It is permissible for subjects to fax a signed copy of the consent form to the research team. See FDA-regulated studies – electronic signature requirements below for details. The FDA has specific requirements for electronic signatures that apply to FDA-regulated research. Per the US Office of Human Research Protections (OHRP): “One method of allowable electronic signatures in some jurisdictions is the use of a secure system for electronic or digital signature that provides an encrypted identifiable ‘signature.’ If properly obtained, an electronic signature can be considered an ‘original’ for the purposes of record keeping.” In other words, it would satisfy requirements in case of an audit. When the IRB reviews the study, it will consider how the electronic signature is being created, whether the signature can be shown to be legitimate, and how the research team plans to provide a version of the consent form to the potential subject for their review and retention.

Subjects must be provided with a version of the consent form that they can retain for their records, whether it is a hard copy or an electronic version. The revised Common Rule also includes language that clarifies, “informed consent shall be documented by the use of a written informed consent form approved by the IRB and signed (including in an electronic format) by the subject…” In either situation, the consent process itself should be designed to ensure that participants are adequately informed about the research, can easily ask and get answers to questions, and recognize that participation is voluntary.įederal regulations allow electronic signatures to document informed consent (see Joint Guidance on Use of Electronic Informed Consent). This guidance describes other methods that are also sufficient documentation of informed consent.Įlectronic documentation of consent may be used when researchers conduct the consent process with participants in person, as well as when potential participants are not physically present during the consent process. Most frequently, subjects document informed consent by providing their written signature in the provided space, at the end of the consent form. The purpose of this document is to provide guidance on documenting consent obtained from subjects utilizing methods other than pen and paper.

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