Electronic Informed Consent (eIC) is a method for obtaining written informed consent from prospective research participants using a computer-based consent form rather than traditional paper documentation. Participant's will 'sign' their consent electronically by typing their name AND date by using a stylus, mouse, or finger to "write" their signature on the form in a 'Signature' field type. The consent form is referred to as an Electronic Consent Form (eICF).
Electronic consent can be used for electronic signatures for HIPAA Authorizations. Standard eTemplates are required for obtaining eSignatures for HIPAA Authorizations.
Yes, electronic consent can be used for full board and expedited protocols to facilitate remote consent or electronic in-person consent. Other protocols that do not obtain a signed consent form but need a signed HIPAA Authorization can use the eTemplate for the standalone HIPAA Authorization (WVU OHRP e04).
Flex/exempt/NHSR can also use an electronic process to present the cover letter or informational sheet to participants.
An eTemplate is a standard file created using REDCap or Qualtrics for use at WVU. The standard eTemplates can be found in the library within REDCap and on the WVU OHRP website for Qualtrics. The eTemplates have a naming convention of OHRP-e01, etc. The eTemplates and the REDCap/Qualtrics survey settings cannot be changed without WVU IRB approval.
The WVU OHRP and WVU Research Office are working to provide a joint service for researchers for developing/understanding the eConsent process. If you have questions or want to schedule a help session, please submit a consultation request.
No.
WVU policy prohibits study teams from emailing eICFs. They are considered to include sensitive data.
The study team may:
WVU employees/students have access to Qualtrics by default. For access to REDCap, please visit WVCTSI's website.
Yes, both REDCap and Qualtrics support mobile devices. Consideration should be given the target audience as the screen size is small and the consent information may be difficult to see.
Both products offer online survey capabilities and data management capabilities.
REDCap was designed for research data management and has a built-in compliant eConsent framework that can provide PDFs of the signed forms and provides advanced capability for informed consent. WVU REDCap eConsent templates are HIPAA and FDA compliant.
Qualtrics is online survey software that has more survey features and fewer research-related data management features. Qualtrics cannot provide a compliant PDF of the consent form that is required by the federal regulations and institution. Qualtrics should only be used for research with a waiver of documentation of informed consent or non-covered entity research.
eConsent may be used to either supplement or replace paper-based informed consent processes to best address the prospective participants' needs. For example, some may prefer one method over another. Others may have difficulty navigating or using electronic systems because of, for example, a lack of familiarity with electronic systems, poor eyesight, or impaired motor skills.
It is important to consider the population and whether eConsent is a good option for the population. In some cases, the eIC process may not be appropriate. Also, if there are technical difficulties with the platform or internet connection, paper-based consent processes may be needed as a back-up.
For federally funded research, the paper-based option must be offered completely or partially throughout the informed consent process. Plan accordingly for this situation; if the prospective participant is remote, the paper-based option will delay signatures. The paper form cannot be scanned and emailed back; it must be mailed using postal mail.
During inspections of clinical investigation sites, access is required to records and reports made by the PI, including site-specific versions of the eICF, the materials submitted to IRBs for review and approval, all amendments to the site-specific eIC, and all participant-specific signed eICFs.
The information should be available at the site either in electronic or paper form. Federal OHRP reserves the right to review the content of the eIC program or informed consent documents and the corresponding informed consent of the Participant or the Participant's authorized representative and the signature of a witness, where applicable, along with the date that the eICF was signed. Updates to the documentation should also be available for review.
