As with the standard consent process for written consent, the electronic consent process has two parts:
- Consent Discussion: Informing a participant using electronic means.
- Consent Documentation: The individual indicates agreement to participate in the study by documenting consent using an electronic signature.
Before involving a person in research, an investigator needs to obtain and document the legally effective informed consent of that person (45CFR46.116). Historically, documenting consent would mean a written signature on a paper consent form stating that the person agreed to participate in the study. As technology has advanced, electronic (and digital) signature has become acceptable for documenting legally effective informed consent if implemented correctly by the study team.
The Board can grant a waiver of documentation of consent for studies which have been determined to be no more than minimal risk. This means that the requirement to collect a written signature (documentation of consent) has been waived (is not required) and for that study, the study team is not required to document a written signature on the consent form. This type of consent process can be helpful for remote studies that are minimal risk. The templates for consent forms without signature can be found here.
Please remember that collection of written signature (whether wet-ink or electronic) from a person to document their informed consent to participant in the study is always the default expectation. The study team should clearly indicate in their protocol if they would like to request the IRB-SBS to grant a waiver of documentation of consent.
If your study qualifies as minimal risk and the study has been granted a waiver of documentation of consent, then the study team will not be required to document a signature from participants. For example, an anonymous online survey is often determined by the Board to be exempt and not requiring documentation of participant consent. However, the Board requires that you provide participants with an “electronic study information” page (also called a consent without signature) that covers the same required elements of the consent form even though you are not required to document consent. In most cases, this information/consent is provided to the participants electronically on the first page that they see before engaging the survey activity.
Researchers will often include an “electronic study information/notification” page at the introduction of an online survey or online study with an “I agree” button indicating that the participant agrees with the electronic study notification before they proceed with the survey. To be clear, this process of asking the participant to select an “I agree” button does not constitute legally effective documentation of consent, but it is acceptable if the study has been granted a waiver of documentation of consent. Alternatively, participants could click the “continue” button to indicate their agreement with the consent information in the electronic study notification and to move them onto the next step in the online study.
Finally, it is important to provide participants with instructions on how to access a copy of the electronic study notification (consent without signature). For example, you could instruct participants to print the screen to retain a copy of the study information. Please see the Consent Templates page for an example document of how to provide an electronic study notification to participants.
Again, please remember that collection of a legally effective written signature from a person to document their informed consent to participate in the study is always the default expectation. If you plan to use an electronic consent process, you will need to explain the process of documenting consent in your protocol and provide a copy of the electronic consent form. An electronic consent form needs to cover all the required consent information as provided in the Electronic Consent Template. In general, it is expected that the study team will adapt the consent process to the online format in a way that makes sense for participants and helps them to understand the information provided about the study.
Because an electronic consent form differs from a paper consent form, you will need to do the following:
- Provide participants with a way to access a copy of the consent form.
- For example, you could include instructions on how to print the consent form or provide a mechanism to email a copy of the consent form to the participant.
- Use an application that meets the required UVA Data Security standards.
- Document consent using an electronic signature (see below).
- Document the participant’s agreement, through two separate consent fields:
- A field to confirm that the person agrees to participate in the study.
- A field to confirm that the person agrees to provide electronic consent (see below).
An electronic signature can be used as legally effective documentation of consent. To be legally effective, the electronic signature needs to be attributable to a verified identity. (Note: This only applies to studies conducted in the United States. If you are conducting research outside of the United States and want to document consent using electronic signatures, you will need to become familiar with the foreign country’s laws regarding what constitute a legal signature.)
Examples of how this could be accomplished include:
- Having the potential study participant write their signature on a digital screen when in the presence of a member of the study team (either physically present or remote via a video conferencing platform).
- Typing of name to indicate electronic signature when the potential study participant is signed into a password protected system like NetBadge (please note that NetBadge identifiers should be recorded from the system).
- The potential study participant could orally agree on a digital recording to provide their consent by electronic signature.
- Sending an email to a school email address or text message to a phone number given by the potential participant with a link to access the electronic consent included in the message.
As noted above, a participant clicking “I agree” after reading the informed consent does not constitute a legally effective documentation of informed consent. Always review your approved protocol to confirm whether documentation of informed consent is required or has been waived.
Again, if you are conducting a study that requires you to document consent, you must ensure that participants’ electronic consents can be traced to their verified identities for the electronic signature to be legally effective. The ability to verify identity and show that the signature is attributable to the study participant is important to consider when designing the consent process for the study and choosing the electronic platform/program to use for the consent process. An email address alone may not be considered adequate to verify identity.
Your protocol must also provide a basic explanation about how an application or platform keeps participant data secure.
Unique to studies using electronic signatures is the requirement to obtain an agreement from the participant to sign the consent electronically. This may be done in a separate form or within the consent document itself. The statement/notification for the participant’s agreement to sign electronically should be clearly displayed and separately agreed to (e.g., with its own “I agree” button). For an example, please see the Electronic Consent Template (see the Consent Templates page under the “Consent or Assent (signature required)” header).
For example, if using Qualtrics, you can add a “signature question” which allows the user to handwrite a name in the box. However, if the potential participant’s identify is not verified in some way (for example, by visual interaction with the study team or through digital identifiers), then writing a name in the box does not qualify as a legally effective electronic signature. Qualtrics can be used to collect electronic signatures of participants that have a UVA NetBadge account if the study team requires that the participants login to NetBadge prior to electronically signing the consent. For instructions on how to place a NetBadge authentication step for participants prior to the consent form, please see the UVA Qualtrics FAQs website, under the Build and Share Surveys section, "How do I set up a NetBadge-authenticated survey?" or the steps outlined in the Qualtrics SSO authenticator webpage here.
Other frequently used applications for collecting electronic signature include DocuSign, REDCap, or AdobeSign. These applications have developed processes for collecting electronic signatures that are connected to individual’s identity and are often a good choice for documenting legally effective consent signatures electronically.
Ultimately, if your study requires that written consent be collected from participants and you plan to do the process electronically, then you will need to document how this will be accomplished within the protocol. It’s important to plan this process and confirm that the application the study team will use to collect electronic signatures is capable of collecting legally effective signatures, will appropriately respect participant privacy, and that the records of these electronically signed consent forms will be retained with the study documents for the duration of the required record retention period.
Review UVA’s standards for Data Security and Information Policy. All faculty, staff, and students at UVA have access to Qualtrics, and Board recognizes its validity for human subjects research (though it may not be adequate for collecting electronic signatures, see above). You are welcome to use other applications, but they must meet the same standards, and you must provide a basic explanation in the protocol about the program and what features the application has to keep participant data secure. Applications such as SurveyMonkey and Google Forms do not meet the level of security needed and should not be used for human subjects research.