№ lp_1_2_21897
Checklist documenting regulatory determinations by an institutional review board regarding eligibility criteria for waiving written consent documentation in human subjects research.
Document type: Institutional Review Board checklist
Subject matter: Waiver of written documentation of informed consent
Regulatory framework: Human subjects research regulations
Related worksheet: Criteria for Approval (HRP-314)
Review procedures: Initial review, continuing review, modification, convened IRB review, expedited review
Applicability: Research involving waiver of written documentation of consent
Risk level referenced: Minimal Risk
FDA regulation status: Not FDA-regulated
Rule referenced: 2018 Rule
Issuing body: IRB Office
Responsible party: Designated Reviewer or convened IRB
Consent provisions: Oral consent script and written information requirements
Signature required: Yes
Price: 8 / 10 USD
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