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Purpose
- These templates are intended to assist in documenting the consent discussion and process with potential participants. There are many ways to document the informed consent process.
- Below are several examples that can be customized to meet your specific study needs/requirements (study populations, optional items etc.).
Best Practice Considerations
- Documentation of the consent/assent process should be completed as a source document at time of consent.
- This process should be used throughout the life of the study.
- It is best to file this type of documentation with the associated consent/assent document.
Verbal Consent
- Verbal Consent is used only in studies with an IRB-approved waiver of documentation of consent (no written signature required).
Consent Using LAR/PG
Templates
