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Waiving the Requirement for a Signed Consent Form - University - compliance vpr okstate

Waiving the Requirement for a Signed Consent Form - University - compliance vpr okstate 2025

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The document discusses the ethical requirement of informed consent in human research, emphasizing that while signed consent forms are standard, they may be waived under certain conditions by the Institutional Review Board (IRB). These conditions include risks associated with confidentiality breaches or minimal risk research procedures. Researchers must still ensure voluntary informed consent through alternative methods, such as information sheets or oral scripts, which require IRB review. The document advises consulting with the IRB chair regarding these exceptions.

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We have answers to the most popular questions from our customers. If you can't find an answer to your question, please contact us.

Can informed consent be waived?

While FDA regulations currently do not permit a waiver or alteration of consent for FDA-regulated clinical investigations, FDA guidance allows IRBs to waive or alter the informed consent requirements for minimal risk clinical investigations using the Common Rule criteria.

What is the criteria for waiver of documentation of consent?

A criterion is a standard for judging something. If you are holding a cupcake competition, your number one criterion might be the smoothness of frosting. A criterion is a category for judging, but can also be a prerequisite for an achievement.

Can the requirement for informed consent be waived?

An IRB may waive the requirement for informed consent under specific conditions. Paramount to this is the minimal risk to the research participants.

What are the requirements for waiver of consent?

However, an IRB may approve a consent or parental permission procedure that does not include, or that alters, some or all of the elements of informed consent, or may waive the requirements to obtain informed consent (45 CFR 46.116(c) or (d)).

Are there exceptions to the requirement to obtain informed consent?

Four findings must be determined by the IRB before any or all of the elements may be waived. The research involves no more than minimal risk to the subjects. The waiver will not adversely affect the rights and welfare of the subject. The research could not be practicably carried out without a waiver or alteration.

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