Wake Forest School of Medicine now has a Part 11 compliant electronic informed consent (eConsent) option for research.
We currently have a limited number of user licenses, so we are prioritizing its use to include only treatment studies that are enrolling patients who are critically ill, such as those with severe COVID-19 or other life threatening conditions rendering them unable to provide informed consent.
In those cases, Legally Authorized Representatives (persons who are allowed by law to make medical decisions on behalf of the patient) will be contacted by phone for the consent discussion and they may sign the consent document from any computer or mobile device.
Please contact us if you have questions about the eConsent option or if you want to know if your study is eligible.
|Joseph Andrews, PhD
Assistant Dean for Regulatory Affairs and Research Integrity