The Food and Drug Administration (FDA) believes that obtaining a research participant's verbal or written informed consent is only part of the process. Informed consent involves providing a potential participant with: adequate information to allow for an informed decision about participation in the clinical investigation.
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 for CFR Part 11 Validated Project. 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.
Version Control
When informed consent documents are updated, it is important to track new versions and use 1 of 2 options:
If using .png images of the consent document, add descriptive text field(s) with new version pages with variable names appended with _v2. Apply branching logic to show field depending on conditions.
If using inline descriptive text with the consent document information, simply copy the field, append _v2 to the new field, make edits where necessary, and apply branching logic to show field versions depending on conditions as shown above.
Copy the consent instrument, and rename it with the version number appended and suffix _v2 added to variables.
In the survey settings, make sure to edit the e-consent Framework fields to the new v2 variables added.
Finally, add form display logic for your consent instruments. In this example, if v1 is being used up to 12/10/2022, I will update the logic for both instruments to follow that.
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