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 informed consent document. The FDA does not dictate the specific language required for the informed consent document, but does require certain basic elements of consent be included.
Informed consent is a procedural process, not specific to REDCap. 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:
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.
2. Use branching logic within the instrument to show v2 fields
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