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.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 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 REDCapattestation 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.
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