The Office of Research has developed an in-house electronic consent tool, Signet. Signet includes a built-in informed consent form builder, electronic signatures and integration with Buck-IRB.
Access
Signet is currently in an open pilot phase. Access to the pilot is restricted to Ohio State investigators who are listed on an IRB protocol with an “obtains consent” activity (or are the principal investigator) and a valid BuckeyePass login. If you would like to use the tool, please email econsentforresearch@osu.edu.
Building a form
Forms in Signet are built using a graphical editor similar to Microsoft Word. Users can create a consent form from scratch or use one of the built-in templates. Users can add sections for signatures, text entry and checkboxes to the consent form as additional interactive elements, if needed.
Once the form is completed, it can be published and the project can begin. If a published form requires revision, additional versions may be created. All signatures obtained for the consent form will be tied to the specific revision that was used at the time of signature.
Electronic signatures
Signet has an electronic signature feature that meets university requirements for a legally binding electronic signature. The authenticity requirement for electronic signatures can vary in the application, depending on the protocol.
Signature types
In-Person Signature: All individuals required to sign the form must be present during the signing process.
- A participant is physically present with the investigator at the time of signing. The investigator must state that they have confirmed the identity of the participant as required by their protocol.
Remote Signing with Access Code: The investigator enters a participant’s name and email address into the system, which generates a secure/unique link + access code combination.
- The system automatically emails the unique link to the participant.
- The access code is presented to the investigator so that he/she can provide the code to the participant using whatever secure methods are required by their protocol (e.g., over the phone or a separate email).
- After the participant signs the consent, the form is directed to the investigator for his/her signature.
The form is complete after the signatures of the participant and investigator are obtained. Upon request (with either signing method), a copy of the completed consent form may be emailed to the participant.
Data retrieval
Researchers may download a consent form (blank or signed version) at any time. Blank consent forms may be uploaded to Buck-IRB or used to obtain an in-person consent signature. Data will be retained by the system as long as required by the associated study.
Integrations
Signet is integrated with Buck-IRB to control who has access to the consent form.
- Only the principal investigator and team member with the “obtains consent” activity may access this information.
- Additionally, consent forms can be exported from Signet and uploaded to Buck-IRB for review.