E-Consent

Consenting in REDCap requires using REDCap survey functionality. 

If the project is using REDCap for e-consent:

• The protocol should describe using REDCap for e-consent.
• Refer the wiki page: 2 - Regulatory Considerations & Preparing to Use REDCap (e-consent). 

Email Invitations

The protocol should describe using email to send survey invitations and reminders, including the following details:

• Specify the number of reminders that will be sent for each invitation
• Include the content of survey email invitation(s):
  • Subject line
  • Message
    • Describe plans to personalize the message by embedding any identifiable information.

Messaging to Participants

All participant facing messaging related to sending out surveys to participants and collecting their response should be submitted to IRB for approval. This includes:

• Survey title(s)
• Survey instructions
• Survey completion message(s)

Piping Identifiable Information into the Survey

Modifying a survey to pipe in participant identifiable information should be described in your protocol.

Save & Return on Surveys Collecting Identifiable Information

The protocol should describe the mechanism that's been enabled for Save & Return, and if Login has been enabled, how login has been configured, i.e. what information the participant would be required to enter to log in.

Using Twilio for Texting Survey Invitations

• The protocol should describe using Twilio to send survey invitations and reminders by SMS text message.
• The consent should describe using Twilio to send survey invitations and reminders by SMS text message.
  • Suggested language for the the consent: When the study team sends you a survey invitation or reminder by text message, your phone number will be shared with Twilio, Inc.. No other data will be shared.