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Version: 1
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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A central part of the informed consent process is the informed consent attestation 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:
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| title | 1. Use branching logic within the instrument |
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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.
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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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| title | 2. Create new instrument |
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Copy the consent instrument, and rename it with the version number appended and suffix _v2 added to variables.
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In the survey settings, make sure to edit the e-consent Framework fields to the new v2 variables added.
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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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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.
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