Importance of Secure eConsent Implementation

Importance of Secure eConsent Implementation

eConsent forms must be implemented in a way that meets applicable regulatory requirements for the study. This page focuses on the requirements outlined in the Personal Information Protection and Electronic Documents Act (PIPEDA).

Privacy Regulations and REDCap eConsent

Meeting the requirements of a secure electronic signature

Essential components for eConsent include:

Essential components for eConsent include:

An eConsent form must meet the following requirements:

  1. Unique Signature: The form should include a signature that is specific to the individual and can consist of letters, characters, numbers, or other symbols.

  2. Sole Control: The person should have sole control over attaching their signature to the form, ensuring that they have full authority over its inclusion.

  3. Person Identification: The form should clearly identify the person providing the consent, ensuring their identity is accurately recorded.

  4. Modification Detection: There should be a mechanism in place to determine if any modifications were made to the form after the signature was obtained, ensuring the integrity of the consent process.

What strategies can be implemented in REDCap to meet these requirements?

What strategies can be implemented in REDCap to meet these requirements?

To meet these requirements in REDCap, the following strategies can be implemented:

  1. Signature Field: Utilize a signature field or a text box field to capture the necessary information, such as name or initials, to serve as the unique signature.

  2. Read-Only Form: Mark the signature field with the @READONLY-FORM action tag, preventing it from being completed directly in REDCap. Instead, participants can complete the form in a separate survey.

  3. Linking the eConsent Form: Establish a connection between the eConsent form and the participant's record. This can be done by either including the form as part of the participant's record or using a study ID or other means of linking the two together.

  4. Enable the "e-Consent Framework + Auto-Archiver": Activate the "e-Consent Framework + Auto-Archiver" feature, which automatically captures a static copy of the form upon submission. This ensures that the consent form remains intact and unaltered for future reference.

By implementing these strategies in REDCap, you can meet the requirements for an eConsent process that includes a unique signature, maintains participant control over the signature attachment, accurately identifies the person, and allows for detection of any modifications made to the form after obtaining the signature.

Sending completed eConsent forms to participants

Email is not considered a secure means of communication and should not be used when sending identifying information.

If your eConsent form has a blank copy available for download (a good practice for allowing the use of accessibility or other tools), include a reminder that the participant should not email the form.

To send a participant a copy of their completed form, use one of the following methods:

To send a participant a copy of their completed form, use one of the following methods: