Validated Projects, part 2: Informed Consent

Version: 1

To make an informed decision about whether to participate or not in a clinical trial, participants need to be informed about:

• what will be done to them,

• how the protocol (plan of research) works,

• what risks or discomforts they may experience,

• participation being a voluntary decision on their part.

This information is provided to potential participants through the informed consent process.  Informed consent means that the purpose of the research is explained to them, including what their role would be and how the trial will work. 

A central part of the informed consent process is the attestation document. The University of Utah IRB requirements for informed consent are met by using the eConsent survey(s) and Attestation data entry instrument in the eConsent REDCap Template. The purpose of the attestation instrument is to document that the research team has given the participant every opportunity to understand and make an informed decision before signing the consent document, and verify the individual who is attesting the participant’s signature.

Operational aspects of informed consent can be captured in REDCap to meet part 11 compliance. For more information, see U of U policies or the FDA website.