Conducting Research Online: Waiving the Requirement to Document Consent

The IRB can apply §46.117 of the Common Rule (Subpart A of 45 CFR 46) to waive the requirement for the documentation of informed consent when research takes places online, if the research presents no more than minimal risk to participants.

While researchers must still conduct a consent process, participants do not have to sign or type their names.

For example, consent processes for online surveys can close with instructions that tell participants to “click ‘Next’” if they agree to be in the research study. Similarly, emails soliciting participation in a Skype interview can close by informing participants to contact research team members to schedule an interview.

There are certain instances in which the IRB cannot apply the waiver for the requirement to document consent for research taking place online. Researchers asking students for access to educational records or are collecting identifiable, sensitive information that must be protected, must document consent. Documentation could be secured online via an authentication procedure, for example Duke Shibboleth, or an electronic signature verification function, such as provided by Qualtrics.

It is important that all informed consent processes, including online consent processes, include the Campus IRB protocol number that corresponds to the study. The Campus IRB protocol number is an 8-digit number that begins with a four-digit year followed by a four-digit number (for example: 2020-0100).