Electronic Consent


As with the standard consent process for written consent, the electronic consent process has two parts:

  1. Consent Discussion: Informing a participant using electronic means.
  2. 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. 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 IRB 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. 

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 must specifically note in the IRB application (Informed Consent Process Form) if they would like to request the IRB to grant a waiver of documentation of consent.

Electronic Consent Using a Consent Cover Letter or Information Sheet

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 OPRS to be exempt and not requiring documentation of participant consent. However, you will generally be required to provide participants with a “Cover Letter” or “Information Sheet” page 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 in the survey activity.

Researchers will often include a Consent Cover Letter 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. In these examples, the researcher is not collecting the name of the participant as specifically providing consent. 

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.

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