ legally authorized representatives or the parents of subjects who are children. Some form of the consent document must be made available to the subjects or the parents of subjects who are children in a format they can retain. OHRP would allow electronic signature of the document if such signatures are legally valid within the jurisdiction where the research is to be conducted. OHRP does not mandate a specific method of electronic signature. Rather, OHRP permits IRBs to adopt such technologies for use
