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:
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When informed consent documents are updated, it is important to track new versions and use 1 of 2 options:
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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.  |
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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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