To facilitate research, REDCap has built in E-Consent Framework for getting consent signed remotely by sending a survey to participants which they can sign. The study personnel will then verify the info and countersign to produce a valid consent pdf document. Outlined below are the steps to create an E-Consent project.
Steps to create an E-Consent project
- Request the E-Consent project.
- Once approved, create the E-Consent instrument. First, last names and signatures are required fields for the e-consent framework. To cut down on resulting pdf size, consent body should be copied and pasted into a descriptive field instead of attaching the consent itself. A date field with actions for read only and current date should also be added to the E-Consent instrument: @READONLY @NOW
- Enable ‘Use surveys in this project’ under Project Setup and enable the E-Consent instrument as a survey within Online Designer
- Under ‘Survey settings’ next to the instrument within Online Designer, enable ‘Auto-Archiver + e-Consent Framework’ and map the corresponding fields for first name, last name and signature(please note signature field must be set to ‘required’ in order to show up for the mapping). If you would like to send your subject their signed copy of the consent form, choose ‘Yes’ for ‘Send confirmation email’. Complete the draft email and check the box for ‘Include PDF of completed survey as attachment’. Be sure to start the subject line with ‘#secure‘ (e.g. #secure Copy of your signed e-consent) so that the email is encrypted.
- Create a new instrument for countersigning the e-consent. This instrument should contain fields for the name and signature of the person countersigning the consent as well as any extra wording in a descriptive field.
- Create a new instrument with a file upload field for storing the merged E-Consent instrument and Countersign instrument.
- Request the ‘Multi Signature Consent’ external module to be added to the project and configure module as outlined in Multi Signature Consent.
- Test the project and check the File Repository for e-consent documents saved under ‘PDF Survey Archive’ as well as the file upload field.