Electronic Consent

Electronic informed consent (eIC) refers to the use of electronic processes and systems or information that is presented via computers, websites, smartphones, tablet.

Electronic informed consent procedures must meet the same regulatory and institutional requirements of an in-person paper-based informed consent process.

It must contain all elements of informed consent required by HHS regulations at 45 CFR 46.116.
If the research study is FDA regulated it must contain all elements of informed consent required by FDA regulations at 21 CFR 50.25.

Electronic Consent

For anonymous internet-based surveys, include I agree or I do not agree buttons on the website for participants to click or some other electronic method for indicating consent.
- For anonymous surveys sent to and returned by participants through email, include an information sheet with consent information and inform participants that submitting the completed survey implies their consent.
If the IRB determines that written consent is required, the consent form can be mailed or emailed to the participant who can then sign the form and return it via fax or postal mail.
If you are conducting web-based research you should be careful not to make guarantees of confidentiality or anonymity, as the security of online transmissions is not guaranteed.

A statement in the informed consent form indicating the limits to confidentiality is typically required.

The following statements may be used:

Your confidentiality will be maintained to the degree permitted by the technology used. Specifically, no guarantees can be made regarding the interception of data sent via the Internet by any third parties.”
Although every reasonable effort has been taken, confidentiality during actual Internet communications procedures cannot be guaranteed.

Institutional Review Board (IRB)

Electronic Consent

Electronic Consent