Obtaining Consent

Obtaining written consent is a key step in the clinical research process. REDCap offers a digital method to acquire and store participant consent through e-Consent and PDF Auto-Archiver. Electronic-Consent (e-Consent) is a method for consenting research participants using a computer-based consent form rather than traditional paper documentation. REDCap has a feature that implements consent forms through an online survey which can be accessed on a computer, mobile phone, or tablet. Participants can ‘sign’ their consent by typing in their name or by using REDCap’s ‘Signature’ field type on the survey.

Please note that the signature process is NOT implemented by REDCap automatically; a survey must be constructed using one of these two methods in order to capture a signature. The University of Manchester Research Governance, Ethics and Integrity Office has approved the use of the REDCap e-consent framework to obtain and store legally valid electronic consent signatures, please note:

• e-Consent and research surveys are segregated in REDCap

• e-Consents are stored in REDCap as PDFs

• e-Consents cannot be linked to the backend database within REDCap If using other electronic formats (e.g. Qualtrics survey) to record the consent, you still must include all of the consent statements that you would for a traditional paper form. You must also include:

• The data protection statement

• A place for the participant to type their full name

• A place for the date

• If socially or personally sensitive data is being collected, you must include the identity declaration (see the consent form template  for exact wording)