The Office for the Protection of Human Subjects at Children's National Hospital and the CTSI-CN REDCap team are pleased to announce that Phase 2 of e-consent using the REDCap platform is now live. Phase 1, launched in July 2020, made it possible to add REDCap remote consenting to IRB-approved studies by uploading existing consent/parental permission forms to the platform and submitting an amendment to the IRB. Now, in Phase 2, investigators submitting new non-FDA regulated studies can create consent/parental permission forms directly in REDCap for e-consent. This will save investigators time and has the added advantage providing of document versioning. Both REDCap e-consent methods enable study teams to electronically obtain and document permission from two parents when required by the IRB, even if they reside in different households.
Detailed instructions for using REDCap e-consent for both existing (IRB-approved) and new studies are available to assist you, as well as a series of REDCap e-consent FAQs. Please note that the instructions for IRB-approved studies have been revised. Do not refer to older versions of this document.
- REDCap e-Consent Guidance (Updated 11/17/20)
- REDCap e-Consent Instructions for Existing, IRB-Approved Studies
- REDCap e-Consent Instructions for New Studies
FAQs and instructions are also available in the Guidance Documents section of the IRBear Home page and in the REDCap template under the "Researcher Instructions."
In addition to using REDCap, there are a number of other ways to obtain informed consent/parental permission without being in face-to-face contact with subjects or their families.
Please see the Remote Informed Consent FAQs to help you determine which method(s) may be most appropriate for your study.
REDCap Resources: Information and Obtaining Account Login
Reminder: To create projects and receive full access in REDCap, you will need to complete the required new REDCap 101 Online Training. In-person training has been suspended because of COVID-19.
Questions? Please contact the Office for the Protection of Human Subjects at Children's National Hospital, 301-565-8447 or OPHS@childrensnational.org