Alteration of Elements of Informed Consent (Option #2) Checklist
Alteration of Elements of Informed Consent (Option #2) Checklist: All conditions must be met:
Alteration of Elements of Informed Consent (Option #2): All conditions must be met:
(1) The research involves no more than minimal risk to the participants.
(2) The waiver or alteration does not adversely affect the rights and welfare of the participants.
(3) The research cannot practicably be carried out without the waiver or alteration.
(4) When appropriate, the participants will be provided with additional pertinent information after participation.
(5) The research is not FDA-regulated.