Quick Links: Electronic Informed Consent
Overview of the eIC Process and Expectations
The use of eConsent for research is supported by the Office of Human Research Protections (OHRP) and the Food and Drug Administration (FDA), with the understanding that an eConsent process must fulfill all the usual requirements for informed consent. A HIPAA Authorization may also be obtained electronically. WVU OHRP has created the templates listed below to assist researchers in meeting and maintaining compliance with applicable regulatory requirements.
An eConsent process must satisfy all the usual requirements for informed consent for research.
| OHRP | Participant must receive a signed copy of the consent document.
|
| FDA | Participant must receive a signed copy of the consent document. The investigator
is responsible for obtaining legally effective informed consent. Must be
21 CFR Part 11 compliant.
|
| HIPAA | Participant must receive a copy of the signed authorization. Must use a HIPAA-compliant
system.
|
| GCP | Participant should receive a signed copy of the consent document with
both his/her signature (or LARs) with the date and the signature with the
date of the person who conducted the informed consent process.
|
Study teams utilizing eConsent must thoroughly test the eConsent process, even when using the available templates. The study team should understand their role in the consent process as well as understand the experience of the participant. This will allow the study team to assist participants during the consent process and address any questions/concerns the participants may have.
The WVU OHRP/IRB expects principal investigators and study teams to understand the eConsent process and be able to execute their consent process independently. WVU OHRP has resources for eConsent and can provide assistance. However, as with any other research procedure, the PI is ultimately responsible for the conduct of the study and ensuring study staff members have been trained appropriately.
As with any human subjects research project, the eConsent process is more than the document. Study teams must give careful consideration to how the consent will be presented, how participants’ understanding will be evaluated, how participants’ questions and concerns will be addressed, etc.