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This full waiver of the consent process means that subjects will not be informed they're in a research study, will not be given the option to opt out of the research, and won't be given any of the other information commonly provided via a consent document.
A waiver of consent refers to cases where researchers are collecting data or tissue about people without their knowledge or consent.
A waiver of documentation removes the requirement of collecting signatures from the research participant. All of the required informed consent information is still provided to the participant but the documentation of the process (the actual signature) has been waived by the IRB.
The IRB can grant the waiver of alteration if it deems the following criteria are met: An adequate plan to destroy identifiers at the earliest opportunity absent a health or research justification or legal requirement to retain them.
Waiver of documentation of consent: Also known as a verbal consent or waiving a signed consent. The investigator obtains consent, and the consent process still has all the requirements as written consent, but the subject does not sign a consent form.