The Office of Quality Compliance sends a “Tip of the Month” directly to your email! Learn more and subscribe by going to their website at: https://qualitycompliance.research.utah.edu/tip-of-the-month.php.
This month’s tip: The informed consent process must be documented in the research record. The note should include the following details:
- Informed Consent Form (ICF) obtained voluntarily
- Participant consented in their primary language
- ICF signed before any research procedures were performed
- Date and time the discussion began
- Whether the participant had time to review the ICF and ask questions
- Who reviewed the ICF with the participant
- Date and time the consent was signed
- Confirmation that a copy was provided to the participant to take home
The informed consent process note template can serve as a helpful reminder of the key details to document at the time of consent.
Go to the OQC Toolkit for templates and more information: https://qualitycompliance.research.utah.edu/toolkit.php.