FDA Guidance: IRB Waiver, Alteration of Informed Consent
Scope:
- IRB waiving or altering informed consent requirements for certain minimal risk
clinical investigations - no objection to a sponsor initiating, or an investigator conducting, a minimal risk clinical investigation for which an IRB waives or alters informed consent requirements
- in accordance with 21st Century Cures Act
Waiver: Current Rule
- life-threatening situations
- emergency research
- ‘where it is not feasible or it is contrary to the best interest of such human
beings’
Waiver Revisions: Based on 21st Century Cures Act
- clinical investigation involves minimal risk (21 CFR 50.3(k), or 56.102(i))
- will not adversely affect the rights and welfare of the subjects
- clinical investigation could not practicably be carried out without the waiver
- subjects will be provided with additional pertinent information after participation
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