As with the basic consent scenario, electronic consent has two parts—first, informing a participant using electronic means and second, documenting consent using an electronic signature. For exempt studies or studies where the Board waives documenting consent, researchers are not required to document consent and there is more flexibility about how you can present the consent information to a participant; see “Electronic Study Information Page” below. Non-exempt studies (expedited and full board review studies) require researchers to document consent; it is important to understand what constitutes an acceptable electronic signature and which applications have an adequate level of data security for documenting consent and protecting participant confidentiality.
If your study qualifies for exemption or if the Board allows you to waive documenting consent, you will not be required to document a signature. For example, an anonymous online surveys is usually exempt and does not require documentation of participant consent. However, even though you are not required to document consent, the Board requires that you provide participants with an “electronic study information” page that covers the same topics address in the general consent form. In most cases, this information is provided to the participants as part of the online survey as the first page that they see before engaging the survey activity.
Often at the end of an electronic study notification, researchers will include an “I agree” button indicating that the participant agrees with the electronic study notification before they proceed with the survey. As mentioned in “Electronic Signatures” having the participant select an “I agree” button would not constitute documentation of consent if the study is anonymous. From the Board’s perspective, this step is not necessary but it is not restricted either if it makes sense from a process perspective. Instead of making the participant click “I agree” to move forward, consider providing participants with a “continue” button to move them onto the next step in the process. In addition, you will need to provide participants with instructions on how to access a copy of the electronic study notification; for example, you could instruct participants to print the screen to retain a copy of the study information. Look for the “Electronic Study Information Page” template in the Consent Templates page (under the “Consent or Notification (no signature required)” header) as an example of how to provide an electronic study notification to participants.
Unless your study qualifies for exemption or the Board allows you to waive consent documentation, you will be required to document consent. If you plan to use an electronic consent process, you will need to demonstrate in your protocol how the process will work and provide a copy of the electronic consent form. An electronic consent form differs from a paper consent form and you will need to do the following:
- Provide participants with a way to access a copy of the consent form. 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 a verifiable electronic signature.
- Document the participant’s agreement to participant in the study and their agreement to provide electronic consent (two separate consent fields).
An electronic consent form needs to cover all of the required consent information as provided in the Electronic Consent Template (see Consent Templates under the “Consent or Assent (Signatures Required)” header). In general, the Board expects you to adapt the consent process to the online format in a way that makes sense for participants and helps them to understand the information provided.
According to federal and state law, an electronic signature is a digital act that demonstrates consent. A digital act could be writing a signature on a digital screen, clicking an “I agree” button, voicing consent on a digital recording, submitting a picture of a signed document, or a myriad of other possibilities. To be enforceable, the electronic signature needs to be attributable to a verified identity.*
For example, a participant marking “I agree” in an anonymous survey would not constitute an enforceable electronic signature because it cannot be attributable to a specific individual. Anonymous surveys usually qualify for exemption, however, in which case a signature would not be required (see “Electronic Study Notification”).
If you are conducting a study that requires you to document consent, you must ensure that participants’ electronic consent can be traced to their verified identity. For example, if a participant logs into a survey with a Netbadge account and then selects “I agree,” their electronic act of consent is connected to a verified identification (their UVA Netbadge account) and meets the definition of electronic consent. In another example, if a participant engages with the researcher using Zoom and indicates their consent prior to the interaction (and the consent is recorded), it can be considered an acceptable electronic signature. However, a signature on a screen, when it is not attached to a verified account, does not count as an electronic signature. For example, Qualtrics allows you to add a “signature question” which allows the user to handwrite a name in the box. However, if the name is not attached to a verified account, it does not qualify as an acceptable electronic signature. Applications such as DocuSign or AdobeSign have a process in place for collecting signatures that are connected to individual’s identity and would be the more appropriate choice for documenting consent electronically.
If your study requires that you document consent and you plan to do the process electronically, you will need to demonstrate that the application you will use is capable of collecting and retaining a record of proper electronic signatures and that the process will keep participant identities secure and confidential. You must also 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, as long as it is conspicuously displayed and separately agreed to (e.g., with its own “I agree” button). For an example, see the Electronic Consent Template (see the Consent Templates page under the “Consent or Assent (signature required)” header).
*Please note that the above description only applies to 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 country’s laws regarding what constitute a legal signature.
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 “Electronic Signatures”). Researchers are welcome to use other applications but they must meet the same standards, and it is recommended that you 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.